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Toxicological information

Acute Toxicity: oral

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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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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.
Body weight:
Not recorded
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.