Tetracopper hexahydroxide sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental Phase: 18 February 2002 to 23 February 2002. Report issue: 13 June 2002.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tetracopper hexahydroxide sulphate

EC Number:

215-582-3

EC Name:

Tetracopper hexahydroxide sulphate

Cas Number:

1333-22-8

Molecular formula:

Cu4H6O10S

IUPAC Name:

tetracopper(2+) hexahydroxide sulfate

Test material form:

solid: bulk

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: Individually housed in suspended cages
- Diet & Water: Free access to mains drinking water and food (certified rabbit diet).
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 changes per h
- Photoperiod (hrs dark / hrs light): 12h continuous light (06:00 to 18:00) and 12h darkness

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye by gently pulling the lower lid away from the eyeball.

Observation period (in vivo):

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.

Number of animals or in vitro replicates:

Three

Details on study design:

Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.

Initially, a single rabbit was treated. A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment using a numerical evaluation according to Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).

Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 120, 121, 122

Time point:

other: 1h

Score:

ca. 0

Max. score:

80

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: 120, 121, 122

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

80

Results 3

Irritation parameter:

iris score

Basis:

animal: 120, 121, 122

Time point:

other: 1h

Score:

ca. 0

Max. score:

10

Results 4

Irritation parameter:

iris score

Basis:

animal: 120, 121, 122

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

10

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: 120

Time point:

other: 1 h

Score:

4

Max. score:

20

Reversibility:

fully reversible

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal: 120

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

20

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal: 121

Time point:

other: 1 h

Score:

ca. 8

Max. score:

20

Reversibility:

fully reversible

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal: 121

Time point:

24 h

Score:

ca. 2

Max. score:

20

Reversibility:

fully reversible

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal: 121

Time point:

other: 48/72h

Score:

ca. 0

Max. score:

20

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal: 122

Time point:

other: 1 h

Score:

ca. 8

Max. score:

20

Reversibility:

fully reversible

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal: 122

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

20

Results 12

Irritation parameter:

chemosis score

Basis:

animal: 120

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Results 13

Irritation parameter:

chemosis score

Basis:

animal: 121

Time point:

other: 1 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible

Results 14

Irritation parameter:

chemosis score

Basis:

animal: 121

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Results 15

Irritation parameter:

chemosis score

Basis:

animal: 122

Time point:

other: 1 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 16

Irritation parameter:

chemosis score

Basis:

animal: 122

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Results 17

Irritation parameter:

chemosis score

Basis:

animal: 120

Time point:

other: 1h

Score:

ca. 0

Max. score:

4

Other effects:

No corneal or iridial effects were noted during the study.

Any other information on results incl. tables

Results

Moderate conjunctival irritation was noted in two treated eyes with minimal conjunctival irritation in the remaining treated eye one hour after treatment. Minimal conjunctival redness was noted in one treated eye at the 24-hour observation.

Two treated eyes appeared normal at the 24-hour observation and the remaining treated eye appeared normal at the 48-hour observation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced a maximum group mean score of 6. 7 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following gudielines:

 

• OECD Guidelines for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987)

 

• Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)

 

Method

Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used. Initially, a single rabbit was treated. A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The left eye remained untreated and was used for control purposes. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.

 

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.

 

 

Result

A single application of the test material to the non-irrigated eye of three rabbits produced minimal to moderate conjunctival irritation. Two treated eyes appeared normal at the 24-hour observation and the remaining treated eye appeared normal at the 48-hour observation.

 

Conclusion

The test material produced a maximum group mean score of 6.7 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.