Registration Dossier
Registration Dossier
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EC number: 273-258-7 | CAS number: 68955-20-4 This substance is identified by SDA Substance Name: C16-C18 alkyl alcohol sulfuric acid sodium salt and SDA Reporting Number: 19-062-04.
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 are three studies regarding skin sensitisation with C16-18AS Na (CAS 68955-20-4) available.
The skin sensitizing potential of C16-18AS Na (CAS 68955-20-4, analytical purity 55%) was assessed in a Guinea Pig Maximisation Test according to OECD Guideline 406 (Kästner, 1986). In this study guinea pigs were induced by intradermal and epicutaneous application of the test item at concentrations of 0.01% (intradermal induction) and 10% (epicutaneous induction). Challenge was performed with 5% after 14 days. Water was used as vehicle. 1/20 (5%) animals treated with the test item and 0/20 animals of the control group showed a positive reaction at the 24h reading after challenge. At the second reading (48 h after challenge) no skin reactions were observed. Thus, the test item showed no significant sensitising potential within this study.
A second study on skin sensitisation with C16-18AS Na (CAS 68955-20-4) was performed as a Landsteiner test. Small amounts of a 25% aqueous solution were rubbed to the clipped skin of guinea pigs. This induction procedure was repeated in 24 h intervals for another 9 times. 14 days after the induction the animals were challenged by brushing a 1% aqueous solution of the test item onto the skin. This treatment was repeated after 24 h. The induction caused a slight redness of the treated skin in all animals, while no skin reactions were observed upon challenge. Thus, the test item showed no significant sensitising potential within this study.
The third study with C16-18AS Na (CAS 68955-20-4) assessed the skin sensitising potential on humans. Human volunteers (97) were induced with 0.25% aqueous solutions of the test item under occlusive conditions for 24 h, three times a week for a period of three weeks. The volunteers were challenged with the same concentration 14 days after the induction period on both arms. Mild erythema was observed at challenge. However no evidence of skin sensitisation was observed.
Results of the above mentioned studies show that C16-18AS Na (CAS 68955-20-4) is not a skin sensitiser. Another alkyl sulfate, i.e. sodium lauryl sulphate (C12AS Na) is recommended as an agent to induce local irritation in a 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 occurred that it shows sensitising properties. Thus, skin sensitisation by members of the alkyl sulfates is generally unlikely.
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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