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 Authority for Biocides and Existing Substances Regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot/Batch number: 02-0084
Description: Brown/black powder.
Purity: 97.7% cupric oxide.
Stability: Stable at room temperature.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Source: Charles River (UK) Ltd, Margate, Kent, UK.
Age/weight at study initiation: At the start of the study the animals weighed at least 200g and were approximately 8 weeks old.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
The test substance was moistened with distilled water.
Details on dermal exposure:
Area covered: 10% of body surface.
Removal of test substance: The test site was swabbed with arachis oil BP to remove any residual material.
Duration of exposure:
24 hours.
Doses:
2000 mg/kg b.w.
Concentration in vehicle: Not reported.
Total volume applied: Not reported.
No. of animals per sex per dose:
5 male and 5 female animals per group.
Control animals:
no
Details on study design:
Postexposure period: 14 days.
Examinations: Clinical observations, mortality, dermal reactions, irritation, bodyweights and necropsy.
Observations for death or toxicity were taken 0.5, 1, 2 and 4 hours after dosing and then once daily for fourteen days. Dermal reactions and signs of irritation were measured after removal of the dressings and once daily for fourteen days. Individual bodyweights were measured prior to dosing and seven and fourteen days after treatment. All animals were subjected to gross pathological examination after death.
Statistics:
Acute dermal median lethal dose (LD50) was determined from mortality data and not by statistical analysis.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities among any of the treated animals at study termination.
Clinical signs:
There were no signs of systemic toxicity at any observation time point in any of the treated animals.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
There were no signs of dermal irritation at any observation time point in any of the treated animals.

Any other information on results incl. tables

There were no mortalities or signs of systemic toxicity among any of the animals treated with copper oxide at the test concentration of 2000 mg/kg b.w.

 

The acute median lethal dose (LD50) of copper oxide in the Sprague-Dawley CD (Crl: CD (SD) IGS BR) strain of rat was, therefore, found to be >2000 mg/kg b.w.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute median lethal dose (LD50) of copper oxide in the Sprague-Dawley CD (Crl: CD (SD) IGS BR) strain of rat was found to be >2000 mg/kg b.w.
Executive summary:

Materials and Methods

The study was performed to assess the acute dermal toxicity of copper oxide in Sprague-Dawley CD (Crl:CD (SD) IGS BR) strain rats. A group of 10 animals (five male and five female) were given a single, 24-hour semi-occluded dermal application of test material moistened with distilled water at a dose level of 2000 mg/kg bw to an area of shorn skin (approximately 10% of the total body surface area).

 

The animals were observed for death or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Following removal of the dressing (after 24-hours exposure), the test sites were examined for evidence of primary irritation and scored according to the scale from Draize J. H. 1977.

Individual bodyweights were recorded prior to application of the test material, on Day 0, 7 and 14.

At the end of the study, animals were sacrificed and subjected to gross necropsy.
 The appearance of any macroscopic abnormalities was recorded.

The study was conducted according to OECD Guidelines for the Testing of Chemicals No. 402 'Acute Dermal Toxicity' (adopted 24 February 1987) and Commission Directive 92/69/EEC Method B3 Acute Toxicity (Dermal).  The study was also conducted according to GLP.

 

No deviations from the test guidelines, or deficiencies in the method were reported. Results and Discussion There were no mortalities, signs of systemic toxicity, or dermal irritation among any of the animals treated with copper oxide at the test concentration of 2000 mg/kg b.w. All animals showed expected gains in bodyweight over the study period and there were no abnormalities noted at necropsy.

The acute median lethal dose (LD50) of copper oxide in the Sprague-Dawley CD (Crl: CD (SD) IGS BR) strain of rat was, therefore, found to be >2000 mg/kg b.w.

 

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.