Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not reported

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
2.22, 3.33, 5.00, 7.50 g/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Other examinations performed: clinical signs
Statistics:
not reported

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 250 mg/kg bw
Based on:
test mat.
95% CL:
3 540 - 4 960
Mortality:
In the dose group of 2.22 g/kg, no animal died during the observation period of 14 days. In the dose group of 3.33 g/kg, one animal died on the second day following oral exposure. In the dose group of 5.00 g/kg, 3 animals died on day one, 4 animals died on day two and one animal died respectively on day 7 and day 8 following oral exposure. In the dose group of 7.50 g/kg, 4 animals died respectively on day one and day two and 2 animals died on day three following oral exposure.
Clinical signs:
Coma was observed prior to death in animals of the dose group of 5.00 g/kg. Piloerection, urinary incontinence and lethargy were observed in dose group of 7.5 g/kg.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was not acutely toxic to rats in an acute oral toxicity test. With an LD50 value of 4250 mg/kg bw. The substance is not classified according to CLP.
Executive summary:

The acute oral toxicity of the test substance 3,5,5-trimethylhexyl acetate was studied in a non-GLP test according to principles slightly deviating from those of current OECD guideline 401. Groups of 10 animals were exposed to single oral doses of 2.22, 3.33, 5.00 and 7.50 g/kg bw. Animals were observed during a period of 14 days. No mortality was observed in the low-dose group, whereas one animal in the 3.33 g/kg bw dose group, 9 animals in the 5.00 g/kg dose group and 10 (all) animals in the 7.50 g/kg dose group died within the observation period. The LD50 value was 4.25 g/kg bw with a 95% confidence interval of 3.54 and 4.96 g/kg bw. Coma prior to death was observed in animals dosed with 5.00 g/kg bw, whereas piloerection, urinary incontinence and lethargy were observed in animals dosed with 7.50 g/kg bw.