Registration Dossier

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 key study was performed in compliance with GLP and to OECD Guideline 429 and EU Method B.42 with a sufficient level of detail to assess the quality of the study. The study was performed to a good standard in line with an accepted, standardised guideline and was assigned a reliability score of 1 using the criteria for assessing data quality as set out in Klimisch (1997).


Migrated from Short description of key information:
Key study:- Sanders (2011e) 'CN-3384A: Local lymph node assay in the mouse' conducted in line with OECD Guideline 429 and EU Method B.42. The Stimulation Index for 3HTdR incorporation into lymph node cells were less than three for all substance concentrations and so the substance is not considered to be a sensitiser.

Justification for classification or non-classification

The data do not indicate that any classification for sensitisation is required.