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EC number: 263-193-2 | CAS number: 61791-59-1
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Genetic toxicity
- Carcinogenicity
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-02-15 to 2006-03-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umweltschutz und Gewerbeaufsicht
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Glycine, N-methyl-, N-coco acyl derivs., sodium salts
- EC Number:
- 263-193-2
- EC Name:
- Glycine, N-methyl-, N-coco acyl derivs., sodium salts
- Cas Number:
- 61791-59-1
- Molecular formula:
- Not applicable
- IUPAC Name:
- disodium 2-(N-methyldodecanamido)acetate 2-(N-methyltetradecanamido)acetate
- Test material form:
- not specified
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102 and TA 1535
- Additional strain / cell type characteristics:
- other: histidin-deficient
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- First experiment:
- 1.5, 5, 15, 50, 149 µg/plate with and without metabolic activation
Second experiment:
- 37.5, 75, 150 µg/plate with and without metabolic activation - Vehicle / solvent:
- water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other:
- Remarks:
- NPD: 80 μg/plate in water, -S9, TA 97a, TA 98, TA 102; Sodium azide: 6 μg/plate in water, -S9, TA100 and TA1535; 2-AA: 3 μg/plate in DMSO, +S9, TA 98; BaP: 40 μg/plate in DMSO, +S9, TA 97a, TA 100, TA 102, TA 1535
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 12 h
- Exposure duration: 48 h
NUMBER OF REPLICATIONS:
- dublicates each in two independent experiments.
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- The test material may be considered positive in this test system if the following
criteria are met:
For the test item to be considered mutagenic, two-fold (or more) increases in mean revertant numbers must be observed at one strain with or without S9 mixture or there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose levels - Statistics:
- Mean values and standard deviation were calculated
Results and discussion
Test results
- Key result
- Species / strain:
- other: S. typhimurium: TA 97a, TA 98, TA 100, TA 102 and TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- above 150 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
- The highest concentration used in the study was 150 µg/plate, based on the cytotoxicity at higher concentrations.
Any other information on results incl. tables
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 2 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
TA102 |
TA98 |
TA97a |
||
– |
0 |
114 ± 49 |
9 ± 2.4 |
9 ± 2.4 |
12 ± 0.5 |
130 ± 34.5 |
– |
1.5 |
71 ± 15 |
6 ± 4 |
164 ± 25 |
8 ± 1 |
124 ± 36 |
– |
5 |
97 ± 22 |
7 ± 2 |
125 ± 9 |
8 ± 1 |
97 ± 38 |
– |
15 |
86 ± 12 |
6 ± 2 |
106 ± 19 |
6 ± 3 |
80 ± 7 |
– |
50 |
90 ± 16 |
8 ± 1 |
101 ± 10 |
4 ± 2 |
83 ± 31 |
– |
150* |
113 ± 41 |
8 ± 3 |
139 ± 7 |
14 ± 6 |
120 ± 55 |
Positive controls, –S9 |
Name |
NaN3 |
NaN3 |
NPD |
NPD |
NPD |
Concentrations (μg/plate) |
6 |
6 |
80 |
80 |
80 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
366 ± 101 |
1001 ± 0 |
657 ± 122 |
205 ± 98 |
1001 ± 0 |
|
+ |
0 |
138 ± 38 |
6 ± 2.6 |
158 ± 27.9 |
15 ± 2.4 |
101 ± 26.9 |
+ |
1.5 |
74 ± 13 |
5 ± 2 |
154 ± 44 |
12 ± 7 |
93 ± 42 |
+ |
5 |
127 ± 22 |
7 ± 1 |
156 ± 26 |
9 ± 6 |
115 ± 38 |
+ |
15 |
104 ± 14 |
8 ± 3 |
146 ± 9 |
8 ± 5 |
86 ± 31 |
+ |
50 |
103 ± 17 |
11 ± 3 |
159 ± 23 |
12 ± 7 |
101 ± 21 |
+ |
150* |
78 ± 9 |
9 ± 1 |
115 ± 32 |
8 ± 5 |
102 ± 31 |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
BP |
2AA |
Concentrations (μg/plate) |
3 |
3 |
3 |
40 |
3 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
1218 ± 251 |
130 ± 12 |
382 ± 42 |
200 ± 48 |
718 ± 231 |
Plate incorporation
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 2 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
TA102 |
TA98 |
TA97a |
||
– |
0 |
145 ± 17 |
12 ± 3.4 |
186 ± 3.6 |
8 ± 2.2 |
153 ± 27.3 |
– |
37.5 |
158 ± 45 |
7 ± 3 |
136 ± 47 |
7 ± 3 |
122 ± 54 |
– |
75 |
131 ± 19 |
8 ± 4 |
128 ± 42 |
13 ± 5 |
125 ± 20 |
– |
150* |
146 ± 7 |
6 ± 4 |
129 ± 28 |
11 ± 5 |
115 ± 37 |
Positive controls, –S9 |
Name |
NaN3 |
NaN3 |
NPD |
NPD |
NPD |
Concentrations (μg/plate) |
6 |
6 |
80 |
80 |
80 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
1001 ± 0 |
1001 ± 0 |
1001 ± 0 |
1001 ± 0 |
1001 ± 0 |
|
+ |
0 |
153 ± 7 |
13 ± 1.7 |
137 ± 43.2 |
10 ± 3.4 |
141 ± 23.6 |
+ |
37.5 |
95 ± 16 |
8 ± 3 |
86 ± 25 |
10 ± 4 |
104 ± 31 |
+ |
75 |
104 ± 21 |
11 ± 3 |
117 ± 15 |
10 ± 4 |
156 ± 29 |
+ |
150* |
120 ± 10 |
5 ± 2 |
134 ± 44 |
6 ± 2 |
89 ± 28 |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
BP |
2AA |
Concentrations (μg/plate) |
3 |
3 |
3 |
40 |
3 |
|
Mean No. of colonies/plate (average of 2 ± SD) |
1001 ± 0 |
1001 ± 0 |
1001 ± 0 |
105 ± 6 |
1001 ± 0 |
Preincubation
*Remark: 150 µg/plate was the highest concentration of test substance due to toxicity testing
NPD: 4-Nitro-1,2-phenylene diamine
NaN3: sodium azide
2AA: 2-Amino-anthracene
BaP: Benzo-a-pyrene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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