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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 May 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
Study conducted outside the EU over 10 years before the EU cosmetic testing ban came into effect.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: CFR 16, Part 1500.41
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl 12-hydroxyoctadecanoate
EC Number:
249-793-7
EC Name:
2-ethylhexyl 12-hydroxyoctadecanoate
Cas Number:
29710-25-6
Molecular formula:
C26H52O3
IUPAC Name:
2-ethylhexyl 12-hydroxyoctadecanoate
Test material form:
other: oil
Details on test material:
a-ethyl-hexyl-oxystearate
Specific details on test material used for the study:
a-ethyl-hexyloxystearate

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
2 animals received none of the test material
2 aniamls received 3.9 ml/kg BW
2 animals recieved 6ml/kg BW
2 animals recieved 9.4ml/kg BW
Duration of treatment / exposure:
24 hours
Observation period:
24 and for the 2 weeks subsequent to treatment
Number of animals:
8

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other:
Remarks:
mean results
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material failed to induce sufficient dermal irritation to be considered irritating to skin.
Executive summary:

In this guideline (CFR 1500.41) study, the test material (unchanged) was administered topically to the intact skin of 8 rabbits. Results were measured at 24 hours using the draize scale. The test material produced a mild irritation which disappeared and failed to induce sufficient dermal irritation to be considered a dermal irritant.