Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Constituent 1
Chemical structure
Reference substance name:
3,5,5-trimethylhexyl acetate
EC Number:
261-245-9
EC Name:
3,5,5-trimethylhexyl acetate
Cas Number:
58430-94-7
Molecular formula:
C11H22O2
IUPAC Name:
.

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:
other: 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.