<b>Bijsluiter</b>. De hyperlink naar het originele document werkt niet meer. Daarom laat Woogle de tekst zien die in dat document stond. Deze tekst kan vreemde foutieve woorden of zinnen bevatten en de opmaak kan verdwenen of veranderd zijn. Dit komt door het zwartlakken van vertrouwelijke informatie of doordat de tekst niet digitaal beschikbaar was en dus ingescand en vervolgens via OCR weer ingelezen is. Voor het originele document, neem contact op met de Woo-contactpersoon van het bestuursorgaan.<br><br>====================================================================== Pagina 1 ======================================================================

<pre>Tellurium and tellurium compounds
(excluding TeF6)
Health-based Reassessment of Administrative
Occupational Exposure Limits
Committee on Updating of Occupational Exposure Limits,
a committee of the Health Council of the Netherlands
No. 2000/15OSH/055, The Hague, 31 October 2002
</pre>

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<pre>Preferred citation:
Health Council of the Netherlands: Committee on Updating of Occupational
Exposure Limits. Tellurium and tellurium compounds (excluding TeF6);
Health-based Reassessment of Administrative Occupational Exposure Limits.
The Hague: Health Council of the Netherlands, 2002; 2000/15OSH/055.
all rights reserved
</pre>

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<pre>1     Introduction
      The present document contains the assessment of the health hazard of tellurium
      and its compounds, except for tellurium hexafluoride, by the Committee on
      Updating of Occupational Exposure Limits, a committee of the Health Council
      of the Netherlands. The first draft of this document was prepared by MA
      Maclaine Pont, M.Sc. (Wageningen University, Wageningen, the Netherlands).
           The evaluation of the toxicity of tellurium and its compounds has been
      based on the review by the American Conference of Governmental Industrial
      Hygienists (ACG99). Where relevant, the original publications were reviewed
      and evaluated as will be indicated in the text. In addition, literature was
      retrieved from the data bases Toxline, Medline, and Chemical Abstracts,
      covering the periods of 1981 to April 1999, 1966 to May 1999, and 1937 to
      April 1999, respectively*. The final literature search was carried out in May
      1999.
           The literature search focused on those tellurium compounds of which some
      information could be found in either the Dictionary of chemical names and
      synonyms (How92) or in the CRC Handbook of chemistry and physics (Lid96);
      for dimethyltelluride and diethyltelluride a separate search was performed.
           In September 2001, the President of the Health Council released a draft of
      the document for public review. The committee received no comments.
2     Identity
      Forty-two isotopes of tellurium are known with atomic masses ranging from
      106 to 138; natural Te exists of eight isotopes (mainly 130Te, 128Te, and 126Te).
      The half-life times of the unstable isotopes range from 0.06 milliseconds to 1.3
      x 1013 years (Lid96).
*     The following key words were used: tellurium, telluride, methyltelluride, tellurobismethane, ethyltelluride,
      tellurobisethane, hydrogen telluride, and the CAS numbers 593-80-6, 627-54-3, 7446-07-3, 7783-09-7,
      7789-54-0, 7790-48-9, 7803-68-1, 10025-71-5, 10026-07-0, 10031-27-3, 10049-23-7, 10102-20-2, 13451-18-8,
      13494-80-9, 13845-35-7, 15192-26-4 and 20941-65-5. Health effects from radiation were excluded.
055-3 Tellurium and tellurium compounds (excluding TeF6)
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<pre>      The following data have been found:
      name                              molecular  synonyms                          CAS number
                                        formula
      ethane, tellurobis-               Te(C2H5)2  diethyltelluride;                 627-54-3
                                                   diethyltellurium; ethyltelluride
      hydrogen telluride                H2Te       hydrogen tellurite                7783-09-7
      methane, tellurobis-              Te(CH3)2   dimethyltelluride;                593-80-6
                                                   dimethyltellurium;
                                                   methyltelluride
      telluric (VI) acid                H6TeO6                                       7803-68-1
      telluric acid                     H2TeO3     tellurous acid                    10049-23-7
      telluric acid, disodium salt      H2O3Te.2Na sodium tellurate; sodium          10102-20-2
                                                   tellurate (IV); sodium tellurite;
                                                   tellurous acid, disodium salt
      telluric acid, lead (2+) salt 1:1 H2O4Te.Pb  lead tellurate; lead tellurite    13845-35-7
      tellurium                         Te         aurum paradoxum; metallum         13494-80-9
                                                   problematum; telloy
      tellurium dibromide               TeBr2      tellurium bromide                 7789-54-0
      tellurium dichloride              TeCl2      tellurium chloride                10025-71-5
      tellurium dioxide                 TeO2                                         7446-07-3
      tellurium tetrabromide            TeBr4                                        10031-27-3
      tellurium tetrachloride           TeCl4      telluric chloride; tellurium      10026-07-0
                                                   chloride; tellurium chloride
                                                   (T-4)-; tetrachlorotellurium
      tellurium tetrafluoride           TeF4                                         15192-26-4
      tellurium tetraiodide             TeI4                                         7790-48-9
      tellurium trioxide                TeO3                                         13451-18-8
055-4 Health-based Recommended Occupational Exposure Limits
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<pre>3            Physical and chemical properties
Physical and chemical properties of tellurium and some of its compounds.
name            physical form                mol.          solubility in melting    boiling point   vapour       odour
                                             weight        water         point                      pressure     threshold
Te(C2H5)2                                    185.72
                             c
H2Te            unstable gas                 129.62        soluble       -49°C      -2°C
                                                                                                                 a
Te(CH3)2        liquid                       157.67                      -10°C      91-92°C
H6TeO6          white monoclinic crystals    229.64        soluble       136°C      -
H2TeO3          white crystals               177.61        slightly      decomp.    -
                                                                         40°C
                                                                                                                 b
H2O3Te.2Na                                   223.59
Te              gray-white rhombohedral      127.6         insoluble     449.5°C    988°C           at 520°C:
                crystals                                                                            0.13 kPa
TeBr2           green-brown hygroscopic      287.41        reacts        210°C      339°C
                crystals
TeCl2           black amorphous              198.51        reacts        208°C      328°C
                hygroscopic solid
TeO2            white orthorhombic           159.6         insoluble     733°C      1245°C                       0.003 mg/m3
                crystals
TeBr4           yellow-orange monoclinic     447.22        reacts        388°C      ±420°C,
                crystals                                                            decomposes
TeCl4           white monoclinic             269.41        reacts        224°C      387°C           at 253°C:
                hygroscopic crystals                                                                2.66 kPa
TeF4            colourless crystals          203.59        reacts        129°C      195°C,
                                                                                    decomposes
TeI4            black orthorhombic           635.22        reacts        280°C      -
                crystals
TeO3            yellow-orange crystals       175.6         insoluble     430°C      -
a
      Measured in waste water, after biological treatment: approximately 0.15 mg Te/kg organic sludge (Dij88).
b
      Taste threshold in water: 10 mg/L (Len67).
c
      The lower ignition limit is lower than 10 kPa; it decomposes with the evolution of 23.83 kcal/mol of heat into H2 and
      Te (Mik77).
Data from Ano94, Lid96, Yak74.
             Conversion factors for dimethyltelluride (20oC, 101.3 kPa) are: 1 ppm = 6.56
             mg/m3; 1 mg/m3 = 0.15 ppm and for hydrogen telluride (20oC, 101.3 kPa): 1
             ppm = 5.40 mg/m3 ; 1 mg/m3 = 0.19 ppm. For the other compounds conversion
             factors are not applicable.
055-5        Tellurium and tellurium compounds (excluding TeF6)
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<pre>           Further, no flash points, explosion limits, and log Poctanol/water values were
      found.
      Elemental tellurium will burn slowly in air; a finely divided suspension in air
      can explode. Reactions with zinc, chlorine, fluorine, and solid sodium are
      vigorous and have a potential to cause fires (Bel94). Tellurium alkyls are
      normally inert in air or in contact with water at room temperature. They form
      tellurium dioxide as the final product of oxidation or combustion. They also
      undergo slow oxidation in the presence of water or moisture to form
      alkylhydroxytellurium derivatives, which are not well characterised (Roy93).
4     Uses
      Elemental tellurium is used as an additive to copper, iron, and steel, in
      vulcanising rubber, as a colouring agent in glass and ceramics, and in some
      other applications (ACG99, Bud96). Certain telluride alloys are employed in the
      semiconductor industry (ACG99). Tellurium tetrachloride is used as a catalyst
      in several condensation reactions. Tellurium dioxide is used in acousto-optical
      filters in astronomy and in lasers, as a catalyst in oxidation reactions, in
      electroconductivity devices, as an additive in glass, in optical and photoacoustic
      devices. Tellurium trioxide is used as a catalyst in oxidation reactions (12th
      Collective Index of Chemical Abstracts: 12CI).
5     Biotransformation and kinetics
      Elemental tellurium is only slowly metabolised, and it is eliminated as
      dimethyltelluride in urine, sweat, and expired air (ACG99). The proof for the
      formation of dimethyltelluride in man or laboratory animals was not given. In
      the literature, one study from 1884 was found that deals with this issue (Tay97).
      However, the formation of dimethyltelluride by bacteria (P. fluorescens) and
      fungi (A. falciforme and P. citrinum) has been proven after growth in the
      presence of potassium tellurite (K2TeO3) (Cha90). In humans, the formation of
      dimethyltelluride is probably reduced by the intake of ascorbic acid (DeM47a)
      and by 2,3-dimercaptopropanol (BAL = British Anti Lewisite) (Amd47).
      However, others report that BAL is not effective, and that Te induces kidney
      and liver toxicity (Amd58 in Ein84).
           The daily intake for man is estimated to be 0.6 mg, with an oral absorption
      of 25% and a half-life time of 3 weeks. The body burden is approximately 0.12
055-6 Health-based Recommended Occupational Exposure Limits
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<pre>      ppm (mainly in the bones). The losses for a reference man are: 83% via the
      urine, 15.6% via the faeces, and 1.6% in exhaled air (Sca92).
          In a group of workers who were occupationally exposed to Te and TeO2
      fumes, the urinary concentration was measured: heavy exposure (0.1-0.29 mg
      Te/m3): 9/22 samples contained 0.02-0.03 mg Te/L; moderate exposure
      (0.05-0.09 mg Te/m3): 18/30 samples contained 0.01-0.02 mg Te/L; light
      exposure (0.01-0.05 mg Te/m3): 33/46 samples contained < 0.01 mg Te/L; the
      control group (n=26) had no Te in the urine (Ste42).
          After an oral dose of a Te compound, human volunteers showed an
      intestinal absorption of 25 ± 10% for soluble tellurium salts. The renal tellurium
      excretion was faster after administration of hexavalent tellurium than after
      ingestion of the tetravalent form. The introduction of Te to cress (the water
      plant Lepidium sativum L.) lowered the intestinal absorption to approximately
      15%. For metallic Te, the fractional intestinal absorption was found to be about
      10% (Kro91b).
      Animal data are summarised in Table 1.
      The estimated biological half-life times for the major retention sites of tellurium
      in rats were estimated to be about 9 days in blood, 10 days in liver, 17 days in
      muscles, 23 days in kidneys, and 600 days in bones (Fis91).
      Summarising, the kinetics of tellurium-compounds after intravenous injection
      and after oral dosing differ. After intravenous injection, a higher percentage of
      the dose is found in the liver and the kidneys than after oral dosing. A lower
      percentage can be found in blood, spleen, and brain. Exhalation comprises a
      small part of the excretion: 0.1-7% of the intravenously injected dose (DeM47b,
      Kor65, Mos60, Sca92). After oral dosing, tellurium is absorbed from the
      intestines to a maximum of 25%; it is excreted mainly via the faeces. After
      intravenous injection in rats, Te excretion is higher via the urine than via the
      faeces. After intravenous injection, a half-life time for Te clearance from the
      body of rats is calculated to be 6 days (Kor65).
055-7 Tellurium and tellurium compounds (excluding TeF6)
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<pre>Table 1 Summary of experimental animal toxicokinetic data.
animal   Te compound dosing regimen      results                                                               reference
species
         127
rat          TeCl4,   intratracheal;     88% was removed from the lungs in the first 24 h; 60% was still       Dob70
(white)  3 µCi        dose(s) not given retained in the body after 7 days.
         132
rat          TeCl4,   iv, single;        6 h after injection: 20% in the liver; 8.2% in the bones; 7.3% in the Kor65
         3.2 µCi      dose(s) not given kidneys; 2.2% in the lungs; 0.7% in the spleen, 0.4% in the brain; t½:
                                         for Te clearance from the body: 6 days.
rat      Te           iv, single;        distribution in the body: 24.2% in bones; 16.4% in liver, 10% in      Mos60
                      dose(s) not given blood, 10% in muscles, 10% in skin, 7% in lungs, 5.8% in kidneys.
rat      Te           oral, single;      20-25% absorbed via the intestines; 0.55% in kidneys; 0.35% in        Mos60
                      dose(s) not given blood; 0.4% in liver; 6.2 % in spleen; 70-75% of the excreted
                                         quantity was via the faeces; within 16 days, 15% of the amount
                                         administered was excreted.
         127
rat          Te       iv, single;        distribution: 18.6% in blood, 11.9% in muscles; 9.7% in liver; 8.6%   Mos64
                      dose(s) not given in skeleton; 2.5% in kidneys.
         127
rat          Te       oral, single;      10-25% absorbed via the intestines; of that fraction, 1.2%            Mos64
                      dose(s) not given accumulated in muscles, 0.4% in liver, 0.4% in skeleton, 0.2% in
                                         kidneys.
         127
rat          Te       oral, single;      distribution: blood, kidneys>spleen, liver, lungs>heart, adrenal      San63
                      dose(s) not given glands>muscles, brain; 79% was excreted via the faeces, 2.7% via the
                                         urine
rat      Te,          iv, single ;       33% was excreted via the urine in the first week and ca. 14% via the  Slo70a
         radioactive  dose(s) not given faeces; in the first 24 h, >14% was excreted, in subsequent days
                                         2-3%; the highest concentrations were found in kidneys, liver, bone,
                                         and thyroid gland.
rat      Na2127TeO3   oral, single;      ca. 25% was absorbed via the intestines; in the first week ca. 65%    Slo70b
                      dose(s) not given was excreted via the faeces; ca. 9% was excreted via the urine.
rabbit   Na2TeO3      iv, single: 0.18   fractional intestinal absorption: 40%.                                Kro91a
                      mg Te; oral,
                      single: 2.5 mg
                      Te
055-8        Health-based Recommended Occupational Exposure Limits
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<pre> Table 1 Continued.
 animal       Te compound     dosing regimen              results                                                  reference
 species
 rabbit, rat, Na2TeO3         iv, single: 0.1 - 0.5 mg    in the first 24 h: <0.1% was exhaled; the largest        DeM47b
 dog                          Te/kg bw                    concentration was found in kidneys; in heart, lungs,
                                                          and spleen, concentration was from 1/3 to 1/10 of that
                                                          of kidneys, but 1.5 to 2 times as much as that of liver;
                                                          in 5-6 days, 20% of the amount injected was excreted
 rabbit, rat, Na2TeO3         oral, single;               3.3% excreted within 6 d                                 DeM47b
 dog                          dose(s) not given
 piglet       Te, radio-      dermal, single;             within 15 min, ca. 5% of the activity could be detected Nor68
              active in ionic dose(s) not given           deeper than 30 µm; there was no difference in
              or colloidal                                penetration among 7 different isotopes used
              form
 rat,         Te              oral, feed, 35 d;           on the 2nd day: Te in cytoplasm of Schwann cells         Duc79
 15-day                       dose(s) not given
 old
 rat          K2TeO3          ip; 112 d                   accumulation of Te in the cerebellum                     Wal78
                              2 mg/kg bw (i.e., ca. 0.95
                              mg Te/kg bw/d
 rat, male    TeCl4           oral, drinking water, 35 d; concentration in blood: 45 nmol/g; liver: 5.7 nmol/g;    Val85
                              total ingested dose: 1025 ± kidneys: 2.7 nmol/g; brain: 3.1 nmol/g
                              115 mmol Te/kg bw (131
                              mg Te/kg bw)
6              Effects and mechanism of action
               Human data
               In a group of 62 men, who were examined after 15 and 22 months of
               occupational exposure, the order of frequency of occurrence of symptoms were:
               garlic odour of the breath, dryness of the mouth, metallic taste, somnolence,
               garlic odour of the sweat. The odour can remain for months. Its intensity was
               directly related to the exposure concentration. There was no evidence of Te
               intoxication (Ste42).
                    The minimum amount of Te in Na2TeO3 required to cause garlic breath
               varied from 1 to 50 µg per person as a single oral dose (DeM47a).
055-9          Tellurium and tellurium compounds (excluding TeF6)
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<pre>            Animal data
            Acute toxicity data of tellurium and compounds are summarised in Table 2.
Table 2 Acute toxicity data of tellurium and compounds.
animal species  Te compound          dosing regimen            results                                            reference
rat             Te                   oral                      LD50: 83 mg/kg bw                                  Lew92
mouse           Te                   oral                      LD50: 20 mg/kg bw                                  Lew92
rabbit          Te                   oral                      LD50: 67 mg/kg bw                                  Lew92
guinea pig      Te                   oral                      LD50: 45 mg/kg bw                                  Lew92
                                                                               3
rat, female     Te(C2H5)2            inhalation (no further    LC50: 55 mg/m                                      Koz81
rat, male                            details)                  LC50: 54.1 mg/m3
guinea pig                                                     LC50: 45.1 mg/m3
mouse                                                          LC50: 154.0 mg/m3
rat             Na2TeO3              oral                      LD75: 2.25-2.50 mg/kg bw                           Fra36
rat             Na2TeO4              oral                      LD75: 20.0-30.0 mg/kg bw                           Fra36
rat             Te or TeO2           intratracheal, single     after 180 days: no progressive fibrosis            Gea78
                                     dose; sufficient to cause
                                     observable stress
rabbit          Na2TeO3              iv, single;               garlic breath; administration of ascorbic acid     DeM47a
                                     50 µg Te/kg bw            reduces Te in expired air to 20 or 25% of control
                                     iv, single;               garlic breath
                Te                   20-30 mg Te/kg bw
rabbit          H6O6Te               iv, single                LDlo: 5.6 mg/kg bw                                 Lew92
rat             H6O6Te               iv, single                LDlo: 31 mg/kg bw                                  Lew92
rabbit          H6O6Te               oral, single              LDlo: 56 mg/kg bw                                  Lew92
mouse           Na2TeO3              sc, single;               decrease in body temp; increase in gastric content Wat90
                                     1.28 mg Te/kg bw
055-10      Health-based Recommended Occupational Exposure Limits
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<pre>               The data on toxicity of tellurium and compounds following repeated exposure
               are summarised in Table 3.
Table 3 Toxicity data of tellurium and compounds following repeated exposure.
animal species Te           dosing regimen            results                                                       reference
                  compound
rat               Te, TeO2  inhalation, 2 h/d, 13-15  in both cases: 100 mg/m3 is approx. LD50; weight loss;        San63
                            w;                        irritation of the respiratory tract; loss of fur; haemolysis
                            differently dispersible
                            aerosols 10-100 mg/m3
rat, guinea       Te(C2H5)2 inhalation, chronic (no   dermatitis; weight loss; effects on liver enzymes, serum      Koz81
pig, mouse                  further data);            proteins, CNS; haemolytic effects; effects on liver,
                            1 mg/m3 (i.e., 0.69 mg    kidneys, heart, and other organs
                            Te/m3)
rat, less than    Te        oral, feed, 1-8 d;        demyelination of sciatic nerves; oedema of nerves;            Lam70
3-week old                  dose(s) not given         vacuolar degeneration of Schwann cells; recovery
                                                      occurred despite continued ingestion of Te
rat, 3-week       Te        oral, feed, several days; on day 2 and 3: paresis of the hind legs, most severe at      Tak77
old                         10,000 ppm (i.e., ca. 500 day 7, recovery by day 10; demyelination; vacuolar
                            mg Te/kg bw/d)            degeneration of Schwann cells
rat, 11-week      Te        idem                      no effects                                                    Tak77
old
rat, 3-4-week     Te        oral, feed, several days; on day 6 and 7: paresis; degeneration of Schwann cells        Ham 86
old                         12,500 ppm (i.e., ca. 625
                            mg Te/kg bw/d)
rat (white)       Te        oral, feed (period        at 1500 ppm: some effect on growth; no pathological           DeM46
                            unkown); 375, 750, 1500   effects; at all dose levels: garlic-like breath within 24-72
                            ppm (i.e., ca. 19, 38 and h, disappearing 1-2 days after discontinuation of
                            75 mg Te/kg bw/d)         treatment
rat (white)       TeO2      oral, feed, 26 d;         at 1500 ppm: rats died; at other dose levels: no growth;      DeM48
                            375, 750,1500 ppm as Te   loss of hair; redness and oedema of the digits; temporary
                            (i.e., ca. 19, 38, 75 mg  paralysis of hind legs; oligouria or anuria; necrosis of
                            Te/kg bw/d)               liver and kidneys
rat, 15-day       Te        oral, feed, 35 d;         within 24 h: demyelination of sciatic nerve; on day 3:        Duc79
old                         dose(s) not given         paralysis of the hind legs lasting 7-10 days; after 7 days or
                                                      more: decreased motor nerve conduction velocity;
                                                      recovery of paralysis and demyelination
pig, weanling TeCl4         oral, feed, 10 wk;        necrosis of cardiac and skeletal muscle in 50-65% of the      Vle81
                            500 ppm                   pigs; decrease in blood GSH activity
055-11         Tellurium and tellurium compounds (excluding TeF6)
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<pre>Table 3 Continued.
animal species Te            dosing regimen                     results
                  compound
rat               Te         oral, feed, 5 mo;                  impaired learning ability even after discontinuation for 3
                             3300 ppm (i.e., ca. 165 mg Te/kg months
                             bw/d
rat, rabbit       Na2TeO3    oral, 7 mo;                        reduced catalase activity, sulfhydryl, and ascorbic acid
                             0.005 mg/kg bw/d (i.e., ca.        concentrations; altered conditioned reflexes and brain
                             0.00285 mg Te/kg bw/d)             morphology
rat, rabbit       Na2TeO3    oral, 6 mo;                        no effects
                             0.0005 mg/kg bw/d (i.e., ca.
                             0.00028 mg Te/kg bw/d)
rat (n = 50),     Na2TeO3    oral, 7 mo;                        necrosis of liver and intestines; effects on CNS; altered brain
rabbit (n = 25)              0.005, 0.05, 0.5 mg/kg bw/d (i.e., morphology
                             ca. 0.00285-0.28 mg Te/kg bw/d)
rat, rabbit       Na2TeO4    oral (period unkown);              necrosis of liver and intestines
                             1, 10, 25, 50 mg/kg bw/d (i.e.,
                             ca. 0.5, 5.4, 13.4, 26.8 mg Te/kg
                             bw/d)
mouse             Te6+       oral, drinking water, lifetime;    no effect on organ content of Cr, Cu, Mg, Zn
                             3 ppm
rat               K2TeO3     ip; 112 d                          impaired growth; increased activity; no effect on learning
                             2 mg/kg bw/d (i.e., ca. 0.95 mg    ability
                             Te/kg bw/d)
              The results found by Len67 were not confirmed by more recent studies; may be
              there was a calculation error in the low dose.
              Carcinogenicity
              Sodium tellurite or potassium tellurate was given in the drinking water to mice
              during lifetime. The dose of Te was 2 ppm. Groups of 54 males and 54 females
              received either tellurite or tellurate. The control group for the tellurite-dosed
              animals consisted of 51 males and 56 females, the control group for the
              tellurate-dosed animals consisted of 54 males and 48 females. Males fed
              tellurate had an increased lifespan, females fed tellurite had a decreased
              lifespan. Te-fed mice were reported to be less active than their controls, to
              appear unhealthy, and to have poor coats. Since there was no significant
              difference in tumour incidence between the tellurite-fed and tellurate-fed mice,
              the data on tumour incidences were pooled for both the exposed animals and the
055-12        Health-based Recommended Occupational Exposure Limits
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<pre>       unexposed controls. Moreover, the tumour data of males and females were also
       pooled. Of the 216 mice fed tellurite or tellurate, 187 were necropsied and 90
       were examined histologically. In the mice subjected to histological examination,
       there were 7 lymphoma-leukaemias, 5 lung carcinomas, 1 lung adenoma,
       several fibromas, and 1 (benign) adrenocortical adenoma. In the 119 control
       animals examined histologically (total number: 209; number necropsied: 180),
       there were 2 lymphoma-leukaemias, 7 lung carcinomas, 1 carcinoma of
       unknown origin, and 13 benign tumours of, amongst others, breast and ovary
       (Sch72). The committee agrees with the authors that the study did not produce
       evidence of carcinogenic potential of tellurium. The committee notes the
       considerable difference between the number of animals necropsied and the
       number of animals examined histologically. Because of this remarkable
       difference which was not discussed at all by Schroeder and Mitchener, the
       committee questions the validity of the long-term carcinogenicity study.
           Sodium tellurite was given in the drinking water to rats during lifetime. The
       dose of Te4+ was 2 ppm. [The intake was estimated to be 0.150 mg Te/kg bw/d
       (Sch68).] When the rats were 21 months old, an epidemic of pneumonia caused
       considerable loss of life in all groups. The group size before and after the
       epidemic of pneumonia, at the age of 28 months was: 52 and 36 males and 53
       and 42 females; the control groups consisted of 52 and 38 males and 44 and 35
       females, respectively. Tellurite had no influence on lifespan. The body weight
       of the exposed males and females at 30 months was larger than the controls;
       however, treated and control group were losing weight between 24 and 30
       months of age. At 36 months, the treated females weighed more than their
       controls, the treated males weighed as much as their controls. Treatment did not
       induce a statistically significant increase in the incidence of total or malignant
       tumours (total: 36.4% vs. 30.8% in controls; malignant: 18.2% vs. 16.9% in
       controls) (Sch71). The committee notes the difference between the number of
       animals necropsied and the number of those examined histologically (controls:
       75 and 65, respectively; tellurite treated: 67 vs. 44, respectively), probably due
       to severe post-mortem changes, and questions the validity of this study.
       Mutagenicity and genotoxicity
       TeO2 was positive in a DNA repair test in E. coli strains WP2, WP2uvrA,
       CM571, and WP100 (Yag77).
           TeCl4, Na2H4TeO6, and Na2TeO3 were positive in a DNA repair test
       (rec-assay) in B. subtilis strains H17 and M45 (Kan80).
055-13 Tellurium and tellurium compounds (excluding TeF6)
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<pre>           Na2TeO3 induced mutations in a spot test with S. typhimurium strain TA98
       (Kan80).
           Na2H4TeO6 induced mutations in a spot test with S. typhimurium strains
       TA1535 and TA100 (Kan80).
           (NH4)6TeO6 induced chromatid breaks in human leukocytes in vitro (Pat72).
           Na2H4TeO6 gave equivocal results in a spot test with S. typhimurium TA98
       (Kan80).
           Na2TeO3 did not induce mutations in a spot test with E. coli strains B/r
       WP2, WP2, and with S. typhimurium strains TA100, TA1535, TA1537 and
       TA1538 (Kan80).
           Na2TeO3 did not induce chromatid breaks in human leukocytes in vitro
       (Pat72).
           Na2H4TeO6 did not induce mutations in a spot test with E. coli strains B/r
       WP2, WP2, and with S. typhimurium strains TA1537 and TA1538 (Kan80).
           The committee is of the opinion that the positive outcome in several studies
       indicates the effect of redox cycling; this is a high-dose phenomenon and does
       not support a carcinogenic mechanism.
       Reproduction toxicity
       The data on reproduction toxicity are presented in Table 4.
7      Existing guidelines
       The current administrative occupational exposure limit (MAC) for tellurium and
       tellurium compounds in the Netherlands is 0.1 mg/m3, 8-hour TWA (measured
       as Te).
           Existing occupational exposure limits for tellurium and tellurium
       compounds in some European countries and in the USA are summarised in the
       annex.
8      Assessment of health hazard
       Human data
       In humans, occupational exposure to tellurium and its compounds leads to
       symptoms such as garlic odour of the breath, dryness of the mouth, metallic
       taste, somnolence, garlic odour of the sweat. The odour can remain for months
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<pre>Table 4 Reprodcution toxicity data on tellurium and compounds.
animal species     Te          dosing regimen                   results                                             reference
                   compound
rat, female        Te          oral, feed; during pregnancy;    no data on maternal toxicity; all pups of 50% of    Duc70
                               3000 ppm (i.e., ca. 14           the litters had hydrocephalus; no brain anomalies.
                               mg/animal/d)
rat, female        TeO2        subcutaneous; GD 15-19;          dams: reduced food consumption and weight gain; Per88a
(Wistar; n=5 per               500 µmol Te/kg bw (i.e., ca.     centrilobular fatty changes in the liver; no
dose); one control             64 mg Te/kg bw/d)                histological changes in any organ.
group pair-fed,                                                 Fetuses: 100% hydrocephalus, exophthalmia,
one control group                                               oedema; 39-47% ocular haemorrhage; reduced
fed ad lib                                                      fetal weight and length. No effect was attributable
                                                                to low food intake.
rat, female        TeO2        subcutaneous; GD 15-19;          dams: reduced weight gain at the two higest dose Per88b
(Wistar; n=10 per              0, 10, 100, 500, 1000 µmol       levels; in the highest dose group, 4 dams died.
dose)                          Te/kg bw/d (i.e., ca. 0, 1.3,    Fetuses: at the two highest dose levels: 11 and
                               12.8, 64, 128 mg Te/kg bw)       81% mortality, resp; dose-related decrease in fetal
                                                                weight, increase in undescended testes,
                                                                hydrocephalus and oedema all over the body,
                                                                exophthalmia, ocular haemorrhage, umbilical
                                                                hernia. At 12.8 mg/kg: fetal toxicity in the
                                                                absence of maternal toxicity (100%
                                                                hydrocephalus and oedema). At 1.3 mg/kg: no
                                                                effects.
rat, female        Te          intramuscular; GD 9 and 10;      no data on maternal toxicity; hydrocephalus in the Agn72
                               13 mg/kg bw                      offspring, visible only 5-6 days after birth.
rat, female        Te          oral, feed; GD 6-15; 0, 30,      maternal toxicity at 300 ppm; no effect on          Joh88
(Sprague Dawley;               300, 3000, 15,000 ppm (i.e.,     pregnancy rate, litter size, dead or resorbed
n=22 per dose)                 ca. 0, 2.2, 19.6, 166 and 633    implantations, fetal sex ratio. In 2 highest dose
                               mg/kg bw/d on GD 6-10; and       groups: skeletal and soft tissue malformations
                               0, 1.9, 18, 173 and 579 mg/kg    (primarily hydrocephalus).
                               bw/d on GD 11-15;
                               calculated by the authors)
rabbit, female     Te          oral, feed; GD 6-18;             maternal toxicity at 1750 ppm; no effect on         Joh88
(New Zealand;                  0, 17.5, 175, 1750, 5250 ppm     pregnancy rate, litter size, dead or resorbed
n=17 per dose)                 (i.e., ca. 0, 0.74, 7.6, 53, 101 implantations, fetal sex ratio. Highest dose group:
                               mg/kg bw/d; based on food        slightly elevated evidence of delayed skeletal
                               intake and maternal body         development and non-specific abnormalities.
                               weight given by the authors)
055-15       Tellurium and tellurium compounds (excluding TeF6)
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<pre>       (Ste42). The most important indication of exposure to tellurium is the garlic-like
       odour of the breath. Probably, dimethyltelluride is formed in the body and
       exhaled. However, its formation in humans and laboratory animals was not
       proven. Only in bacteria and fungi, the formation of dimethyltelluride from
       potassium tellurite was established (Cha90).
       Animal data
       Tellurium element
       Inhalation of tellurium aerosols by rats resulted in weight loss, irritation of the
       respiratory tract, loss of fur, and haemolysis. It is not clear what the threshold
       concentration for these effects is. The range used in the experiment was 10-100
       mg/m3 (San63). This Russian study was only available in abstract form, despite
       considerable effort to obtain the full paper.
           Tellurium induced neurotoxicity in rats after feeding high doses (from 500
       mg/kg), in the form of degeneration of Schwann cells and demyelination. The
       rat was the only species studied in this respect (Duc79, Ham86, Lam70, Tak77).
           At maternally toxic doses, administered during organogenesis, tellurium
       induced skeletal malformation and hydrocephalus in the offspring of rats (at
       doses of 18-20 mg/kg bw and higher), and delayed skeletal development and
       non-specific abnormalities in offspring of rabbits (at doses of 53 mg/kg bw and
       higher) (Joh88).
           Due to lack of data, the committee cannot indicate a critical effect or a target
       organ for toxicity after inhalation exposure to tellurium.
       Tellurium compounds
       The tellurium compounds will be evaluated groupwise, according to their water
       solubility. Only one compound was found to be soluble (H6TeO6), 2 are
       insoluble (TeO2, TeO3), 6 were reactive (TeBr2, TeCl2, TeI4, TeBr4, TeCl4,
       TeF4), one was an unstable gas (H2Te), and of the remaining compounds, the
       water solubility could not be found. Apparently, the valence state of tellurium
       was not decisive for the water solubility of the compound.
       H6TeO6 (water soluble)
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<pre>       Of this compound only acute toxicity data from animals are available without
       reporting the signs of toxicity before death (Lew92).
       TeO2, TeO3 (water insoluble)
       No animal data have been found on the toxicity of TeO3.
           The investigators who studied the inhalation exposure to tellurium aerosol in
       rats, also studied inhalation exposure to TeO2 in rats. At the same concentration
       range, 10-100 mg/m3, the effects were the same as those after exposure to
       tellurium (San63). Due to lack of data, the committee cannot indicate a
       threshold for these effects.
           Feeding of doses of TeO2 of 19 mg/kg bw and higher (expressed as Te) to
       rats for 26 days induced symptoms similar to those after inhalation exposure: no
       growth, loss of hair, oedema of digits and temporary paralysis of the hind legs,
       and necrosis of liver and kidneys. In this study, haemolytic effects were not
       mentioned (DeM48). Subcutaneous injection during organogenesis of 12.8
       mg/kg bw (expressed as Te) induced hydrocephalus and oedema in 100% of the
       offspring of rats, without maternal toxicity. A tenfold lower dose did not induce
       any reproductive effects (Per88b).
           Due to lack of data, the committee cannot indicate a critical effect or a target
       organ for toxicity for the tellurium oxides.
       TeBr2, TeCl2, TeI4, TeBr4, TeCl4, TeF4 (reactive)
       Only one study is available, in which TeCl4 is fed to weanling pigs at a
       concentration of 500 mg/kg feed (expressed as Te). No control group was
       included. Muscle necrosis and a decrease in blood GSH activity was found
       (Vle81). Since only one dose was used, the committee cannot indicate a
       threshold dose for these effects.
           Due to lack of data, the committee cannot indicate a critical effect or a target
       organ for toxicity of reactive tellurium compounds.
       H2Te (unstable)
       No data are available.
       Te compounds with unknown water solubility
055-17 Tellurium and tellurium compounds (excluding TeF6)
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<pre>       The acute toxicity of diethyltelluride was rather high after inhalation exposure.
       LC50 values were 54-55 mg/m3 and 154 mg/m3 for rats and mice, respectively
       (Koz81). Inhalation of 1 mg/m3 for an unknown period of time induced a
       variety of effects like dermatitis, weight loss, haemolysis, and effects on internal
       organs (Koz81). Due to lack of data, the committee cannot indicate a threshold
       dose for these effects.
           Although the committee questions the validity of the studies, no evidence
       for a carcinogenic activity of tellurium was found in long-term studies in which
       rats and mice were given tellurite or tellurate in the drinking water at low levels
       (2 ppm). Due to lack of data, the committee cannot indicate a critical effect or a
       target organ for toxicity of Te compounds with unknown water solubility.
       Overall conclusion
       Since occupational exposure concerns the inhalation route and the kinetics of
       tellurium compounds differ after intravenous injection from that after oral
       dosing, a study using the inhalation route should be taken as a starting point in
       the risk assessment. The longest exposure study is that by Sandratskaya
       (San63). The author studied the effects of inhalation exposure of Te or TeO2
       aerosol in rats during 13-15 weeks. However, the paper lacks details in study
       design and data presentation.
       The committee considers the toxicological database on tellurium and tellurium
       compounds too poor to justify recommendation of a health-based occupational
       exposure limit.
       The committee concludes that there is insufficient information to comment on
       the present MAC level. The committee expects differences in valence state of
       the various tellurium compounds to play an important role in the toxic effects.
       Tellurium can penetrate the skin (Nor68). However, since there are no
       quantitative data, the committee is unable to pronounce upon the assignment of
       a skin notation.
055-18 Health-based Recommended Occupational Exposure Limits
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<pre>       References
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<pre>Vle81  van Vleet JF, Boon GD, Ferrans VJ. Induction of lesions of selenium-vitamin E deficiency iin
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<pre>              Annex
Occupational exposure limits for tellurium and tellurium compounds in various countries.
country                              occupational exposure          time-weighted        type of exposure noteb   referencec
  -organisation                      limita                         average              limit
                                     ppm           mg/m3
the Netherlands
  - Ministry of Social Affairs       -             0.1              8h                   administrative           SZW02
and Employment
Germany
  - AGS                              -             0.1d             8h                                            TRG00
                                     -             0.4d             15 min
- DFG MAK-Kommission                 -             0.1d             8h                                            DFG02
                                                   0.2d             15 mine
Great Britain
  - HSE                              -             0.1f             8h                   OES                      HSE02
Sweden                               -             0.1g             8h                                            Arb00b
Denmark                              -             0.1              8h                                            Arb00a
USA
  - ACGIH                            -             0.1f             8h                   TLV                      ACG02b
  - OSHA                             -             0.1              8h                   PEL                      ACG02a
  - NIOSH                            -             0.1              10 h                 REL                      ACG02a
European Union
  - SCOEL                            -             -                                                              CEC00
a
       As tellurium.
b
       S = skin notation; which means that skin absorption may contribute considerably to the body burden; sens = substance
       can cause sensitisation.
c
       Reference to the most recent official publication of occupational exposure limits.
d
       Measured as the inhalable fraction of the aerosol.
e
       Maximum number per shift: 4, with a minimum interval between peaks of 1 hour.
f
       Except hydrogen telluride.
g
       Total dust.
055-24        Health-based Recommended Occupational Exposure Limits
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