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Toxicological information

Acute Toxicity: dermal

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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:
1949
Reference Type:
publication
Title:
Unnamed
Year:
1944
Reference Type:
publication
Title:
Unnamed
Year:
1948
Report Date:
1948

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Sex:
not specified
Details on test animals 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.