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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: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dicopper chloride trihydroxide
EC Number:
215-572-9
EC Name:
Dicopper chloride trihydroxide
Cas Number:
1332-65-6
Molecular formula:
ClCu2H3O3
IUPAC Name:
dicopper(2+) chloride trihydroxide
Details on test material:
- Name of test material (as cited in study report): Copper oxychloride.
- Composition of test material, percentage of components: Not stated.
- Lot/batch No.: 3/0369

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three male New Zealand white rabbits weighing 2.28 to 2.33 kg were acclimatised prior to dosing.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 grams.
Duration of treatment / exposure:
Refer to details on study design.
Observation period (in vivo):
6 days.
Number of animals or in vitro replicates:
Three.
Details on study design:
0.1 g of the test substance was applied into the conjunctival sac of the right eye of each rabbit and the eyelids held together for one or two seconds before release. Animals were examined for signs of eye irritation after 1, 24, 48 and 72 hours and 4, 5 and 6 days as appropriate, and irritation scored according to Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable.
Irritant / corrosive response data:
Dicopper chloride trihydroxide caused slight iris lesion and conjunctival redness (up to score 1) of the eyes in some animals at one or more assessment times. Effects persisted for up to 72 hours (iris lesion) or 5 days (conjunctival redness). No cornea opacity at any time or conjunctival chemosis from Day 2 was recorded. Refer to Table 1.
Other effects:
Records of non relevant endpoints for classification such as the area of the cornea affected and conjunctival discharge were also made in the study but these are not presented in this summary, as they do not affect the outcome.

Any other information on results incl. tables

Table 1. Summary of individual and mean eye irritation scores according to Draize

 

Assessment time

Scores according to Draize for animal number

Cornea opacity

Iris lesion

Conjunctival redness

Conjunctival chemosis

401

402

403

401

402

403

401

402

403

401

402

403

1 hour

0

0

0

1

0

1

1

1

1

0

1

1

24 hours

0

0

0

1

0

1

1

1

1

0

0

0

48 hours

0

0

0

0

0

1

0

0

1

0

0

0

72 hours

0

0

0

0

0

1

0

0

0

0

0

0

4 days

-

-

0

-

-

0

-

-

1

-

-

0

5 days

-

-

0

-

-

0

-

-

1

-

-

0

6 days

-

-

0

-

-

0

-

-

0

-

-

0

Mean score per animala

0.0

0.0

0.0

0.3

0.0

1.0

0.3

0.3

0.7

0.0

0.0

0.0

Mean score
for three animalsa

0.0

0.4

0.4

0.0

a        Mean scores after 24, 48 and 72 hours (shaded).

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean eye irritation scores recorded in 2/3 of test animals at 24, 48 and 72 hours were <= 1 (cornea opacity and iris lesion) and <= 2 (conjunctival redness and chemosis).
Classification according to Directive 67/548/EEC: Not classified.
Classification according to CLP/GHS: Not classified.
Executive summary:

A GLP-compliant study was conducted in accordance with the requirements of EC Guideline B.5 and OECD 405 withoit significant deviation. Dicopper chloride trihydroxide was used for the study. Three male New Zealand white rabbits weighing 2.28 to 2.33 kg were acclimatised prior to dosing. 0.1 g of the test substance was applied into the conjunctival sac of the right eye of each rabbit and the eyelids held together for one or two seconds before release. Animals were examined for signs of eye irritation after 1, 24, 48 and 72 hours and 4, 5 and 6 days as appropriate, and irritation scored according to Draize.

 

Dicopper chloride trihydroxide caused slight iris lesion and conjunctival redness (up to score 1) of the eyes in some animals at one or more assessment times. Effects persisted for up to 72 hours (iris lesion) or 5 days (conjunctival redness). No cornea opacity at any time or conjunctival chemosis from Day 2 was recorded.

 

The mean eye irritation scores recorded in 2/3 of test animals at 24, 48 and 72 hours were <= 1 (cornea opacity and iris lesion) and <= 2 (conjunctival redness and chemosis). On this basis dicopper chloride trihydroxide is not classified as irritating to eyes.