Sulfuric acid, mono-C12-18-alkyl esters, sodium salts

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The skin sensitizing potential of C12-18AS Na (CAS 68955-19-1, analytical purity 100%) was assessed in a Buehler Test according to OECD Guideline 406 under occlusive conditions (Hoyer, 1996). In this study, 20 guinea pigs of the treatment group were induced three times via epicutaneous application of a 12.5% aqueous solution of the test item for 6 h at an interval of 7 days. The procedure was also performed on 10 animals of the control group with water as inducing agent. Challenge was performed 7 days after the last induction treatment for 6 h at a concentration of 6.25% on all animals (treated and control). Animals of the control group were additionally challenged with water on the opposite flank. Each challenge site was examined 24 and 48 h after removal of the challenge patch. At the 24 h reading skin reactions of the control group were observed on 2/10 (20%) guinea pigs at the site challenged with the test item. Skin reactions were also observed on one of these animals on the site challenged with water (10%). No skin reaction was observed at the second reading on any animal of the control group. Skin reactions were seen in 4/20 (20%) animals after 24 h and on 2/19 (10%) animals after 48 h in the treatment group. Thus, C12-18AS Na (CAS 68955-19-1) is not a skin sensitiser.

A supporting study with C12-18AS Na (CAS 68955-19-1, analytical purity 25%) was performed similar to OECD Guideline 406 as Guinea pig maximization test with intradermal and topical induction (Peano, 1984). Challenge was performed 14 days after dermal induction with a concentration of 12.5% test substance. At the first reading (24 h) 2/20 animals showed skin reactions. At the second reading (48 h) no skin reactions were observed. Thus the test substance was not sensitizing.

Another supporting study with C12-18AS Na (CAS 68955-19-1) was performed similar to OECD Guideline 406 as Guinea pig maximization test with intradermal and topical induction (Middleton and Hickey, 1979). Only limited information on the test material is available. Challenge was performed with concentration of 50 and 100 % test substance, respectively. No skin reactions were observed. Thus the test substance was not sensitizing.

Moreover, 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.

 

[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:
The reliable OECD Guideline study was chosen.

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.