Oleic acid, copper salt

Endpoint summary

Description of key information

No sensitisation studies with oleic acid, copper salts are available, thus the sensitising potential will be addressed with existing data on the dissociation products copper and oleic acid.

Human data for oleic acid (and other naturally occurring fatty acids with a similar structure than oleic acid) showed no skin sensitising potential. Data from copper substances do not show any skin sensitisation potential. Thus, oleic acid, copper salt 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)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

No sensitisation studies with oleic acid, copper salts are available, thus the sensitising potential will be addressed with existing data on the dissociation products copper and oleic 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.

Oleic acid

Skin sensitisation

A registration dossier shall contain information on the human health hazard assessment (regulation 1907/2006, Art.10). However, it is considered that the information requirements for oleic acid as laid down in annex VII to IX can be fulfilled by adaptation of the standard testing regime according to Annex XI, points 1.2. and 1.3. as presented in the following:

According to Regulation (EC) No 1907/2006 Annex V substances obtained from natural sources and not modified such as vegetable fats and oils as well as fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts are excluded from the obligation to register.

The substance subjected to registration is a monounsaturated C18- fatty acid. Based on this, the following endpoint is covered by publicly available data on fatty acids with the same or similar structure. Due to the structural similarity and the fact that only one hydrogenation of the double bond of oleic acid yields the saturated derivative stearic acid, most of the data are focused on stearic acid.

Based on human and animal data the HERA document on fatty acid salts (2002) reported that “in a skin sensitisation study in 28 volunteers, five 48-hour covered applications of 1% decanoic acid (C10) in petrolatum were made over a 10 day period. The results were negative since none gave positive reactions when challenged 10-14 days after the induction phase with a final 48-hour closed patch test using 1% in petrolatum. De Groot et al. (1988) reported that 25 subjects showed no sensitisation reactions when exposed to 5% stearic acid (C18) in petrolatum and a 1% aqueous sodium stearate solution. In two Magnusson and Kligman guinea pig maximisation tests, carried out in conformity with OECD Guideline No. 406 and EC test method B.6 as described in the Annex of EC Directive 84/449/EEC, using two different types of mixed fatty acid sodium salts, no skin sensitisation potential was demonstrated in either material (CIR, 1982)" (HERA, 2002).

Sensitisation by or intolerance to an abundantly available essential element such as stearic acid would be grossly implausible and can therefore safely be excluded.

For reference list please refer to endpoint summary of the moieties.

 

Oleic acid, copper salts

Human data for oleic acid (and other naturally occurring fatty acids with a similar structure than oleic acid) showed no skin sensitising potential. Data from copper substances do not show any skin sensitisation potential. Thus, oleic acid, copper salt is not expected to show signs of dermal sensitisation, since both individual moieties are considered non-sensitising.

Oleic acid copper salt does not require a classification 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 section in the IUCLID.

Justification for classification or non-classification

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