Tetracopper hexahydroxide sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental phase: 13 February 2002 and 16 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 404 (Acute Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-10 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: Individually in suspended cages
- Diet: Free access to food (Certified rabbit diet) was allowed throughout the study
- Water : Free access to mains drinking water was allowed throughout the study
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 deg. C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h light / 12h dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored accordingly.

Number of animals:

Three.

Details on study design:

TEST SITE
- Area of exposure: back of each rabbit
- Coverage: 2.5 cm x 2.5 cm patch
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: four hours.

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 29, 31, 32

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

No effects observed

Remarks on result:

other: Additional time point

Remarks:

Assessment immediately after application was also made which is recorded as time '0'

Results 2

Irritation parameter:

edema score

Basis:

animal: 29, 31, 32

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

No effects observed

Remarks on result:

other: Additional time point

Remarks:

Assessment immediately after application was also made which is recorded as time '0'

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal: 29, 31, 32

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other:

Remarks:

No effects observed

Remarks on result:

other: Additional time point

Remarks:

Assessment immediately after application was also made which is recorded as time '0'

Any other information on results incl. tables

Faint light blue coloured staining was noted at all treated skin sites one hour after patch removal and at one treated skin site at the 24-hour observation. The staining did not affect evaluation of skin responses.

No evidence of skin irritation was noted during the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

Introduction

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

 

• OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992)

 

• Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation)

 

Method

On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.

 

A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period. Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

 

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation.

 

Results

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation.

 

Conclusion

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.