Registration Dossier
Registration Dossier
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EC number: 201-604-9 | CAS number: 85-42-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted to internationally recognised test methods. Some details on methods / results not available
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Cyclohexane-1,2-dicarboxylic anhydride
- EC Number:
- 201-604-9
- EC Name:
- Cyclohexane-1,2-dicarboxylic anhydride
- Cas Number:
- 85-42-7
- Molecular formula:
- C8H10O3
- IUPAC Name:
- octahydro-2-benzofuran-1,3-dione
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- % coverage: 10%
- Type of wrap if used: porous gauze dressing
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Constant volume or concentration used: yes
- For solids, paste formed: no - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 male / 5 female
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed daily. Bodyweights recorded on Day 1, 8 and 15
- Necropsy of survivors performed: yes
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: minimal irritation on Day 2 following 24 hours exposure
- Gross pathology:
- Not remarkable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Acute dermal toxicity has been investigated in the rabbit according to OECD test methods. No mortality occurred at a dose level of 2000 mg/kg body weight.
- Executive summary:
Acute dermal toxicity has been investigated in the rabbit according to OECD test methods. No mortality occurred at a dose level of 2000 mg/kg body weight.
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