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:

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 was identified for “hexane”. (Basketter, 2000, Klimisch=2). The study did not specify the purity of the test substance. This substance was negative in two Mouse local lymphnode assays (LLNA) (OECD TG 429). Based on data these data this substance is not a dermal sensitizer.

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.