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:
Migrated from Short description of key information:
One LLNA study performed with 4,4-methylenebis(2-chloroaniline) under GLP was available. Also, data from an old in vivo test performed with a substance containing 4,4-methylenebis(2-chloroaniline) and other chloroanilines was available. As the result of the in vivo test was negative, QSAR was applied to support the results of the in vivo test, indicating that none of the individual chloroanilines would cause a positive skin senzitisation reaction.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No data available. However, the respiratory system is not considered to be a likely route of exposure.

Justification for classification or non-classification

Based on the above mentioned results, the substance does not need to be classified according to the Dangerous Substance Directive 67/548/EC andCLP Regulation (EC) 1272/2008.