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Description of key information

No skin sensitisation study with 2-ethylhexanoic acid, cerium salt is available, thus the skin sensitisation potential will be addressed with existing data on the individual assessment entities cerium and 2-ethylhexanoate.

2-ethylhexanoic acid, cerium salt is not expected to show signs of dermal sensitisation, since the two moieties cerium and 2-ethylhexanoate have not shown any skin sensitisation potential in animal studies.

Key value for chemical safety assessment

Skin sensitisation

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

Cerium

The skin sensitisation potential of cerium chloride was evaluated by performing an in vivo local lymph node assay. In a range finding study 50% of cerium chloride was selected as maximum concentration suitable for dosing in solubility trials. The main study was performed with 10, 25 and 50% with 4 animals per dose. These concentrations were selected as at 50% no excessive irritation was noted. DPM served as positive control. At concentrations of 50% and 25%, the stimulation indexes are only slightly higher than the threefold increase in 3HTdR incorporation compared to the control values (4.29 and 4.44 respectively). It was observed that the test item has the potential to cause irritation as shown in the main test animals (50% and 25%). On this basis the test item can not be clearly classified as a sensitiser.

 

Thus, for clarification, a guinea pig maximisation test was performed. Intra-dermal injection of 0.01, 0.1, 0.5, 1, 2.5 and 5% cerium chloride as well as dermal application of 25, 50, 75 and 100 % were tested in a range finding study. Based on these results 0.01% cerium chloride were used for the induction exposure. Two weeks after the topical induction application, the animals were exposed to a dermal challenge dose of 100% or 50% (day 22 of treatment) for 24 hours. The control animals were treated similarly as the test group. Body weight, mortality and clinical signs were recorded. Under the conditions of the present assay the test item Cerium chloride was shown to have no sensitisation potential and classified as a non-sensitizer, according to current EU-regulations.

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, cerium salt

2-ethylhexanoic acid, cerium salt is not expected to show signs of dermal sensitisation, since the two moieties cerium and 2-ethylhexanoate have not shown any skin sensitising potential in animal studies. 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.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

2-ethylhexanoic acid, cerium salt is not expected to show signs of dermal sensitisation, since the two assessment entities cerium and 2-ethylhexanoate have not shown any skin sensitisation potential in experimental testing. Thus, 2-ethylhexanoic acid, cerium salt is not to be classified according to regulation (EC) 1272/2008 as skin sensitising.