Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From 10 to 25 of July 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study following official guideline not in GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous . Substances Labelling Act Sect. 191.12 (February 1965) with slight modification.
GLP compliance:
no
Remarks:
Pre GLP.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Tested Substance: Similar Substance 01
- Color Index: Acid Red 249
- CAS: 6416-66-6
- EC: 229-192-2
- Maroon powder
- Trade name: FAT 21'070/A
- Coupage: 22%
- Sodium sulfate: 20.6%
- Essotex: 1.4 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Number of animals: 6 (3 male; 3 female)
- Age at study initiation: 9 -14 weeks
- Weight at study initiation: 2.15 (male); 2.57 (female)
- Housing: singly caged
- Diet : commercial irradiated diet (Syles Oxoid), ad libitum
- Water : sterile water, ad libitum for all test duration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C ± 2°
- Relative humidity: 50-70 %
- Photoperiod (hrs dark / hrs light): 10 hours of light (8:00-18:00)

Test system

Controls:
other: right eye (not treated)
Amount / concentration applied:
100 mg of the test compound
Duration of treatment / exposure:
1 second
Observation period (in vivo):
1, 24, 48, 72 h after application and for any further period considered necessary (6 and 10 days)
Number of animals or in vitro replicates:
6 (3 male and 3 female)
Details on study design:
TEST SITE
The eyes of the experimental animals were examined and found normal prior to the test.

REMOVAL OF TEST SUBSTANCE
After 30 seconds the compound was, as far as possible, flushed out of the eye of three of the rabbits with warm water For 1 minute.

SCORE SYSYEM
The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
22.16
Max. score:
110
Reversibility:
fully reversible within: 10 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
20
Max. score:
110
Reversibility:
fully reversible within: 10 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
12.7
Max. score:
110
Reversibility:
fully reversible within: 10 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
7.5
Max. score:
110
Reversibility:
fully reversible within: 10 days
Irritant / corrosive response data:
CONJUNTIVAL REACTION:
A mild to moderate reaction was seen in all treated eyes one hour after application of the compound.
This had subsided very slightly by 24 hours and thereafter continued to do so until all eyes had returned to normal by day 6 (1/3 unwashed, 3/3 washed) and 10 (2/3 unwashed). Staining of the conjunctivae by the compound was seen in the unwashed eyes at 24 hours.

CORNEAL REACTION:
Slight opacity and damage to the surface epithelium was seen in all treated eyes at one hour. This was still present at 24 hours. These returned to normal by 48 hours (2/3 washed), 72 hours (1/3 washed) and 6 days (3/3 unwashed).

IRIS:
Increased folding of the iris was seen in 2/3 unwashed eyes, (no. 11) at 24 hours and (no. 13) at 40 hours only.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information According to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
Based on the evaluation of the overall score of the eye reaction on Cornea, Iris and Conjunctivae, the substance can be considered slightly irritant under the conditions of the study.
Executive summary:

The determination of the eye irritation was determined in an eye irritation test. No guideline is available and the test was not performed on GLP. The reaction on the test substance was observed in albino rats for 10 days after the instillation. Reactions on Cornea, Conjunctivae and Iris were evaluated.

CONJUNTIVAL REACTION: a mild to moderate reaction was seen in all treated eyes one hour after application of the compound.

This had subsided very slightly by 24 hours and thereafter continued to do so until all eyes had returned to normal by day 6 (1/3 unwashed, 3/3 washed) and 10 (2/3 unwashed). Staining of the conjunctivae by the compound was seen in the unwashed eyes at 24 hours.

CORNEAL REACTION: slight opacity and damage to the surface epithelium was seen in all treated eyes at one hour. This was still present at 24 hours. These returned to normal by 48 hours (2/3 washed), 72 hours (1/3 washed) and 6 days (3/3 unwashed).

IRIS: increased folding of the iris was seen in 2/3 unwashed eyes, (no. 11) at 24 hours and (no. 13) at 40 hours only. Based on the evaluation of the overall score of the eye reactions of Cornea, Iris and Conjunctivae, the substance can be considered slightly irritant under the conditions of the study.