Registration Dossier
Registration Dossier
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EC number: 222-376-7 | CAS number: 3452-97-9
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: Pre-guideline study. Basic data given: comparable to guideline studies. Restriction: methods described in previous publications (1944, 1988; cf. references)
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 949
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 944
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 948
- Report date:
- 1948
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Pre-guideline study
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Pre-GLP study
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3,5,5-trimethylhexan-1-ol
- EC Number:
- 222-376-7
- EC Name:
- 3,5,5-trimethylhexan-1-ol
- Cas Number:
- 3452-97-9
- Molecular formula:
- C9H20O
- IUPAC Name:
- 3,5,5-trimethylhexan-1-ol
Constituent 1
Test animals
- Species:
- rabbit
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: no data
- Type of wrap if used: impervious rubber film, or vinyl plastic
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: several unspeified doses. Up to 20 mL/kg possible with this method.
- Concentration: undiluted
- Constant volume or concentration used: no - Duration of exposure:
- 24 hours
- Doses:
- not specified
- No. of animals per sex per dose:
- 6
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- Method of Thompson (1947)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- 2 307 mg/kg bw
- Based on:
- act. ingr.
Applicant's summary and conclusion
- Conclusions:
- The dermal LD50 (rabbit) was 2307 mg 3,5,5-trimethylhexan-1-ol/kg bw
- Executive summary:
The dermal toxicity of 3,5,5-trimethylhexan-1-ol was tested using a pre-guideline protocol that is comparable to OECD TG 402. In brief, several volumes of undiluted test material was placed onto the shaved skin of rabbits, 6 animals per dose group. The test material was held in place for 24 hours by an impervious cover, i.e. under occlusive conditions. Mortality was observed for 14 days, the LD50 was calculated using the method of Thompson (1947).
TheLD50(rabbit) was 2.8 mL/kg bw, equivalent to 2307 mg 3,5,5-trimethylhexan-1-ol / kg bw (Smyth and Carpenter, 1949).
The study is considered to be acceptable for assessment.
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