Dicopper chloride trihydroxide

Eye irritation

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:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

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 chloride trihydroxide

Details on test material:

- Name of test material (as cited in study report): Copper oxychloride.
- Composition of test material, percentage of components: 57.72% w/w copper
- Lot/batch No.: 31762/86

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Six female New Zealand white rabbits weighing 2.240 to 2.595 kg were acclimatised prior to dosing.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 grams.

Duration of treatment / exposure:

24 hours.

Observation period (in vivo):

21 days.

Number of animals or in vitro replicates:

Six

Details on study design:

0.1 g of the test substance was applied to the corneal surface of the right eye of each rabbit and the eyelids held together for one or two seconds before release. After 24 hours, the treated eyes were flushed with lukewarm water. Animals were examined for signs of eye irritation after 1, 24, 48 and 72 hours and 7, 14 and 21 days after administration as appropriate, and irritation scored according to Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: Six animals

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.4

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: Six animals

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.9

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: Six animals

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Six animals

Irritant / corrosive response data:

Dicopper chloride trihydroxide caused cornea opacity (up to score 2), iris lesion (up to score 1), conjunctival redness (up to score 3) and chemosis (up to score 4) of the eyes in all animals at one or more assessment times. Effects persisted in one or more animals for up to 14 days (cornea opacity) or 72 hours (iris lesion, conjunctival redness, conjunctival chemosis). 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
	51	53	55	57	59	61	51	53	55	57	59	61
	Cornea opacity						Iris lesion
1 hour	0	1	0	0	0	0	1	1	0	1	1	1
24 hours	2	1	2	1	1	1	1	0	1	0	1	0
48 hours	2	1	1	0	0	1	1	0	1	0	0	0
72 hours	2	1	0	1	1	0	1	0	1	0	0	0
7 days	1	0	1	0	0	-	0	0	0	0	0	-
14 days	1	-	0	-	-	-	0	-	0	-	-	-
21 days	0	-	-	-	-	-	0	-	-	-	-	-
Mean score per animal^a	2	1	1	0.6	0.6	0.6	1	0	1	0	0.3	0
Mean score all animals^a	1.0						0.4
	Conjunctival redness						Conjunctival chemosis
1 hour	1	2	2	2	2	2	3	3	2	3	3	3
24 hours	3	0	3	1	1	1	4	0	4	1	2	1
48 hours	3	0	2	0	0	0	4	0	3	0	0	0
72 hours	2	0	1	0	0	0	3	0	1	0	0	0
7 days	0	0	0	0	0	-	0	0	0	0	0	-
14 days	0	-	0	-	-	-	0	-	0	-	-	-
21 days	0	-	-	-	-	-	0	-	-	-	-	-
Mean score per animal^a	2.7	0	2	0.3	0.3	0.3	3.7	0	2.7	0.3	0.7	0.3
Mean score all animals^a	0.9						1.3
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 (i.e. 4 animals) at 24, 48 and 72 hours were <= 1 (cornea opacity and iris lesion), <= 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 EC Guideline B.5, OECD 405 and EPA 40 CFR Section 798.4500 without significant deviation. Dicopper chloride trihydroxide was used for the study. Six female New Zealand white rabbits weighing 2.240 to 2.595 kg were acclimatised prior to dosing. 0.1 g of the test substance was applied to the corneal surface of the right eye of each rabbit and the eyelids held together for one or two seconds before release. After 24 hours, the treated eyes were flushed with lukewarm water. Animals were examined for signs of eye irritation after 1, 24, 48 and 72 hours and 7, 14 and 21 days after administration as appropriate, and irritation scored according to Draize.

 

Dicopper chloride trihydroxide caused cornea opacity (up to score 2), iris lesion (up to score 1), conjunctival redness (up to score 3) and chemosis (up to score 4) of the eyes in all animals at one or more assessment times. Effects persisted in one or more animals for up to 14 days (cornea opacity) or 72 hours (iris lesion, conjunctival redness, conjunctival chemosis). 

 

The mean eye irritation scores recorded in 2/3 of test animals (i.e. 4 animals) at 24, 48 and 72 hours were <= 1 (cornea opacity and iris lesion), <= 2 (conjunctival redness and chemosis). On this basis, dicopper chloride trihydroxide is not classified as irritating to eyes.