Registration Dossier

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:
other: Test procedure in accordance with generally accepted scientific standards. Similar to OECD guideline 405. Non-GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Draize JH et al. J. Exp. Pharmacol. Ther., 83, 377-390, 1944. Draize JH Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, 36-45, Ass. of Food and Drug Officials of the United States, Topeka, Kansas, 1965
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Anti-oxidant 703 (AN-703)
- Substance type: Yellow, crystalline solid
- Physical state: solid
No additional details reported in the report.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data reported
- Age at study initiation: no data reported
- Weight at study initiation: no data reported
- Housing: no data reported
- Diet (e.g. ad libitum): no data reported
- Water (e.g. ad libitum): no data reported

ENVIRONMENTAL CONDITIONS: no data reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of finely powdered AN-703 instilled onto one eye.
Observation period (in vivo):
Observation were made at 24, 48, 72 and 168 hours after application
Number of animals or in vitro replicates:
6 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE: No removal of the test substance

SCORING SYSTEM: Draize score system used to report result in the report. Raw data of the observations were available in the report, therefore, EU scoring has been reported in the results section for Cornea - Opacity, Iris - Inflammation, Conjunctivae - Redness and Chemosis.

TOOL USED TO ASSESS SCORE: Not reported in the report.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks:
(after 168 hours - score: 1)
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1.66
Max. score:
2
Reversibility:
fully reversible within: 168 hours
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 24, 48 and 72 hours
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 168 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1.66
Max. score:
2
Reversibility:
fully reversible within: 168 hours
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24, 48 and 72 hours
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 168 hours
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 24, 48 and 72 hours
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Conjunctiva Chemosis score:
* Animal 1 - 24, 48 and 72 hours - 1.66 max: - 2 - fully reversible within: 168 hours
* Animal 2 - 24, 48 and 72 hours - 0
* Animal 3 - 24, 48 and 72 hours - 1 max: 2 - fully reversible within: 72 hours
* Animal 4 - 24, 48 and 72 hours - 1 max: 2 - fully reversible within: 72 hours
* Animal 5 - 24, 48 and 72 hours - 2 max: 3 - fully reversible within: 168 hours
* Animal 6 - 24, 48 and 72 hours - 0

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According the study performed the test item is considered as irritant to New Zealand white Rabbits with full reversibility after 168 hours. The test item needs to be classified as eye irritation- category 2 according to the criteria defined in the ECHA guidance on the application of CLP criteria, 2009 (249-250) CLP regulation N°1272/2008. This is based on a score of 1 or greater for cornea opacity in 4 or more of 6 animals. According to the criteria of Directive 67/548/EEC and amendments the test item is not classified as irritant to eyes.
Executive summary:

0.1 ml of the test item was applied into the conjunctival sac of one eye in each of 6 New Zealand white rabbits. The eye reactions were scored after 24, 48, 72 and 168 h. All effects were fully reversible within the observation period with the exeption of corneal opacity in one animal that however showed signs of reversibility. Mild irritation effects were observed at grades that are borderline for classification. According to the ECHA guidance on application of CLP criteria, 2009 a classification as category 2 eye irritant (H319) is proposed based on the fact that 4 of 6 rabbits had cornea scores at or above 1 for the 24, 48, 72 h average. Based on Dir. 67/548/EEC however, no classification as eye irritant (R36) would be attributed.