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Toxicological information

Genetic toxicity: in vitro

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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: Study was performed in accordance with OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay). A GLP certificate is provided.
Justification for type of information:
see attached justification

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
The stability of the test substance in the vehicle water has not been determined analytically .
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine
EC Number:
223-362-3
EC Name:
N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine
Cas Number:
3855-32-1
Molecular formula:
C11H27N3
IUPAC Name:
N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine
Test material form:
solid - liquid: suspension

Method

Target gene:
TA. 1535, TA 100, TA 1537, TA 98 and E . coli WP2 uvrA
Test concentrations with justification for top dose:
20 - 5,000 ug/plate
Details on test system and experimental conditions:
Standard plate test and preincubation test both with and without metabolic activation (Aroclor-induced rat liver S-9 mix)

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No precitation of the test sub stance was found.

Occasionally, a slight decrease in the number of revertants was observed in the standard plate test with S-9 mix at 5,000 ug/ plate . In the preincubation assay bacteriotoxicity was found depending on the strain and test conditions_at doses > 2,500 ug / plate
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 result's of the present study, the substance is not mutagenic in the Ames test and in the Escherichia coli - reverse mutation assay under the experimental condition chosen.