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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Exposure related observations in humans: other data

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Administrative data

exposure-related observations in humans: other data
Type of information:
other: review and OEL assessment
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference Type:
review article or handbook
Health and Environmental Effects Profile for Maleic Anhydride
Bibliographic source:
NTIS, U.S. EPA, Report EPA/600/X-86/196 :

Materials and methods

Type of study / information:
Review article
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
Maleic anhydride
EC Number:
EC Name:
Maleic anhydride
Cas Number:
Molecular formula:
Details on test material:
no data

Results and discussion

Occupational exposure of humans to maleic anhydride has been associated with sensitization dermatitis, chronic bronchitis, asthma, pulmonary edema, upper respiratory tract irritation and corneal burns (U .S. EPA, 1981; Grigoriyeva 1966; ACGIH 1986). Exposures to 1.0-8.0 mg/m3 for 15 minutes may cause eye irritation and continued exposure may result in chronic eye irritation and keratitis (ACGIH 1986).
An ADI of 0.10 mg/kg/day or 7.0 mg for a 70 kg human was derived from the NOAEL of 10 mg/kg/day in the 2-year dietary study in rats by Preache (1983), using an uncertainty factor of 100. An respiratory quotient (RQ) of 100 was derived based on the upper respiratory tract lesions observed in rats exposed by inhalation to >0.012 mg/l for 6 hours/day, 5 days/week in the study reported by Goldenthal et al. (1979). Maleic anhydride is an IARC Group 3 and a CAG Group D chemical, indicating that data regarding the carcinogenicity of maleic anhydride to rats are inadequate.

Applicant's summary and conclusion