Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Short description of key information:
OECD guideline fot testing of chemicals, TG 471 (1997). Bacterial Reverse mutation test in four histidine-requiring strain of Salmonella typhimurioum TA98, TA100, TA1535 and TA1537 and one tryprophan-requiring strain of Escherichia coli WP2 uvrA both in the absence and presence of metabolic activation system (S9 mix).
(Bacterial reverse mutation assay / Ames test): S. typhimurium TA 100: positive with and without metabolic activation; TA 1535: positive without metabolic
activation (equivalent to OECD )

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

After dose range finding, 5000 mcg/plate was chosen as the higest dose level for mutation experiment.

In the first mutation experiment significant increases of revertant colonies were not observed in any test strains at dose levels from 33.3 to 5000 mcg/plate bot in the absence and in presence of a metabolic activation system.

In the second mutation experiment significant increases of revertant colonies were not observed in any test strains at dose levels from 33.3 to 5000 mcg/plate bot in the absence and in presence of a metabolic activation system. In the presence of metabolic activation system, cytotoxicity was observed at 5000 mcg/plate of all strains.

AM03 was therefore considered not mutagenic and it is not classified.