Registration Dossier
Registration Dossier
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EC number: 244-846-0 | CAS number: 22221-10-9
Endpoint summary
Administrative data
Description of key information
No skin sensitisation study with 2-ethylhexanoic acid, copper salt is available, thus, the skin sensitisation potential will be addressed with existing data on the individual moieties copper and 2-ethylhexanoate.
2-ethylhexanoic acid, copper salt is not expected to show signs of dermal sensitisation, since the two moieties copper and 2-ethylhexanoate 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.
2-ethylhexanoic acid
In a guinea pig maximization assay (Berol Kemi AB, 1979), 0/10 female Dunkin-Hartley guinea pigs exhibited a response 48 h after induction and challenge with 5 % (w/w) and 2 % (w/w) aqueous 2‑ethylhexanoic acid solution, respectively. The intracutaneous injections were performed with 1 % (w/w) aqueous 2-ethylhexanoic acid solution. In summary, there is no evidence of a notable sensitization potential of 2-ethylhexanoic acid.
2-ethylhexanoic acid, copper salt
2-ethylhexanoic acid, copper salt is not expected to show signs of dermal sensitisation, since the two moieties copper and 2-ethylhexanoate have not shown any skin sensitisation potential in experimental testing. Thus, 2-ethylhexanoic acid, copper salt 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 adverse effect observed (not sensitising)
Justification for classification or non-classification
2-ethylhexanoic acid, copper salt is not expected to show signs of dermal sensitisation, since the two moieties copper and 2-ethylhexanoate have not shown any skin sensitisation potential in experimental testing. Thus, 2-ethylhexanoic acid, copper salt is not to be classified according to regulation (EC) 1272/2008 as skin sensitising.
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