Registration Dossier
Registration Dossier
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EC number: 203-593-6 | CAS number: 108-55-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study appears to be well conducted. No evidence that GLP was followed, but likely conducted in the spirit of GLP. Study used an appropriate number fo animals to assess the endpoint.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Glutaric anhydride
- EC Number:
- 203-593-6
- EC Name:
- Glutaric anhydride
- Cas Number:
- 108-55-4
- Molecular formula:
- C5H6O3
- IUPAC Name:
- glutaric anhydride
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Doses:
- Males - 500mg, 1000mg, 2000mg, 8000mg
Females - 250 m, 500mg, 1000mg - No. of animals per sex per dose:
- Males
500 mg = 5
1000 mg = 5
2000 mg = 5
8000 mg = 2
Females
250 mg = 5
500 mg = 5
1000 mg = 5 - Control animals:
- no
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 410 mg/kg bw
- 95% CL:
- > 800 - < 2 490
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 540 mg/kg bw
- 95% CL:
- > 360 - < 790
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Female rats appeared to be more sensitive to the effects of the test material. Based on the LD50 value reported for the female rats, the substance meets the criteria for classification as Harmful in the EU.
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