Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
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:
cadmium
Details on test material:
Lot/batch number - 26694/4/ROX
Desription - Green powder
Purity - Not reported
Stability - Stable at room temperature

Test animals

Species:
rat
Strain:
other: Sprague-Dawley CD (Crl:CD(SD) IGS BR)
Sex:
male/female
Details on test animals or test system and environmental conditions:
Source - Charles River (UK) Ltd, Margate, UK.
Age at test initiation - Approximately 8 weeks
Weight at test initiation - males weighted 225-242 g and the females 204-230 g

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
Distilled water
Details on dermal exposure:
Area of exposure - 10% of body surface
Total volume applied - Not reported
Duration of exposure - 24 hours
Removal of test substance - Distilled water was used to remove any residual material
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females.
Control animals:
not required
Details on study design:
Mortality and clinical signs: The test animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently
once daily for 14 days.
Dermal examination: After removal of the dressings and subsequently once daily for 14 days, the test sites were examined for evidence of primary
irritation.
Scoring system: Draize scoring system.
Bodyweights: Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
Pathology: At the end of the study all animals were sacrificed and subjected to gross necropsy examination. This consisted of an external examination and opening of abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded.
Statistics:
Mortality data was used to determine the LD50. Statistical analysis were applied to the data.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Mortality: No deaths occurred during the study period.
Clinical signs:
Clinical observations: There were no signs of systemic toxicity noted during the study period.
Body weight:
Bodyweight: All animals showed expected gain in bodyweight during the study period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
Dermal reactions: Staining was noted at the treatment sites of all males one day after dosing. The staining did not affect the evaluation of skin
responses. There were no signs of dermal irritation.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) in male and female Sprague-Dawley rats was found to be greater than 2000 mg/kg bw. The test material
does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with EU labelling regulations Commission
Directive 93/21/EEC.
Executive summary:

Materials and methods

A group of ten animals (5 male and 5 female) were given a single, 24-hour, semi-occluded dermal application of undiluted copper carbonate to intact skin at a dose level of 2000 mg/kg bw. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy examination.

 

The study was GLP compliant and was conducted in accordance with the following guidelines;

Commission Directive 92/69/EEC Method B3 Acute Toxicity (Dermal). OECD Guidelines for the Testing of Chemicals No. 402 'Acute Dermal Toxicity' (adopted 24 February 1987). EPA Health effects Test Guidelines OPPTS 870.1200 Acute Dermal Toxicity, August 1998.

Results and discussion

There was no mortality, signs of clinical observations or dermal reactions noted in any of the test organisms during the study. The acute dermal median dose (LD50) of the test material in Sprague Dawley strain rats was found to be greater than 2000 mg/kg bw.

 

The test material does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with EU labelling regulations Commission Directive 93/21/EEC.