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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:
26 April 1982 - 23 April 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study with adequate description of husbandry, species, methods and results, but limited details.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: US 16 CFR 1500.42 Federal Hazardous Substances Act
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Temperature: 70 degrees F +/- 2 degrees F; Relative hunmidity: 45% +/- 5%; Light: 12 hour light/dark cycle; Diet: Wayne 15% Rabbit Ration and tap water provided ad libitum; Caging: Stainless steel, elevated wire mesh flooring, 1 rabbit/cage; Bedding: Techboard

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
Observation period (in vivo):
1, 2, 3, 4, and 7 days
Number of animals or in vitro replicates:
6 animals
Details on study design:
A dose of 0.1 ml of the test material was instilled in the right eyes of six healthy young adult albino rabbits. The untreated left eyes served as controls. The treated eyes were examined at 1, 2, 3, 4, and 7 days following instillation of the test material in accordance with the Draize method.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.2
Max. score:
3
Reversibility:
not reversible
Remarks:
at the last (7 day) observation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.8
Max. score:
4
Reversibility:
not reversible
Remarks:
at the last (7 day) observation

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is required for eye irritation.
Executive summary:

The eye irritation potential of the test substance was evaluated in rabbits. A dose of 0.1 ml of the test material was instilled in the right eyes of six healthy young adult albino rabbits. The untreated left eyes served as controls. The treated eyes were examined at 1, 2, 3, 4, and 7 days following instillation of the test material in accordance with the Draize method. The calculated mean scores from the 24, 48, and 72 hour observations for corneal opacity, iritis, conjunctival redness, and conjuntival chemosis were 0.6, 0.0, 1.2, and 1.8, respectively. The effects were not reversible by the last observation at 7 days. In accordance with EU CLP Regulation No. 1272/2008 classification as an irreversible eye irritant is required.