Registration Dossier

Diss Factsheets

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.