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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: R7623 Technical, solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
14 days
Observation period (in vivo):
Immediately after instillation, 65 minutes, 24, 48, and 72 hours, 7 and 14 days
Number of animals or in vitro replicates:
3 female

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: range
Time point:
other: 65 minutes to 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: mean score of 3 rabbits
Irritation parameter:
iris score
Basis:
other: range
Time point:
other: 65 minutes to 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: mean score of 3 rabbits
Irritation parameter:
other: conjunctivae score: redness
Basis:
other: range
Time point:
other: 65 minutes to 72 hours
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: mean score of 3 rabbits
Irritation parameter:
other: conjunctivae score: edema
Basis:
other: range
Time point:
other: 65 minutes to 72 hours
Score:
1.2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean score of 3 rabbits

Any other information on results incl. tables

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand white rabbits. An aliquot of 0.1 mL of the test substance was administered to 1 eye of each animal. The eyes remained unwashed following treatment. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to a numerical scale approximately 1, 24, 48, and 72 hours, and 7 and 14 days following administration. Under the conditions of this study, the test substance was mildly irritating. All ocular irritation reversed by 14 days.

Applicant's summary and conclusion

Interpretation of results:
other: mildly irritating
Remarks:
Criteria used for interpretation of results: other: Draize score and scheme of Kay and Calandra
Conclusions:
Test substance was scored as mildly irritating.
According to the EEC criteria for classification and labeling of dangerous substances, the test substance need not be labeled as an eye irritant.
Executive summary:

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand white rabbits. An aliquot of 0.1 mL of the test substance was administered to 1 eye of each animal. The eyes remained unwashed following treatment. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to a numerical scale approximately 1, 24, 48, and 72 hours, and 7 and 14 days following administration. Under the conditions of this study, the test substance was mildly irritating. All ocular irritation reversed by 14 days.

According to the EEC criteria for classification and labeling of dangerous substances, the test substance need not be classified as an eye irritant.