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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 dermal application

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ethyl hexyl palmitate

IUPAC Name:

ethyl hexyl palmitate

Details on test material:

Test substance name : ethylhexy palmitate
No other details provided

Test animals

Species:

rabbit

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

Type of coverage:

not specified

Vehicle:

not specified

Details on dermal exposure:

Ne details provided in report

Duration of exposure:

No data

Doses:

5g/kg bw

No. of animals per sex per dose:

10 rabbits in total

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

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

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

Mortality:

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

Clinical signs:

other: No clinical signs were recorded for any of the treated rabbits.

Gross pathology:

Necropsy revealed several macropscopic changes including :

brown anogenital exudate - 2 rabbits
Intestines, red areas - 3 rabbits; yellow areas - 1 rabbit; bloated - 1 rabbit
Liver, dark - 6 rabbits, mottled appearance - 1 rabbit; white nodules - 1 rabbit.
Dark areas on lungs - 2 rabbits

Other findings:

Nine of the ten rabbits developed slight or moderate erythema and 9/10 also had slight oedema formation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

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