3,5,5-trimethylhexyl acetate

Acute Toxicity: oral

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

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

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:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system 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:

other: 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.