<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>      Ethyl formate
      (CAS reg no: 109-94-4)
      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/033, The Hague, 7 March 2002
033-1
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<pre>      Preferred citation:
      Health Council of the Netherlands: Committee on Updating of Occupational
      Exposure Limits. Ethyl formate; Health-based Reassessment of Administrative
      Occupational Exposure Limits. The Hague: Health Council of the Netherlands,
      2002; 2000/15OSH/033.
      all rights reserved
033-2
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<pre>1     Introduction
      The present document contains the assessment of the health hazard of ethyl
      formate 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 KJ van den Berg, Ph.D. (TNO Nutrition and Food
      Research, Zeist, the Netherlands).
           The evaluation of the toxicity of ethyl formate 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 online data
      bases Medline, Toxline, and Chemical Abstracts covering the period 1966 to 26
      April 1999 (19990426/UP), 1965 to 29 January 1999, and 1967 to 24 April 1999
      (19999042/ED), respectively, and using the following key words: ethyl formate,
      ethyl methanoate, methanoic acid ethyl ester, and 109-94-4. HSDB and RTECS,
      data bases available from CD-ROM, were consulted as well (NIO99, NLM99). The
      final literature search has been carried out in April 1999.
           In July 2001, the President of the Health Council released a draft of the
      document for public review. The committee received no comments.
2     Identity
       name                   :    ethyl formate
       synonyms               :    ethyl methanoate; methanoic acid, ethyl ester; formic
                                   acid, ethyl ester; formic ether
       molecular formula      :    C3H6O2
       structural formula     :
       CAS reg no             :    109-94-4
      Data from ACG99, NLM99.
033-3 Ethyl formate
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<pre>3     Physical and chemical properties
       molecular weight                    :      74.08
       boiling point                       :      54.3 oC
       melting point                       :      -80 oC
       flash point                         :      -20 oC (closed cup)
       vapour pressure                     :      at 20 oC: 25.9 kPa
       solubility in water                 :      soluble (13.6 g/100 mL)
       Log P octanol/water                 :      0.23
       conversion factors                  :      1 ppm      = 3.1 mg/m 3
       (20 oC, 101.3 kPa)                  :      1 mg/m 3 = 0.32 ppm
      Data from ACG99, NLM99, Ric94 .
      Ethyl formate is a colourless to water-white, unstable liquid (ACG99).            An odour
      threshold of 96 mg/m 3 (31 ppm) has been reported (Amo83).
4     Uses
      Ethyl formate is used as flavour for lemonade and essences; as a solvent for
      nitrocellulose; as a fungicide and larvicide for, amongst others, tobacco, cereals,
      dried fruits; and in organic synthesis (ACG99, Ric94).           In the Netherlands, ethyl
      formate is not registered for use as a pesticide (CTB01).
5     Biotransformation and kinetics
      Ethyl formate is readily absorbed into the blood via the alveoli of the respiratory
      system.
            It is also reported to be absorbed from the gastrointestinal tract and slightly
      through the skin (Bis93).
            With moisture, ethyl formate readily hydrolyses into formic acid and ethanol
      (Gre98). Enzymatic hydrolysis also occurs. Formic acid is metabolised further              by
      the tetrahydrofolate system to CO 2. Ethanol is metabolised further in the liver to
      acetaldehyde, acetic acid, and, finally, CO       2 , by alcohol dehydrogenase, aldehyde
      dehydrogenase, and the tricarbonic acid cycle, respectively (Gre98).
033-4 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>6     Effects and mechanism of action
      Human data
      Without presenting details, it was stated that human exposure to 330 ppm ethyl
      formate (~1000 mg/m3) resulted in a slight irritation of eyes and nose, persisting
      for at least 4 hours (Flu31). Exposure to 10,500 ppm (32,500 mg/m3) is reported to
      cause moderate, but progressive, irritation of eyes and nose (Gre98).
          Dermal application of 4% ethyl formate under occlusion did not result in
      signs of irritation in human volunteers (Gre98).
          It is estimated that occupational exposure to 100 ppm (300 mg/m3) does not
      lead to metabolic acidosis caused by accumulation of acidic metabolites (Gre98).
      Animal data
      Acute toxicity
      Exposure of mice and cats to ethyl formate at concentrations of 500 ppm (1600
      mg/m3) and 10,000 ppm (31,000 mg/m3) for 20 min, caused eye irritation and
      dyspnea. In dogs, pulmonary oedema was observed after exposure to 10,000 ppm
      (31,000 mg/m3) ethyl formate for 4 hours (Flu31). In acute inhalation studies using
      guinea pigs and frogs, ethyl formate (concentration unknown) was reported to
      be irritating to mucous membranes (ACG99).
          In rabbits, liquid ethyl formate has been found irritating to the eyes (scoring
      an injury grade of 4 on a scale of 1 to 10, indicating a so-called 'severe burn' from
      0.02 mL undiluted material; see also Car46), but not to the skin (scoring an injury
      grade of 1, indicating 'the least visible capillary injection' from undiluted material)
      (Smy54).
          No studies were found on the sensitising potential of ethyl formate.
      Following exposure of rats to 8,000 ppm (24,000 mg/m3) ethyl formate for 4 hours,
      5 out of 6 animals died. When exposed to saturated vapour*, 5 minutes was the
      maximum exposure duration which did not induce mortality (Smy54). Deaths were
      reported in cats and in dogs, following exposure to 10,000 ppm (31,000 mg/m3)
      ethyl formate for 80 minutes and 4 hours, respectively (Flu31). Citing studies
*     The (theoretic) concentration in saturated air can be calculated using the formula: (vapour pressure in Pa
      x 10 6 ppm)/10 5 Pa. Using a vapour pressure of 25,900 Pa, the committee estimates that these animals
      could have been exposed to, at most, 259,000 ppm or (roughly) 800,000 mg/m 3.
033-5 Ethyl formate
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<pre>      from the 1930s, it was stated that concentrations of 12,800 to 41,600 ppm
      (40,000-130,000 mg/m3) (duration not presented) caused marked nervous system
      depression and, frequently, development of pneumonia in rabbits and guinea
      pigs while in guinea pigs, air saturated with ethyl formate vapours resulted in
      tremors, progressive CNS depression, and death from circulatory and respiratory
      failure within a few minutes (Oet59).
          The dermal LD 50 of ethyl formate in rabbits is reported to be over 20 mL/kg
      bw (> 18,000 mg/kg bw) (Smy54).
      Oral LD 50s of 1850 and 4290 mg/kg bw have been reported in rats (Jen64,
      Smy54).Toxic signs observed include CNS depression within 5-10 minutes, and
      laboured respiration, while mortality occurred within a period of 15 minutes to 2
      hours (Jen64). In guinea pigs, the oral LD 50 was 1110 mg/kg bw. CNS depression
      and irritation of the gastrointestinal tract were observed, and deaths occurred
      within 10 minutes to 2 hours (Jen64). In rabbits, an oral (gavage) LD 50 of 2070
      mg/kg bw is reported (observation time: 24 h). The ND50 (i.e., the narcotic dose or
      the dose producing stupor, loss of voluntary movements in half of the animals)
      was estimated to be 2070 mg/kg bw as well (Mun72).
      Repeated dose toxicity
      In a range-finding experiment preceding testing its carcinogenicity in mice
      (A/He) (see below), the maximum tolerated dose of ethyl formate following 6
      intraperitoneal injections over a 2-week period was found to be 500 mg/kg body
      weight (Sto73).
          Groups of Osborne Mendel rats (n=10/sex/group) were exposed to doses of
      ethyl formate of 1000, 2500, and 10,000 mg/kg diet (approximately equivalent to 0,
      50, 150, and 500 mg/kg bw) for 17 weeks. At the termination of the study, there
      were no changes in body weight gain, organ weights, or histology of major
      organs. No further details were reported. Considering the volatility of ethyl
      formate, administration through feed will not be an appropriate way of
      administration. No details were given on the stability on ethyl formate in the feed
      although for other componds tested losses of up to 30 (or incidentally up to 58)
      percent over a 7-day period occurred (Hag67).
          A/He mice (n=15/sex/dose) received intraperitoneal injections thrice weekly,
      for 8 weeks, followed by a 16-week follow up, resulting in total doses of ethyl
      formate of 2400 or 12,000 mg/kg bw. From preceding experiments, the latter dose
      was calculated to be the maximum tolerated dose (see above). Emphasis was on
033-6 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>      the occurrence of pulmonary tumours (expressed as number of mice with lung
      tumours and number of lung tumours per mouse), but other organs and tissues,
      such as liver, kidney, spleen, thymus, intestine, and salivary and endocrine
      glands, were also examined. No increase in tumour incidence was observed in the
      lungs or any of the other.organs examined However, no further details were
      given (Sto73). The committee judges the study as insufficient to draw any
      conclusion on the carcinogenic potential of ethyl formate.
      Mutagenicity and genotoxicity
      No mutagenic activity of ethyl formate was observed in the bacterial strains S.
      typhimurium TA1535, TA1537, TA1538 and in the yeast S. cerevisiae (Lit76).
          Ethyl formate is not reported to give mitotic chromosomal loss and
      duplication ('malsegregation' ) in the yeast S. cerevisiae (Liu97, Zim85).
          Reported in an abstract, there was an increase in the rate of lethal mutations
      (4.7% ± 1.6% vs 0.5% ± 0.3% in controls) in the second pair of autosomes of
      males, following treatment of fertilised eggs from D. melanogaster with an
      unknown concentration of ethyl formate vapour, for 5 to 20 minutes in a moist
      sealed chamber. A very high mortality (only 7.5% developed into fertile males)
      was observed in the treated eggs (Alt56).
      Reproduction toxicity
      No teratogenicity was found in the developing chicken embryo test at a
      concentration of ethyl formate of 25 mg per egg (Ver80).
          No other data from animal studies were found on the reproduction toxicity
      potential of ethyl formate.
7     Existing guidelines
      The current administrative occupational exposure limit (MAC) for ethyl formate
      in the Netherlands is 100 ppm (300 mg/m3), 8-hour TWA.
          Existing occupational exposure limits for ethyl formate in some European
      countries and in the USA are summarised in the annex.
033-7 Ethyl formate
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<pre>8     Assessment of health hazard
      In man, it was stated that exposure to concentrations of ethyl formate of 330 ppm
      (1000 mg/m3) and higher were slightly irritating to the eyes and nose, but the
      significance of this finding could not be assessed due to limited reporting. Ethyl
      formate is not irritating to the human skin.
          In experimental animals, ethyl formate was found to be irritating to the eyes
      and the lungs, but not to the skin. No studies on potential sensitisation were
      found.
          In acute inhalation studies, ethyl formate caused lethality in 5 out of 6 rats at
      a concentration of 8,000 ppm (24,000 mg/m3). No LC50 values were found. Signs
      of toxicity included depression of the central nervous system (CNS) and
      respiratory and circulatory effects. The dermal LD 50 in rabbits is greater than 20
      mL/kg bw (or 18,000 mg/kg bw). Oral LD 50 values of 1110, 1850, and 2070 mg/kg
      bw were reported for guinea pigs, rats, and rabbits, respectively. CNS
      depression, laboured respiration, and irritation of the gastrointestinal tract were
      observed.
          Ethyl formate did not induce mutations in bacteria or yeast or chromosome
      damage in yeast, but caused a positive response in an old, not standardised
      mutation assay in Drosophila.
          The committee did not find adequate data on repeated dose toxicity
      (including those on carcinogenicity and reproduction toxicity) or on genotoxicity
      tests in mammalian cell systems in vitro or in mammals in vivo.
      The committee concludes that there are no adequate data to derive a
      health-based occupational exposure limit. However, following and in line with the
      approach by the German MAK-Kommission (Gre98)*, the risk of effects due to
      accumulation of metabolites and of metabolic acidosis due to exposure to the
      current MAC value of 300 mg/m3 can be assessed. Assuming a 70-kg worker
      inhales 1.25 m3 during one working hour and retention is 100%, exposure to 300
      mg/m3 of ethyl formate will result in an hourly uptake of 375 mg (5.06 mmol) or 5.4
      mg (0.072 mmol)/kg bw. Assuming hydrolysis is complete, this implies the uptake
      of equimolar amounts of ethanol and formic acid. For the conversion of formic
      acid into carbon dioxide, the metabolic rate in primates is reported to be 0.75
      mmol/kg bw/hour. For ethanol, the elimination rates are 1.15 and 1.35 mmol/kg
      bw/hour in women and men, respectively. From these figures, it can be seen that
*      Figures presented in the following lines are reproduced from Gre98.
033-8 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>       accumulation of metabolites will not occur. Assuming a human blood volume of
       4.5 L, the aforementioned hourly uptake of 375 mg or 5.06 mmol of ethyl formate
       will result in blood levels of formic or acetic acid of 1.12 mmol/L or of 2.24 mmol
       H+ -ions/L, assuming a complete dissociation of these acids. This leads to a
       decrease in the blood bicarbonate level from 24 to 21.76 mmol/L. Using the
       Henderson-Hasselbalch equation and taking a pK value for bicarbonate of 6.1
       and a concentration of nondissociated acid in open systems of 1.2 mmol/L, it can
       be calculated that this will cause a blood pH value of 7.38 which is at the low end
       of the normal physiological blood pH-range of 7.37-7.46. In these calculations,
       the extracellular space and other physiological buffering systems are not taken
       into consideration, and a one-hour bolus intake is assumed. Therefore,
       overloading of the buffer capacity of the body and, subsequently, a metabolic
       acidosis is not expected.
       The committee considers the toxicological data base on ethyl formate too poor to
       justify recommendation of a health-based occupational exposure limit.
       The committee concludes that no accumulation of metabolites or metabolic
       acidosis are expected to occur at the present MAC-value, and hence that the
       current MAC value is about right with respect to systemic effects.
       References
ACG99  American Conference of Governmental Industrial Hygienists (ACGIH). Ethyl formate. In:
       TLVs ® and other occupational exposure values -1999. [CD-ROM]. Cincinnati OH, USA:
       ACGIH® , Inc, 1999.
ACG00  American Conference of Governmental Industrial Hygienists (ACGIH). Guide to occupational
       exposure values - 2000. Cincinnati OH, USA: ACGIH® , Inc, 2000: 56.
ACG01  American Conference of Governmental Industrial Hygienists (ACGIH). 2001 TLVs ® and
       BEIs® . Threshold Limit Values for chemical substances and physical agents. Biological
       Exposure Indices. Cincinnati OH, USA: ACGIH® , Inc, 2001: 32.
Alt56  Altenburg LS. The production of mutations in Drosophila by ethyl formate vapor. Genetics
       1956; 41: 632-3.
Amo83  Amoore JE, Hautala E. Odor as an aid to chemical safety: odor thresholds compared with
       threshold limit values and volatilities for 214 industrial chemicals in air and water dilution. J
       Appl Toxicol 1983; 3: 272-90.
Arb00a Arbejdstilsynet. Grænseværdier for stoffer og materialer. Copenhagen, Denmark:
       Arbejdstilsynet, 2000; (At-vejledning C.0.1).
033-9  Ethyl formate
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<pre>Arb00b Arbetarskyddstyrelsen. Hygieniska gränsvärden och åtgärder mot luftföroreningar. Solna,
       Sweden: National Board of Occupational Safety and Health, 2000; (Ordinance AFS 2000/3).
Bis93  Bisesi MS . Esters. In: Clayton GD, Clayton FE, eds. Toxicology. 4th ed. New York: John
       Wiley & Sons, 1993: 2972-5; (Patty’s industrial hygiene and toxicology; Vol II, Pt D).
Car46  Carpenter CP, Smyth HF Jr. Chemical burns of the rabbit cornea. Am J Ophthalmol 1946;
       29: 1363-72.
CEC00  Commission of the European Communities (CEC). Commission Directive 2000/39/EC of 8
       June 2000 establishing a first list of indicative occupational exposure limit values in
       implementation of Council Directive 98/24/EC on the protection of the health and safety of
       workers from the risks related to chemical agents at work. Official Journal of the European
       Communities 2000; L142 (16/06/2000): 47-50.
CTB01  College voor de Toelating van Bestrijdingsmiddelen. Bestrijdingsmiddelendatabank (last
       update: August 2001). http://www.bib.wau.nl/ctb/geel.html.
DFG01  Deutsche Forschungsgemeinschaft (DFG): Commission for the Investigation of Health
       Hazards of Chemical Compounds in the Work Area. List of MAK and BAT values 2001.
       Maximum concentrations and biological tolerance values at the workplace. Weinheim, FRG:
       Wiley-VCH, 2001: 61; (rep no 37).
Flu31  Flury F, Zernik F. Ameisensäureäthylester (Äthylformiat). In: Schädliche Gase. Dämpfe,
       Nebel, Rauch- und Staubarten. Berlin, FRG: Julius Springer Verlag, 1931: 375-6.
Gre98  Greim H, ed. Ethylformiat. In: Gesundheidsschädliche Arbeitsstoffe.
       Toxikologisch-arbeitsmedizinische Begründungen von MAK-Werte (Maximale
       Arbeitsplatz-Konzentrationen). 1st-27th ed. Weinheim, FRG: Wiley-VCH, 1998.
Hag67  Hagan EC, Henson WH, Fitzhugh OG, et al. Food flavourings and compounds of related
       structure. II. Subacute and chronic toxicity. Food Cosmet Toxicol 1967; 5: 141-57.
HSE01  Health and Safety Executive (HSE). EH40/2001. Occupational Exposure Limits 2001.
       Sudbury (Suffolk), England: HSE Books, 2001: 18.
JEC80  Joint FAO/WHOExpert Committee on Food Additives (JECFA). Ethyl formate. In:
       Toxicological evaluation of certain food additives. Geneva, Switzerland: WHO, 1980: 37-9;
       (WHO Food Add Ser No 14).
Jen64  Jenner PM, Hagan EC, Taylor JM, et al. Food flavourings and compounds of related
       structure. I. Acute oral toxicity. Food Cosmet Toxicol 1964; 2: 327-43.
Lit76  Litton Bionetics, Inc. Mutagenic evaluation of compound FDA 75-49 000109-94-4, Ethyl
       formate (food grade). Kensington MD, USA: Litton Bionetics, Inc, 1976 (available from
       NTIS, Springfield VA, USA; rep no PB266890).
Liu97  Liu M, Grant SG, Macina OT, et al. Structural and mechanistic basis for the induction of
       mitotic chromosomal loss and duplication ('malsegregation') in the yeast Saccharomyces
       cerevisiae. Relevance to human carcinogenesis and developmental toxicology. Mutat Res
       1997; 374: 209-31.
033-10 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>Mun72  Munch JC. Aliphatic alcohols and alkyl esters: narcotic and lethal potencies to tadpoles and
       to rabbits. Ind Med Surg 1972; 41: 31-3.
NIO99  National Institute of Occupational Safety and Health (NIOSH). Formic acid, ethyl ester.
       Registry of Toxic Effects of Chemical Substances (RTECS) [CD-ROM], issue July 1999.
       SilverPlatter International, 1999 (last update ethyl formate file: July 1999).
NLM99  US National Library of Medicine (NLM). Ethyl formate. In: Hazardous Substances Data Bank
       (HSDB). [CD-ROM], issue July 1999. SilverPlatter International, 1999 (last update ethyl
       formate file: January 1999).
Oet59  von Oettingen WF. The aliphatic acids and their esters - toxicity and potential dangers.
       AMA Arch Ind Health 1959; 20: 517-31.
Ric94  Richardson ML, Gangolli S, eds. E133 Ethyl formate. In: The dictionary of substances and
       their effects. (Vol. 4). Cambridge, UK: Royal Society of Chemistry, 1994: 100-2.
Smy54  Smyth HF Jr, Carpenter CP, Weil CS, et al. Range-finding toxicity data. List V. Arch Ind Hyg
       Occup Med 1954; 10: 61-8.
Sto73  Stoner, GD, Shimkin, MB, Kniazeff, AJ, et al. Test for carcinogenicity of food additives and
       chemotherapeutic agents by the pulmonary tumor response in strain A mice. Cancer Res
       1973; 33: 3069 -85.
SZW01  Ministerie van Sociale Zaken en Werkgelegenheid (SZW). Nationale MAC-lijst 2001. The
       Hague, the Netherlands: Sdu, Servicecentrum Uitgevers, 2001: 27.
Tra74  Tracor-Jitco, Inc. Scientific literature reviews on generally recognized as safe (GRAS) food
       ingredients-formic acid and derivatives. Rockville MD, USA: Tracor-Jitco, Inc, 1974
       (available from NTIS, Springfield VA, USA; order no PB-228558).
TRG00  TRGS 900. Grenzwerte in der Luft am Arbeitsplatz; Technische Regeln für Gefahrstoffe.
       BArbBl 2000; 2.
Ver80  Verrett MJ, Scott WF, Reynaldo EF, et al. Toxicity and teratogenicity of food additive
       chemicals in the developing chicken embryo. Toxicol Appl Pharmacol 1980; 56: 265 -73.
Zim85  Zimmermann FK, Mayer VW, Scheel I, et al. Acetone, methyl ethyl ketone, ethyl acetate,
       acetonitrile and other polar aprotic solvents are strong inducers of aneuploidy in
       Saccheromyces cerevisiae. Mutat Res 1985; 149: 339 -51.
033-11 Ethyl formate
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<pre>            Annex
Occupational exposure limits for ethyl formate in various countries.
country                                 occupational                time-weighted      type of        notea   lit refb
- organisation                          exposure limit              average            exposure limit
                                        ppm          mg/m 3
The Netherlands
- Ministry of Social Affairs and        100          300            8h                 administrative         SZW01
Employment
Germany
- AGS                                   100          300            8h                                        TRG00
                                        100          300            15 min
- DFG MAK-Kommission                    100          310            8h                 MAK            S; d    DFG01
                                        100          310            15 min c
Great Britain
- HSE                                   100          308            8h                 OES                    HSE01
                                        150          402            15 min
Sweden                                  -            -                                                        Arb00b
Denmark                                 100          300            8h                                        Arb00a
USA
- ACGIH                                 100          303            8h                 TLV                    ACG01
- OSHA                                  100          300            8h                 PEL                    ACG00
- NIOSH                                 100          300            10 h               REL                    ACG00
European Union
- SCOEL                                 -            -                                                        CEC00
a
     S = skin notation; which means that skin absorption may contribute considerably to the body burden; sens =
     substance can cause sensitisation
b
     Reference to the most recent official publication of occupational exposure limits
c
     Maximum frequency per shift: 4, with a minimum interval between peaks of 1 hour
d
     Classified in pregnancy risk group C, i.e., there is no reason to fear a risk of damage to the embryo or fetus
     when MAK and BAT (Biological Tolerance Value for Working Materials) values are observed
033-12      Health-based Reassessment of Administrative Occupational Exposure Limits
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