Registration Dossier
Registration Dossier
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EC number: 200-662-2 | CAS number: 67-64-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study meets basic scientific principles with the following restrictions: reduced animal number of 4 per test group, less detailed documentation of testing procedure, documentation of test results limited to LD50 values; information acceptable for weight of evidence approach
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative acute effects of some chemicals on the skin|of rabbits and guinea pigs
- Author:
- Roudabush RL, Terhaar CJ, Fassett DW, Dziuba SP
- Year:
- 1 965
- Bibliographic source:
- Toxicol Appl Pharmacol 7: 559-565.
Materials and methods
Test guideline
- Guideline:
- other: Code of federal regulations: 21 CFR 191.10
- Principles of method if other than guideline:
- A minimum of 3 dosages was applied to the clipped abraded skin of groups of 4 rabbits under an occlusive dressing
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- Acetone
- EC Number:
- 200-662-2
- EC Name:
- Acetone
- Cas Number:
- 67-64-1
- Molecular formula:
- C3H6O
- IUPAC Name:
- propan-2-one
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: white
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: local supplier
- Weight at study initiation: 1 to 4 kg
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: not specified
- Type of wrap if used: cuff of dental rubber dam - Duration of exposure:
- presumably 24 hrs
- Doses:
- not specified
- No. of animals per sex per dose:
- 4
- Statistics:
- LD50 calculated by method of Finney (1952)
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 7 426 mg/kg bw
- Remarks on result:
- other: abraded skin; value calculated with a density of 0.79 g/mL
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 9.4 mL/kg bw
- Remarks on result:
- other: abraded skin
Applicant's summary and conclusion
- Conclusions:
- The dermal LD50 in rabbits was higher than 9.4 mL acetone/kg bw (ca. 7400 mg/kg bw) for application on abraded skin.
- Executive summary:
After application of a minimum of three dosages on the clipped abraded skin of groups of 4 rabbits under an occlusive dressing the dermal LD50 was found to be higher than 9.4 mL acetone/kg bw (ca. 7400 mg/kg bw).
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