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:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
A group of ten animals was exposed topically to one dermal dose of test substance. Animals were observed during a period of 14 days.
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

Administration / exposure

Type of coverage:
not specified
Doses:
5 g/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily

Results and discussion

Preliminary study:
No data
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died during the observation period of 14 days.
Clinical signs:
No clinical signs were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was acutely non toxic to rabbits in an acute dermal toxicity test with an LD50 value >5000 mg/kg bw. The substance is not classified according to CLP.
Executive summary:

The acute dermal toxicity of the test substance 3,5,5-trimehylhexyl acetate was studied in a non-GLP test according to principles slightly deviating from those of current OECD guideline 402. A group of 10 rabbits was exposed to a single dermal dose of 5 g/kg bw. Animals were observed during a period of 14 days. No mortality was observed during the 14-day period. The dermal LD50 value was >5 g/kg bw.