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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

There are no studies available for Reaction product of 4 -hydroxy-2 -butanone, ammonia and hydrogen, only for (R)-3 -Amino-butan-ol.

Ames test

According to the results of the study, the test substance did not lead to an increase in the number of revertant colonies either without S9 mix or after adding a metabolizing system in several experiments carried out independently of each other (standard plate test and preincubation assay). In the 2nd Experiment using the tester strain E.coli WP2 uvrA no bacterial growth occured. It has to be considered that the lacking bacterial growth was caused by a technical error. Therefore, this experimental part was repeated in the 3rd Experiment. Besides, the results of the negative as well as the positive controls performed in parallel corroborated the validity of this study, since the values fulfilled the acceptance criteria of this study. In this study with and without S9 mix, the number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain. In addition, the positive control substances both with and without S9 mix induced a significant increase in the number of revertant colonies within the range of the historical positive control data or above. [BASF, 2008]


Justification for selection of genetic toxicity endpoint
only one study available

Short description of key information:
(R)-3-Aminobutan-1-ol is not a mutagenic substance in the bacterial reverse mutation test in the absence and the presence of metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No need for classification according to Annex VI of Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.