Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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 OECD guideline study, conducted according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(tetrahydrofuran-3-yl)methanamine
EC Number:
676-405-7
Cas Number:
165253-31-6
Molecular formula:
C5 H11 N O
IUPAC Name:
1-(tetrahydrofuran-3-yl)methanamine
Test material form:
other: liquid
Details on test material:
Name of test substance: 3-Aminomethyl-THF
Test substance No.: 13/0314-1
Batch identification: C520 069/2013 Fr.3 Fl.1
Purity/composition: 99.96 area-%
Homogeneity: The homogeneity of the test substance was ensured by mixing before preparation of the test substance solutions.
Storage stability: The stability of the test substance under storage conditions throughout the study period was guaranteed until 30 Apr 2014, as indicated by the sponsor, and the sponsor holds this responsibility.
ADDITIONAL TEST SUBSTANCE INFORMATION
Date of production/supply: Apr 2013
Physical state, appearance: Liquid, colourless, clear
Storage conditions: Room temperature (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:
S9 fraction
Test concentrations with justification for top dose:
33 μg - 5 000 μg/plate (SPT)
33 μg - 5 000 μg/plate (PIT)
Controls
Untreated negative controls:
yes
Remarks:
Additional plates were treated with soft agar, S9 mix, buffer, vehicle or the test substance but without the addition of tester strains
Negative solvent / vehicle controls:
yes
Remarks:
The vehicle control with and without S9 mix only contains the vehicle used for the test substance at the same concentration and volume for all tester strains
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
9-aminoacridine
other: 2-aminoanthracene, N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylenediamine
Details on test system and experimental conditions:
Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats).

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:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
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:
Under the experimental conditions of this study, the test substance 3-Aminomethyl-THF is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
Executive summary:

According to the results of the study, the test substance did not lead to a biologically relevant increase in the number of revertant colonies either without S9 mix or after adding a metabolizing system in two several experiments carried out independently of each other

(standard plate test and preincubation assay). 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.

Categories Display