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Toxicological information

Acute Toxicity: dermal

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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 Substance Regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
These deviations are not considered to have influenced the outcome or the integrity of the study:The relative humidity in the experimental animal room was 50-85% (and not 30-70% as recommended), Full details on dressing were not provided.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Cuprous oxide [Copper (I) oxide]
Lot/batch number: Not specified
Specification: No information was provided on the specification of the sample used in this study.
Description: Orage-brown fine powder.
Purity: Not specified
Stability: Not specified.

Test animals

Species:
rat
Strain:
other: Crl.:(WI)BR-Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Source: Charles River Wiga, 8741 Sultzfeld, Germany.
Age/weight at study initiation: At the start of the study males weighed 211.2 to 232.5 g and females weighed 222.6 to 258.7 g. The age of the animals was not reported.

Administration / exposure

Type of coverage:
other: Unclear if bandage used was occlusive or semi-occlusive
Vehicle:
water
Remarks:
(sterile water)
Details on dermal exposure:
TEST SITE
Area of exposure: An area of 8 x 5 cm.
Type of wrap if used: ‘Elasopast’ bandage
REMOVAL OF TEST SUBSTANCE
After a 24 h exposure period, the bandage and any excess test article was removed. The method for removal of the test material was not specified.
TEST MATERIAL
The test material was applied moistened at 2000 mg/kg bw. The total volume applied was not specified.
VEHICLE
Test material was moistened with 2-3 drops of ‘Ampuwa’ (sterile water).
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
One group of 5 males and 5 females.
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days
Statistics:
No data.

Results and discussion

Preliminary study:
Dose range finding study: In a dose range finding study, 2 females rats were administered dermally 2000 mg/kg bw. No mortality or dermal findings were seen.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None.
Clinical signs:
There were no deaths, clinical signs of systemic toxicity, or dermal findings in this study.
Body weight:
All animals gained weight during the study.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
None.

Any other information on results incl. tables

Table 1 Acute dermal toxicity study - Summary of findings

Dose

[mg/kg bw]

Number dead/ number investigated

Time of death (range)

Observations

2000

(Male)

0/5

-

There were no deaths, clinical signs of systemic toxicity, or dermal findings in this study.

All animals gained weight during the study.

No abnormalities were noted at necropsy.

2000

(Female)

0/5

-

LD50> 2000 mg/kg bw (males and females)

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 in the male and female rat was found to be greater than 2000 mg/kg bw.
Therefore, cuprous oxide did not meet the criteria for classification for acute dermal toxicity according to labelling regulations outlined in Annex VI
of Commission Directive 2001/59/EC.
Executive summary:

Materials and methods

This study was conducted according to GLP, and to OECD Test Guideline 402 'Acute Dermal Toxicity' (adopted 24 February 1987). Only minor deviations from test guideline occurred. These deviations are not considered to have influenced the outcome or the integrity of the study.

Cuprous oxide, moistened with sterile water, was applied to the shaven, intact dorsal skin of 5 male and 5 femaleCrl.:(WI)BR-Wistarrats at 2000 mg/kg bw under a ‘Elasoplast’ bandage. After a 24 h exposure period the dressing and any excess test article was removed.

At the start of the study males weighed 211.2 to 232.5 g and females weighed 222.6 to 258.7 g.

Animals were observed for overt signs of toxicity 1, 2, 3, 6 and 24/48 hours after test material application, and each day thereafter for 14 days. Dermal irritation was measured daily using a modified Draize scheme. Individual bodyweights were recorded on days 0, 7 and 14. Animals were killed and necropsied after a 14 day observation period.

Results and discussion

There were no deaths, clinical signs of systemic toxicity, or dermal findings in this study.

All animals gained weight during the study. No abnormalities were noted at necropsy. See also Table 1 for a summary of results.