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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labeling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute 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: 98.5%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately three and a half to four months old
- Weight at study initiation: 2.76 - 3.30 kg
- Housing: They were individually housed in suspended stainless steel cages mounted in mobile batteries. The cages measured 61 x 76 x 46 cm high and were fitted with perforated counter-sunk floor panels. A tray beneath the floor was lined with absorbent crepe paper which was changed regularly.
- Diet: Animals had free access to a commercially available standard pelleted rabbit diet
- Water: The rabbits had free access to tap water supplied to each cage by an automatic piped system.
- Acclimation period: three or four weeks

ENVIRONMENTAL CONDITIONS
- The animals were housed in a lagomorph room within a limited-access building. The room was kept at slight positive pressure relative to the outside and had its own filtered air supply giving approximately 15 complete air changes per hour without re-circulation. A temperature range of 18-19°C and a relative humidity range of 39 - 56% were achieved during the study. The achieved values were monitored daily. Electric time-switches operated a lighting cycle of 12 hours of artificial light per day. An emergency generator was available to maintain the electricity supply in the event of a power failure.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye was used as a comparison with the treated eye during assessment of ocular lesions.
Amount / concentration applied:
TEST MATERIAL
- Amount(s): 0.1 g



Duration of treatment / exposure:
72 hours
Observation period (in vivo):
Ocular reactions to treatment were assessed one hour, 24, 48 and 72 hours after treatment
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize, JH (1959). In "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" p.47. Association of Food and
Drug Officials of the United States, Austin, Texas.

The Official Journal of the European Communities (L257/8-9, Vol. 26., 16/9/83 and L257/19, Vol.26., 16/9/83) Directive 83/467/EEC.

TOOL USED TO ASSESS SCORE: An ophthalmoscope was used to facilitate inspection of the eyes.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
0 - 2
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
cornea opacity score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no corneal opacity observed in any animal
Irritation parameter:
iris score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
0 - 1
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
A diffuse crimson-red appearance to the conjunctiva and slight chemosis and/or discharge were observed in all animals one hour after
instillation. Iritis was also observed in two rabbits at this time. The eyes of all rabbits were overtly normal at the 24 hour observation.
Instillation of the test material caused a very slight initial pain response.

The mean values for ocular lesions recorded 24, 48 and 72 hours after treatment did not equal or exceed the EEC limit values for classifying the test material as irritant to the eye.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).
Under the conditions of this test, the test item was classified as 'non-irritant' to the eye.
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 g 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, following administration. A diffuse crimson-red appearance to the conjunctiva and slight chemosis and/or discharge were observed in all animals one hour after instillation. Iritis was also observed in two rabbits at this time. The eyes of all rabbits were overtly normal at the 24 hour observation. All ocular irritation reversed by 24 hours.