Tetracopper hexahydroxide sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental phase: 07 February 2002 to 28 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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class 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: Overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: The animals were housed in groups of three by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: provided ad libitum (except for immediately prior to and after dosing)
- Water: provided ad libitum (except for immediately prior to and after dosing)
- 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

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5%

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml for 2000 mg/kg dose and 200 mg/ml for 200 mg/kg dose.
- Amount of vehicle (if gavage): 10 ml/kg

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

2000 mg/kg and 200 mg/kg

No. of animals per sex per dose:

2000 mg/kg: 3 female
200 mg/kg: 3 female and 3 male

Control animals:

no

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 300 - < 500 mg/kg bw

Based on:

test mat.

Mortality:

Animals treated with 2000 mg/kg were found dead during the day of dosing or one day after dosing. No deaths were noted in animals treated with 200 mg/kg.

Clinical signs:

other: Signs of systemic toxicity noted in females were hunched posture, pilo-erection and diarrhoea. Additional signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg were lethargy, decreased respiratory rate, laboured respiration and

Gross pathology:

Abnormalities noted at necropsy of animals that died during the study were haemorrhagic or abnormally red lungs, dark liver, dark kidneys, blue liquid present in the stomach, epithelial sloughing of the gastric mucosa and non-glandular region of the stomach and haemorrhagic small intestine. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl:CD® (SD) IGS BR) strain rat was estimated to be in the range of 300 - 500 mg/kg bodyweight.

Executive summary:

Introduction

The study was performed to assess the acute oral toxicity of the test material. The method used was designed to meet the requirements of the following guidelines:

• OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute ToxicClass Method" (adopted 22 March 1996)

• Commission Directive 96/54/EC Method B1 tris Acute Oral Toxicity (Oral - Acute ToxicClass Method)

Method

A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. Based on the results from this dose level further groups of fasted animals were treated at a dose level of 200 mg/kg bodyweight. Dosing was performed sequentially. The test material was administered orally as a dispersion in 0.5% carboxy methyl cellulose.

Results

Animals treated with 2000 mg/kg were found dead during the day of dosing or one day after dosing. No deaths were noted in animals treated with 200 mg/kg.

Signs of systemic toxicity noted in females were hunched posture, pilo-erection and diarrhoea. Additional signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg were lethargy, decreased respiratory rate, laboured respiration and ataxia. One female treated with 2000 mg/kg was found comatose four hours after dosing. All females treated with 200 mg/kg recovered one day after dosing. No signs of systemic toxicity were noted in males treated with 200 mg/kg.

Bodyweight. The surviving animals showed expected gains in bodyweight.

Conclusion

The acute median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl:CD® (SD) IGS BR) strain rat was estimated to be in the range of 300 - 500 mg/kg bodyweight.