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EC number: 205-281-5 | CAS number: 137-16-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 03 May 1996 - 06 May 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (Lack on test material details and no TA102 or E. coli strain was included in the test.)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- 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:
- lack on test material details, no TA102 or E. coli strain was included.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium N-lauroylsarcosinate
- EC Number:
- 205-281-5
- EC Name:
- Sodium N-lauroylsarcosinate
- Cas Number:
- 137-16-6
- Molecular formula:
- C15H29NO3.Na
- IUPAC Name:
- sodium [dodecanoyl(methyl)amino]acetate
- Test material form:
- not specified
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA1538, TA 98 and TA 100
- 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:
- 10, 100, 1000 and 10000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
The material under examination was used following dilution in distilled water in an amount of 100 mg/mL.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (5 µg/plate, -S9, TA1535 and TA100); 9-aminoacridine (40 µg/plate, -S9, TA1537); 2-nitrofluorene (10 µg/plate, -S9, TA 1538 and TA98); 2-acetylaminoflurorene (1 µg/plate, +S9, all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 24 h
- Exposure duration: 48-72 h
- Fixation time (start of exposure up to fixation or harvest of cells): 48-72 h
NUMBER OF REPLICATIONS: Three repetitions were carried out for the assay sample and two for the positive controls.
DETERMINATION OF CYTOTOXICITY
- Method: The toxicity of the assay sample for the mutant strains of Salmonella typhimurium was evaluated by planting the bacteria in the minimum medium and determining any reduction in the background lawn and in the number of spontaneous revertants caused by the assay sample at the maximum concentration tested. - Evaluation criteria:
- CRITERIA FOR THE VALIDITY OF THE ASSAY
The S9 Mix must not be contaminated by more than two colonies per 0.5 mL in the sterility assay carried out following conclusion of the experiment on plates containing the full medium.
In the sterility assay carried out following conclusion of the experiment with the greatest concentration used, the assay sample must not be contaminated by more than two colonies per plate.
On average, the positive control must induce the development of revertant colonies in an amount at least three times greater than the negative control.
The number of spontaneous revertant colonies in the negative controls must lie within the following thresholds:
Strain: TA-1535
Threshold: 20 ± 15
Strain: TA-1538
Threshold: 20 ± 15
Strain: TA-1537
Threshold: 15 ± 10
Strain: TA-98
Threshold: 40 ± 25
Strain: TA-100
Threshold: 150 ± 90 - Statistics:
- Mean and standard deviation were calculated.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- at 10000 µg/plate with and without metabolic activation
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 10000 µg/plate (with and without metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1. Plate test without metabolic activation.
Strain |
Plate |
No. of revertant colonies/plate |
Positive controls µg/plate |
||||
ASSAY SAMPLE µg/plate |
|||||||
TA 1535 |
|
C |
10 |
102 |
103 |
104 |
Na azide 5 |
1 |
24 |
24 |
22 |
22 |
0 |
NC |
|
2 |
20 |
22 |
12 |
12 |
0 |
NC |
|
3 |
21 |
25 |
19 |
19 |
0 |
/ |
|
average |
21.7 |
23.7 |
17.7 |
17.7 |
/ |
/ |
|
s.d. |
2.08 |
1.53 |
5.13 |
5.13 |
/ |
/ |
|
TA 1537 |
|
|
|
|
|
|
9-AA 40 |
1 |
5 |
13 |
10 |
9 |
0 |
222 |
|
2 |
10 |
16 |
11 |
4 |
0 |
192 |
|
3 |
12 |
13 |
15 |
10 |
0 |
/ |
|
average |
9 |
14 |
12 |
7.7 |
/ |
207 |
|
s.d. |
3.60 |
1.73 |
2.64 |
3.21 |
/ |
21.2 |
|
TA 1538 |
|
|
|
|
|
|
2-NF 10 |
1 |
22 |
24 |
23 |
26 |
0 |
73 |
|
2 |
21 |
40 |
34 |
24 |
0 |
97 |
|
3 |
19 |
22 |
31 |
20 |
0 |
/ |
|
average |
20.7 |
21.7 |
29.3 |
23.3 |
/ |
85 |
|
s.d. |
1.53 |
9.86 |
5.67 |
3.05 |
/ |
16.97 |
|
TA 98 |
|
|
|
|
|
|
2-NF 10 |
1 |
16 |
16 |
24 |
20 |
0 |
106 |
|
2 |
23 |
22 |
23 |
10 |
0 |
107 |
|
3 |
15 |
17 |
19 |
17 |
0 |
/ |
|
average |
18 |
18.3 |
22 |
15.7 |
/ |
106.5 |
|
s.d. |
4.36 |
3.21 |
2.64 |
5.13 |
/ |
0.71 |
|
TA 100 |
|
|
|
|
|
|
Na azide 5 |
1 |
129 |
112 |
141 |
118 |
0 |
NC |
|
2 |
137 |
136 |
123 |
125 |
0 |
NC |
|
3 |
130 |
130 |
129 |
122 |
0 |
/ |
|
average |
132 |
126 |
131 |
122 |
/ |
/ |
|
s.d. |
4.36 |
12.48 |
9.16 |
3.51 |
/ |
/ |
Table 2. Plate test with metabolic activation.
Strain |
Plate |
No. of revertant colonies/plate |
Positive controls µg/plate |
||||
ASSAY SAMPLE µg/plate |
|||||||
TA 1535 |
|
C- |
10 |
102 |
103 |
104 |
2-AA 1 |
1 |
10 |
10 |
28 |
15 |
3 |
160 |
|
2 |
16 |
19 |
25 |
14 |
6 |
180 |
|
3 |
18 |
20 |
19 |
9 |
7 |
|
|
average |
14.7 |
16.3 |
24 |
12.7 |
5.3 |
|
|
s.d. |
4.17 |
5.51 |
4.58 |
3.21 |
2.08 |
|
|
TA 1537 |
|
|
|
|
|
|
2-AA 1 |
1 |
16 |
13 |
8 |
17 |
0 |
90 |
|
2 |
18 |
18 |
15 |
10 |
0 |
110 |
|
3 |
23 |
17 |
10 |
17 |
0 |
/ |
|
average |
19 |
16 |
11 |
14.7 |
/ |
100 |
|
s.d. |
3.60 |
2.64 |
3.60 |
4.04 |
/ |
14.14 |
|
TA 1538 |
|
|
|
|
|
|
2-AA 1 |
1 |
17 |
29 |
8 |
9 |
0 |
NC |
|
2 |
13 |
15 |
14 |
12 |
0 |
NC |
|
3 |
14 |
17 |
17 |
20 |
0 |
/ |
|
average |
14.7 |
18.3 |
13 |
13.7 |
/ |
/ |
|
s.d. |
2.08 |
4.16 |
4.58 |
5.67 |
/ |
/ |
|
TA 98 |
|
|
|
|
|
|
2-AA 1 |
1 |
15 |
12 |
5 |
10 |
2 |
154 |
|
2 |
20 |
10 |
10 |
12 |
3 |
150 |
|
3 |
19 |
15 |
16 |
15 |
4 |
/ |
|
average |
18 |
12.3 |
10.3 |
12.3 |
/ |
152 |
|
s.d. |
2.64 |
2.52 |
5.51 |
2.52 |
30 |
2.83 |
|
TA 100 |
|
|
|
|
|
|
2-AA 1 |
1 |
240 |
125 |
175 |
137 |
1 |
NC |
|
2 |
200 |
156 |
174 |
360 |
0 |
NC |
|
3 |
176 |
168 |
174 |
180 |
0 |
/ |
|
average |
205.3 |
149.7 |
174.3 |
225.7 |
0.33 |
/ |
|
s.d. |
32.33 |
22.19 |
0.58 |
118.3 |
0.58 |
/ |
N.C.: no explanation given in the study report. However, all positive controls resulted in a significant increase in the number of revertants.
Applicant's summary and conclusion
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