Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

A GLP-compliant Guinea Pig Maximisation Test was carried out in accordance with OECD Guideline 406 and EU Method B.6 (Richeux, 2012).  After induction (intradermal injection at 0.05% and topical application at 70%) of 10 Guinea Pigs and a 10-day rest phase, the challenge phase consisted of a topical application of the test item diluted at 70% and 35% in liquid paraffin.

In the 70% treatment group, a slight to moderate erythema was recorded in 8/10, in 5/10 and 3/10 animals, 24, 48 and 72 hours respectively after the challenge. In the 70% control group, a slight erythema was recorded in 1/5 animals, 24, 48 and 72 hours after the challenge.

In the 35% treatment group, a slight to moderate erythema was recorded in 10/10, in 7/10 and 4/10 animals, 24, 48 and 72 hours respectively after the challenge. A slight to moderate oedema was seen in 1/10 animals, 24 and 48 hours after the challenge. In the 35% control group, a slight erythema was recorded in 2/5, in 2/5 and in 1/5 animals, 24, 48 and 72 hours respectively after the challenge.

Only reactions in the test group animals that exceeded the most severe reactions seen in the control group were attributed to skin sensitization. Therefore, a sensitization reaction was noted:

- in 4/10 and 5/10 animals from the treated group, 24 and 48 hours respectively after challenge with the test item at 70%;

- in 9/10, 6/10 and 2/10 animals from the treated group, 24, 48 and 72 hours after challenge with the test item at 35%.

On this basis it is concluded that copper iodide is a potential skin sensitiser and that the following classification applies:

  • According to Directive 67/548/EEC: Irritant (Xi). R38, May cause sensitisation by skin contact.
  • According to CLP/GHS: Category 1, Sub-category 1A.  H317, May cause an allergic skin reaction.

With regard to sensitisation by inhalation, in the absence of relevant human or animal data, there is no basis for classification of copper substances covered by this Risk Assessment for respiratory sensitisation.

Justification for classification or non-classification