Isopropyl palmitate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991-03-13 to 1991-03-19

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

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:

Only 5 animals (mice) tested (female), observation time only 6 d after treatment, no necropsy, analytical purity of test substance not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isopropyl palmitate

EC Number:

205-571-1

EC Name:

Isopropyl palmitate

Cas Number:

142-91-6

Molecular formula:

C19H38O2

IUPAC Name:

propan-2-yl hexadecanoate

Details on test material:

- Name of test material (as cited in study report): palmitate isopropyle
- Physical state: liquid, clear
- Batch/Lot Nr.: 0412D

Test animals

Species:

mouse

Strain:

NMRI

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Weight at study initiation: 19 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 (female)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 6 days
- Frequency of observations and weighing: daily, body weight before and at the end of the study.
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality

Clinical signs:

other: No abnormality observed

Any other information on results incl. tables

Single administration of the test substance at 5000 mg/kg bw to female mice had no effects on clinical signs, viability or body weight change in the observation period of 6 days. Although there was a short observation time, the lack of any symptomes within this time gave evidence, that the test substance has not to be classified according to DSD and CLP.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU