Registration Dossier
Registration Dossier
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EC number: 203-571-6 | CAS number: 108-31-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Complied with OECD Test Guideline 401
Data source
Reference
- Reference Type:
- publication
- Title:
- Maleic Anhydride and Maleic Acid
- Author:
- UNEP
- Year:
- 2 005
- Bibliographic source:
- Published OECD SIDS initial assessments of HPV chemicals (2005)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- 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:
- furan-2,5-dione
- Details on test material:
- Name of test material: Maleic anhydride
Analytical purity: 99.7%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Weight at study initiation: 113 g (females) and 134 g (males)
Room temperature:20 °C(+1 °C)
relative humidity: 60% (+ 5%)
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- Concentration in vehicle: 10 – 19.9%
- Doses:
- 1.0, 1.125, 1.25, and 1.99 g/kg.
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 090 mg/kg bw
- Mortality:
- No animal died.
- Clinical signs:
- Two animals in the 1.0 mg/kg dose group, six animals in the 1.125 g/kg dose group, nine animals in the 1.25 g/kg dose group and all animals in the 1990 mg/kg dose group showed signs of toxicity.
Signs of toxicity began 15 minutes post-application and included sedation and ataxia, ruffled fur, squatting posture, staggering gait, breathing difficulty, tremors, convulsions and glassy eyes. - Body weight:
- no data
- Gross pathology:
- Postmortem examinations showed hyperemia of the stomach a duodenum mucous membranes, liver congestion, and spotted and
pale kidneys. - Other findings:
- no data
Any other information on results incl. tables
no data
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The substance is classified as low acute oral toxicity based on this experimental result.
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