Registration Dossier
Registration Dossier
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EC number: 928-842-2 | CAS number: 1184648-08-5
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation of potassium (R)-2-(4-hydroxyphenoxy)propionate, (CAS 1184648-08-5) was determined by read-across from a skin sensitisation study conducted with the free acid, namely (R)-2-(4-hydroxyphenoxy)propanoic acid (CAS 94050-90 -5).
Only a single skin sensitisation study conducted according to guideline OECD 406 and under GLP is available for the source substance, the free acid (R)-2-(4-hydroxyphenoxy)-propanoic acid (CAS 94050-90-5). The study is considered to be relevant, reliable (Klimisch 1) and adequate for the purposes of risk assessment, classification and labelling. The maximisation study in guinea pigs elicited no positive responses in any animal after 24 and 48 hours. According to Magnusson and Kligman, the source substance is graded as a weak sensitiser.
The sensitisation potential of the target substance propanoic acid, 2-(4-hydroxyphenoxy)-, potassium salt (2R) (CAS 1184648-08-5) is determined by read-across from the maximisation test with the free acid. The analogue approach is based on the facts that source and target contain the identical molecular structure and the same functional groups (except the K+ counterion), and they form a pH-dependent equilibrium. Upon intradermal induction in the maximisation test, the free acid is neutralized to the Na+ salt (due to the buffer capacity of body fluids), whereas the K+counterion of the salt is exchanged to Na+(due to the sodium excess in body fluids), which makes the two forms indistinguishable. In the subsequent epidermal induction, the acid is more likely than the K+ salt to permeate the stratum corneum, so it is assumed to evoke a stronger effect, if any. No signs of skin sensitisation were observed with the source (free acid). As a conclusion, the target substance propanoic acid, 2-(4-hydroxyphenoxy)-, potassium salt (2R) is also unlikely to be a skin sensitiser.
Migrated from Short description of key information:
Skin sensitisation (maximisation guinea pig) [(R)-2-(4-hydroxyphenoxy)-propanoic acid]: No positive response in any animal (Winkler 1995)
Respiratory sensitisation
Endpoint conclusion
- Additional information:
No experimental information for respiratory sensitisation is available.
Migrated from Short description of key information:
No data available
Justification for classification or non-classification
The results from the Skin Sensitisation Test in the Guinea Pig, Maximisation test indicate that the substance is not a skin sensitiser. As a result the substance does not meet the criteria for classification according to Directive 2001/59/EC, Annex VI, 3.2.7.2.
The results from Skin Sensitisation Test in the Guinea Pig, Maximisation test indicate that the substance is not a skin sensitiser. As a result the substance does not meet the criteria for classification according to Regulation (EC) No. 1272/2008, Part 3, 3.4.2.2.
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