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Registry of Toxic Effects of Chemical Substances (RTECS)

Phthalic anhydride

RTECS #

TI3150000

CAS #

85-44-9

Updated

October 2017

Molecular Weight

148.12

Molecular Formula

C8H4O3

Synonyms

1,2-Benzenedicarboxylic acid anhydride
1,3-Dioxophthalan
1,3-Isobenzofurandione
1,3-Phthalandione
Anhydrid kyseliny ftalove (Czech)
Anhydride phtalique (French)
Anidride ftalica (Italian)
ESEN
Ftaalzuuranhydride (Dutch)
Ftalanhydrid (Czech)
Ftalowy bezwodnik (Polish)
Isobenzofuran, 1,3-dihydro-1,3-dioxo-
NCI-C03601
Phthalandione
Phthalic acid anhydride
Phthalic anhydride (ACGIH:OSHA)
Phthalsaeureanhydrid (German)
RCRA waste number U190
Retarder AK
Retarder PD
Vulkalent B

Skin and Eye Irritation and References

Route/OrganismDoseEffectReference
eye /rabbit 50 mg/24H moderateATDAEI 15(Suppl 1),S68,1996

Mutation Data and Reference

System TestRoute/Organism/TissueDoseReference
DNA Damageliver/rat3 mmol/LEMMUEG 24,181,1994
DNA Damageother cell types/human1000 µmol/L/24HMUTAEX 31,83,2016
micronucleus testlymphocyte/mouse140 mg/L/3HMUREAV 789,7,2015
micronucleus testother cell types/human150 mg/L/3HMUREAV 789,7,2015
micronucleus testlung/hamster1380 mg/L/3H (-enzymatic activation step)MUREAV 742,11,2012
micronucleus testother cell types/human575 mg/L/3H (-enzymatic activation step)MUREAV 742,11,2012
micronucleus testliver/human1481 mg/L/3H (-enzymatic activation step)MUREAV 742,11,2012
specific locus testother cell types/human1000 µmol/L/24HEMMUEG 54,737,2013

Reproductive Effects Data and References

Route/OrganismDoseEffectReference
inhalation/rat 1 mg/m3 (45D male)Reproductive: Paternal effects: Spermatogenesis (including genetic material, sperm morphology, motility, and count)

Reproductive: Paternal effects: Testes, epididymis, sperm duct
GISAAA 35(1),105,1970
intraperitoneal/mouse 203 mg/kg (8-10D pregnant)Reproductive: Other developmental abnormalitiesTCMUD8 2,61,1982

Acute Toxicity Data and References

Route/OrganismDoseEffectReference
In Vitro/Human, leukemia cells Inhibitor Concentration (5 percent kill): 475 mg/L/30MIn Vitro Toxicity Studies: Cell countingTIVIEQ 27,857,2013
In Vitro/Human, melanoma Inhibitor Concentration (50 percent kill): 755.4 mg/L/48HIn Vitro Toxicity Studies: Cell viability (lysosomal damage): neutral red assay etc.FCTOD7 50,2084,2012
In Vitro/Human, monocyte Inhibitor Concentration Low: 2500 mg/L/2HIn Vitro Toxicity Studies: Other assaysTIVIEQ 27,1233,2013
In Vitro/jrdInhibitor Concentration (50 percent kill): >3200 mg/L/24HIn Vitro Toxicity Studies: Other assaysTIVIEQ 28,626,2014
intraperitoneal/guinea pig lethal dose (50 percent kill): 100 mg/kg29ZWAE -,410,1968
intratracheal/rat Lethal dose: >30 mg/kgGastrointestinal: Hypermotility, diarrhea

Gastrointestinal: Necrotic changes

Liver: Fatty liver degeneration
TPKVAL 2,59,1961
ocular/rabbit lowest published toxic dose: 100 pphEye: Conjunctiva irritationTPKVAL 4,35,1962
oral/cat lethal dose (50 percent kill): 800 mg/kg85JCAE -,322,1986
oral/mouse lowest published lethal dose: 1000 mg/kgLung, Thorax, or Respiration: Structural or functional change in trachea or bronchi

Lung, Thorax, or Respiration: Changes in pulmonary vascular resistance

Gastrointestinal: Ulceration or bleeding from stomach
TPKVAL 2,59,1961
oral/mouse lethal dose (50 percent kill): 1500 mg/kgTPKVAL 2,59,1961
oral/rat lowest published lethal dose: 1500 mg/kgTPKVAL 2,59,1961
oral/rat lethal dose (50 percent kill): 1530 mg/kgBehavioral: Somnolence (general depressed activity)ATDAEI 15(Suppl 1),S68,1996
rectal/mouse lethal dose (50 percent kill): 400 mg/kgFCTOD7 41,405,2003

Other Multiple Dose Data and References

Route/OrganismDoseEffectReference
inhalation/mouse lowest published toxic concentration: 15 mg/m3/3D- intermittentImmunological Including Allergic: Increased immune response

Biochemical: Metabolism (intermediary): Other proteins

Biochemical: Metabolism (intermediary): Effect on inflammation or mediation of inflammation
TXCYAC 261,103,2009
inhalation/rat lowest published toxic concentration: 0.1 gm/m3/14D- intermittentLung, Thorax, or Respiration: Structural or functional change in trachea or bronchi

Lung, Thorax, or Respiration: Other changes

Liver: Other changes
TPKVAL 2,59,1961
inhalation/rat lowest published toxic concentration: 500 µg/m3/5D- intermittentLung, Thorax, or Respiration: Other changes

Immunological Including Allergic: Increase in humoral response
TOXID9 60,173,2001
inhalation/rat lowest published toxic concentration: 0.008 gm/m3/30D- intermittentPeripheral Nerve and Sensation: Recording from peripheral motor nerve

Blood: Eosinophilia

Nutritional and Gross Metabolic: Weight loss or decreased weight gain
TPKVAL 4,35,1962
inhalation/rat lowest published toxic concentration: 0.008 gm/m3/0.5Y- intermittentLung, Thorax, or Respiration: Structural or functional change in trachea or bronchi

Liver: Other changes

Kidney, Ureter, and Bladder: Changes in tubules (including acute renal failure, acute tubular necrosis)
TPKVAL 4,35,1962
oral/guinea pig lowest published toxic dose: 6 gm/kg/42D- intermittentLung, Thorax, or Respiration: Other changes

Gastrointestinal: Gastritis

Gastrointestinal: Other changes
TPKVAL 2,59,1961
oral/guinea pig lowest published toxic dose: 10500 mg/kg/42D- intermittentNutritional and Gross Metabolic: Weight loss or decreased weight gain

Biochemical: Metabolism (intermediary): Other proteins
TPKVAL 2,59,1961
oral/guinea pig lowest published toxic dose: 7000 mg/kg/28D- intermittentLung, Thorax, or Respiration: Changes in pulmonary vascular resistance

Gastrointestinal: Gastritis

Gastrointestinal: Necrotic changes
TPKVAL 2,59,1961
oral/rat lowest published toxic dose: 7000 mg/kg/4W- intermittentReproductive: Paternal effects: Spermatogenesis (including genetic material, sperm morphology, motility, and count)

Nutritional and Gross Metabolic: Weight loss or decreased weight gain
TERP2* -,310,2004
skin/mouse lowest published toxic dose: 25 pph/3D- intermittentImmunological Including Allergic: Increased immune response

Biochemical: Metabolism (intermediary): Other proteins

Biochemical: Metabolism (intermediary): Effect on inflammation or mediation of inflammation
TXCYAC 261,103,2009
skin/mouse lowest published toxic dose: 1036 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: 60 mg/kg/3D- intermittentSkin: After topical application: Cutaneous sensitization (experimental)

Biochemical: Metabolism (intermediary): Effect on inflammation or mediation of inflammation
TXAPA9 184,46,2002
skin/mouse lowest published toxic dose: 90 mg/kg/3D- intermittentSkin: After topical application: Cutaneous sensitization (experimental)TXCYAC 193,191,2003
unreported route/guinea pig lowest published toxic dose: 5000 mg/kg/50D- intermittentCardiac: Other changes

Liver: Other changes

Kidney, Ureter, and Bladder: Other changes
TPKVAL 2,59,1961

Reviews

OrganizationStandardReference
American Conference of Governmental Industrial Hygienists (ACGIH)Threshold Limit Value-time-weighted average 1 ppm (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 REVIEWBPCT** -,183,1974
TOXICOLOGY REVIEWEVHPAZ 4,3,1973
TOXICOLOGY REVIEWCMTVAS 10(3),49,1973
TOXICOLOGY REVIEWTOLED5 140-141,213,2003
TOXICOLOGY REVIEWEMMUEG 43,36,2004
TOXICOLOGY REVIEWMUREAV 584,1,2005
TOXICOLOGY REVIEWMUREAV 653,99,2008
TOXICOLOGY REVIEWFCTOD7 49,1877,2011
TOXICOLOGY REVIEWFCTOD7 55,596,2013
TOXICOLOGY REVIEWMUREAV 802,1,I2

Standards and Regulations

OrganizationStandardReference
Mine Safety and Health Administration (MSHA) STANDARD-airtime-weighted average 2 ppm (12 mg/m3)DTLVS* 3,212,1971
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 1 ppm (6.1 mg/m3), JUL2008
Occupational Exposure Limit-AUSTRIAMAK-TMW 1 mg/m3;KZW 2 mg/m3, inhal, sen, 2007
Occupational Exposure Limit-BELGIUMtime-weighted average 1 ppm (6.2 mg/m3), MAR2002
Occupational Exposure Limit-DENMARKtime-weighted average 1 mg/m3, MAY2011
Occupational Exposure Limit-FINLANDtime-weighted average 0.2 mg/m3, NOV2011
Occupational Exposure Limit-FRANCEVLE 6 mg/m3, FEB2006
Occupational Exposure Limit-HUNGARYtime-weighted average 1 mg/m3, short term exposure limit 1 mg/m3, SEP2000
Occupational Exposure Limit-ICELANDtime-weighted average 1 ppm (6 mg/m3), sen, NOV2011
Occupational Exposure Limit-JAPANceiling concentration 0.33 ppm (0.2 mg/m3), a1 sen, MAY2012
Occupational Exposure Limit-KOREAtime-weighted average 1 ppm (6 mg/m3), 2006
Occupational Exposure Limit-MEXICOtime-weighted average 1 ppm (6 mg/m3);short term exposure limit 4 ppm (24 mg/m3), 2004
Occupational Exposure Limit-NEW ZEALANDtime-weighted average 1 ppm (6.1 mg/m3), sen, JAN2002
Occupational Exposure Limit-NORWAYtime-weighted average 2 mg/m3, JAN1999
Occupational Exposure Limit-PERUtime-weighted average 1 ppm (6 mg/m3), JUL2005
Occupational Exposure Limit-POLANDMAC(time-weighted average) 1 mg/m3, short term exposure limit 2 mg/m3 (vapors and aerosols), JAN1999
Occupational Exposure Limit-RUSSIAshort term exposure limit 1 mg/m3, Skin, JUN2003
Occupational Exposure Limit-SWEDENtime-weighted average 2 mg/m3, ceiling concentration 3 mg/m3, Sen, JUN2005
Occupational Exposure Limit-SWITZERLANDceiling concentration 1 mg/m3, inhal, sen, JAN2011
Occupational Exposure Limit-THE NETHERLANDSMAC-TGG 1 mg/m3, 2003
Occupational Exposure Limit-THE PHILIPPINEStime-weighted average 2 ppm (12 mg/m3), JAN1993
Occupational Exposure Limit-UNITED KINGDOMtime-weighted average 4 mg/m3;short term exposure limit 12 mg/m3, sen, OCT2007
Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (Construction)8H time-weighted average 2 ppm (12 mg/m3)CFRGBR 29,1926.55,1994
Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (Federal Contractors)8H time-weighted average 2 ppm (12 mg/m3)CFRGBR 41,50-204.50,1994
Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (General Industry)8H time-weighted average 2 ppm (12 mg/m3)CFRGBR 29,1910.1000,1994
Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (Shipyards)8H time-weighted average 2 ppm (12 mg/m3)CFRGBR 29,1915.1000,1993

NIOSH Documentation and Surveillance

OrganizationStandardReference
National Institute for Occupational Safety and Health (NIOSH) Recommended Exposure Level TO PHTHALIC ANHYDRIDE-air10H time-weighted average 1 ppmNIOSH* DHHS #92-100,1992
National Occupational Exposure Survey 1983Hazard Code 59230; Number of Industries 72; Total Number of Facilities 5265; Number of Occupations 67; Total Number of Employees Exposed 81312; Total Number of Female Employees Exposed 14675
National Occupational Hazard Survey 1974Hazard Code 59230; Number of Industries 128; Total Number of Facilities 10056; Number of Occupations 90; Total Number of Employees Exposed 134716

Status in Federal Agencies

OrganizationReference
EPA GENETOX PROGRAM 1988, Negative: Carcinogenicity-mouse/rat
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
NCI Carcinogenesis Bioassay (feed);no evidence:mouse,ratNCITR* NCI-TR-159,1979
On EPA IRIS database
OSHA ANALYTICAL METHOD #90
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