Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The substance was negative in the following tests:

  • Ames Test - salmonella & E. coli
  • Chromosome aberration in vitro – human lymphocytes
  • Three x Mouse Micronucleus test – mouse and hamster PCE

The bacterial reverse mutation tests, showed that the substance does not have any mutagenic properties in different Salmonella and E. Coli strains. The chromosome aberration test demonstrated no genotoxicity in vitro In addition, no genotoxic properties have been seen in the threein vivomouse micronucleus tests conducted on the substance. As such, it is considered inappropriate to conduct a further assessment in vitro when two in vitro studies and three in vivo studies clearly confirm that the substance is not genotoxic.

Repeat-dose studies with oral treatment in rats did not reveal any tumorigenic properties which could be related to the administration of the test substance. The substance contains no groups that are associated with genotoxic potential.

 

Repeat-dose studies with oral treatment in rats did not reveal any tumorigenic properties which could be related to the administration of the test substance. The substance contains no groups that are associated with genotoxic potential.

 

The following information is taken into account for any hazard / risk assessment:

Genetic toxicity "in vitro" and “in vivo” is discussed below.

Value used for CSA: Genetic toxicity: negative


Short description of key information:
Summary of genetic toxicity

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The above studies have all been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were conducted to GLP an in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds. 

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for prolonged effects is therefore required.