Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames test, with and without metabolic activation: negative
HPRT test, with and without metabolic activation: negative
Micronucleus assay, with and without metabolic activation: negative

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

Genetic toxicity in vivo

Description of key information

There are no data avilable.

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In vitro:

The substance was investigated for its genetic toxicity properties in an Ames test according to OECD Guideline 471 in compliance with GLP using S. typhimurium (TA98, TA100, TA1535, TA1537) and E.coli WP2 with and without metabolic activation including doses that were bacteriotoxic (BASF AG, 2007). No potential for genetic toxicity was indicated in the Standard plate or Preincubation test.

In a HPRT test with CHO cells according to OECD guideline in compliance with GLP the substance did not lead to a relevant increase in the number of mutant colonies either without S9 mix or after the addition of a metabolizing system in several experiments performed independently of each other (BASF SE, 2010). The mutant frequencies at any concentration were close to the range of the concurrent vehicle control values and within the range of the historical negative control data.

In an in vitro micronuleus assay in V79 cells according to Draft OECD guideline 487 in compliance with GLP the test substance did not cause any biologically relevant increase in the number of cells containing micronuclei either without S9 mix or after adding a metabolizing system (BASF SE, 2010). The data were confirmed in three experiments carried out independently of each other.

 

In vivo:

There are no data available concerning genetic toxicity in vivo.

Justification for classification or non-classification

GHS classification according to Annex I 1272/2008 CLP (EU GHS):

Conclusive, but not sufficient for classification.