Registration Dossier
Registration Dossier
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EC number: 219-536-3 | CAS number: 2457-02-5
Endpoint summary
Administrative data
Description of key information
No skin sensitisation study with strontium bis(2-ethylhexanoate) is available, thus the skin sensitisation potential will be addressed with existing data on the individual moieties strontium and 2‑ethylhexanoic acid.
Strontium bis(2-ethylhexanoate) is not expected to show signs of dermal sensitisation, since the two moieties strontium and 2‑ethylhexanoic acid 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:
Read-across approach
Selected endpoints for the human health hazard assessment are addressed by read-across, using a combination of data on the metal cation and the organic acid anion. This way forward is acceptable, since metal carboxylates are shown to dissociate to the organic anion and the metal cation upon dissolution in aqueous media. No indications of complexation or masking of the metal ion through the organic acid were apparent during the water solubility and dissociation tests (please refer to the water solubility and dissociation in sections 4.8 and 4.21 of IUCLID). Once the individual transformation products of the metal carboxylate become bioavailable (i.e. in the acidic environment in the gastric passage or after phagocytosis by pulmonary macrophages), the “overall” toxicity of the dissociated metal carboxylate can be described by a combination of the toxicity of these transformation products, i.e. the metal cation and carboxylate anion according to an additivity approach.
Strontium bis(2-ethylhexanoate) is the strontium salt of 2-ethylhexanoic acid, which readily dissociates to the corresponding divalent strontium cation and 2-ethylhexanoic acid anions. The strontium cation and the 2-ethylhexanoic acid anion are considered to represent the overall toxicity of strontium bis(2-ethylhexaate) in a manner proportionate to the free acid and the metal (represented by one of its readily soluble salts).
A detailed justification for the read-across approach is added as a separate document in section 13 of IUCLID.
Sensitisation
No skin sensitisation study with strontium bis(2-ethylhexanoate) is available, thus the skin sensitisation potential will be addressed with existing data on the dissociation products as detailed below.
Strontium
A Guinea pig maximisation test according to OECD Guideline 406 conducted with the test substance strontium neodecanoate is considered to be reliable without restrictions. The results showed that the test item has no skin sensitisation potential.
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.
Strontium bis(2-ethylhexanoate)
Strontium bis(2-ethylhexanoate) is not expected to have a skin sensitising activity, since the two moieties strontium and 2-ethylhexanoic acid have not shown any skin sensitisation potential in experimental testing. Further testing is not required. For further information on the toxicity of the individual moieties, 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
As the two moieties of strontium bis(2-ethylhexanoate) are not sensitising, strontium bis(2-ethylhexanoate) is not expected to show signs of dermal sensitisation. According to the criteria of REGULATION (EC) No 1272/2008 and its subsequent adaptions, strontium bis(2-ethylhexanoate) does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact.
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