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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Acceptable, well documented study report which meets basic scientific principles Read across was performed with Laurylacrylate 1214 (mixture of laurylacrylate (CAS No.: 2156-97-0) and tetradecylacrylate (CAS No.: 21643-42-5) . Please refer to IUCLID section 13 for read across justification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
undiluted
Amount applied: 0.1 mL
Duration of treatment / exposure:
168 hour(s)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
- Comment: not rinsed
- In general, the techniques of tests as published by the FDA of the United States (Fed. Reg. 28 (119): 5582, 1963) and Draize and Kelley (Drug Cosmet. Industr. 71: 36, 1952) were followed.
- Pretest: The eyes of the animals were examined before testing and only those animals without observable eye defects are used.
- Total dose: 0.1 mL of the undiluted test material
- Instillation procedure: 0.1 mL of the undiluted test substance was allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid were then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye remaining untreated, served as a control. The eyes were not washed following instillation.
- Readings of eye reactions: The eyes were examined at one hour, 24, 48, 72 hours and 7 days after instillation of the test material.
- Evaluation of eye reactions: Eye reactions were evaluated by the method published by Draize and Kelley (1952). Drug. Cosmet. Industr. 71: 36

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation

Any other information on results incl. tables

The test compound caused slight lesions of the conjunctivae in all  rabbits. After 24 hours these lesions had subsided completely.

Individual eye irritation scores:
---------------------------------

rabbit cornea iris conjunctivae Total score
opacity area redness chemosis discharge
-------------------------------------------------------------------------- -----------------
after 1 hour
1 0 0 0 1 0 0 2
2 0 0 0 1 1 0 4
3 0 0 0 1 0 0 2
4 0 0 0 1 0 0 2
5 0 0 0 1 0 0 2
6 0 0 0 1 0 0 2

after 24 hours
1 0 0 0 0 0 0 0
2 0 0 0 0 0 0 0
3 0 0 0 0 0 0 0
4 0 0 0 0 0 0 0
5 0 0 0 0 0 0 0
6 0 0 0 0 0 0 0

After 48, 72 hours and 7 days all scores were recorded as 0.
-------------------------------------------------------------------------- ------------------

Mean values over 24, 48, and 72 hours for the single animals for cornea, iris and conjunctivae were without exception zero.
Thus, the eye irritation score was calculated to be zero.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met