Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

A skin sensitivity study of the substance was carried out according to EU Method B.42 (Local Lymph Node Assay) using CBA mice. The substance was applied to the dorsal surface of both ears. Slight irritation of the ears was observed in all animals. The SI values calculated for the substance concentrations 25, 50 and 100% were 18.7, 40.8 and 35.7 respectively. The substance was determined to be a skin sensitiser, as the stimulation index values were all above 3. The response of the 100% group did not follow the expected dose-response relationship which is more often seen in these type of studies. The response of the 100% group may be lower due to differences in skin penetration (no vehicle present) or viscosity or due to underlying systemic toxicity. No reliable EC3 value could be calculated.

The following information is taken into account for any hazard / risk assessment:

Summary of skin sensitisation data

Value used for CSA: sensitising

Respiratory sensitisation

Not assessed. No evidence of respiratory sensitisation was noted in any of the studies conducted, and it is proposed that the substance is not a respiratory sensitiser.


Migrated from Short description of key information:
Summary of skin sensitisation

Respiratory sensitisation

Endpoint conclusion
Additional information:

Not assessed. No evidence of respiratory sensitisation was noted in any of the studies conducted, and it is proposed that the substance is not a respiratory sensitiser.


Migrated from Short description of key information:
Not assessed.

Justification for classification or non-classification

The above study has been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP an in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

The above results triggered classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008) as follows:

Dangerous Substance Directive (67/548/EEC): Xi – R43

CLP Regulation (EC No 1272/2008): Skin Sens. 1 - H317