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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: Already evaluated by the Competent Authorities for Biocides and Existing Substance Regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Slight variations of humidity were noted beyond the norms (minimum 45% RH) with aminimum at 36.4% RH. This deviation is not considered to have affected the outcome of the study.
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Slight variations of humidity were noted beyond the norms (minimum 45% RH) with aminimum at 36.4% RH. This deviation is not considered to have affected the outcome of the study.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot/Batch number: Batch number 844,
Specification: Not stated,
Description: Blue crystals,
Purity: 99.0 - 100.5%, S
tability: Reported to be stable under the conditions of the study

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: E.S.D. (Chatillon-sur-Chalaronne, France)
Adult male rabbits were about 3 months old and in a bodyweight range of 2 - 3 kg at initiation of treatment.

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
Test substance was reduced to a powder
Controls:
yes
Amount / concentration applied:
100 mg powdered test substance was administered by ocular instillation to the right eye of each animal.
Duration of treatment / exposure:
The eyes were not rinsed after instillation of the test material.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3 (male)
Details on study design:
REMOVAL OF TEST SUBSTANCE: The test substance was not removed.
EXAMINATION TIME POINTS: 1, 24, 48, 72 hours. Further examinations were performed at 7, 14 and 21 days to determine possible reversibility.
SCORING SYSTEM: Draize Scale for Ocular Lesions
TOOL USED TO ASSESS SCORE: Eye examination, fluorescein staining, clinical observations, body weight. No ophthalmoscopic examination was
made.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
for 3 animals
Time point:
24/48/72 h
Score:
2.56
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
for 3 animals
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
for 3 animals
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
for 3 animals
Time point:
24/48/72 h
Score:
3.78
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Clinical observations were as follows:
Neovascularisation on an area less than one quarter of the corneal surface (one animal at 72 hour).
Circumcorneal injections plus congestion of the iris (all animals at 1 to 72 hours).
Greyish appearance of the palpebral conjunctiva (made the reading imprecise) (one animal at 24 to 72 hour).
Permanent myosis with preservation of direct photomotor reflex (2 animals at 1 to 72 hour and 1 animal at 1 to 24 hour).
Presence of a whitish humour on the sides of the lids of the treated eye (one animal at 24 and 72 hour).
Other effects:
None.

Any other information on results incl. tables

Lesions observed at 72 hours were still present in the three rabbits when examined on day 21.

Copper II sulphate pentahydrate was shown to elicit severe ocular irritation and other lesions.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is considered to be severely irritating to the eyes of rabbits.
Executive summary:

Materials and Methods

The test substance, copper II sulphate pentahydrate, was evaluated for its potential to produce an irritating and/or corrosive effect on the ocular tissue of laboratory animals (rabbits) following instillation into the eye in the dose of 0.1 mg. The study design was in accordance with OECD 405 (1987), EEC 92/69 - Annex - Method B5 (1992) - 93/21 (1993).

Results and Discussion

The test substance's average score for all animals at 24, 48, 72 h is 1.00 for the iris, 2.56 for the cornea and 3.78 for chemosis and 2.00 for redness of the conjunctiva. Ocular lesions observed at 72 hours were still present in the three rabbits when examined on day 21. Copper II sulphate pentahydrate was shown to elicit severe ocular irritation and other lesions.

Conclusion

The test substance is considered to be severely irritating to the eyes of rabbits.