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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: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Copper hydroxide.
- Composition of test material, percentage of components: Not stated.
- Lot/batch No.: 0210576133.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
The rabbits were housed individually and acclimatised prior to dosing. Body weights were 2.0 to 2.3 kg (males) and 2.1 to 2.4 kg (females).

Administration / exposure

Type of coverage:
other: See details on dermal exposure.
Vehicle:
water
Remarks:
Test material was moistened with deionised water (1.2 mL/g) prior to application.
Details on dermal exposure:
Test material was applied to an area of intact shaven skin of each rabbit on a surgical gauze patch 10 x 13 cm in size on Day 1. The patch was held in place with a bandage and secured with elastic tape. After 24 hours, the patch was removed and residual test substance gently rinsed off with water and a paper towel.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw.
No. of animals per sex per dose:
Five males and five females.
Control animals:
no
Details on study design:
Animals were observed after 4 hours for treatment-related clinical signs on the treatment day and then daily for the 14 day post-dosing period. Animals were weighed prior to treatment and after 7 days (Day 8) and 14 days (Day 15). Decedents and animals surviving to 14 days were subject to gross necropsy.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities.
Clinical signs:
There were no clinical signs of toxicity throughout the observation period.
Body weight:
All males and four females showed weight gain during the study. One female lost weight in the second week after treatment.
Gross pathology:
No gross findings were recorded.
Other findings:
None.

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 of copper dihydroxide to the rabbit was greater than 2000 mg/kg bw for males and females.
Classification according to Directive 67/548/EEC: Not classified.
Classification according to CLP/GHS: Not classified.
Executive summary:

A GLP-compliant study was conducted in accordance with US EPA 81-2 without significant deviation. Copper dihydroxide was moistened with deionised water (1.2 mL/g) prior to application. Five male and five female New Zealand white rabbits weighing 2.0 to 2.3 kg (males) and 2.1 to 2.4 kg (females) were used. The rabbits were housed individually and acclimatised prior to dosing. A dose level of 2000 mg/kg bw was applied to an area of intact shaven skin of each rabbit on a surgical gauze patch 10 x 13 cm in size on Day 1. The patch was held in place with a bandage and secured with elastic tape. After 24 hours, the patch was removed and residual test substance gently rinsed off with water and a paper towel. Animals were observed after 4 hours for treatment-related clinical signs on the treatment day and then daily for the 14‑day post-dosing period. Animals were weighed prior to treatment and after 7 days (Day 8) and 14 days (Day 15). Decedents and animals surviving to 14 days were subject to gross necropsy.

There were no mortalities and no clinical signs of toxicity throughout the observation period. All males and four females showed weight gain during the study. One female lost weight in the second week after treatment. No gross findings were recorded at necropsy.

The acute dermal LD50 of copper dihydroxide to the rabbit was greater than 2000 mg/kg bw for males and females. Copper dihydroxide is not classified.