Tetracopper hexahydroxide sulphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental phase:11 February 2002 to 25 February 2002. Report issue: 12 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Male and female Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rats were supplied by Charles River (UK) Ltd, Margate, Kent, UK.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Approximately eight weeks old
- Weight at study initiation: At least 200g
- Fasting period before study: None
- Housing: The animals were housed in groups of five by sex in solid-floor polypropylene cages furnished with woodflakes except during the 24-hour period when they were housed individually.
- Diet: provided ad libitum
- Water: provided ad libitum
- Acclimation period: At least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
- Environmental enrichment: The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% used to moisten the test material

Details on dermal exposure:

TEST SITE
- % coverage: Approximately 10% of the total body surface ara.
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.
- Application site: Area of shorn skin

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Cotton wool moistened with distilled water was used to remove any residual test material.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 200 mg/kg
-- For solids, paste formed: test material was moistened with 0.5% carboxy methyl cellulose (CMC)

Duration of exposure:

24-hours

Doses:

2000 mg/kg bodywieght

No. of animals per sex per dose:

5 male and 5 female

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no unscheduled deaths on the study.

Clinical signs:

other: There were no signs of systemic toxicity

Gross pathology:

No gross pathological abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rat was found to be greater than 2000 mg/kg bodyweight.

Executive summary:

Introduction

The study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rat. The method was designed to meet the requirements of the following guidelines:

 

• OECD Guidelines for the Testing of Chemicals No. 402 "Acute Dermal Toxicity" (adopted 24 February 1987)

 

• Commission Directive 92/69/EEC Method B3 Acute Toxicity (Dermal)

 

 

Method

A group of ten animals (five males and five females) was given a single, 24-hour, semi-occluded dermal application of test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

 

Results

There were no deaths on the study and no clinical observations or signs of dermal irritation.

No abnormalities were noted at necropsy.

All animals showed expected gains in bodyweight over the study period.

 

Conclusion

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rat was found to be greater than 2000 mg/kg bodyweight.