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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:
1988

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Dicopper chloride trihydroxide
EC Number:
215-572-9
EC Name:
Dicopper chloride trihydroxide
Cas Number:
1332-65-6
Molecular formula:
ClCu2H3O3
IUPAC Name:
dicopper chloride trihydroxide
Details on test material:
- Name of test material (as cited in study report): kupferoxychlorid.
- Composition of test material, percentage of components: Not stated.
- Lot/batch No.: Not stated.

Test animals

Species:
rat
Strain:
other: Crl:(WI)BR-Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
The rats were acclimatised prior to dosing. Initial body weights were 181 to 187 grams (males) and 161 to 189 grams (females).

Administration / exposure

Type of coverage:
other: Refer to details on dermal exposure.
Vehicle:
other: Test material was moistened with Ampuwa prior to application.
Details on dermal exposure:
Test material was applied with a gauze pad to an area of approximately 8 x 4 cm of intact shorn skin, on each rat on Day 1. The treated area was covered with gauze and the bodies of the treated animals were wrapped with an adhesive bandage. After 24 hours, the dressing and any remaining test substance were removed.
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 frequently for treatment-related clinical signs on the treatment day and then daily for the 14 day post-dosing period. Skin reactions were recorded daily from Day 2. 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 or skin reactions throughout the observation period.
Body weight:
All animals showed expected weight gain during the study.
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 dicopper chloride trihydroxide to the rat 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 carried out in accordance with the requirements of EU Guideline B.3 and OECD 402 without significant deviation. Dicopper chloride trihydroxide was moistened with Ampuwa prior to application. Five male and five female Crl:(WI)BR-Wistar rats weighing 181 to 187 g (males) and 161 to 189 g (females) were used. The rats were acclimatised prior to dosing. A dose level of 2000 mg/kg bw (based on a range finding study) was applied with a gauze pad to an area of approximately 8 x 4 cm of intact shorn skin, on each rat on Day 1. The treated area was covered with gauze and the bodies of the treated animals were wrapped with an adhesive bandage. After 24 hours, the dressing and any remaining test substance were removed. Animals were observed frequently for treatment-related clinical signs on the treatment day and then daily for the 14‑day post-dosing period. Skin reactions were recorded daily from Day 2. 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 or skin reactions throughout the observation period. All animals showed expected weight gain during the study. No gross findings were recorded upon necropsy.

The acute dermal LD50 of dicopper chloride trihydroxide to the rat was greater than 2000 mg/kg bw for males and females. Dicopper chloride trihydroxide is not classified.