Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Skin sensitisation to TTP was determined in a guideline study (OECD TG 429, EU method B.42). TTP is a sensitiser. The submission substance is a Nickel complex with TTP as its ligand, which is expected to be rapidly released. Therefore NiL4 is found to be a sensitiser as well.

Migrated from Short description of key information:
Based on results for the surrogate substance, TTP, the submission substance is considered to be a sensitiser.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No information available

Justification for classification or non-classification

Based on the positive results of a skin sensitisation study of the surrogate substance TTP,

according to Regulation 1272/2008, the submission substance should be classified as skin sensitizer (Category 1) and labeled with H317: May cause an allergic skin reaction.

Based on an observed EC3 < 2% (SI at lowest tested concentration of 2.5% was 4.8) the substance is considered to be a strong sensitiser and a specific concentration limit of 0.1% (w/v) is set.