Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

This substance showed a positive effect in the in vitro Ames test, but only in the presence of metabolic activation.

In the in vivo micronucleus test (OECD TG474 protocol) the substance was negative.

It should be noted that its analogue 2,2,6,6 -piperidin-4 -ol (CAS 2403-88-5), i.e. the substance lacking the methyl group on the N, is described in the OECD SIDS for this chemical as follows:

"As for the genotoxicity, this substance was not mutagenic in bacteria [OECD TG 471 and 472].

An increase in chromosome aberrations in Chinese hamster lungs cells without S9 [OECD TG

473], were considered to be due to cytotoxicity and the study was considered to be “equivocal.”

A negative result was obtained in a rat bone marrow micronucleus assay [OECD TG 474]. Thus,

on the basis of the available data, 2,2,6,6-tetramethylpiperidin-4-ol is not considered to be an in

vivo genotoxicant, as the questionable genotoxicity observed in vitro is not expressed in vivo ".


Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

At the observed effect level there is no requirement to classify this substance for genetic toxicity