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:

A skin sensitisation study was conducted to determine the concentration of “hexane” that would be expected to cause sensitization in humans (Basketter, 2000, Klimisch=2).

Results of previous LLNA experiments were used to calculate the EC3 value, the concentration at which the test substance would produce a 3 -fold increase in the proliferative activity of lymph nodes in the LLNA test. The 3 -fold increase is considered a positive response for sensitization in the LLNA test. The EC3 value for hexane was determined to be > 100% concentration. The test substance is therefore not sensitising. Therefore, hexane solvent containing between 5 and 80% n-hexane are not expected to be sensitising.

 


Migrated from Short description of key information:
One read across skin sensitization study (LLNA, OECD TG 429) was identified for “hexane”. (Basketter, 2000, Klimisch=2). Although the study did not specify the purity of the test substance, a negative result was obtained. Results from a QSAR model predicted that n-hexane was not a sensitiser. Based this information it is concluded that Hydrocarbons C5-C7, n-alkanes, isoalkanes, n-hexane rich will not cause dermal sensitization.

Respiratory sensitisation

Endpoint conclusion
Additional information:

Based on data for n-hexane, there are no reports of respiratory sensitization laboratory animals or humans.  A skin sensitization study utilizing n- hexane found no indication of skin sensitization in guinea pigs.  With this observation, it is presumed that commercial hexane solvent containing between 5 and 80% n-hexane will not be a respiratory sensitizing agent.


Migrated from Short description of key information:
no data

Justification for classification or non-classification

The test substance is not classified for the sensitsation endpoint.