1-Butanol, 3-amino-, (3R)-

Genetic toxicity: in vitro

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

(3R)-3-aminobutan-1-ol

EC Number:

640-387-9

Cas Number:

61477-40-5

Molecular formula:

C4 H11 N O

IUPAC Name:

(3R)-3-aminobutan-1-ol

Test material form:

other: liquid

Details on test material:

Test substance No.: 08/0786-1
Batch identification: 33533-193
Purity/composition: 99.4%
(see analytical report, study code 08L00314)
Homogeneity: The homogeneity of the test substance was guaranteed by mixing before preparation of the test substance formulations.
Storage stability: The stability of the test substance under storage conditions throughout the study period was guaranteed as indicated by the sponsor, and the sponsor holds this responsibility.
Date of production: Sep 08
Physical state, appearance: Liquid, colorless, clear
Storage conditions: Room temperature (protected from light; N2 conditions)

Method

Species / strain

Species / strain / cell type:

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)

Controls

Untreated negative controls:

yes

Negative solvent / vehicle 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

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

A bacteriotoxic effect was observed depending on the strain and test conditions from about 500 - 1 000 μg/plate onward

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

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.