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Diss Factsheets

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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
28/02/1988 to 11/03/1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
There are not deviations from the recommended guideline and it is GLP. In accordance to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance. It is hypothesized that the toxicity of the target chemical can be derived from the respective toxicity data of DMAs with comparable length of alkyl chain (source substances). The underlying scientific rationale is based on the physico-chemical property of the target chemical and “chain length category”.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial gene mutation assay

Test material

Constituent 1
Reference substance name:
Dodecyldimethylamine
EC Number:
203-943-8
EC Name:
Dodecyldimethylamine
Cas Number:
112-18-5
IUPAC Name:
N,N-dimethyldodecan-1-amine

Method

Target gene:
Histidine-requiring gene in Salmonella, tryptophane in E.coli
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9 liver extract from Aroclor 1254-induced male Sprague-Dawley rats
Test concentrations with justification for top dose:
At the day of the experiment the test substance was dissolved in Ethanol at appropriate concentrations.
Experiment 1: 0, 4, 20, 100, 500, 2500, 10000 µg/plate
Experiment 2: 0, 0.16, 0.8, 4, 20, 100, 500 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: ethanol
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
TA100 and TA1535 without metabolic activation
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
TA1537 without metabolic activation
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
TA98, TA1538 without metabolic activation
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: N-methyl-N-nitro-N-nitrosoguanidine
Remarks:
E.coli without metabolic activation
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
TA98, TA100, TA1535, TA1537, TA1538, WP2uvrA with metabolic activation
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Remarks:
(with metabolic activation)
Positive control substance:
other: 2-Aminoanthracene
Remarks:
TA98, TA100, TA1535, TA1537, TA1538, WP2uvrA with metabolic activation
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene
Remarks:
TA98, TA100, TA1535, TA1537, TA1538, WP2uvrA with metabolic activation
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48-72 h


SELECTION AGENT (mutation assays): histidine (Salmonella), trypthophane (E.coli)
SPINDLE INHIBITOR (cytogenetic assays):

DETERMINATION OF CYTOTOXICITY
- Method: thinning of bacterial lawn, reduced rate of spontaneously occuring colonies

NUMBER OF REPLICATIONS: 3 plates per concentration

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
starting at concentrations of 100 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
other: WP2uvrA
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
starting at concentrations of 100 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
starting at concentrations of 100 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
other: WP2uvrA
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
starting at concentrations of 100 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
In the first experiment the test compound was tested at doses of 4 to 10000 microgram/plate and proved to be very toxic to the bacterial strains at doses of 100 microgram/plate. Thinning of the bacterial lawn and a reduction in the number of colonies has been observed at this dose. Therefore for mutagenicity testing 500 microgram/plate was chosen as the higest dose in the second experiment.
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

The genetic toxicity of the target substance was assessed based on the analogue appraoch using N,N-dimethyldodecan-1-amine as read-across supporting substance. It can be stated that the substance is not mutagenic in these bacterial test system either with or without exogenous metabolic activation at dose levels investigated.
Executive summary:

The genetic toxicity of the target substance was assessed based on the analogue appraoch using N,N-dimethyldodecan-1-amine as read-across supporting substance.The substance was tested for mutagenicity with the strains TA100, TA1535, TA1537, TA1538, TA98 of Salmonella typhimurium and Escherichia coli. The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. In a first experimet concentrations ranging from 0 - 10000 µg/plate were used. The results showed cytotoxicity starting at a concentration of 100 µg/plate. Therefore for the second experiment a dose range of 6 different doses from 0.16 microgram/plate to 500 microgram/plate was used. Three replications per concentration were done. Control plates without mutagen showed that the number of spontaneous revertant colonies was similiar to that described in the literature. All the positive control compound gave the expected indrease in the number of revertant colonies. Toxicity: The test compound proved to be very toxic to the bacterial strains at 100 microgram/plate. 500 microgram/plate was chosen as top dose level for the mutagenicity study.Mutagenicity: In the absence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains. Also in the presence of a metabolic activation system, treatment of the cells with the substance did not result in relevant increases in the number of revertant colonies.

Therefore under the conditions of this study the test substance is not mutagenic.