Registration Dossier

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:
Application on 1979-04-04
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
The test article as a 6% w/v concentration in propylene glycol (0.1 ml) was applied to right eyes of 6 rabbits. Eyes were examined before testing and at 24, 48 and 72 hours and at 4 and 7 days. The irritation was scored by the method of Draize.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): IFF #79-007-07
- Substance type: Clear fluid
- Physical state: Liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: CSE Colony, Branchville, New Jersey, United States
- Age at study initiation:
- Weight at study initiation: 2.0 to 2.75 kg
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

Test system

Vehicle:
other: Propylene glycol
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL AND VEHICLE
- Volume applied: 0.1 mL
- Concentration of test material: 6 % w/v in propylene glycol
Duration of treatment / exposure:
Single exposure.
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
6
Details on study design:
NON-REMOVAL OF TEST SUBSTANCE
- No washing

SCORING SYSTEM:
- According to the FDA's "Illustrated guide for Grading Eye Irritation by Hazardous Substances" and the "Scale for Scoring Ocular Lesions". Please refer to attached supporting information for full system.

TOOLS USED TO ASSESS SCORE:
- Hand opthalmascope (1 d, 2 d, 3 d, 4 d, 7 d)
- Fluorescein (1 d, 7 d)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal: # 1,4 and 6
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 4 days
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: # 4, 5 and 6
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal: # 3, 4 and 6
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
- No pannus, blistering of the conjunctivae or other effects indicative of corrosive action.
- Ulceration of the corneal surface was observed in 5 rabbits (A421, A446, A431, A450 and A442) at 24 hrs. All had resolved by d 7, except for a pinhead area in A421 which was still retaining dye.
Other effects:
- Rabbit A446 broke its right hind leg while in restraint but remained healthy throughout the study.
- All animals struggled for a short time when the test article was instilled, and tightly closed the dosed eye for 1 hr.
- No other abnormalities of health, behaviour or appearance were observed during the remainder of the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not considered to be irritating to eyes according to CLP Regulation (EC) no. 1272/2008