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:

Following a contact hypersensitivity to FR-513 in the mouse (LLNA), the simulation index (SI) values calculated for the test substance concentrations 1, 5 and 10% were 1.1, 1.1 and 0.9 respectively. There was no indication that the test substance could elicit SI ≥ 3.

Based on the study results and according to the criteria made in the test guidelines (OECD 429, OPPTS 870.2600) , FR-513 is not a skin sensitiser.

Migrated from Short description of key information:
Assessment of contact hypersensitivity to FR-513 in the mouse (Local Lymph Node Assay)

Justification for classification or non-classification

Based on the experimental results and according to the EEC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC, 27th April 1993), FR-513 does not have to be classified and has no obligatory labelling requirement for acute toxicity .