Registration Dossier
Registration Dossier
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EC number: 267-499-7 | CAS number: 67874-71-9
Endpoint summary
Administrative data
Description of key information
No skin sensitisation study with bismuth tris (2-ethylhexanoate) is available, thus the skin sensitisation potential will be addressed with existing data on the individual moieties bismuth and 2-ethylhexanoate.
Bismuth tris (2-ethylhexanoate) is not expected to show signs of dermal sensitisation, since the two moieties bismuth 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:
Bismuth
In an available guideline study with the more bioavailable substance, bismuth hydroxide nitrate oxide, the sensitising potential was determined in the LLNA in mice. Three concentrations (10%, 25% and 50%) of the test item, a positive and a vehicle control were tested. Results show that bismuth hydroxide nitrate oxide does not reveal any sensitising properties. Therefore, it can be considered that bismuth metal has no sensitising properties and should not be classified as such.
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.
Bismuth tris (2-ethylhexanoate)
Bismuth tris (2-ethylhexanoate) is not expected to show signs of dermal sensitisation, since the two moieties bismuth and 2-ethylhexanoate have not shown any skin sensitisation potential in experimental testing. Thus, bismuth tris (2-ethylhexanoate) 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 study available
Justification for classification or non-classification
Bismuth tris (2-ethylhexanoate) is not expected to show signs of dermal sensitisation, since the two moieties bismuth and 2-ethylhexanoate have not shown any skin sensitisation potential in experimental testing. Thus, bismuth tris (2-ethylhexanoate) is not to be classified according to regulation (EC) 1272/2008 as skin sensitising.
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