Fatty acids, C16 and C18-20 (even numbered, unsaturated), 2-ethylhexyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

February 1978

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: A single page summary of the study results is available but insufficient details are present to assess the study reliability accurately

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Standard single dose gavage assay

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl palmitate

EC Number:

249-862-1

EC Name:

2-ethylhexyl palmitate

Cas Number:

29806-73-3

Molecular formula:

C24H48O2

IUPAC Name:

2-ethylhexyl palmitate

Details on test material:

315 chemicals were assessed for sensitising potential - divided into two groups - aliphatics and single benzene ring compounds and aromatics excluding single benzene ring structures. One of te test materials used to assess the predictivity ofthe QSAR model compared with maximisation results from a guinea pig Magnuson & Kligman design study was, 2-ethylhexyl palmitate. No further test material details are available

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No information in study report
- Humidity (%):No information in study report
- Air changes (per hr):No information in study report
- Photoperiod (hrs dark / hrs light):No information in study report

IN-LIFE DATES: From: To:No information in study report

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: Not specified

Doses:

5 g/kg bw

No. of animals per sex per dose:

10 rats

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: No data
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

No information - as a limit test no statistical analysis is required

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths ina group of ten rats dosed at 5 g/kg

Mortality:

No deaths occurred in a group of ten rats administered a dose of 5g ethylhexyl palmitate/kg bw.

Clinical signs:

other: piloerection and a wet anogenital region were observed butthe incidence or persistence of these signs is not specified. No indication is given related to recovery.

Gross pathology:

Eight rats were considered normal, macroscopic examination revealed a dark liver for one rat, dark areas on the lungs of one rat and dark kidneys in one case.

Other findings:

None identified

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No deaths occurred in a group of ten ratsdosed at 5g/kg with ethylhexyl palmitate. On basis of read across toa similar material, no acute toxicity is anticipated for fatty acids, C12-2- and C12-20 unsaturated, 2-ethylhexyl esters and no classification for acute oral hazard isrequired according to CLP.

Executive summary:

No deaths occurred in a group of ten rats dosed at 5 g/kg with ethylhexyl palmitate. On basis of read across toa similar material, no acute toxicity is anticipated for fatty acids, C12-2- and C12-20 unsaturated, 2-ethylhexyl esters and no classification for acute oral hazard isrequired according to the CLP Regulation.