Copper

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study according to OECD Guideline 402 and EU method B3 The test material has no batch number and no information on purity nor particle size distribution

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Commission Directive 92/69/EEC Method B3 Acute Toxicity (dermal).

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Coated copper flakes

IUPAC Name:

Coated copper flakes

Details on test material:

Lot/batch number: not availabl
Specification: no information was provided on the specification of the sample used in this study.

Purity: Not reported
Stability: Not reported

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Age/weight at study initiation: at the start of the study, animals were approximately eight weeks of age; males weighed 257 to 310 g, and the females 221 to 237 g.
One group of 5 males and 5 females; no control animals

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

area covered: approximately 10% of body surface
postexposure period: 14 days

Duration of exposure:

24h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

there were no deaths

Clinical signs:

other: There were no clinical signs of systemic toxicity. Very slight to well-defined erythema was noted at all treated skin sites one day after dosing with very slight erythema at nine treatment sites to days after dosing. Crust formation was noted at the treat

Gross pathology:

no abnormalities were noted at necropsy

Other findings:

the acute dermal LD50 of the test material, in the male and female rat was found to be greater than 2000 mg/kg bw.
No deficiencies

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material corresponds to the composition of “coated copper flakes” .
The acute dermal LD50 of the test material, in the male and female rat was found to be greater than 2000 mg/kg bw. In this study, coated copper flakes does not meet the criteria for classification for acute dermal toxicity according to Annex VI of Commission Directive 2001/59/EC

Executive summary:

The test material identity was not provided in details. Considering the information from the reports on the same material, the tested material falls in the composition category of "coated copper flakes" (see– section 1.2), consistent with a biocidal product use (PBD notification was the reason for doing the test).

The acute dermal LD50 of the test material, in the male and female rat was found to be greater than 2000 mg/kg bw. In this study, coated copper flakes does not meet the criteria for classification for acute dermal toxicity according to Annex VI of Commission Directive 2001/59/EC