Registration Dossier

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: non-GLP, similar to OECD TG 402

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
3 abraded rabbits
Principles of method if other than guideline:
Method described under Section 191.10 of the Final Order, Enforcement Regulations, Federal Register, Vol 26, No 155, p 7336, 12 August 1961.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
no data
Duration of exposure:
no data
Doses:
5 g/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
-3 animals dosed on intact and 3 on abraded skin.
Statistics:
no data

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths were observed.
Clinical signs:
Mild erythema followed by slight drying and cracking of skin.
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was acutely not toxic to rabbits in an acute dermal toxicity test with a LD50 value >5000 mg/kg bw. The substance is not classified according to CLP.
Executive summary:

The acute dermal toxicity of menthyl acetate was studied in a non-GLP test according to the method described under Section 191.10 of the Final Order, Enforcement Regulations, Federal Register, Vol 26, No 155, p 7336, 12 August 1961. Group of six animals (3 intact and 3 abraded skin) were exposed to single dermal dose of 5 g/kg bw. Animals were observed during a period of 14 days. No mortality was reported within observation period. The LD50 value was >5 g/kg bw. As symptoms, mild erythema followed by slight drying and cracking of skin was reported.