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Toxicological information

Acute Toxicity: dermal

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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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
No clinical signs were recorded for any of the treated rabbits.
Body weight:
Notrecorded
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.