Copper dibromide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation, other

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

review article or handbook

Title:

EU RISK ASSESSMENT - [COPPER, COPPER II SULPHATE PENTAHYDRATE, COPPER(I)OXIDE, COPPER(II)OXIDE, DICOPPER CHLORIDE TRIHYDROXIDE] CAS [7440-50-8, 7758-99-8, 1317-39-1, 1317–38–0, 1332-65-6] CHAPTER 4.1.2. HUMAN HEALTH - EFFECTS ASSESSMENT

Author:

RAPPORTEUR: ITALY

Year:

2007

Bibliographic source:

European Copper Institute

Materials and methods

Test material

Test material information

1

Reference substance name:

Copper

EC Number:

231-159-6

EC Name:

Copper

Cas Number:

7440-50-8

Molecular formula:

Cu

IUPAC Name:

copper

Applicant's summary and conclusion

Conclusions:

No published studies are available which report on the potential of copper or its compounds to cause skin sensitisation in animals.
Several unpublished studies have been made available, using the guinea pig maximisation test of Magnusson and Kligman or the Buehler test and all conducted according to EU Annex V or OECD guidelines. These studies have investigated the skin sensitising potential of copper (I) oxide, copper (II) oxide, copper sulphate pentahydrate, copper oxychloride and copper powder. In these tests, none of the substances investigated have demonstrated potential to cause skin sensitisation in guinea pigs.
There have been several reports in humans of skin reactions to copper either as the metal, principally from jewellery and IUDs, or in copper salts, principally from the use of copper sulphate as a pesticide. Positive reactions from patch tests have been reported following challenge with 1-5% solutions of copper sulphate and, in a single case, with copper oxide. The possibility of cross-reactivity to salts of potent sensitisers exists. The prevalence of sensitisation to copper sulphate among patients with pre-existing skin conditions are reported to be of the order of 1% but is unknown among asymptomatic individuals. The largest investigation of women using copper containing IUDs (n=37) who reported side effects including skin reactions (n=10) found that none reacted positively to copper in patch tests. This finding suggests that copper was not responsible for their symptoms.
The following clinical criteria should be satisfied to accept a reported case of skin sensitisation as likely to be caused by copper or its compounds:
a clear history of significant dermal exposure to the copper species, followed by
experience of skin rashes, and
a positive reaction on patch testing
Using the above criteria resulted in very few documented cases of copper and/or its compounds as a cause of skin sensitisation in humans in the medical and scientific literature. Given the extensive use of copper, and the potential for continuous and/or intermittent skin contact, human case-reports of skin sensitisation due to copper or its compounds are rare.
No information is available from animal or human studies concerning the potential of copper substances covered by this Risk Assessment to cause respiratory sensitisation. In the absence of any relevant data, the potential to cause respiratory sensitisation cannot be assessed.