<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>Perlite
(CAS No: 93763-70-3)
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/086, The Hague, 22 October 2003
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<pre>Preferred citation:
Health Council of the Netherlands: Committee on Updating of Occupational
Exposure Limits. Perlite; Health-based Reassessment of Administrative
Occupational Exposure Limits. The Hague: Health Council of the Netherlands,
2003; 2000/15OSH/086.
all rights reserved
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<pre>1     Introduction
      The present document contains the assessment of the health hazard of perlite 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 JAGM van Raaij, Ph.D., WK de Raat, Ph.D., and J Krüse, Ph.D.
      (OpdenKamp Registration & Notification, The Hague, the Netherlands).
           In December 1998, literature was searched in the on-line databases Toxline,
      Medline, and Chemical Abstracts covering the period 1965-1966 until January
      1999, and using the following key word: perlite. Information published by the
      American Conference of Governmental Industrial Hygienists (ACGIH) was also
      used (ACG99). The final search was carried out in Toxline and Medline in
      October 2002.
           It is stated by the ACGIH that perlite is essentially a non-crystalline silicate.
      However, it is also stated that the free crystalline silica content in some perlite
      ores and in expanded perlite ranged from <1% to 5.8% (ACG99, Coo75).
      Crystalline silica is, in contrast to amorphous silica, considered to be hazardous
      to the human respiratory tract (DEC92). Therefore, the short- and long-term
      toxic effects of free crystalline silica, in particular with respect to the effects on
      the respiratory tract, have been taken into account to assess the risk of perlite
      exposure of humans. To this end, the committee applied a review on the risk of
      silica substances to humans from the Dutch Ministry of Social Affairs and
      Employment (DEC92).
           In April 2003, the President of the Health Council released a draft of the
      document for public review. The committee received no comments.
2     Identity
      name                    : perlite
      synonyms                : -
      molecular formula       : -
      structural formula      : -
      CAS number              : 93763-70-3
      Data from ACG99.
086-3 Perlite
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<pre>3     Physical and chemical properties
      molecular weight                       :    -
      boiling point                          :    -
      melting point                          :    >1093oC
      vapour pressure                        :    -
      solubility in water                    :    very slightly soluble (<1%)
      log Poctanol/water                     :    -
      conversion factors                     :    not applicable
      Data from ACG99.
      Commercial perlite is a naturally occurring glass of volcanic origin, which, when
      heated, expands to form a product of low density, high surface area, and low
      thermal conductivity. The ore is essentially an amorphous, hydrated glassy
      volcanic rock consisting of fused sodium potassium aluminium silicate of
      variable composition. The chemical composition depends on the particular ore
      body in which it is found. The colour of crude perlite ranges from transparent
      light grey to glossy black (ACG99). Perlite exists as crude and as expanded
      material (Mic71). High-temperature treatment of the crude material in furnaces
      where temperatures are maintained in the range of 760 to 1100oC yields the
      expanded form. Expanded perlite is a white powder with a bulk weight of 55-220
      kg/m3, available in different sizes, e.g., 4-8 mesh and finer (ACG99). There is no
      evidence that the heat treatment causes the formation of cristobalite as happens
      when kieselgur is calcined (Elm87).
           Perlite ores and expanded perlite are about 75% non-crystalline silicate. Both
      may contain small amounts (<1% to 5.8%) of quartz, which complicates the
      evaluation of the potential health hazards (Coo75). In two material safety data
      sheets, commercial perlite was stated to contain less than 0.1% α-cristobalite and
      tridymite and 0.01-0.05 % α-quartz (Red98, Sch01).
4     Uses
      The commercial production of perlite started in 1946. Heat-expanded perlite is
      used in thermal insulation, in lightweight plasters, as a filter aid, as an inert
      carrier and filler, as concrete aggregate, and as soil improver. It is applied in the
086-4 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>      chemical, foundry, steel, and food industries and in horticulture (ACG99,
      Elm87).
5     Biotransformation and kinetics
      The committee did not find data on the biotransformation or kinetics of perlite.
6     Effects and mechanism of action
      Human data
      To investigate whether long-term exposure of workers to perlite dust is
      associated with the development of pulmonary effects, pneumoconiosis in
      particular, 3 studies have been reported by the same author, over the period 1975-
      1986 (Coo75, Coo76, Coo86). In the first study, conducted in 1972/73, chest
      roentgenograms were examined of 240 men who had worked in the perlite
      industry in the United States, producing crude or expanded perlite, for 1 to 23
      years. The last available film for each worker was used. Since the films studied
      were from men who had terminated work in the past as well as men still at work,
      the last film available for each man had been taken in the period between 1955
      and 1974. Of the 240 workers, 231 showed films without pulmonary changes
      consistent with pneumoconiosis, 7 showed films classified as doubtful, and 2
      showed films classified as positive. The 2 subjects with pneumoconiosis and 2
      out of 7 subjects who had films classified as ‘doubtful’ had prior histories of
      working with diatomaceous earth. None of the 28 workers who had been
      working in the perlite industry for more than 15 years developed
      pneumoconiosis. Limited exposure data suggest that the population had had
      exposures to perlite dust probably exceeding the nuisance dust levels of 10
      mg/m3. The author’s conclusion was that in this worker population, there was no
      evidence of pneumoconiosis associated with perlite exposures (Coo75).
          In the second study, conducted in 1975, possible pulmonary effects were
      examined of 117 men engaged in the mining and processing of perlite in 3 plants
      in the major perlite-producing area of the United States for periods up to 23
      years. Of these, 38 had been employed for 10 years or more, 18 for 15 years or
      more, and 4 men for 20 years or more. The most recent chest roentgenograms of
      the 117 perlite workers were examined. Two out of the 117 workers showed
      films classified as positive. However, the pulmonary changes were not
      interpreted as pneumoconiosis. Pulmonary function was measured during a 4-
      day period by determination of the forced vital capacity (FVC) and the 1-second
086-5 Perlite
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<pre>      forced expiratory volume (FEV1). An increase in FVC, but a decrease in FEV1
      and in the ratio FEV1/FVC was found that correlated with length of employment,
      after effects of cigarette smoking had been taken into account. However, none of
      these changes were statistically significant. The authors concluded that there was
      no evidence of pneumoconiosis in men who had worked in the perlite industry
      for periods up to 23 years. Exposure levels and free silica content of the perlite
      were not reported (Coo76).
          The third study, conducted in 1983, was a follow-up of the 1975 study in
      workers employed in the same 3 plants. The study population comprised 152
      workers with at least 5 years of employment and for whom chest films were
      available. For current employees, new films were requested, if none had been
      taken within the past year. For former perlite workers, the most recent film was
      used. Of the 152 workers, 60 had perlite employment for 5-9 years, 73 for 10-19
      years, and 19 for 20-29 years. Most of the workers were exposed to crude perlite
      rather than the expanded product. Airborne exposure levels to perlite dust in
      representative work areas were nearly all below the nuisance dust concentration
      of 10 mg/m3. The amount of quartz in the perlite was not reported. Chest
      radiography did not show any positive film, consistent with pneumoconiosis, in
      any of the workers. Pulmonary function was conducted in 120 out of the 152
      workers during a 4-day period by determination of FVC and FEV1. Of these 120
      workers, 66 had also been examined in 1975. Both FVC and FEV1 were
      negatively correlated with years of employment in the perlite industry, but the
      association was not statistically significant. In contrast, smoking was found to be
      the most important factor influencing the pulmonary function in the perlite
      workers. This was also seen in the 66 workers who were tested in 1975 and again
      in 1983: the greater mean decrease in FVC observed in workers compared with a
      non-smoking reference population was not due to perlite exposure, but could be
      explained by the severe smoking habits of 28 of the workers. However, the mean
      decrease in FEV1 in the workers compared with the reference population was less
      than expected, which was explained by the very small average decrease in FEV1
      in the groups of light smokers and non-smokers. The authors concluded that
      there was no evidence of perlite-induced pneumoconiosis, and that perlite should
      continue to be treated as a nuisance dust when it is not contaminated with quartz
      dust above 1% (Coo86).
          The findings of Cooper (Coo75, Coo76, Coo86) are in agreement with the
      statement of Elmer (Elm87) that dust particles from perlite (expanded) are
      unlikely to survive long enough in the lung to cause fibrosis after prolonged
      exposure to acceptable levels.
086-6 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>           Pulmonary function tests (FVC; FEV1; FEV1/FVC; FEF50% and FEF75%, i.e.,
      forced expiratory flow when 50 or 75%, respectively, of forced expiratory vital
      capacity has been exhaled; TL, CO, i.e., diffusing capacity of the lung for carbon
      monoxide; and KCO*, i.e., carbon monoxide transfer coefficient) in conjunction
      with chest radiograms were carried out in 9 non-smoking and 27 smoking
      perlite-exposed male workers and 22 unexposed male office workers (all
      smokers) of a Turkish perlite plant in 1992, after an average of 12 years of work,
      and 1996. In 1991 and 1994, perlite concentrations in processing area dust
      samples were on average 7.5 and 12.83 mg/m3, respectively, and in personal
      respirable dust samples 4.56 and 9.89 mg/m3, respectively. In the non-smoking
      workers, the pulmonary function test values observed in 1992 for FEV1, TL, CO,
      and KCO were statistically significantly higher than predicted values. In 1996,
      observed values for FEV1 and FEV1/FVC were significantly higher than
      predicted values. In comparison to 1992, a significant decrease was found in KCO
      in 1996. While TL, CO and KCO values were higher than predicted values in 8/9
      and 9/9 workers, respectively, in 1992, these figures changed to 5/9 and 3/9
      workers, respectively, in 1996. For 4/9 workers, TL, CO values were 81-100% of
      predicted values (vs. 1/9 in 1992); KCO values were 81-100 or 61-80% of
      predicted values in 2/9 and 4/9 workers, respectively. In contrast, the percentage
      of workers with higher than predicted values did not change for FEV1 or FVC
      and increased for FEV1/FVC. According to Polatli et al., the change in diffusing
      capacity suggests that 4-year exposure to relatively high dust levels (i.e., above
      the ‘permissible’ dust level of 5 mg/m3) may affect the condition of the
      interstitial tissue, which may be interpreted as an early indicator for respiratory
      airway effects. In the smoking perlite-workers, the pulmonary function test
      values observed in 1992 were similar to the predicted values except for a
      statistically significantly lower FEF75%. In 1996, observed values were similar to
      predicted values, except for significantly lower FEF75% and KCO. Both these
      parameters and FEV1/FVC and TL, CO were statistically significantly decreased
      in comparison to 1992. Similar changes as found in the non-smoking and the
      smoking perlite workers were observed in the smoking control group. According
      to Polatli et al, damage to small airways, parenchymal and interstitium, caused
      by smoking might be worsened by synergistic action of perlite exposure. There
      was no correlation between duration of work in perlite areas and pulmonary
      function test parameters whereas a significant correlation was found between
      smoking history in smoking perlite and control workers, TL, CO, and KCO.
      Although chest radiography showed abnormalities in 10/27 smoking perlite
*      Or TL, CO/VA (VA: alveolar volume).
086-7 Perlite
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<pre>      workers, large opacities or higher profusion categories were not observed. These
      abnormalities included small rounded opacities in profusion (doubtful) in 3,
      possible tuberculosis in 3, pleural calcification in 2, and probable asbestosis due
      to environmental exposure in 2 workers. In non-smoking perlite workers, all
      chest radiographs were normal (Pol01). Polatli et al summarised results of other
      in Turkish published studies on perlite-exposed workers. In one study, significant
      decreases in FEF50% and FEF75% were found in a group of 27 smoking and non-
      smoking workers (average age: 33 years) exposed to (unreported) perlite dust
      levels for 4 years. As numbers were small, non-smokers were not evaluated
      separately. In another study on 53 perlite workers, small airway obstruction was
      determined. The decrease in flow rate in small airways was concluded to be
      associated with smoking because 70% of the workers had smoking histories up
      to 17.9 pack-years. A significant association between smoking period and
      respiratory functional decrease was found (Pol01).
          In 2 additional, unpublished studies, reported in 1990 and 1994, it was
      concluded that the workers studied were ‘free of any evidence of a silicosis risk,
      or indeed, any measurable adverse respiratory effects of perlite exposure’ (not
      any other information available) (Sch02).
      Animal data
      Irritation and sensitisation
      The committee did not find data from irritation or sensitisation studies with
      perlite.
      Acute toxicity
      The committee did not find data on the acute respiratory or dermal toxicity of
      perlite. The acute oral LD50 in mice was >12,960 mg/kg bw. No signs of toxicity
      were reported (Ohk72, Ito81). In 2 other unpublished studies, the oral LD50 in
      rats was stated to be greater than 10,000 mg/kg bw, the highest dose tested
      (Sch02).
      Short-term toxicity
      In an inhalation study, guinea pigs (n=5/sex/group) were exposed to perlite (non-
      crystalline) dust at mean airborne concentrations of 0 or 6600 mg/m3, 30
      minutes/day, 5 days/week, for 24 weeks. The mass mean aerodynamic diameters
086-8 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>      (MMAD) were between 1.7 and 1.9 µm. Effects observed were minor respiratory
      distress, increased locomotion, and shaking and brushing their faces with their
      paws in an attempt to prevent dust from entering airways. These symptoms
      disappeared 1-2 hours following cessation of exposure. No body weight loss or
      change in food intake was observed in treated animals compared with the
      controls. After 4 weeks, tidal volume and respiratory rate were measured by
      fastening a small pneumograph around the chest of the animal. Parameters were
      recorded before perlite exposure, at 15 and 30 minutes during exposure, and at
      30 minutes following termination of exposure. Tidal volume and respiratory rate
      were decreased by 60% and 40%, respectively, at the end of the 30 minutes
      exposure period, compared with pre-exposure values. However, values returned
      to pre-exposure levels at the end of the 30-minute recovery period. Gross
      examination of the lungs revealed oedematous and haemorrhagic foci.
      Microscopic changes of the lung included lymphoid aggregates in the adventitia
      of blood vessels and terminal bronchioles, and thickened interalveolar septa.
      Dust particles were present in phagocytes and were free in the alveoli and
      terminal bronchioles. However, no evidence of pulmonary fibrosis or extensive
      destruction of parenchymal tissues could be demonstrated. The authors
      concluded that perlite particles are more than just a nuisance substance (McM78,
      McM83).
          Rats given a single intratracheal instillation of 50 mg perlite dust showed
      pulmonary fibrosis at 12 to 18 months following administration. The perlite
      composition was not specified (Liu88). Intratracheal infusing of 5 mg perlite dust
      in 5% alcohol did not result in a strong pulmonary fibrinogenic reaction in rats,
      at 12 weeks after administration. No more details were provided (Ued78). In
      another study, a single 50-mg suspension of crude or expanded perlite was
      administered intratracheally to albino rats. Nine months after administration, it
      was found that expanded perlite had caused more lung fibrosis in the sacrificed
      animals than the crude perlite. The degree of fibrosis was not reported. The
      increased fibrosis from the expanded material was attributed to the higher
      cristobalite and tridymite content (Bor67). A single intratracheal instillation of a
      75 mg/mL saline dose of perlite (18-30% quartz) produced a ‘foreign body
      reaction’ in white male rats, but no pulmonary fibrosis was observed. The post-
      exposure observation period was not reported (Tim65). In an earlier study, 9
      perlite products were tested in guinea pigs, by weekly intratracheal injection of
      0.5 ml of a 5% perlite suspension in saline for 3 weeks. At 4 to 12 months after
      the last injection, no evidence of pulmonary fibrosis was shown (Vor53).
          CRJ:ICR mice (n=21/sex/group) were fed perlite via the diet at doses of
      0, 1500, 15,000, or 30,000 mg/kg bw/day, for 28 weeks. The powder
086-9 Perlite
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<pre>       (characterised as ‘crystalline’ by the authors) consisted mainly of SiO2 (71.74%),
       Al2O3 (14.94%), and K2O (6.86%). No effects on mortality, food intake, or
       behaviour were observed in the treated groups compared with the controls. A
       slight reduction of growth rate was seen in the males that were fed the 2 highest
       doses. No abnormalities were observed in organ weights and in clinical chemical
       and haematological parameters when compared with controls. Microscopic
       examination did not reveal treatment-related changes in any of the organs
       investigated. The NOAEL was 1500 mg/kg bw/day of perlite in the diet, based
       on a slight reduction of growth rate at 15,000 mg/kg bw/day (Sak85).
       Long-term toxicity and carcinogenicity
       In an 18-month inhalation study, guinea pigs and rats (numbers, strain, or sex not
       given) were exposed to perlite dust at a concentration of 226 mg/m3. No
       significant pulmonary reaction, including fibrosis, was observed. No further
       details were given. The authors concluded that perlite acted as inert or nuisance
       dust (Vor53).
       Mutagenicity and genotoxicity
       The committee did not find data from mutagenicity or genotoxicity studies with
       perlite.
       Reproduction toxicity
       The committee did not find data from reproduction toxicity studies with perlite.
7      Existing exposure limits
       The current administrative occupational exposure limit (MAC) for perlite in the
       Netherlands is 10 mg/m3, 8-hour TWA, as inhalable dust.
           In other European countries, no occupational exposure limit for perlite has
       been established. Existing occupational exposure limits in the USA are
       summarised in the annex.
086-10 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>8      Assessment of health hazard
       Workers can be exposed to crude or heat-expanded perlite through inhalation of
       the respirable fraction of the substance. The committee could not find data of the
       percentage uptake of perlite through the lungs, or of the biokinetics or
       metabolism of the compound following absorption.
            In 3 long-term occupational studies in the USA, conducted in the period
       1972-1983 on groups of 450, 117, and 152 workers, no evidence of a relationship
       between working in the perlite industry and the development of lung fibrosis
       (pneumoconiosis) was found. Tests included chest radiography and lung function
       parameters FVC and FEV1. No data on personal air exposures were reported, but
       workplace monitoring in the plants showed that airborne concentrations were
       close to the nuisance dust level of 10 mg/m3. No data were provided on the
       percentage of quartz in the perlite, which may vary from <0.1% to about 6%. In 2
       additional, unpublished studies, reported in 1990 and 1994, no evidence of a
       silicosis risk or any other adverse respiratory effect was stated to have been
       found.
            In experimental animals, the committee could not find data on eye or skin
       irritation, or on skin sensitisation. One acute oral lethal toxicity study revealed
       that the compound did not cause harm after ingestion. A number of short-term
       studies and one long-term study have been reported. These comprised 2
       inhalation studies, 5 intratracheal-instillation studies and one oral (feeding)
       study. Only the latter included the usual range of toxicological endpoints. The
       other studies were all focussed on the effects of perlite on the lungs. Adverse
       local effects on the respiratory tract (lymphoid aggregation, perivascular
       inflammatory response), but no evidence of pulmonary fibrosis or extensive
       destruction of parenchymal tissues, were demonstrated in guinea pigs, exposed
       to an air concentration of 6600 mg/m3, 30 minutes/day, 5 days/week, for 24
       weeks. Because of the unrealistically high air concentration, the committee
       considered this experiment not relevant to the occupational situation. A long-
       term inhalation study (18 months) in rats or guinea pigs, exposed to a much
       lower air concentration (226 mg/m3), did not reveal any effects on the respiratory
       tract. In 3 out of 5 studies, adverse local effects (fibrosis) were found, 9 to 18
       months after single intratracheal instillation at doses of 5 to 50 mg of perlite. The
       committee is of the opinion that fibrosis might have been caused by the presence
       of quartz in the perlite samples tested. The committee also comments that the
       relevance of the intratracheal route of exposure for risk assessment of inhalation
       exposure to perlite is uncertain. The 28-week oral study in mice did not provide
086-11 Perlite
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<pre>       relevant information on local effects on the respiratory tract. The NOAEL was
       1500 mg/kg bw/day, based on a slight reduction of growth rate at 15,000 mg/kg
       bw/day.
           Based on the above data, the committee takes the NOAEL of 226 mg/m3 in
       rats or guinea pigs (18-month inhalation study) as a starting point in deriving a
       health-based recommended occupational exposure limit (HBROEL). For
       extrapolation to a HBROEL, an overall assessment factor of 9 is established.
       This factor covers the following aspects: intra- and interspecies variation.
       Applying this factor and the preferred value approach would lead to a health-
       based occupational exposure limit of 20 mg/m3, which is still higher than the
       usual occupational exposure limit for nuisance dust (10 mg/m3).
           As an alternative, the committee takes the occupational studies of Cooper as
       a starting point in deriving a HBROEL, in spite of lack of personal exposure
       data. However, in the absence of such data, the author gives useful information
       on workplace exposures, which were close to the occupational exposure limit for
       nuisance dust. More importantly, it has been demonstrated that long-term
       exposure to perlite does not lead to lung effects. Therefore, perlite can be
       considered as a nuisance dust, for which a health-based occupational exposure
       limit of 10 mg/m3 is recommended.
           However, perlite may contain varying amounts of crystalline silica. The
       Dutch Expert Committee on Occupational Standards (DECOS), another
       committee of the Health Council of the Netherlands, has recommended a health-
       based occupational exposure limit for crystalline forms of silicon dioxide
       (quartz, including cristobalite and tridymite) of 0.075 mg/m3 as respirable dust,
       8-hour TWA. This concentration should prevent adverse chronic effects on the
       respiratory system (DEC92). Thus, when perlite contains ca. 0.7% or more
       crystalline silica, the MAC value for crystalline forms of silicon dioxide will be
       exceeded.
       The committee recommends a health-based occupational exposure limit for
       perlite (containing <0.7% crystalline silica) of 5 mg/m3 as respirable dust and 10
       mg/m3 as inhalable dust, as 8-hour time-weighted averages (TWA). A skin
       notation is not deemed necessary. For perlite containing 0.7% crystalline silica,
       the MAC value for crystalline silica should be applied.
086-12 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>       References
ACG99  American Conference of Governmental Industrial Hygienists (ACGIH). Perlite. In: TLVs® and other
       occupational exposure values - 1999. [CD-ROM]. Cincinnati OH, USA: ACGIH®, Inc, 1999.
ACG03a American Conference of Governmental Industrial Hygienists (ACGIH). Guide to occupational
       exposure values - 2003. Cincinnati OH, USA: ACGIH®, Inc, 2003: 102.
ACG03b American Conference of Governmental Industrial Hygienist (ACGIH). 2003 TLVs® and BEIs®
       based on the documentaion of the Threshold Limit Values for chemical substances and physical
       agents & Biological Exposure Indices. Cincinnati OH, USA: ACGIH®, Inc, 2003: 46.
Ano87  Anonymous. Non-crystalline silicas. Chemical hazard summary, Hamilton ON, Canada: Canadian
       Centre for Occupational Health and Safety, 1987.
Arb02  Arbejdstilsynet. Grænseværdier for stoffer og materialer. Copenhagen, Denmark: Arbejdstilsynet,
       2002; At-vejledning C.0.1.
Bor67  Borshchevkii YM, Oksova EE, Retnev VM. [Investigation into fibrogenic properties of the dust of
       silicate-containing materials as related to the technology of their manufacture]. in Russain. Gig Tr
       Prof Zabol 1967; 11: 27-30; cited in ACG 99.
Coo75  Cooper WC. Radiographic survey of perlite workers. J Occup Med 1975;17: 304-9.
Coo76  Cooper WC. Pulmonary function of perlite workers. J Occup Med 1976;18: 723-9.
Coo86  Cooper WC, Sargent EN. Study of chest radiographs and pulmonary ventilatory function in perlite
       workers. J Occup Med 1986; 28:199-206.
DEC92  Dutch Expert Committee on Occupational Standards. Health-based recommended occupational
       exposure limits for crystalline forms of silicon dioxide (free silica). The Hague, the Netherlands:
       Ministry of Social Affairs and Employment, 1992; rep no RA 5/92.
DFG02  Deutsche Forschungsgemeinschaft (DFG): Commission for the Investigation of Health Hazards of
       Chemical Compounds in the Work Area. List of MAK and BAT values 2002. Maximum
       concentrations and biological tolerance values at the workplace. Weinheim, FRG: Wiley-VCH, 2002;
       rep no 38.
EC03   European Commission (EC): Directorate General for Employment and Social Affairs. Occupational
       exposure limits (OELs). http://europe.eu.int/comm/employment_social/h&s/areas/oels_en.htm.
Elm87  Elmer PC. Perlite and other ‘nuisance dusts’. J R Soc Med 1987; 80: 403-4.
HSE02  Health and Safety Executive (HSE). EH40/2002. Occupational Exposure Limits 2002. Sudbury
       (Suffolk), England: HSE Books, 2002.
Ito81  Itoh S, Matsuzawa E, Ohno T, et al. An experimental study of perlite 1. The result of acute toxicity
       study for water of perlite (turbid water with powder) in mice. Bull Coll Kokusai Gakuin 1981; 2:1-7.
Liu88  Liu Z, Xiao X, Fang Y. Problems of labour health on preventing dust hazard in township industries.
       Proceedings of the VIIth International Pneumoconiosis Conference, Part II. Pittsburgh, Pennsylvania.
       August 1988:90-108.
086-13 Perlite
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<pre>McM78  McMichael RF, DiPalma JR, Amenta PS. Comparative effects of perlite and fir bark dust on guinea
       pig lungs. Fed Proc 1978; 37: 712.
McM83  McMichael RF, DiPalma JR, Blumenstein R, et al. A small animal model study of perlite and fir bark
       dust on guinea pig lungs. J Pharmacol Methods 1983; 9: 209-18.
Mic71  Michailova-Dotscheva L. Mineralogische Charakteristik des Aerosols bei Gewinnung und
       Verarbeitung von Perlit. Z Gesamte Hyg 1971; 17: 98-101.
Ohk72  Ohkuma S, Fukuda Y, Tamaki N, et al. An acute toxicity study of water of perlite (turbid water with
       powder) in mice; unpublished report dated 1972, cited in Sak85.
Pol01  Polatli M, Erdinç M, Erdinç E, et al. Perlite exposure and 4-year change in lung function. Environ
       Res 2001; 86: 238-43.
Red98  Redco II. Material Safety Data Sheet. Expanded perlite products. North Hollywood CA, USA: Redco
       II, 1998; http://www.perlite.org/redco/index.htm.
Sak85  Sakai T, Nagao S. Twenty-eight week toxicity study of perlite powder in mice. J Toxicol Sci 1985;
       10:83-93.
Sch01  The Schundler Company. Material Safety Data Sheet - Perlite. Metuchen NJ, USA: The Schundler
       Company, 2001; http://www.schundler.com/msdsperl.htm.
Sch02  The Schundler Company. Perlite health issues: studies and effects. Metuchen NJ, USA: The
       Schundler Company, 2001; http://www.schundler.com/perlitehealth.htm.
Swe00  Swedish National Board of Occupational Safety and Health. Occupational exposure limit values and
       measures against air contaminants. Solna, Sweden: National Board of Occupational Safety and
       Health, 2000; Ordinance AFS 2000:3.
SZW03  Ministerie van Sociale Zaken en Werkgelegenheid (SZW). Nationale MAC-lijst 2003. The Hague,
       the Netherlands: Sdu, Servicecentrum Uitgevers, 2003: 38.
Tim65  Timar M, Kendry G, Juhasz Z. [The effect of mineral dusts on the pulmonary tissue]. In Hungarian.
       Egeszsegtudomany 1965; 9:183-188; cited in ACG99.
TRG00  TRGS 900. Grenzwerte in der Luft am Arbeitsplatz; Technische Regeln für Gefahrstoffe. BArbBl
       2000; 2.
Ued78  Ueda A, Ueda T, Nomura S. [Experimental study on fibrogenicity [sic] of oil absorbant particles
       made of perlite dust]. In Japanese. Sangyo Igaku 1978; 20:367-73; cited in ACG99.
Vor53  Vorwald AJ. Perlite dust investigation, Final report: The effect of inhaled perlite dust upon lungs of
       normal animals. Saranac Lake NY, USA: Trudeau Foundation, Saranac Laboratory, 1953; cited in
       Coo75, Coo76, and Coo86.
086-14 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>              Annex
Occupational exposure limits for perlite in various countries.
country                                occupational            time-weighted       type of                  notea       referenceb
- organisation                         exposure limit          average             exposure limit
                                       ppm       mg/m3
the Netherlands
- Ministry of Social Affairs and
Employment                             -         10c           8h                  administrative                       SZW03
Germany
- AGS                                  -         -                                                                      TRG00
- DFG MAK-Kommission                   -         -                                                                      DFG02
Great Britain
- HSE                                  -         -                                                                      HSE02
Sweden                                 -         -                                                                      Swe00
Denmark                                -         -                                                                      Arb02
USA
- ACGIH                                -         10d           8h                  TLV                      A4e         ACG03b
- OSHA                                 -         15f           8h                  PEL                                  ACG03a
                                       -         5g            15 min
- NIOSH                                -         10f           10 h                REL                                  ACG03a
                                       -         5g            15 min
European Union
- SCOEL                                -         -                                                                      EC03
a
     S = skin notation, which means that skin absorption may contribute considerably to body burden; sens = substance can
     cause sensitisation.
b
     Reference to the most recent official publication of occupational exposure limits.
c
     As inhalable dust.
d
     The value is for particular matter containing no asbestos and <1% crystalline silica.
e
     Classified in carcinogen category A4, i.e., not classifiable as a human carcinogen: agents which cause concern that they
     could be carcinogenic for humans but which cannot be assessed conclusively because of lack of data. In vitro or animal
     studies do not provide indications of carcinogenicity which are sufficient to classify the agent into one of the other
     categories.
f
     As total dust.
g
     As respirable dust.
086-15        Perlite
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<pre>086-16 Health-based Reassessment of Administrative Occupational Exposure Limits</pre>

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