Copper(2+) neodecanoate

Endpoint summary

Description of key information

No sensitisation studies with copper (2+) neodecanoate are available, thus the sensitising potential will be addressed with existing data on the dissociation products copper and neodecanoic acid. Neodecanoic acid have not shown any skin sensitisation potential in experimental testing. Data from copper substances do not show any skin sensitisation potential. Thus, copper (2+) neodecanoate is not expected to show signs of dermal sensitisation, since both individual moieties are considered non-sensitising.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

No sensitisation studies with copper (2+) neodecanoate are available, thus the sensitising potential will be addressed with existing data on the dissociation products copper and neodecanoic acid.

 

Copper

Skin sensitisation

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.

Migrated from Short description of key information:

Several high quality criteria studies (reliability 1 or 2) on several copper compounds and copper are available from the VRAR (2008). The data on coated copper flakes and copper oxide were retained for the CSR. The VRAR, 2008 provides additional lower quality studies as well as studies specific to other soluble copper compounds. If not pivotal to this copper REACH dossier, they are described in the copper VRAR (2008) but not further 

­­­­Justification for selection of skin sensitisation endpoint:

Several studies used in WoE. The studies, retained in weight of evidence approach, were already evaluated by competent authorities on existing substances and biocides

Neodecanoic acid

Skin sensitisation

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 animal was examined for signs of skin sensitization. At no point was there any evidence of skin sensitization produced by neodecanoic acid.   

 

Copper (2+) neodecanoate

Copper (2+) neodecanoate is not expected to have a skin sensitising activity, since the two moieties copper and neodecanoic acid have not shown any skin sensitisation potential. Thus, copper (2+) neodecanoate 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

Copper (2+) neodecanoate is not expected to show signs of dermal sensitisation, since the two moieties copper and neodecanoic acid are not considered to have skin sensitisation potential. Thus, copper (2+) neodecanoic acid is not to be classified according to regulation (EC) 1272/2008 as skin sensitising.