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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Constituent 1
Chemical structure
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.