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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:
1977-03-14 to 1977-04-04
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
See attached justification

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not applicable
Principles of method if other than guideline:
One tenth of a milliliter of the test material was instilled into the conjunctival sac of 3 albino rabbits. The test material was allowed to fall on the everted lower lid of each animal and the upper and lower lids were then gently held together for one second to prevent loss of the test material. All treated eyes remained unwashed.
The evaluations were performed at 1, 24, etc hours for a period of 7 days. A 2% instillation of fluorescin was made on each animal at least once during the course of the experimental period.
GLP compliance:
no
Remarks:
Prior to GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The justification for read-across is attached in Section 13 of the IUCLID.

- Name of test material (as cited in study report): Schercemol 1818, Isostearyl Isostearate
- Lot/batch No.: L#121-225

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No details on test animals and environment provided

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
7 days - eye unwashed.
Observation period (in vivo):
1 hour, 24, 48, 72 hours and then up to 7 days exposure.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
20
Reversibility:
fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
20
Reversibility:
fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
20
Reversibility:
fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Redness: All three animals exhibited conjunctival redness with a score of 2 on the Draize scale 1 hour after test material instillation. By the 24 hour observation the score was reduced to 1 for all animals with effects fully reversed by the 48-hour observation.
Minor conjunctival discharge was observed in 2 animals at the 1 hour observation, this was fully reversed in one animal by the 24 hour observation and in the remaining animal at the 48-hour observation.
One animal exhibited minor conjunctival chemosis at the 1-hour observation. This was fully reversed by the 24-hour observation. No other effects on eyes were noted during the course of the study.
Other effects:
No data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is not an irritant to the eyes of rabbit under the conditions of the study. The test item is not classifiable under CLP.
Executive summary:

Introduction

The study was performed in accordance with the US Federal Hazardous Substances Labelling Act.

Method

A volume of 0.1 mL of the test item was placed into the conjunctival sac of one eye of three rabbits, formed by gently pulling the lower li d away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released. The eyes were left unwashed and observations were perfomed one hour after installation and then daily for a period of 7 days. Assessment of ocular damage/irritation was made according to the numerical evaluation (Draize, J.H, 1977).

Results

A single application of the test item to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 48-Hour observation.

Conclusion

The test material is not an irritant in the eye of rabbits. The test item is not classifiable under CLP.