Registration Dossier

Toxicological information

Endpoint summary

Currently viewing:

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

'Benzene, ethylenated by-products' was tested in a standard OECD guideline mouse LLNA. At the mid and high doses (50 and 100%) there was an increase in the stimulation index compared to control that exceeded 3x indicating that this substance was capable of inducing proliferation of the lymph nodes at these concentrations. The EC3 value of 30.3% was calculated indicating that this is possibly a very weak sensitiser. In the mid and high dose groups there was also evidence of swelling of the ears relative to control and this is consistent with the irritancy of the test material. It is possible that the result of the local lymph node assay is due to a non-specific induction of lymphnode proliferation rather than a specific sensitising response to this substance. This could be due in part to the irritancy of the material. In the entire history of use of this material there have been no reports of workers becoming sensitised to this substance through dermal exposure. Therefore, whilst this substance may be technically capable of inducing lymphnode cell proliferation in the LLNA, the relevance of that result to humans may be limited.


Migrated from Short description of key information:
Mouse LLNA assay

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There is no data or indication from humans that this substance is a respiratory sensitiser


Migrated from Short description of key information:
No data available

Justification for classification or non-classification

Due to the classification criteria set out in the CLP being limited to the classification as either a sensitiser or not a sensitiser, this substance must be classified as a sensitiser based solely on the positive result in the LLNA. However the EC3 value of >30% indicates that it is a weak sensitiser and so the risk to humans is relatively small. It is also possible that the irritancy of the material and its solvent activity could have produced a non-specific proliferation response in the lymph nodes, but without additional information it is not possible to make a firm judgment. Therefore this substance should be classified as a (weak) sensitiser, Category 1B according to CLP.