Registration Dossier
Registration Dossier
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EC number: 269-085-1 | CAS number: 68187-30-4
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:
The test substance has been investigated for its sensitization potential in accordance with OECD guideline (Buehler protocol) under GLP conditions. For the induction phase undiluted material was used. During challenge 12 out of 20 animals reacted with distinct erythema. Therefore, a purified sample has been prepared for the re-challenge procedure. During re-challenge with the purified sample no skin reactions were observed after 24 and 48 hours in any animal.The registered substance is not considered to be sensitizing because the purification step is applied to all commercial material.
The study was conducted with a structurally similar substance, namely the monosodium salt. Solubility, bioavailability and toxicity of the surrogate are not expected to differ from the registered substance as the counter ion is not known for a specific toxicity and sodium salts are generally known to be of high solubility.
Migrated from Short description of key information:
Based on the findings in a non-adjuvant sensitization test in guinea pigs, the test item applied at a concentration of 50 % or 25 % in bi-distilled water is not classified and labelled as a skin sensitizer.
Justification for classification or non-classification
Based on skin sensitisation data available, the test item is classified as skin sensitisation cat. 1 (H317: May cause an allergic skin reaction) according to Regulation No (EC) 1272/2008 (CLP) and as Xi; R43 May cause sensitisation by skin contact according to Directive 67/548/EEC (DSD) criteria.
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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