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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication, which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Method according to Ames et al (1975)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N-Methyldiethanolamine
- Analytical purity: 99.8%

Method

Target gene:
histidine gene
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
with and without
Metabolic activation system:
S9 liver homogenate, isolated from Aroclor 1254 induced rat
Test concentrations with justification for top dose:
0.1, 0.3, 1, 3, 5, 10 mg/plate
Vehicle / solvent:
water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: The activation-independent positive controls were 4-nitrophenylenediamin, sodium azide, and 9-aminoacridine, and the activation-dependent control was 2-aminoanthracen.
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48-72 h

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: inhibition of growth of the backgroun lawn




Evaluation criteria:
At least twice the solvent control for at least one concentration and there was evidence of a concentration-related increase in the number of revertant colonies.
Statistics:
no data

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
-S9 mix: from 3 mg/plate onwards; +S9-mix: at 10 mg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No mutagenic activity was observed in any of the 5 strains mutants over the range of concentrations tested in the absence or the presence of S9 activation, either by evidence of a dose-response relation or a doubling of the mean number of colonies over the vehicle control value.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

 Chemical   TA98      TA100     TA1535     TA1537     TA1538     
  Dose(mg/plate)   -S9  +S9  -S9  +S9  -S9 +S9   -S9  +S9  -S9  +S9  
 water  100  22±5  14±5  123±24  127±27  10±2  11±2  7±2  6±2  8±2  11±4  
 4 -NPD  0.01  683±43  -  -  -  -  -  -  -  794±50  -  
 NaN3  0.01  -  -  1087±60  -  917±194  -  -  -  -  -  
 9 -AA  0.06  -  -  -  -  -  -  240±33  -  -  -  
 2 -AA  0.0025  -  1890±34  -  1757±164  - 123±10  -  299±6  -  1655±109  
 MDEA  0.1  26±3 21±6   87±13  124±17 15±12 11±4 11±6 5±2  8±1  13±3  
 MDEA  0.3  19±4  18±1  113±20  104±4 13±5 13±3 4±2 5±3  12±3  10±4  
 MDEA  1  18±3  19±0  106±13  102±6 10±4 11±2 6±3 5±2  8±1  13±5  
 MDEA  3  22 (s)  15±2  80±6  101±16 8 (s) 5±2 4±2 4±2  7 (T)  10±4  
 MDEA  5    15±3    100±11   11±1    3±1    16±1  
 MDEA  10  toxic    toxic    toxic    toxic    toxiv    

 

4-NPD: 4-nitrophenylenediamine;

NaN3: sodium azide;

9-AA: 9-aminoacridine;

2-AA: 2-aminoanthracene.

 

Toxic: clearing of background lawn or average number of colonies less than half of the solvent control value.

S: sparse growth of background lawn in one or two of the triplicates tested. Counts not included in the calculation of mean and standard deviations not calculated.

T: toxic to one or two of the triplicates tested.

No mutagenic activity was observed in any of the 5 strains mutants over the range of concentrations tested in the absence or the presence of S9 activation, either by evidence of a dose-response relation or a doubling of the mean number of colonies over the vehicle control value.

Applicant's summary and conclusion