Registration Dossier

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 one study regarding skin sensitisation with C12-14AS TEA (CAS 90583-18-9) available.

The skin sensitizing potential of C12-14AS TEA (CAS 90583-18-9, analytical purity 41-42%) was assessed in a Guinea Pig Maximisation Test similar to OECD Guideline 406 (Potokar, 1977). In this study 20 guinea pigs were induced by intradermal application of the test item at concentrations of 5% (based on active ingredient) in presence or absence of Freundsches adjuvant. A second induction was performed one week thereafter via epicutaneous application of the test item at concentrations of 5%. Challenge was performed with 1% (based on active ingredient) after 14 days. All animals were scored for skin reactions 24, 48 and 72 h after challenge. Irritating effects were seen after intradermal application of the test substance in presence or absence of Freundsches Adjuvant. These effects reversed until the challenge experiment. No skin reactions were observed upon challenge.

Results of the study show that C12-14AS TEA (CAS 90583-18-9) is not a skin sensitiser. In addition, sodium lauryl sulphate (C12AS Na) was recommended within this study 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 that it shows sensitising properties. Thus, skin sensitisation by members of the alkyl sulfates category 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 study performed smilat to OECD guideline.

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.