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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
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.