Copper di(acetate)

Acute Toxicity: dermal

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:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Copper di(acetate)

EC Number:

205-553-3

EC Name:

Copper di(acetate)

Cas Number:

142-71-2

Molecular formula:

Cu(CO2CH3)2

IUPAC Name:

copper di(acetate)

Details on test material:

- Name of test material (as cited in study report): Copper acetate monohydrate
- Analytical purity: 99.9%
- Lot/batch No.: 11.6.1SD
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK.
- Age at study initiation: Eight to twelve weeks.
- Weight at study initiation: Males 237 - 295 grams. Females 210 - 226 grams.
- Fasting period before study: None.
- Housing: The animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-Hour exposure period and in groups of five, by sex, for the remainder ofthe study.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: At least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C.
- Humidity (%): 30 to 70%.
- Air changes (per hr): 15.
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

TEST SITE
- % coverage: Approximately 10% of the total body surface area.
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24-Hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual test item.
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: No. The appropriate amount of test item, moistened with arachis oil BP, was applied as evenly as possible to an area of shorn skin.

Duration of exposure:

24 hours.

Doses:

2000 mg/kg bw.

No. of animals per sex per dose:

5 males, 5 females.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: The animals were observed for deaths or overt signsof toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to application of the test item on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: Yes.
- Other examinations performed: clinical signs, body weight. After removal of the dressings and subsequently once daily for fourteen days, the test sites were examined for evidence of primary irritation and scored according to Draize. Any other skin reactions, if present were also recorded.

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 deaths.

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

A cavity in the right kidney was noted at necropsy of one animal. No abnormalities were noted at necropsy of the remaining animals.

Other findings:

Very slight erythema was noted at the test sites of all animals. Other signs of dermal irritation noted were small superficial scattered scabs, a hardened light brown coloured scab, scab lifting to reveal glossy skin and scab lifting at edges to reveal dried blood.

Any other information on results incl. tables

The following tables are attached:

Table 1: Individual dermal reactions - males.

Table 2: Individual dermal reactions - females.

Table 3: Individual bodyweights and weekly bodyweight changes.

Table 4: Individual necropsy findings.

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 ) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
Classification according to Directive 67/548/EEC: Not classified.
Classification according to CLP/GHS: Not classified.

Executive summary:

A GLP-compliant study was performed to assess the acute dermal toxicity of copper acetate monohydrate in the Wistar strain rat. The method was designed to be compatible with OECD Guideline 402 and EU Method B3. A group of ten animals (five males and five females) was given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths. There were no signs of systemic toxicity. Very slight erythema was noted at the test sites of all animals. Other signs of dermal irritation noted were small superficial scattered scabs, a hardened light brown coloured scab, scab lifting to reveal glossy skin and scab lifting at edges to reveal dried blood. All animals showed expected gains in bodyweight over the study period. A cavity in the right kidney was noted at necropsy of one animal. This was considered not to be related to treatment. No abnormalities were noted at necropsy of the remaining animals.

The acute dermal median lethal dose (LD50) of copper acetate monohydrate in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. The test item is considered not to be classified with regard to dermal toxicity.