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Toxicological information

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Description of key information

No skin sensitisation study with fatty acids, C9-13-neo-, copper salts is available, thus the skin sensitisation potential will be addressed with existing data on the individual moieties copper and neodecanoate.

Fatty acids, C9-13-neo-, copper salts is not expected to show signs of dermal sensitisation, since the two moieties copper and neodecanoate have not shown any skin sensitisation potential in experimental testing.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Copper

Available animal data on the skin sensitisation properties of copper (II) oxide and copper coated flakes have been considered against EU classification criteria as contained in Annex VI of Directive 67/548/.  The available animal data do not meet the criteria requiring these substances to be classified for skin sensitisation. Considering the lower solubility and bioaccessability of copper powders compared to copper oxides and copper flakes, the data are read-across to copper (powders and massive forms) do not require classification for skin sensitisation.

Neodecanoate

Neodecanoic acid has been examined for skin sensitization potential in the guinea pig maximization procedure of Magnusson and Kligman. Groups of ten male and ten female guinea pigs were used for the test and a further five males and five females as controls. Induction was accomplished in two stages. 

 1) Intradermal injection: Two rows of three injections were made, one on each side of the midline in the shorn skin of the shoulder region. 2) Topical application: One week after the intradermal injections, the same area was clipped free from hair. A 4x4 cm patch of filter paper was soaked in a solution of the test material and placed over the injection sites and covered with an occlusive dressing. The dressing was left in place for 48 hours. The challenge procedure was carried out two weeks after topical induction. Challenge was accomplished by topical application of the test material to the flank of animals via an occluded patch. The challenge lasted 24 hours. Immediately after the challenge, and then again at 24 and 48 hours later, each animals was examined for signs of skin sensitization. At no point was there any evidence of skin sensitization produced by neodecanoic acid.   

Fatty acids, C9-13-neo-, copper salts

Fatty acids, C9-13-neo-, copper salts is not expected to show signs of dermal sensitisation, since the two moieties copper and neodecanoate have not shown any skin sensitisation potential in experimental testing. Thus, fatty acids, C9-13-neo-, copper salts is not to be classified according to regulation (EC) 1272/2008 as skin sensitising. Further testing is not required. For further information on the toxicity of the individual assessment entities, please refer to the relevant sections in the IUCLID and CSR.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Fatty acids, C9-13-neo-, copper salts is not expected to show signs of dermal sensitisation, since the two moieties copper and neodecanoate have not shown any skin sensitisation potential in experimental testing. Thus, fatty acids, C9-13-neo-, copper salts is not to be classified according to regulation (EC) 1272/2008 as skin sensitising.