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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Genetic toxicity in vitro

Description of key information

OECD 471, 1994, positive


modified OECD 471, analogue substance, 2020, positive


OECD 476, in vitro HPRT, 1995, negative


 

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Genetic toxicity in vivo

Description of key information

OECD 474, 2002, in vivo MNT, analogue substance, negative


OECD 489, testing proposal, analogue substance, to be performed

Endpoint conclusion
Endpoint conclusion:
no study available (further information necessary)

Additional information

Justification for classification or non-classification

A read across approach is proposed for assessing the in vivo gene mutation properties of the taregt substance, by using the results of a Comet Assay OECD 489 submitted as testing proposal on analogue substance.

The Comet Assay requirement is the results of the application of Column 2 Annex VII of the REACH Regulation which requires that substances with positive results for in vitro gene mutation study in bacteria are further investigated for their mutagenic properties in vivo.

Based on the available information no final conclusion on genotoxicity classification can be drawn since further in vivo data are required.

The dossier will be promptly updated when reliable and pertinent results for the substance will be available.