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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:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific priciples.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: English Silver
Details on test animals or tissues and environmental conditions:
TEST ANIMALS:
- Housing: individually
- Diet: NAFAG, Gossau SG, rabbit food, ad libitum
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
No rinsing of eyes in 3 animals (group 1), rinsing after 30 seconds in other 3 animals (group 2)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
No rinsing of eyes in 3 animals (group 1), rinsing after 30 seconds in other 3 animals (group 2) with 10 ml lukewarm water

SCORING SYSTEM: basically in accordance with OECD TG 405

TOOL USED TO ASSESS SCORE: slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: group 1 + group 2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Remarks on result:
other: group 1 + group 2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2 (group 1), #3, #4, #5 (group 2)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Remarks on result:
other: no differentiation between redness, chemosis, discharge
Irritant / corrosive response data:
No eye responses were observed except conjunctivae score 6 (incl. chemosis, discharge) in animal #3 (group 1) 24 h after application, fully reversible by 48 h after application.

Any other information on results incl. tables

         Rabbit #3 (group 1)
 Days after appl.  Cornea  Iris  Conjunctivae
 1  0  0  6
 2  0  0  0
 3  0  0  0
 4  0  0  0
 7  0  0  0

Conjunctivae = [Redness (max. score 3) + Chemosis (max. score 4) + Discharge (max. score 3)] x 2

The conjunctivae score for animal #3 one day after application is put together like (3 + 0 + 0) for redness score 3 or (0 + 3 + 0) for chemosis score 3 in the worst case. Discharge is not relevant for classification according to the criteria of Regulation (EC) No 1272/2008. Therefore, the maximum mean value for either conjunctival redness or chemosis over 24 h, 48 h and 72 h after application is 1, which falls below critical values for classification according to the criteria of Regulation (EC) No 1272/2008.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions. This conclusion is legitimate as three animals (group 1) were tested basically in accordance with today's standard methods regarding dosing, exposure duration, scoring system, reading time points and the observed eye responses were fully reversible 48 hours after application.
Executive summary:

The test material was tested for eye irritancy according to the technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). 0.1 g test substance was applied to the conjunctival sac of one eye each of 6 animals (no washing in 3 animals, group 1, washing after 30 seconds in other 3 animals, group 2) and eye responses were watched for seven days. No eye responses were observed except conjunctival score 6 (incl. redness, chemosis, discharge) in animal #3 (group 1) 24 h after application, fully reversible by 48 h after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.