2-ethylhexanoic acid, iron salt

Endpoint summary

Description of key information

No skin sensitisation study with 2-ethylhexanoic acid, iron salt is available, thus, the skin sensitisation potential will be addressed with existing data on the individual assessment entities iron and 2-ethylhexanoate. 2-ethylhexanoic acid, iron salt is not expected to show signs of dermal sensitisation, since both assessment entities iron (both species) and 2-ethylhexanoic acid 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:

Iron

Ferric iron

A local lymph node assay was performed to assess the skin sensitisation potential of iron sulphate. Since there was no indication that the test substance elicits an SI ≥ 3 when tested at 50%, iron sulphate was considered not to be a skin sensitizer. No EC3 value (the estimated test substance concentration that will give a SI =3) (if any) could be established. Based on these results, iron sulphate would not be regarded as a skin sensitizer according to the recommendations made in the test guidelines. It does not have to be classified and has no obligatory labeling requirement for sensitization by skin contact according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007) and the Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures.

 

Ferrous/ferric iron

A guinea pig optimization test was conducted to evaluate the sensitising properties of iron oxides (iron oxide, black (FeO x Fe2O3); iron oxide, red (Fe2O3); and iron oxide, yellow (FeO(OH) x H2O). 20 animals per group wer induced by 10 intradermal injections of a 0.1 % solution of the test items within 3 weeks, followed by an intradermal and an epicutaneous challange. It was concluded that all iron oxides do not induce 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, iron salt

2-ethylhexanoic acid, iron salt is not expected to show signs of dermal sensitisation, since the two assessment entities iron (both species) and 2-ethylhexanoate have not shown any skin sensitisation potential in experimental testing. 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

2-ethylhexanoic acid, iron salt is not expected to show signs of dermal sensitisation, since the two assessment entities iron (both species) and 2-ethylhexanoivc acid do not show any skin sensitisation potential in animal studies. Thus, 2-ethylhexanoic acid, iron salt is not classified according to regulation (EC) 1272/2008 as skin sensitising.