<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>      Paraffin wax (fume)
      (CAS No: 8002-74-2)
      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/064, The Hague, 3 March 2003
064-1
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<pre>      Preferred citation:
      Health Council of the Netherlands: Committee on Updating of Occupational
      Exposure Limits. Paraffin wax (fume); Health-based Reassessment of
      Administrative Occupational Exposure Limits. The Hague: Health Council of
      the Netherlands, 2003; 2000/15OSH/064.
      all rights reserved
064-2
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<pre>1     Introduction
      The present document contains the assessment of the health hazard of paraffin
      wax fume 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. and H Stouten, M.Sc. (TNO
      Nutrition and Food Research, Zeist, the Netherlands).
          The evaluation of the toxicity of paraffin wax (fume) has been based on the
      review by the American Conference of Governmental Industrial Hygienists
      (ACG91). Where relevant, the original publications were reviewed and
      evaluated as will be indicated in the text. In addition, literature was retrieved
      from the on-line databases Medline, Toxline, and Chemical Abstracts covering
      the period 1966 to November 1997, 1965 to October 1997, and 1967 to
      November 1997, respectively, and using (combinations of) the following key
      words: paraffin, wax, fume, and 8002-74-2. HSDB (no record) and RTECS,
      databases available from CD-ROM, were consulted as well (NIO97, NLM97).
      The final literature search was carried out in November 1997.
          In February 1999, the President of the Health Council released a draft of the
      document for public review. The committee received no comments.
          An additional literature search in May 2002 did not result in information
      changing the committee's conclusions.
2     Identity
       name                    :    paraffin wax (fume)
       synonyms                :    hydrocarbon waxes; Ceratak; Gatch; hard paraffin; Slopvox;
                                    paraffin
       molecular formula       :    CnH2n+2 (C20 to C50)
       CAS number              :    8002-74-2
      Data from ACG91, EC00.
064-3 Paraffin wax (fume)
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<pre>3     Physical and chemical properties
       molecular weight         :   350-420
       boiling point            :   -
       melting point            :   46-68oC
       flash point              :   >215oC
       vapour pressure          :   not volatile
       solubility in water      :   insoluble
       log Poctanol/water       :   >6 (estimated)
       conversion factors       :   -
       (20oC, 101.3 kPa)
      Data from ACG91, EC00.
      Paraffin wax is a white or slightly yellow, odourless solid, obtained from
      petroleum (ACG91). Generally, petroleum waxes are rarely characterised in
      terms of boiling range and autoflammability. They are very non-volatile
      materials, almost totally insoluble in water, and do not contain any oxidising
      constituent. Petroleum waxes consists of high-molecular-weight alkanes and
      cycloalkanes. There are 3 classifications, viz., paraffin, intermediate, and
      microcrystalline waxes. Paraffin waxes, the subject of this evaluation, typically
      contain C20-C50 n-alkanes with smaller quantities of iso-alkanes. They form
      visible crystalline structures, and are also known as macrocrystalline waxes
      (EC00).
4     Uses
      Paraffin wax is used for making candles; as a sealant or coating for paper and
      food products; in extracting perfumes from flowers; as a chewing gum base; as
      a stiffening ingredient in pharmaceutical ointment and salve bases; in
      paraffin-wax baths for the relief of pain (ACG91, Moo84, Ric94). In cosmetics,
      paraffin wax is used in baby products, eye and facial makeup preparations,
      fragrance products, colouring and non-colouring hair preparations, manicuring
      products, personal cleanliness preparations, shaving and skin care products, and
      suntan preparations (Moo84).
064-4 Health-based Recommended Occupational Exposure Limits
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<pre>5     Biotransformation and kinetics
      Paraffin is considered to be neither absorbed nor digested (ACG91).
           The skin is impermeable to hydrocarbons with a molecular structure above
      20 carbon atoms, e.g., paraffin substances (WHO82).
6     Effects and mechanism of action
      Human data
      Pure paraffin wax and paraffin-wax-containing products were tested for their
      potential skin irritation by 24-hour single applications under occlusion to the
      forearm or upper back and readings immediately after removal of patches.
      Testing 2 samples of 100% pure paraffin wax in 20 volunteers each resulted in
      only one case of a barely perceptible erythema at one sample and one case of a
      pink uniform erythema at the other sample, all the others being negative. Three
      8% paraffin-wax-containing products and one 15% paraffin-wax-containing
      product produced no irritation in 18, 19, 20, and 19 subjects, respectively. Out
      of four 16% paraffin-wax-containing formulations, one produced a mild
      erythema in 1/17 subjects, the second erythema in 2/18 subjects, and the third
      erythema in 9/18 (maximum score observed: 0.75) while application of the
      fourth formulation resulted in a maximum irritation score of 0.35 out of a
      maximum possible score of 40 (all unpublished studies, cited by Moo84).
           In a 21-day cumulative irritancy test, patches with a 5%
      paraffin-wax-containing formulation were applied daily to the same site on the
      backs of each of 10 subjects for 4 consecutive days. Patches remained in contact
      with the skin for 23 hours and scores were read just before the next patch
      application. This procedure resulted in an irritation score of 18 out of a
      maximum possible score of 630 (unpublished study, cited by Moo84). No
      irritation was reported in 187 women after 2-week daily use of a 5%
      paraffin-wax-containing cosmetic product (unpublished study, cited by Moo84).
           When an undiluted 15% paraffin-wax-containing product was applied under
      occlusion to the back or arm of 48 subjects, every other day for a total of 9-15
      induction results, followed by a challenge application to an adjacent untreated
      site after a 10-21-day rest, no irritation or sensitisation was observed. Reactions
      were scored immediately, and 24, 48, and 72 hours after removing patches
      (unpublished study, cited by Moo84).
064-5 Paraffin wax (fume)
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<pre>          No irritation and no sensitisation was observed in 3 different groups of 25,
      30, and 39 subjects, respectively, when testing a 5% paraffin-wax-containing
      formulation. The test material was applied under occlusion to the same site of
      the volar forearm for five 48-hour periods. The patch sites were pre-treated for
      24 hours with 2.5% aqueous sodium lauryl sulphate under occlusion. After a
      14-day rest, challenge patches were applied and sites were read immediately
      after and 24 hours after patch removal (unpublished studies, cited by Moo84).
      Paraffin fumes (exposure levels not reported) are stated to be mildly irritating to
      the human eye, nose, and throat (Ric94).
          Work around molten paraffin is reported to be uncomfortable and
      nauseating as is the use of paraffin sprays in printing shops. Concentrations of
      paraffin fume of 0.6 to 1.0 mg/m3 were found mildly disagreeable by workers in
      one plant, but in other plants, no complaints or discomfort were recorded at
      levels up to 2 mg/m3 (ACG91).
          A possible association has been observed between a decrease in lung
      function (forced expiratory volume in one second, FEV1) and occupational
      exposure to waxes, estimated by job exposure matrices. In women, FEV1 was
      reported to be significantly decreased with the level of exposure, but no
      information is given on the actual exposure levels (LeM95).
          The effects of using ski waxes, containing mostly paraffins but also, in some
      cases, silicone compounds and, in one case, polytetrafluoroethylene have been
      examined in 5 male professional waxers (40-50-year old; 2 smokers; 3
      non-smokers) after waxing for 2-3 hours. The components were stated to
      vaporise on heating and to condense rapidly on cooling in air to smoke
      consisting of particles less than 1 µm in diameter. Exposure levels ranged from
      0.62-2.36 and from 0.18-1.60 mg/m3, when determined by personal sampling
      and stationary measurements, respectively. These total dust concentrations,
      consisting of C17 to C40 straight aliphatic hydrocarbons, were found to correlate
      with the intensity of ski waxing. The main findings were an increase in
      complaints including itching eyes, rhinitis, coughing, and breathlessness and a
      decrease in lung function as indicated by an average decrease of 15% of the
      diffusion capacity. This decrease occurred immediately after waxing, varied
      between 10 and 25%, and tended to increase upon repeated exposure. There was
      some recovery after a night’s break. It was found both in smokers and in
      non-smokers, and therefore attributed to ski waxing rather than to smoking.
      From results from blood samples taken one to 2 days after waxing, there were
      no indications of systemically toxic effects, including inflammation and
064-6 Health-based Recommended Occupational Exposure Limits
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<pre>      immunological responses (parameters: haemoglobin, mean cell haemoglobin
      concentration, volume fraction of erythrocytes, white blood cell counts, red
      blood cell counts, platelet counts, acute inflammatory protein, liver function
      tests, immunoglobulins) (Dah92).
          In a Swiss study, pulmonary function, determined as CO-diffusion capacity,
      was decreased for at least 24 hours in 5 healthy volunteers exposed to hot ski
      wax, containing paraffin and Cera-F. No changes were observed in the dynamic
      and static lung volumes. No information was given on the actual exposure
      levels (Knö92).
          It should be kept in mind that ski wax in the form of a spray can contain
      appreciable levels of organic solvents, i.e., toluene and benzene. During waxing
      procedures, also exposure to the solvents can occur as can be observed from
      markedly elevated levels of urinary hippuric acid (Sug87).
          Hydrocarbons with 21-23 carbon atoms, e.g., paraffins, were found to be
      non-dermatotoxic (WHO82).
      Animal data
      Irritation
      No irritation was observed when rabbits (n=9) were treated for 24 hours
      applying 3 x 0.5 mL of the test substance to the clipped intact skin and covering
      with a closed patch. Treating 6 rabbits for 24 hours applying 3 x 0.5 mL of a
      50/50 blend of paraffin wax and petrolatum to the clipped intact skin and
      covering with an open patch caused slight irritation consisting of a 3-day-lasting
      erythema produced by 2 samples (out of 3 tested) in 4 animals and of a
      2-day-lasting erythema in a single animal produced by the third sample. Closed-
      and open-patch testing of 4 cosmetic formulations containing 8% paraffin wax
      resulted in minimal to severe and no to minimal irritation, respectively. The
      tests were repeated 3 times. A 15% paraffin-wax-containing formulation was
      minimally irritating in a single, open insult patch test while single, closed-patch
      testing of three 16% paraffin-wax-containing formulations resulted in scores
      indicative of mild to minimal irritation (no more information available) (all
      unpublished studies, cited by Moo84).
          Instillation of 0.1 mL of a 50/50 blend of paraffin wax and petrolatum into
      the eyes of rabbits (n=6) was found slightly irritating. Of the 4 samples tested, 2
      caused mild irritation in one animal at the 24-hour observation point. All other
      observations were negative (no rinsing; observation time: 3 days). No signs of
064-7 Paraffin wax (fume)
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<pre>      irritation or corneal damage was observed up to 72 hours following instillation
      of 0.1 mL of a 5% paraffin-wax-containing cosmetic product into the left eyes
      of monkeys (n=6). Three treated eyes were washed 30 minutes after instillation
      while the other eyes were not rinsed. When 0.1 mL of another, similar product
      was instilled into the eyes of monkeys (n=6) and albino rabbits (n=9; rinsing in
      3), no irritation or damage was seen in monkeys. In rabbits, there was minimal
      conjunctival redness at 48 hours after instillation in 4/6 and 2/3 animals with
      unrinsed and rinsed eyes, respectively (observation points: 24, 48, and 72 hours,
      and 4 and 7 days). Testing of four 8% and three 16% paraffin-wax-containing
      products in rabbits (n=6/product) caused mild irritation 24 or 48 hours after
      instillation in one animal in each test while a 15% paraffin-wax-containing
      formulation caused mild irritation in 3/6 animals at 24 hour (observation time: 3
      days) (all unpublished studies, cited by Moo84). Paraffin wax, implanted in
      eyes of rabbits (to study its use as an implant material for substitution of
      silicone sponges), elicited an intense foreign body response but had no adverse
      effects on the ciliary and conjunctival epithelial and the retina (Mur83).
      Acute toxicity
      A dermal LD50 of >3600 mg/kg was reported in rabbits when one single dose of
      50% paraffin wax of 4 mL/kg bw was applied under occlusion for 24 hours.
      There were no systemic effects or abnormalities at necropsy (no more details
      available) (unpublished study, cited by Moo84).
           In 2 separate tests, single oral (gavage) doses of 5000 mg/kg bw of pure
      (100%) paraffin and a 75% solution in corn oil, respectively, were not lethal to
      rats (n=5 and 6, respectively) (no more details available) (unpublished study,
      cited by Moo84). Administration of an amount of a cosmetic product containing
      5% paraffin wax did not cause toxic effects or abnormalities at necropsy in 4/4
      dogs (dose: 25 mL/kg bw) but mortality in 1/10 rats (dose: 60 mL/kg bw), the
      other animals being unaffected. Findings in the dead animal included urinary
      staining of the abdomen and intestines filled with red fluid (observation time: 14
      days). No deaths were found when cosmetic products containing 8 or 16%
      paraffin wax were given to rats at amounts of 10,000 and 8000 mg/kg bw,
      respectively (observation time: 7 days) (no more details available) (unpublished
      studies, cited by Moo84).
064-8 Health-based Recommended Occupational Exposure Limits
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<pre>      Repeated-dose toxicity
      Daily dermal application (site and conditions not reported) of a 8%
      paraffin-containing cosmetic product, 5 days/week, for 13 weeks, to groups of
      female albino rats (strain and number not reported) at dose levels of at least 100
      times the normal use concentration (not further specified) did not cause
      systemic toxic or abnormal cumulative dermal effects (no more information
      available; unpublished study, cited by Moo84).
          Subchronic feeding studies with paraffin waxes (10-3000 mg/kg/day) in
      Fischer 344 rats have been reported to result in accumulation of paraffin wax in
      tissues and a dose-dependent increase in inflammatory responses consisting of
      histiocytosis of the mesenteric lymph nodes, liver microgranulomas, and
      inflammatory thickening at the base of the mitral valve of the heart. These
      findings are probably a specific property of the Fischer strain of rats, because in
      other rat strains (Sprague-Dawley and Long-Evans), and in dogs, these
      inflammatory responses have not been observed (Mil96). In a later study in
      which female Fischer 344 and Sprague-Dawley (SD) rats were given 2% of
      low- melting-point paraffin wax in the diet (i.e., 1000 mg/kg bw/day, assuming
      a body weight of 200 mg and a food intake of 10 g/day) for 60 days, the
      aforementioned findings were confirmed. In Fischer 344 rats only, effects on
      the liver were found consisting of granuloma formation/lymphoid cell
      aggregates with small areas of necrosis and significant increases in serum
      alanine and aspartate transferase as well as γ-glutamyltransferase activities. In
      addition, detectable amounts of this paraffin wax were present only in the livers
      of the treated Fischer 344 rats. Further, in Fischer 344 rats only, paraffin wax
      was present in Kupfer cells. These cells were markedly activated or otherwise
      altered both functionally and morphologically (presence of large, irregularly
      shaped, membrane-associated vacuoles; increased phagocytic activity and nitric
      oxide and superoxide anion production; decreased LPS-stimulated production
      of TNF and LTB4) when compared to Kupfer cells from SD or control rats.
      Through the altered production of inflammatory mediators, the Kupfer cells
      were thought to play a direct role in paraffin wax-induced formation of
      granulomas (Hog98).
      Carcinogenicity
      Different samples of petroleum wax, when applied by repeated skin application
      to mice, did not result in carcinogenic effects. When 5 petroleum waxes were
064-9 Paraffin wax (fume)
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<pre>       subcutaneously implanted in disc form in mice, fibrosarcomas developed
       around the implants with incidences that correlated to the melting points of the
       waxes. It was concluded that the sarcomas developed as a result of the physical
       rather than the chemical properties of the substance (WHO82).
           In a long-term study, the incidence of tumours following a diet containing
       10% ground wax was similar to that in control animals (Eke93).
           In a series of 180-day feeding studies in rats with chewing-gum bases
       containing hydrocarbon wax in proportions ranging from 2-57% of the gum
       base, no compound-related effects were observed (Eke93).
           Implantation of paraffin wax pellets in the bladder of Fischer 344 rats
       promoted the formation of tumours in the bladder. Tumour formation was found
       to be strictly dependent on the simultaneous presence of urine. The authors
       concluded that the presence of an (unidentified) factor or substance in the urine
       together with a foreign body (the pellet) was responsible for the induction of
       tumours (Cha73). In this respect, the bladder model resembles the solid state
       carcinogenesis process in the skin implantation test (see above).
           In another study, paraffin wax pellets were surgically implanted into the
       bladder lumen of mice. The tumour response to paraffin wax significantly
       depended on the type of pellet used. Paraffin wax pellets made in Leeds, UK,
       induced 10.6, 26.7, and 53.8% bladder tumours after approximately 45, 75, and
       105 weeks, respectively; paraffin wax pellets prepared in Vancouver, Canada, 0
       and 33.3% tumours after approximately 45 and 75 weeks, respectively. The
       progressions of lesions in time and the presence of mucosal inflammation in the
       majority of bladders suggest a non-genotoxic mechanism for the induction of
       bladder tumours. Incorporation of known carcinogens into the pellet enhanced
       the proliferative response somewhat. Unresolved questions are rate of diffusion
       of the carcinogen from the pellet and its stability (Jul79).
       The committee did not find data on the irritation, acute and repeated-dose
       toxicity, including carcinogenicity or reproduction toxicity, and genotoxicity or
       mutagenicity of paraffin wax fumes or on the genotoxicity, mutagenicity, and
       reproduction toxicity of paraffin waxes.
7      Existing guidelines
       The current administrative occupational exposure limit (MAC) of paraffin wax
       fume in the Netherlands is 2 mg/m3, 8-hour TWA.
064-10 Health-based Recommended Occupational Exposure Limits
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<pre>            Existing occupational limits in some European countries and in the USA are
       summarised in the annex.
8      Assessment of health hazard
       Paraffin wax and paraffin-wax-containing products were at most slightly
       irritating but not sensitising to human skin. There is some information that these
       fumes can cause irritation of the eyes and the respiratory tract and impairment
       of lung function. There is only one study available in which both exposure
       levels and effects were reported. In this study, an increase in subjective
       symptoms and a decrease in pulmonary lung function was observed in 5
       professional ski waxers after exposure for 2 to 3 hours to mean dust levels of
       approximately 0.6 to 2.4 mg/m3. However, since waxes containing other
       compounds such as silicones and polytetrafluoroethylene were used as well, it
       cannot be assessed to what extent the effects found can be attributed to
       paraffins. The committee did not find data on effects following long-term
       occupational exposure to paraffin wax fumes.
            In experimental animals, undiluted pure paraffin wax did not cause irritation
       to the skin of rabbits while application of a 50/50 mixture of paraffin wax in
       petrolatum or of products containing 8-16% paraffin wax produced minimal to
       severe irritation. Instillation of 50% solutions or of products containing 5-16%
       paraffin wax caused no or minimal irritation to the eyes of rabbits.
            A single dermal application of a dose of 4 mL/kg bw or a single oral dose of
       5000 mg/kg bw did not affect rabbits or rats, respectively. Upon subchronic oral
       administration of 10 to 3000 mg/kg bw, there were no effects in dogs or
       Long-Evans or Sprague-Dawley rats, while in Fischer 344 rats, dose-dependent
       inflammatory responses were seen in lymph nodes, the liver, and the heart. No
       increased tumour incidence was observed after topical, subcutaneous, or oral
       administration to rats. Bladder tumours reported in rats and mice following
       implantation of paraffin-wax-containing pellets in the bladder are not
       considered to be compound related.
            The committee did not find experimental animal data on the irritation, acute
       and repeated-dose toxicity, including carcinogenicity or reproduction toxicity,
       and genotoxicity or mutagenicity of paraffin wax fumes or on the genotoxicity,
       mutagenicity, and reproduction toxicity of paraffin waxes.
       The committee considers the toxicological database on paraffin wax fume too
       poor to justify recommendation of a health-based occupational exposure limit.
064-11 Paraffin wax (fume)
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<pre>       The committee concludes that there is insufficient information to comment on
       the level of the present MAC-value.
064-12 Health-based Recommended Occupational Exposure Limits
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<pre>       References
ACG91  American Conference of Governmental Industrial Hygienists (ACGIH). Paraffin wax fumes. In:
       Documentation of the threshold limit values and biological exposure indices. 6th ed. Cincinnati OH,
       USA: ACGIH, 1991: 801-2.
ACG02a American Conference of Governmental Industrial Hygienists (ACGIH). Guide to occupational
       exposure values - 2002. Cincinnati OH, USA: ACGIH®, Inc, 2002: 99.
ACG02b American Conference of Governmental Industrial Hygienists (ACGIH). 2002 TLVs® and BEIs®.
       Threshold Limit Values for chemical substances and fysical agents. Biological Exposure Indices.
       Cincinnati OH, USA: ACGIH®, Inc, 2002: 46.
Arb02  Arbejdstilsynet. Grænseværdier for stoffer og materialer. Copenhagen, Denmark: Arbejdstilsynet,
       2002: 33 (At-vejledning C.0.1).
Cha73  Chapman WH, Kirchheim D, McRoberts JW. Effect of the urine and calculus formation on the
       incidence of bladder tumors in rats implanted with paraffin wax pellets. Cancer Res 1973; 33:
       1225-29.
Dah92  Dahlqvist M, Alexandersson R, Andersson B, et al. Exposure to ski-wax smoke and health effects in
       ski waxers. Appl Occup Environ Hyg 1992; 7: 689-93.
DFG02  Deutsche Forschungsgemeinschaft (DFG): Senatskommission zur Prüfung gesundheitsschädlicher
       Arbeitsstoffe. MAK- und BAT-Werte-Liste 2002. Maximale Arbeitsplatzkonzentrationen und
       Biologische Arbeitsstofftoleranzwerte. Weinheim, FRG: Wiley-VCH, 2002; rep no 38.
EC00   European Commission (EC) - European Chemicals Bureau (ECB). IUCLID Dataset - paraffin
       waxes and hydrocarbon waxes. In: Public data on high volume chemicals. IUCLID CD-ROM. Year
       2000 ed. Ispra, Italy: European Commission, Joint Research Centre, Institute for Health and
       Consumer Protection, European Chemicals Bureau, 2000.*
EC02   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.
Eke93  Ekelman KB. Microcrystalline wax and paraffin wax. In: Toxicological evaluation of certain food
       additives and naturally occuring toxicants. Geneva, Switzerland: World Health Organization/
       International Programme on Chemical Safety, 1993: 253-60 (WHO Food Additive Series; Vol 30).
Hog98  Hoglen NC, Regan SP, Hensel JL, et al. Alteration of Kupffer cell function and morphology by low
       melt point paraffin wax in female Fischer-344 but not Sprague-Dawley rats. Toxicol Sci 1998; 46:
       176-84.
HSE02  Health and Safety Executive (HSE). EH40/2002. Occupational exposure limits 2002. Sudbury
       (Suffolk), England: HSE Books, 2002: 23.
*      This dossier is a compilation based on data reported by the European Chemicals Industry following ‘Council
       Regulation (EEC) No 793/93 on the Evaluation and Control of the Risks of Existing Substances’ to allow a risk
       assessment by member states of the EC. However, the data in this dossier have not undergone any evaluation by
       any EC member state yet.
064-13 Paraffin wax (fume)
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<pre>Jul79  Jull JW. The effect of time on the incidence of carcinomas obtained by the implantation of paraffin
       wax pellets into mouse bladder. Cancer Lett 1979; 6: 21-5.
Knö92  Knöpfli B, Güntensperger U, Schibler A, et al. Akute Verschlechterung der CO-Diffusionskapazität
       nach Exposition mit Skiwachsdämpfen. Schweiz Rundsch Med Prax 1992; 81: 884-7.
LeM95  Le Moual N, Orlowski E, Schenker MB, et al. Occupational exposures estimated by means of job
       exposure matrices in relation to lung function in the PAARC survey. Occup Environ Med 1995; 52:
       634-43.
Mil96  Miller MJ, Lonardo EC, Greer RD, et al. Variable responses of species and strains to white mineral
       oils and paraffin waxes. Regul Toxicol Pharmacol 1996; 23: 55-68.
Moo84  Moore A. Final report on the safety assessment of fossil and synthetic waxes. J Am Coll Toxicol
       1984; 3(3): 43-99.
Mur83  Murthy RK, Rajkumar KN, Shankar SK. Study of ocular response to paraffin wax. Indian J
       Ophthalmol 1983; 31: 511-6.
NIO97  US National Institute of Occupational Safety and Health (NIOSH). Registry of Toxic Effects of
       Chemical Substances (RTECS) [CD-ROM], issue April 1997. SilverPlatter International, 1997 (last
       update paraffin wax (fume) file: April 1997).
NLM97  US National Library of Medicine (NLM). Hazardous Substances Data Bank (HSDB) [CD-ROM],
       issue March 1997. SilverPlatter International, 1997.
Ric94  Richardson ML, Gangolli S, eds. P6. Paraffin wax. In: The dictionary of substances and their effects.
       Cambridge, UK: Royal Society of Chemistry, 1994: 399-400 (Vol 6).
Sug87  Sugita M, Aikawa H, Yamasaki T, et al. Urinary hippuric acid excretion after use of spray ski-wax
       and remover. Tokai J Exp Clin Med 1987; 12: 215-22.
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.
SZW02  Ministerie van Sociale Zaken en Werkgelegenheid (SZW). Nationale MAC-lijst 2002. The Hague,
       the Netherlands: Sdu, Servicecentrum, 2002: 37.
TRG00  TRGS 900. Grenzwerte in der Luft am Arbeitsplatz; Technische Regeln für Gefahrstoffe. BArbBl
       2000; 2.
WHO82  World Health Organization (WHO): International Programme on Chemical Safety (IPCS). Selected
       petroleum products. Geneva, Switzerland: WHO/IPCS, 1982; Environmental Health Criteria; Vol
       20.
064-14 Health-based Recommended Occupational Exposure Limits
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<pre>             Annex
Occupational exposure limits for paraffin wax fume 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   -          2               8h              administrative             SZW02
and Employment
Germany
-AGS                          -          -                                                          TRG00
-DFG MAK-Kommission           -          -                                                          DFG02
Great-Britain
-HSE                          -          2               8h              OES                        HSE02
                                         6               15 min
Sweden                        -          -                                                          Swe00
Denmark                       -          2               8h                                         Arb02
USA
-ACGIH                        -          2               8h              TLV                        ACG02b
-OSHA                         -          -                                                          ACG02a
-NIOSH                        -          2               10 h            REL                        ACG02a
European Union
-SCOEL                        -          -                                                          EC02
a
     S = skin notation; this 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.
064-15       Paraffin wax (fume)
</pre>

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