Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

A bacterial reverse mutation assay (Ames test) has been undertaken following OECD/EU test methods. Experiments were performed both in the absence and presence of metabolic activation at concentrations up to 5000 µg/plate. The substance did not induce reverse mutation inSalmonella typhimuriumorEscherichia coli.

 

The ability to cause chromosomal damage has been investigated in cultured human lymphocytes,in vitroin the absence and presence of S9 metabolic activation according to OECD/EU test methods. Two independent experiments were performed, in the first the cells were treated for 3 hours in the presence and absence of S9 metabolism and harvested after 24 hours, this corresponding to approximately 1.5 cell cycles. The second experiment was performed using the same 24 hour harvest time with continuous exposure until harvest. 4 -MHHPA) did not induce chromosomal aberrations.

 

Gene mutation has been investigated by assaying for the induction of 5‑trifluorothymidine resistant mutants in mouse lymphoma L5178Y cells afterin vitrotreatment, in the absence and presence of S9 metabolic activation, using a fluctuation method. Methods used were in accordance with OECD/EU test guidelines. Two independent assays were performed. 4-MHHPA did not induce mutations at the TK locus of L5178Y mouse lymphoma cells.

 

REACH Regulation 1907/2006 (Annex VIII, 8.4 Column 2) states that appropriatein vivomutagenicity studies should be considered in those cases of a positive result in any of the in vitro genotoxicity studies. In vitro investigations were negative and in vivo studies are therefore regarded as inappropriate and not in line with current concerns regarding animal welfare and the use of animals in scientific experiments.


Short description of key information:
Genetic toxicity in-vitro: Negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Potential genotoxic effects have been examined using three separate in-vitro assays, one using bacterial cells and two using mammalian cell lines. All tests were negative and classification is not indicated.