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Registry of Toxic Effects of Chemical Substances (RTECS)

Maleic anhydride

RTECS #

ON3675000

CAS #

108-31-6

Updated

October 2017

Molecular Weight

98.06

Molecular Formula

C4H2O3

Synonyms

2,5-Furandione
Anhydrid kyseliny maleinove (Czech)
cis-Butenedioic anhydride
Maleic acid anhydride
Maleic anhydride (ACGIH:OSHA)
Maleinanhydrid (Czech)
RCRA waste number U147
Toxilic anhydride

Skin and Eye Irritation and References

Route/OrganismDoseEffectReference
eye /rabbit 1% severeAJOPAA 29,1363,1946

Mutation Data and Reference

System TestRoute/Organism/TissueDoseReference
Cytogenetic Analysislung/hamster230 mg/LGMCRDC 27,95,1981

Reproductive Effects Data and References

Route/OrganismDoseEffectReference
oral/rat 4060 mg/kg (multigenerations)Reproductive: Effects on newborn: Growth statistics (e.g., reduced weight gain)FAATDF 7,359,1986
oral/rat 1400 mg/kg (6-15D pregnant)Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus)NTIS** OTS0555583
oral/rat 150 mg/kg (multigeneration)Reproductive: Effects on fertility: Female fertility index (e.g., # females pregnant per # sperm positive females; # females pregnant per # females mated)

Reproductive: Effects on fertility: Male fertility index (e.g., # males impregnating females per # males exposed to fertile nonpregnant females)
NTIS** OTS0555583
oral/rat 12000 mg/kg (multigeneration)Reproductive: Other effects on male

Reproductive: Other effects on female
HPV041 -,-,2002

Tumorigenic Data and References

Route/OrganismDoseEffectReference
subcutaneous/rat lowest published toxic dose: 1220 mg/kg/61W- intermittentTumorigenic: Equivocal tumorigenic agent by RTECS criteria

Tumorigenic: Tumors at site of application
BJCAAI 17,100,1963

Acute Toxicity Data and References

Route/OrganismDoseEffectReference
In Vitro/Human, leukemia cells Inhibitor Concentration (25 percent kill): 658.0 mg/L/24HIn Vitro Toxicity Studies: Cell viability (dye exclusion): trypan blue assay etc.TIVIEQ 26,1150,2012
In Vitro/Human, lung fibroblast Inhibitor Concentration Low: 5040 µmol/L/6HIn Vitro Toxicity Studies: Other assaysTIVIEQ 28,209,2014
In Vitro/Human, monocyte Inhibitor Concentration Low: 1800 mg/L/2HIn Vitro Toxicity Studies: Other assaysTIVIEQ 27,1233,2013
In Vitro/Human, skin Inhibitor Concentration Low: 40 mg/well/3MIn Vitro Toxicity Studies: Cell viability (mitochondrial reductase assays): MTT, XTT, MTS, WSTs assays etc.TIVIEQ 28,616,2014
In Vitro/Human, skin Inhibitor Concentration (20 percent kill): 0.5 mg/L/24HIn Vitro Toxicity Studies: Cell viability (mitochondrial reductase assays): MTT, XTT, MTS, WSTs assays etc.TIVIEQ 27,1127,2013
In Vitro/jrdInhibitor Concentration (50 percent kill): 187.9 mg/L/24HIn Vitro Toxicity Studies: Other assaysTIVIEQ 28,626,2014
intraperitoneal/rat lethal dose (50 percent kill): 97 mg/kg85GMAT -,79,1982
oral/guinea pig lethal dose (50 percent kill): 390 mg/kg85GMAT -,79,1982
oral/mouse lethal dose (50 percent kill): 465 mg/kgGTPZAB 13(4),42,1969
oral/rabbit lethal dose (50 percent kill): 875 mg/kg85GMAT -,79,1982
oral/rat lethal dose (50 percent kill): 400 mg/kgIAEC** 17JUN1974
skin/guinea pig lethal dose (50 percent kill): >20 gm/kgIAEC** 17JUN1974
skin/rabbit lethal dose (50 percent kill): 2620 mg/kgTXAPA9 42,417,1977

Other Multiple Dose Data and References

Route/OrganismDoseEffectReference
inhalation/hamster lowest published toxic concentration: 3 mg/m3/24W- intermittentLung, Thorax, or Respiration: Other changes

Nutritional and Gross Metabolic: Weight loss or decreased weight gain

Biochemical: Metabolism (intermediary): Effect on inflammation or mediation of inflammation
HPV041 -,-,2002
inhalation/monkey lowest published toxic concentration: 3 mg/m3/24W- intermittentLung, Thorax, or Respiration: Other changes

Nutritional and Gross Metabolic: Weight loss or decreased weight gain

Biochemical: Metabolism (intermediary): Effect on inflammation or mediation of inflammation
HPV041 -,-,2002
inhalation/rat lowest published toxic concentration: 500 µg/m3/5D- intermittentImmunological Including Allergic: Increase in humoral responseTOXID9 60,173,2001
inhalation/rat lowest published toxic concentration: 3 mg/m3/24W- intermittentLung, Thorax, or Respiration: Other changes

Nutritional and Gross Metabolic: Weight loss or decreased weight gain

Biochemical: Metabolism (intermediary): Effect on inflammation or mediation of inflammation
HPV041 -,-,2002
inhalation/rat lowest published toxic concentration: 9800 µg/m3/6H/26W- intermittentBlood: Changes in spleen

Nutritional and Gross Metabolic: Weight loss or decreased weight gain
FAATDF 10,517,1988
oral/rat lowest published toxic dose: 5760 mg/kg/24W- intermittentBlood: Changes in leukocyte (WBC) countHPV041 -,-,2002
skin/mouse lowest published toxic dose: 686 mg/kg/13D- intermittentImmunological Including Allergic: Increase in cellular immune response

Immunological Including Allergic: Hypersensitivity delayed (multiple organ involvement)
JJATDK 20,221,2000
skin/mouse lowest published toxic dose: 3 mg/kg/3D- intermittentImmunological Including Allergic: Increase in cellular immune responseJJATDK 20,221,2000
skin/mouse lowest published toxic dose: 150 mg/kg/3D- intermittentSkin: After topical application: Cutaneous sensitization (experimental)TXCYAC 193,191,2003

Reviews

OrganizationStandardReference
American Conference of Governmental Industrial Hygienists (ACGIH)Threshold Limit Value-time-weighted average 0.01 mg/m3 (inhal, vapor, sen)DTLVS* TLV/BEI,2013
American Conference of Governmental Industrial Hygienists (ACGIH)Threshold Limit Value-Not classifiable as a human carcinogenDTLVS* TLV/BEI,2013
TOXICOLOGY REVIEW85CVA2 5,250,1970
TOXICOLOGY REVIEWFCTOD7 55,596,2013

Standards and Regulations

OrganizationStandardReference
Mine Safety and Health Administration (MSHA) STANDARD-airtime-weighted average 0.25 ppm (1 mg/m3)DTLVS* 3,148,1971
Occupational Exposure Limit IN ARGENTINA, BULGARIA, COLOMBIA, JORDAN check ACGIH TLV;
Occupational Exposure Limit IN SINGAPORE, VIETNAM check ACGIH TLV
Occupational Exposure Limit-AUSTRALIAtime-weighted average 0.25 ppm (1 mg/m3), JUL2008
Occupational Exposure Limit-AUSTRIAMAK-TMW 0.1 ppm (0.4 mg/m3);KZW 0.2 ppm (0.8 mg/m3), sen, 2007
Occupational Exposure Limit-BELGIUMtime-weighted average 0.1 ppm (0.41 mg/m3), MAR2002
Occupational Exposure Limit-DENMARKtime-weighted average 0.1 ppm (0.4 mg/m3), MAY2011
Occupational Exposure Limit-FINLANDtime-weighted average 0.1 ppm (0.41 mg/m3), ceiling concentration 0.2 ppm (0.81 mg/m3), NOV2011
Occupational Exposure Limit-FRANCEVLE 1 mg/m3, FEB2006
Occupational Exposure Limit-GERMANYMAK 0.1 ppm (0.41 mg/m3), 2011
Occupational Exposure Limit-HUNGARYtime-weighted average 0.4 mg/m3, short term exposure limit 0.4 mg/m3, SEP2000
Occupational Exposure Limit-ICELANDtime-weighted average 0.1 ppm (0.4 mg/m3), sen, NOV2011
Occupational Exposure Limit-JAPANOccupational Exposure Limit 0.1 ppm (0.4 mg/m3), Occupational Exposure Limit-continuous 0.2 ppm (0.8 mg/m3), a2 sen, s2 sen, MAY2012
Occupational Exposure Limit-KOREAtime-weighted average 0.25 ppm (1 mg/m3), 2006
Occupational Exposure Limit-MEXICOtime-weighted average 0.25 ppm (1 mg/m3), 2004
Occupational Exposure Limit-NEW ZEALANDtime-weighted average 0.25 ppm (1 mg/m3), sen, JAN2002
Occupational Exposure Limit-NORWAYtime-weighted average 0.2 ppm (0.8 mg/m3), JAN1999
Occupational Exposure Limit-PERUtime-weighted average 0.1 ppm (0.4 mg/m3), JUL2005
Occupational Exposure Limit-POLANDtime-weighted average 0.5 mg/m3, short term exposure limit 1.0 mng/m3, JAN1999
Occupational Exposure Limit-RUSSIAshort term exposure limit 1 mg/m3, Skin, JUN2003
Occupational Exposure Limit-SWEDENtime-weighted average 0.3 ppm (1.2 mg/m3);short term exposure limit 0.6 ppm (2.5 mg/m3), Sen, JUN2005
Occupational Exposure Limit-SWITZERLANDceiling concentration 0.1 ppm (0.4 mg/m3), sen, JAN2011
Occupational Exposure Limit-THE NETHERLANDSMAC-TGG 0.4 mg/m3, 2003
Occupational Exposure Limit-THE PHILIPPINEStime-weighted average 0.25 ppm (1 mg/m3), JAN1993
Occupational Exposure Limit-UNITED KINGDOMtime-weighted average 1 mg/m3; short term exposure limit 3 mg/m3, sen, OCT2007
Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (Construction)8H time-weighted average 0.25 ppmCFRGBR 29,1926.55,1994
Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (Federal Contractors)8H time-weighted average 0.25 ppm (1 mg/m3)CFRGBR 41,50-204.50,1994
Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (General Industry)8H time-weighted average 0.25 ppm (1 mg/m3)CFRGBR 29,1910.1000,1994
Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (Shipyards)8H time-weighted average 0.25 ppmCFRGBR 29,1915.1000,1993

NIOSH Documentation and Surveillance

OrganizationStandardReference
National Institute for Occupational Safety and Health (NIOSH) Recommended Exposure Level TO MALEIC ANHYDRIDE-air10H time-weighted average 0.25 ppmNIOSH* DHHS #92-100,1992
National Occupational Exposure Survey 1983Hazard Code 43660; Number of Industries 65; Total Number of Facilities 5924; Number of Occupations 69; Total Number of Employees Exposed 81551; Total Number of Female Employees Exposed 14807
National Occupational Hazard Survey 1974Hazard Code 43660; Number of Industries 51; Total Number of Facilities 5310; Number of Occupations 69; Total Number of Employees Exposed 71386

Status in Federal Agencies

OrganizationReference
EPA TSCA 8(a) PRELIMINARY ASSESSMENT INFORMATION, FINAL RULEFEREAC 47,26992,82
EPA TSCA Section 8(b) CHEMICAL INVENTORY
EPA TSCA Section 8(d) unpublished health/safety studies
EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JANUARY 2001
NIOSH Analytical Method, 1994: Maleic anhydride, 3512
On EPA IRIS database
OSHA ANALYTICAL METHOD #25
OSHA ANALYTICAL METHOD #86
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