Registration Dossier
Registration Dossier
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EC number: 939-693-8 | CAS number: 1268005-68-0
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:
There is no study regarding skin sensitisation with C12-14AS K (CAS 1268005-68-0) available. Therefore this endpoint is covered by read across to structurally related alkyl sulfates (AS), i.e. C12-14AS NH4 (CAS 90989-98-3) and C12-14AS Na (CAS 85586-07-8). The possibility of a read-across to other alkyl sulfates in accordance with Regulation (EC) No 1907/2006 Annex XI 1.5. Grouping of substances and read-across approach was assessed. In Annex XI 1.5 it is given that a read-across approach is possible for substances, whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity. The AS reported within the AS category show structural similarity. The most important common structural feature of the category members is the presence of a predominantly linear aliphatic hydrocarbon chain with a polar sulfate group, neutralized with a counter ion. This structural feature confers the surfactant properties of the alkyl sulfates. The surfactant property of the members of the AS category in turn represent the predominant attribute in mediating effects on mammalian health. Therefore, the AS of the AS category have similar physico-chemical, environmental and toxicological properties, validating the read across approach within the category. The approach of grouping different AS for the evaluation of their effects on human health and the environment was also made by the OECD in the SIDS initial assessment profile [1] and by a voluntary industry programme carrying out Human and Environmental Risk Assessments (HERA [2]), further supporting the read across approach between structurally related AS.
There is one study available addressing skin sensitisation for each of the read-across substance C12-14AS NH4 (CAS 90989-98-3) and C12-14AS Na (CAS 85586-07-8).
The skin sensitizing potential of C12-14AS Na (CAS 85586-07-8, analytical purity 29.9%) was assessed in a Guinea Pig Maximisation Test similar to OECD Guideline 406 (Unilever, 1977). In this study 10 guinea pigs were induced by intradermal and occlusive epicutaneous application of the test item at concentrations of 0.08% (intradermal induction) and 0.5% (epicutaneous induction). Challenge and rechallenge was performed with 0.1%. Water was used as vehicle. None of the treated animals showed a positive reaction after challenge. Thus, the test item showed no significant sensitising potential within this study.
Another study was performed as Buehler test similar to OECD Guideline 406 with C12-14AS NH4 (CAS 90989-98-3) on 10 guinea pigs. Only limited data on the test item and the experimental method is available (Cerven, 1991). The animals were challenged wit 0.1% test substance and skin reactions were scored 24 and 48 h after application. No skin reactions were observed. Thus the test item showed no significant sensitising potential within this study.
Results of the above mentioned studies show that both substances used for read across showed no skin sensitising properties. In addition, sodium lauryl sulphate (C12AS Na) was used within this studies as known irritant to produce irritant effects. Likewise sodium lauryl sulphate is also recommended as an agent to induce local irritation in an OECD method to assess skin sensitising properties of chemicals (OECD guideline 406, Guinea Pig Maximisation Test). Therefore there is a lot of experience with sodium lauryl sulfate in sensitising studies and no evidence occured that it shows sensitising properties. Thus, skin sensitisation by members of the alkyl sulfates is generally unlikely.
[1] SIDS initial assessment profile, (2007);
http://www.aciscience.org/docs/Alkyl_Sulfates_Final_SIAP.pdf[2] (HERA Draft report, 2002);
http://www.heraproject.com/files/3-HH-04-%20HERA%20AS%20HH%20web%20wd.pdf
Migrated from Short description of key information:
Skin sensitisation (GPMT - OECD 406): not sensitising
Justification for selection of skin sensitisation endpoint:
Reliable OECD guideline study.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
No data available for respiratory sensitisation.
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