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Administrative data

Key value for chemical safety assessment

Additional information

The mutagen potential of Menaphtacyan was analised by an external expert. The report of the expert analysis is available at Biologie Servier. (Reference: Pr. Daniel Marzin: Analyse des données de mutagenese du produit Menaphtacyan pour Les Laboratories Servier, Lille le 1 juillet 2008).

Summary of the report: Menaphtacyan produced mutagenic effect in the first Ames test on TA 1537 strain, with metabolic activation,

but this effect was modest, and was not well reproducible in different batches. The second Ames test on TA 1537 strain was clearly negative in two different batches. The in vitro mammalian cell mutation test and the in vivo mouse nucleous study was clearly negative also. As a conclusion Menaphtacyan can be considered as devoid of mutagenic potential.


Short description of key information:
Ames test was positive (in vitro 001, CIT 2005).
In vitro mammalian cell mutation test was negative. (invitro 002, CIT 2005)
In vivo mouse nucleous study was negative (in vivo 001, CIT 2008)
Ames test in two different batches was negative (in vitro 003, Biologie Servier 2008)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Menaphtacyan can be considered as devoid of mutagenic potential.

No classification needed.