Copper dichloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable study report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Principles of method if other than guideline:

BASF Test
Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. The test substance was applied to the conjunctival sac of the right eye of the animal. The adjacent eye was treated with talcum powder and served as a control. The animals were observed several times on the treatment day and 8 days afterwards and the findings were recorded on working days. The report usually describes findings after 1 and 24 hours and at the end of the observation period. Thus, for a final evaluation, the findings after 48 and 72 hours from the raw data have to be taken into account.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Copper chloride

EC Number:

231-842-9

EC Name:

Copper chloride

Cas Number:

7758-89-6

Molecular formula:

ClCu

IUPAC Name:

copper (I) chloride

Details on test material:

- Name of test material: Kupfer-I-Chlorid
- Molecular formula: CuCl
- Molecular weight: 98.999
- Smiles notation: [Cu]Cl
- InChl: 1S/ClH.Cu/h1H;/q;+1/p-1
- Analytical purity: 98-99%

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.94 - 3.02 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye was treated with talcum powder and served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: approx. 50 mg

Duration of treatment / exposure:

unspecified

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

2 animals

Time point:

24/48 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

2 animals

Time point:

24/48 h

Score:

0

Max. score:

3

Reversibility:

other: no effects

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

2 animals

Time point:

24/48 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

2 animals

Time point:

24/48 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Any other information on results incl. tables

Severe corneal opacity (grade 3), moderate conjunctival chemosis (grade 2) and necrotic lacrimation were observed in all animals 1 hour after application and persisted for the duration of the study (8 days). Additionally, bulbus loss were noted in all animals at the end of the observation period. The ocular reactions were not reversible within 8 days after application.

Animal		Cornea	Iris	Conjunctivae		Additional findings
				Redness	Chemosis
01	24 h	3	0	0	2	a, b
	48 h	3	0	0	2	a, b
	8 d					a, b corrosion
	Mean score	3	0	0	2
02	24 h	3	0	0	2	a, b
	48 h	3	0	0	2	a, b
	8 d					a, b corrosion
	Mean score	3	0	0	2

a = necrotic lacrimation

b = grey mucous and nictitating membrane

Justification for read-across from copper chloride to copper dichloride:

Acute toxicity, irritation and sensitisation data for copper dichloride have been read across from the closely analogous substance copper chloride. These substances are chemically similar; copper dichloride contains only cupric copper and ionic chlorine, whereas copper chloride contains cuprous copper and ionic chlorine. Available data on (cuprous) dicopper oxide and (cupric) copper oxide show that cuprous copper is inherently more acutely toxic and irritant than the cupric form (neither compound is a skin sensitiser). The results of an acute oral toxicity test available in the public literature (Singh and Junnarkar, 1991) confirm that this principle can also be applied to the cuprous and cupric chlorides. On this basis, and in order to minimise animal testing, a worst-case approach has been adopted in which data generated using copper choride has been directly read across to copper dichloride.

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:

The test item causes serious eye damage.
Classification according to Directive 67/548/EEC: Irritant (Xi). R41, risk of serious damage to eyes.
Classification according to CLP/GHS: Eye Damage 1, H318: Causes serious eye damage.