Copper(II) carbonate-copper(II) hydroxide (1:1)

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Copper(II) carbonate-copper(II) hydroxide (1:1)

EC Number:

235-113-6

EC Name:

Copper(II) carbonate-copper(II) hydroxide (1:1)

Cas Number:

12069-69-1

Molecular formula:

CuCO3.Cu(OH)2

IUPAC Name:

copper(II) carbonate, basic

Details on test material:

Lot/batch number - 26694/4/ROX
Description - Green powder
Purity - Not reported
Stability - Stable at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Source - David Percival Ltd, Moston, Sandbach, Cheshire, UK.
Sex - One male and two females
Age/weight at test initiation - At the start of the study the animals weighed 2.73-2.81 kg and were twelve to sixteen weeks old.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

The test substance was used as supplied with no additional preparation.
0.1 ml (91 mg) instilled per eye.

Duration of treatment / exposure:

72-hours

Observation period (in vivo):

1 hour and 24, 48 and 72 hours following treatment.
Additional observations were made in two treated eyes on Days 7 and 14

Number of animals or in vitro replicates:

3

Details on study design:

No details on removal/washing of treated eyes were given.
Opthalmic examinations for ocular damage/irritation were made approximately 1, 24, 48 and 72 hours after treatment.
Any other ocular effects were also noted. Additional observations were made in two treated eyes on Days 7 and 14 to assess the reversibility of the ocular effects.
SCORING: Draize scoring system and modified Kay and Calandra classification system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0.88

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0.44

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

1.22

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

1.22

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Reversability: One treated eye appeared normal at the 48-hour observation and two other treated eyes appeared normal at the 14-day observation.

Other effects:

Green residual test material around the eyelids of the treated eye was noted in two animals one hour after treatment. Diffuse or translucent corneal opacity was noted in two treated eyes at 24 and 48-hour observations with diffuse corneal opacity at the 72-hour and 7-day observations.

Vascularisation of the cornea was noted in two treated eyes at the 7-day observation. Iridial inflammation was noted in one treated eye one hour after treatment and in two treated eyes at the 24 and 48-hour observations. No other iridial effects were noted. Moderate conjunctival irritation were noted in all treated eyes one hour after treatment with minimal to moderate conjunctival irritation at the 24-hour observation. Moderate conjunctival
irritation was noted in two treated eyes at the 48-hour observation with minimal conjunctival irritation at the 72-hour observation. For further details please refer to Table 1.

Any other information on results incl. tables

Table 1 ACUTE EYE IRRITATION - SUMMARY OF RESULTS

 

	CORNEA		IRIS (Congestion)	CONJUNCTIVA
	(Degree of opacity)	(Area of Opacity)		Redness	Chemosis	Discharge
Score (average of animals investigated)	0-4	0-4	0-2	0-3	0-4	0-3
1 hour	0	0	0.33	1.66	1.33	2
24 hour	1	1	0.66	1.66	1.66	1.66
48 hour	1	1	0.66	1.33	1.33	0.66
72 hour	0.66	1	0	0.66	0.66	0
Average 24h, 48h and 72h	0.88	1	0.44	1.22	1.22	0.77
Area effected	Not reported	Not reported	Not reported	Not reported	Not reported	Eyelids
Maximum average score (including area affected, max 110)	Not reported	Not reported	Not reported	Not reported	Not reported	Not reported
Reversibility	Completely reversible	Completely reversible	Completely reversible	Completely reversible	Completely reversible	Completely reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material produced a maximum group mean score of 20.0 and was classified as a moderate irritant to the rabbit eye according to a modified
Kay and Calandra classification system. The test material did not meet the criteria for classification as an eye irritant according to EU labelling
regulations Commission Directive 93/21/EEC.

Executive summary:

Materials and methods

This study was conducted to assess the irritancy potential of copper carbonate to the eye of the New Zealand White rabbit.

 

Three New Zealand White rabbits (2 female, 1 male) were given a single dose of 0.1 ml copper carbonate (91 mg) applied directly into the conjunctival sac of the right eye. The left eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made 1, 24, 48 and 72 hours following treatment, according to the Draize scoring system and a modified version of the Kay and Calandra classification system. Any other ocular effects were also noted.

 

Additional observations were made in two treated eyes on days 7 and 14 to assess the reversibility of the ocular effects.

 

The study was conducted according to Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation/Corrosion), OECD Guidelines for the Testing of Chemicals No. 405 'Acute Eye Irritation/Corrosion' (adopted 24 February 1987) and EPA Health Effects Test Guidelines OPPTS 870.2400 Acute Eye Irritation, August 1998. The study was also conducted according to GLP.

No deviations from the test guidelines, or deficiencies in the method were reported.

Results and discussion

A single application of the test material to the non-irrigated eye of three rabbits produced diffuse or corneal opacity, iridial inflammation and moderate conjunctivae irritation. Vascularisation of the cornea was noted in two treated eyes at the 7-day observation. One treated eye appeared normal at the 48-hour observation and two treated eyes appeared normal at the 14-day observation.