Registration Dossier
Registration Dossier
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EC number: 203-571-6 | CAS number: 108-31-6
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- other: review and OEL assessment
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Health and Environmental Effects Profile for Maleic Anhydride
- Author:
- U.S. EPA
- Year:
- 1 986
- Bibliographic source:
- NTIS, U.S. EPA, Report EPA/600/X-86/196 : https://ntrl.ntis.gov/NTRL/#PB88251244
Materials and methods
- Type of study / information:
- Review article
- GLP compliance:
- no
Test material
- Reference substance name:
- Maleic anhydride
- EC Number:
- 203-571-6
- EC Name:
- Maleic anhydride
- Cas Number:
- 108-31-6
- Molecular formula:
- C4H2O3
- IUPAC Name:
- 2,5-dihydrofuran-2,5-dione
- Details on test material:
- no data
Constituent 1
Results and discussion
- Results:
- 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
