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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 March 1984- March 1984
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:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.42
Deviations:
no
GLP compliance:
no

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-hexyl-oxystearate

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1mL to one eye
Duration of treatment / exposure:
Eyes remained unwashed for 24 hours
Observation period (in vivo):
24, 48, 72 hours,
Number of animals or in vitro replicates:
6
Details on study design:
All eyes remained unwashed for 24 hours. Observation of corneal opacity, iritis and conjunctivitis were recorded

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0

Any other information on results incl. tables

Draize Scores

 group  24 hours  48 hours  72 hours  4 days  7 days
 Unwashed  0  0  0  0  0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
not irritating
Executive summary:

The test item (0.1mL in 10% corn oil) was applied to one eye of each of 6 rabbits.All eyes remained unwashed for 24 hours. Observation of corneal opacity, iritis and conjunctivitis were recorded. No adverse effects were recorded accoring to the Draize system. The test item was not irritating to the eye under these conditions.