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Key value for chemical safety assessment

Genetic toxicity in vitro

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.
Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: modern GLP and guideline study.
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay
Test material information:
Composition 1
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
prepared from Wistar rats [Crl:WI(Han)] rats which received 80 mg/kg b.w. phenobarbital i.p. and β-naphthoflavone orally
Test concentrations with justification for top dose:
20 μg - 5 000 μg/plate (SPT; all tester strains)
20 μg - 5 000 μg/plate (PIT; TA 1535, TA 1537, TA 98, E. coli)
20 μg - 5 000 μg/plate (PIT; TA 100 with S9 mix)
4 μg - 5 000 μg/plate (PIT; TA 100 without S9 mix)
Negative controls:
yes
Solvent controls:
yes
True negative controls:
yes
Positive control substance:
other: 2-aminoanthracene (with S9-mix) and N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylenediamine, 9-aminoacridine, 4-nitroquinoline-N-oxide (without S9-mix
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
A bacteriotoxic effect was observed depending on the strain and test conditions from about 500 - 1 000 μg/plate onward
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative

According to the results of the study, the test substance (R)-3-Aminobutan-1-ol is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under the experimental conditions chosen.
Executive summary:

The substance (R)-3-Aminobutan-1-ol was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay. 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 S9 mix or after the addition of a metabolizing system. According to the results of the study, the test substance (R)-3-Aminobutan-1-ol is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under the experimental conditions chosen.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

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

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.