3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

13 - 19 Mar 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Comparable to guideline study with acceptable restrictions. No gross necropsy performed, no details on animal husbandry, observation period 7 days in the absence of mortality/signs of toxicity, few details on study protocol, analytical purity not given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no gross necropsy performed, no details on animal husbandry, few details on study protocol, observation period 7 days in the absence of mortality/signs of toxicity

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

111973-03-2

IUPAC Name:

111973-03-2

Details on test material:

- Name of test material (as cited in study report): isononanoate de cetearyl
- Physical state: transparent liquid
- Lot/batch No.: 0510 C

Test animals

Species:

mouse

Strain:

other: NMRI EOPS

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 19-20 g (range)

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.8 mL/kg bw, (dose calculated assuming test substance density of 0.8550 g/mL)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days (in the absence of mortality and signs of toxicity)
- Frequency of observations and weighing: mortality was recorded daily; the animals were observed daily for the presence of clinical signs; body weights were determined on Day 0 and 6
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 7-day observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified