Registration Dossier
Registration Dossier
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EC number: 932-051-8 | CAS number: -
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 one GLP Guideline (OECD 406 - Buehler Test) study and one supporting, non-guideline study for sodium toluene sulphonate (CAS No. 12068-03-0). The guideline study was performed with 0.5 mL of a 43% solution of the test material, readings at 24 and 48 hours, and the inclusion of a positive control. No sensitisation effects were observed; there were no clinical signs; and body weight increase was normal. The older, non-guideline study with 12068-03-0 exposed 10 male guinea pigs to a 5.0% solution via occlusive, epicutaneous induction and challenge. No sensitisation was observed at 24 and 48 hours following challenge.
The GLP Guideline OECD 406 test of sodium 4-undecylbenzenesulfonate - CAS No. 68411-30-3 included intradermal injections of 25% test solution followed one week later with a second induction was done by epidermal exposure to 25% test solution for 24 hrs. The challenge was performed on day 21 with a 12.5% test solution for 24 hours. No sensitization was observed at 48 and 72 hrs after the challenge.
There are two additional sensitization studies with another member of the hydrotropes category with a similar outcome.
Migrated from Short description of key information:
There are skin sensitisation guideline studies for both of the substances that comprise the reaction product. The 2 studies for sodium toluene sulphonate - CAS No. 12068-03-0) and the single study for sodium 4-undecylbenzenesulfonate - CAS No. 68411-30-3 support a conclusion that these substance are "not sensitising".
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
N/A
Justification for classification or non-classification
The available studies demonstrate that the members of the hydrotrope category are not skin sensitizers. Therefore a classification is not justified.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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