Copper chloride

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: GLP guideline study (OECD)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Copper chloride

EC Number:

231-842-9

EC Name:

Copper chloride

Cas Number:

7758-89-6

Molecular formula:

ClCu

IUPAC Name:

λ¹-copper(1+) chloride

Details on test material:

Name of test material: Copper monochloride
Analytical purity: 97%
Source: Simga-Aldrich corporation
Lot/batch No: Lot No. 17119BO

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Group mean bodyweight at study initiation: 255.3 g for males; 216.6 - 225 g for females

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: The test substance was wetted with a saline lotion

Details on dermal exposure:

TEST SITE:
- Area of exposure: dorsal part.
- % coverage: approximately 10% of the total body surface area.
- Type of wrap if used: porous gauze dressing covered from a non-irritating tape for 24 hours.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed using a saline solution.
- Time after start of exposure: 24 hours.

TEST MATERIAL
- For solids, paste formed: yes.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw for males: 2000, 1500, 1000, 500 mg/kg bw for females

No. of animals per sex per dose:

5 (In total: 5 males; 25 females)

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Cages of rats were checked at least once a day for any mortality. Animals were individually observed hourly during the first 4 hours after dosing with special attention, and daily for a total of 14 days. The nature and severity of the clinical signs and time were recorded at each observation. The body weight of each rat was recorded on day 1 (prior to dosing), day 8 and day 15 (prior to necropsy). Individual body weight changes were calculated.
- Necropsy: All animals were killed on day 15 by carbon dioxide asphyxiation and subjected to a gross necropsy. All gross pathological changes were recorded for each animal. Microscopic examination was not conducted because evidence of gross pathological changes was not showed.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 224 mg/kg bw

95% CL:

1 032 - 1 453

Mortality:

Males showed no death but females showed 4 deaths in 2000 mg/kg bw, 4 deaths in 1500 mg/kg bw, and 1 death in 1000 mg/kg bw, respectively.

Clinical signs:

other: It was observed that there was hardness of the skin, an exudation from the hardness site, formation of scar/falling off of scar, and reddish change in application sites. These findings were considered to be related to application of test substance. Red

Gross pathology:

In macroscopic examination of application sites, the males showed hardness of skin and subcutaneous necrosis and hemorrhage. At test conclusion, a crust was observed at the application sites in necropsied rats. These findings were severe at the higher dose concentration. There appeared to be an inflammatory response at the application site with toxicity. Internally, no abnormality was observed in any animal. One female from the 1500 mg/kg bwgroup had enlarged kidney, adrenal gland and spleen, whereas lungs were smaller. This was considered not to be related to the test substance (it was a lesion in the rodent).

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute lethal dose (LDso) of copper chloride was >= 2,000 mg/kg bw for males and 1,224 mg/kg bw for females. The 95 % confidence limits for females were 1,032 - 1,453 mg/kg bw.

Executive summary:

Copper chloride administered to rats by the dermal route was found to cause skin inflammation and injury. Dermal absorption was found to cause symptoms of systemic toxicity. Female rats appeared to be more susceptible to copper chloride than males, based on mortality and clinical signs.