Registration Dossier

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:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
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
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

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:
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'.

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.