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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 result of an Ames Test (OECD Guideline 471) with the test substance was negative with and without metabolic activation.

A negative result (with and without metabolic activation) was obtained in the in vitro mammalian chromosome aberration study (OECD Guideline 473).

In addition, the test substance was not mutagenic (with and without metabolic activation) in the mouse lymphoma L5178Y test system (OECD Guideline 476).

Justification for selection of genetic toxicity endpoint

No one study is selected as there are three in vitro studies available, which all provided negative results.

Short description of key information:

The test substance was evaluated using three in vitro genetic toxicity studies; the results of all 3 studies were negative.

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 Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and 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 genetic toxicity is therefore required.