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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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 based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 29 February 1996 to 1 April 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to guideline, but only two bacterial strains tested

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
only two bacterial strains tested
GLP compliance:
not specified
Type of assay:
bacterial gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Decyldimethylamine
EC Number:
214-302-7
EC Name:
Decyldimethylamine
Cas Number:
1120-24-7
Molecular formula:
C12H27N
IUPAC Name:
N,N-dimethyldecan-1-amine

Method

Target gene:
Histidine
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 100
Details on mammalian cell type (if applicable):
contains a histidine missense mutation but is also deficient in a DNA repair system and has a defective lipopolysaccharide coat on the cell wall
Species / strain / cell type:
S. typhimurium TA 98
Details on mammalian cell type (if applicable):
contains a histidine frameshift mutation. Again it has a definitive DNA repair system and lipopolysaccharide coat
Metabolic activation:
with and without
Metabolic activation system:
Liver extract from Aroclor 1254-induced male Sprague-Dawley rats
Test concentrations with justification for top dose:
A solution of the substance was prepared in ethanol at 5 mg/mL, and four half-log dilutions were prepared from this solution. Aliquots (0.1mL) of each concentration of the substance were placed in sterile tubes.
Test material (µg per plate): 2500 (sterility check), 5000, 500, 50, 5, 2500, 250, 25, 2.5, 0, 0 (0.2 mL solvent).
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:
benzo(a)pyrene
Remarks:
in both strains with and without metabolic activation
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
in TA100 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:
in TA98 without metabolic activation
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 500 µg and above
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 500 µg and above
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Standard tests for bacterial sensitivity:

   TA100  TA98
 2-Aminofluorene (10µg/plate) with activation  +  +
  9-Aminoacridine (80µg/plate) non-activated  -  -
  Sodium azide (2µg/plate) non-activated  +  -
  Ampicillin (8mg/mL in purified water)  Resistant  Resistant

+ Increased reversion (his - to his +) over solvent controls

- No increase in reversion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test material did not exhibit any mutagenic activity under the conditions of test.
Executive summary:

The material was examined for mutagenic activity in two histidine-dependent auxotrophs of Salmonella typhimurium, strains TA 98 and TA 100, using plate-incorporation assays.

The studies, which were conducted in the presence and absence of an activiting system derived from rat liver (S-9 mix), employed a range of levels of the substance from 5 to 500 µg per plate, selected following a preliminary toxicity test in strain TA 98. The test included solvent (ethanol) controls with and without S-9 mix.

The substance did not exhibit any mutagenic activity under the conditions of test. Positive controls were effective, such indicating the validity of the test system.