Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Acute oral toxicity:

Three high quality GLP-compliant studies conducted in accordance with internationally accepted guidelines are available for acute oral toxicity. The most sensitive LD50 value obtained was 489 mg/kg bw for combined sexes in the rat (James, 1991a). On this basis, it is concluded that the following classification applies to copper dihydroxide on the basis of acute oral toxicity:

  • Classification according to Directive 67/548/EEC: Harmful (Xn). R22, Harmful if swallowed.
  • Classification according to CLP/GHS: Acute Tox. 4, H302: Harmful if swallowed.

This conclusion is supported by the results obtained in the remaining studies.

Acute inhalation toxicity:

Two high quality GLP-compliant studies conducted in accordance with internationally accepted guidelines are available for acute inhalation toxicity. The most sensitive LC50 value obtained in the rat following a 4 hour exposure was 0.451 mg/l air (Chevalier, 2006). On this basis, it is concluded that the following classification applies to copper dihydroxide on the basis of acute inhalation toxicity:

  • Classification according to Directive 67/548/EEC: Toxic (T). R23, Toxic by inhalation.
  • Classification according to CLP/GHS: Acute Tox. 2, H330: Fatal if inhaled.

This conclusion is supported by the result obtained in the remaining high quality study.

Acute dermal toxicity:

Three high quality GLP-compliant studies conducted in accordance with internationally accepted guidelines are available for acute dermal toxicity. In each case the LD50 value obtained in both sexes was > 2000 mg/kg bw. On this basis is is concluded that copper dihydroxide is not classified on the basis of dermal toxicity.

Justification for classification or non-classification