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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ames test

There are no studies available for (R)-3 -Ammmonium-1-hydroxybutyl (S)-mandelat, but for (R)-mandelic acid (Cas: 611 -71 -2) and 1-Butanol, 3-amino, (3R)- (Cas: 61477 -40 -5).

(R)-mandelic acid (Cas: 611 -71 -2)

The test substance (R)-mandelic acid was tested for its mutagenic potential in bacterial strains, i.e. Salmonella typhimurlium TA 1535, TA 100, TA 1537 and TA 98 and E. coli WP2 uvrA in a standard plate test (SPT) and preincubation test (PIT) with and without metabolic activation.

The dose range was 20 - 5000 µg/plate (SPT) and 4 - 2500 µg/pate (PIT). No precipitation of the test substance was found. A bacteriotoxic effeet was observed under all test conditions. An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S-9 mix or after the addition of a metabolizing system. According to the results of the present study, the test substance (R)-mandelic acid is not mutagenic in the Salmonella Typhimurium / Escherichia coli reverse mutation assay under the experimental conditions chosen here. [BASF, 2002]


1-Butanol, 3-amino, (3R)- (Cas: 61477 -40 -5)

The test substance, 1-Butanol, 3-amino, (3R)-, 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:
Ames (R)-mandelic acid): negative
Ames (1-Butanol, 3-amino, (3R)-,): negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

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