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EC number: 209-421-6 | CAS number: 578-36-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 17-04-2018 - 10-05-2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- This study was performed to investigate the potential of Sodium 2-hydroxybenzoate (CAS No. 54-21-7) to induce gene muta¬tions in comparison to negative control according to the plate incorporation test (Trial I) and the pre-incubation test (Trial II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102.
- GLP compliance:
- not specified
- Remarks:
- Test conducted originally for other purposes than REACH and thus conducted as per the OECD guidelines only.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium salicylate
- EC Number:
- 200-198-0
- EC Name:
- Sodium salicylate
- Cas Number:
- 54-21-7
- Molecular formula:
- C7H6O3.Na
- IUPAC Name:
- sodium salicylate
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):sodium salicylate- Molecular formula :C7H6O3.Na- Molecular weight : 160.1035 g/mol- Substance type: organic- Physical state: solid- Smilies notation: c1(c(cccc1)O)C(=O)[O-].[Na+]- InChI: 1S/C7H6O3.Na/c8-6-4-2-1-3-5(6)7(9)10;/h1-4,8H,(H,9,10);/q;+1/p-1
Constituent 1
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other:
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced S9 metabolic activation system
- Test concentrations with justification for top dose:
- 0.0 (NC), 0.002, 0.005, 0.016, 0.050 and 0.158 mg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: RO water - Justification for choice of solvent/vehicle: The test chemical was soluble in RO water
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- RO water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-Nitro-o-phenylenediamine (TA 1537, TA 98, without S9); 2-Aminoanthracene (TA 1535, TA 1537, TA 98, TA 100 and TA 102, with S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation- Trial I); preincubation (Trial II)DURATION- Preincubation period: Trial I: Not applicable Trial II: 60 min - Exposure duration: 48 hrs- Expression time (cells in growth medium): 48 hrs- Selection time (if incubation with a selection agent): No data- Fixation time (start of exposure up to fixation or harvest of cells): No dataSELECTION AGENT (mutation assays): No dataSPINDLE INHIBITOR (cytogenetic assays): No data STAIN (for cytogenetic assays): No dataNUMBER OF REPLICATIONS: Each concentration, including the negative, vehicle and positive controls was tested in triplicate in two independent experiments performedMETHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: Not applicableNUMBER OF CELLS EVALUATED: No dataNUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): No dataCRITERIA FOR MICRONUCLEUS IDENTIFICATION: No dataDETERMINATION OF CYTOTOXICITY- Method: mitotic index; cloning efficiency; relative total growth; other: No data- Any supplementary information relevant to cytotoxicity: No dataOTHER EXAMINATIONS:- Determination of polyploidy: No data- Determination of endoreplication: No data- Methods, such as kinetochore antibody binding, to characterize whether micronuclei contain whole or fragmented chromosomes (if applicable): No data- OTHER: No data
- Rationale for test conditions:
- No data
- Evaluation criteria:
- A test item is considered as a mutagen, if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100 and TA 102) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding vehicle/solvent control is observed.A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration. An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative control and vehicle control such an increase is not considered biologically relevant.
- Statistics:
- No data
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS- Effects of pH: No data- Effects of osmolality: No data- Evaporation from medium: No data- Water solubility: No data- Precipitation: No precipitation was noted at a dose upto 5 mg/plate in the pre-experiment- Definition of acceptable cells for analysis: No data- Other confounding effects: No dataRANGE-FINDING/SCREENING STUDIES: To evaluate the toxicity of the test item, a pre-experiment was performed with strains TA 98 and TA 100. Eight concentrations 0.0 (NC), 0.002, 0.005, 0.016, 0.050, 0.158, 0.501, 1.582 and 5 mg/plate) were tested for toxicity and mutation induction with 3 plates each (triplicates). The experimental conditions in this pre-experiment were the same as described below for the Trial-I (Plate incorporation test). Toxicity of the test item results in a reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn.In the pre-experiment, the concentration range of the test item was 0.002 – 5.0 mg/plate based on the solubility and precipitation test. In TA 98 and TA 100, cyto-toxicity was observed in the treated concentrations 1.582 and 5 mg/plate (T7 to T8), moderate inhibition was observed in the treated concentrations 0.501 mg/plate (T6) and there was no reduction in colony count as well as background lawn in any of the following concentrations tested; 0.002, 0.005, 0.016, 0.050 and 0.158 ( T1 to T5) mg/plate both in absence and in the presence of metabolic activation, when compared to that of the negative control group. Based on the results of pre-experiment following doses were selected for the main study trials: 0.002, 0.005, 0.016, 0.050 and 0.158 mg/plate, both in the absence (-S9) as well as in the presence of metabolic activation (+S9).CYTOKINESIS BLOCK (if used)- Distribution of mono-, bi- and multi-nucleated cells: No dataNUMBER OF CELLS WITH MICRONUCLEI- Number of cells for each treated and control culture: No data- Indication whether binucleate or mononucleate where appropriate: No dataHISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)- Positive historical control data: No data- Negative (solvent/vehicle) historical control data: No dataADDITIONAL INFORMATION ON CYTOTOXICITY:- Measurement of cytotoxicity used: No data- Other observations when applicable: No data
- Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
TABLE1- REVERTANT COUNT FOR PRE-EXPERIMENT
Dose (mg/plate) |
R |
Without metabolic activation (-S9) |
With metabolic activation (+S9) |
||
TA100 |
TA 98 |
TA100 |
TA 98 |
||
NC (0.00) |
R1 |
122 |
24 |
126 |
25 |
R2 |
118 |
20 |
119 |
20 |
|
R3 |
124 |
19 |
121 |
22 |
|
T1 (0.002) |
R1 |
106 |
17 |
108 |
19 |
R2 |
110 |
19 |
112 |
17 |
|
R3 |
111 |
17 |
106 |
17 |
|
T2 (0.005) |
R1 |
108 |
19 |
112 |
21 |
R2 |
102 |
20 |
108 |
23 |
|
R3 |
104 |
18 |
110 |
20 |
|
T3 (0.016) |
R1 |
114 |
20 |
108 |
18 |
R2 |
106 |
22 |
110 |
16 |
|
R3 |
102 |
19 |
114 |
18 |
|
T4 (0.050) |
R1 |
116 |
21 |
106 |
21 |
R2 |
112 |
17 |
114 |
23 |
|
R3 |
118 |
18 |
108 |
19 |
|
T5 (0.158) |
R1 |
102 |
18 |
100 |
17 |
R2 |
98 |
17 |
96 |
18 |
|
R3 |
100 |
15 |
104 |
17 |
|
T6 (0.501) |
R1 |
36 (+ + +) |
2 (+ + +) |
42 ( + + + ) |
4 (+ + +) |
R2 |
26 (+ + +) |
5 (+ + +) |
34 (+ + +) |
3 (+ + +) |
|
R3 |
24 (+ + +) |
3 (+ + +) |
30 ( + + +) |
3 (+ + +) |
|
T7 (1.582) |
R1 |
0 (+) |
0 (+) |
0 (+) |
0 (+) |
R2 |
0 (+) |
0 (+) |
0 (+) |
0 (+) |
|
R3 |
0 (+) |
0 (+) |
0 (+) |
0 (+) |
|
T8 (5) |
R1 |
0 (+) |
0 (+) |
0 (+) |
0 (+) |
R2 |
0 (+) |
0 (+) |
0 (+) |
0 (+) |
|
R3 |
0 (+) |
0 (+) |
0 (+) |
0 (+) |
|
PC |
R1 |
1088 |
960 |
1584 |
1242 |
R2 |
1136 |
992 |
1616 |
1180 |
|
R3 |
1168 |
1008 |
1600 |
1208 |
NC = Negative control
PC = Positive control
R = Replicate
T = Test concentration (T8: Highest, T1: Lowest)
4-Nitro-o-phenylenediamine [10μg/plate]: TA 98
Sodium azide [10μg/plate]: TA 100,
2-Aminoanthracene [2.5μg/plate]: TA98, TA100
TABLE 2 - REVERTANT COUNT IN PLATE INCORPORATION METHOD (TRIAL I)
Dose (mg/plate) |
R |
In the Presence of Metabolic Activation (+S9) |
||||
TA 1537 |
TA 1535 |
TA 98 |
TA 100 |
TA 102 |
||
NC (0.00) |
R1 |
7 |
16 |
25 |
126 |
280 |
R2 |
6 |
15 |
20 |
119 |
272 |
|
R3 |
8 |
14 |
22 |
121 |
260 |
|
T1 (0.002) |
R1 |
4 |
13 |
19 |
108 |
242 |
R2 |
5 |
11 |
17 |
112 |
238 |
|
R3 |
5 |
10 |
17 |
106 |
232 |
|
T2 (0.005) |
R1 |
5 |
12 |
21 |
112 |
240 |
R2 |
4 |
13 |
23 |
108 |
248 |
|
R3 |
4 |
13 |
20 |
110 |
252 |
|
T3 (0.016) |
R1 |
6 |
14 |
18 |
108 |
256 |
R2 |
5 |
12 |
16 |
110 |
248 |
|
R3 |
4 |
13 |
18 |
114 |
264 |
|
T4 ((0.050) |
R1 |
6 |
15 |
21 |
106 |
260 |
R2 |
5 |
12 |
23 |
114 |
254 |
|
R3 |
5 |
14 |
19 |
108 |
268 |
|
T5 (0.158) |
R1 |
6 |
14 |
17 |
100 |
270 |
R2 |
6 |
15 |
18 |
96 |
266 |
|
R3 |
5 |
14 |
17 |
104 |
258 |
|
PC |
R1 |
168 |
480 |
1242 |
1584 |
1384 |
R2 |
186 |
452 |
1180 |
1616 |
1336 |
|
R3 |
170 |
492 |
1208 |
1600 |
1312 |
Dose (mg/plate) |
R |
In the Absence of Metabolic Activation (-S9) |
||||
TA 1537 |
TA 1535 |
TA 98 |
TA 100 |
TA 102 |
||
NC (0.00) |
R1 |
7 |
16 |
24 |
122 |
276 |
R2 |
6 |
14 |
20 |
118 |
264 |
|
R3 |
7 |
13 |
19 |
124 |
258 |
|
T1 (0.002) |
R1 |
5 |
12 |
17 |
106 |
232 |
R2 |
4 |
14 |
19 |
110 |
240 |
|
R3 |
5 |
11 |
17 |
111 |
236 |
|
T2 (0.005) |
R1 |
6 |
13 |
19 |
108 |
242 |
R2 |
4 |
15 |
20 |
102 |
238 |
|
R3 |
5 |
13 |
18 |
104 |
246 |
|
T3 (0.016) |
R1 |
5 |
14 |
20 |
114 |
240 |
R2 |
5 |
14 |
22 |
106 |
252 |
|
R3 |
6 |
15 |
19 |
102 |
236 |
|
T4 ((0.050) |
R1 |
6 |
14 |
21 |
116 |
254 |
R2 |
5 |
12 |
17 |
112 |
250 |
|
R3 |
6 |
13 |
18 |
118 |
262 |
|
T5 (0.158) |
R1 |
6 |
15 |
18 |
102 |
256 |
R2 |
6 |
15 |
17 |
98 |
260 |
|
R3 |
6 |
14 |
15 |
100 |
252 |
|
PC |
R1 |
180 |
1320 |
960 |
1088 |
1824 |
R2 |
174 |
1272 |
992 |
1136 |
1840 |
|
R3 |
170 |
1344 |
1008 |
1168 |
1888 |
NC= Negative Control,T=Test concentration (T5: Highest, T1: Lowest),R= Replicate
PC= Positive
control 2-Aminoanthracene
[2.5μg/plate]: TA 1537, TA1535, TA 98, TA 100
2- Aminoanthracene [10μg/plate]:TA
102 Sodium azide [10μg/plate]: TA
1535, TA 100
4-Nitro-o-phenylenediamine: TA 1537[50μg/plate], TA 98[10μg/plate] Methyl methanesulfonate [4μl/plate]: TA 102
TABLE 3 - REVERTANT COUNT IN PRE-INCUBATION METHOD (TRIAL II)
Dose (mg/plate) |
R |
In the Presence of Metabolic Activation (+S9) |
||||
TA 1537 |
TA 1535 |
TA 98 |
TA 100 |
TA 102 |
||
NC (0.00) |
R1 |
8 |
16 |
28 |
128 |
272 |
R2 |
6 |
14 |
25 |
123 |
258 |
|
R3 |
7 |
13 |
23 |
124 |
260 |
|
T1 (0.002) |
R1 |
5 |
11 |
20 |
120 |
230 |
R2 |
4 |
10 |
20 |
118 |
238 |
|
R3 |
5 |
13 |
19 |
121 |
244 |
|
T2 (0.005) |
R1 |
5 |
13 |
21 |
123 |
250 |
R2 |
4 |
12 |
23 |
120 |
246 |
|
R3 |
4 |
12 |
24 |
124 |
240 |
|
T3 (0.016) |
R1 |
6 |
10 |
19 |
122 |
238 |
R2 |
5 |
14 |
25 |
119 |
246 |
|
R3 |
5 |
15 |
26 |
125 |
254 |
|
T4 ((0.050) |
R1 |
6 |
13 |
25 |
123 |
248 |
R2 |
6 |
12 |
24 |
124 |
256 |
|
R3 |
5 |
15 |
23 |
124 |
250 |
|
T5 (0.158) |
R1 |
7 |
15 |
26 |
125 |
258 |
R2 |
6 |
14 |
22 |
123 |
264 |
|
R3 |
6 |
14 |
25 |
123 |
260 |
|
PC |
R1 |
162 |
380 |
1344 |
1440 |
1680 |
R2 |
174 |
440 |
1360 |
1472 |
1704 |
|
R3 |
180 |
420 |
1384 |
1504 |
1712 |
Dose (mg/plate) |
R |
In the Absence of Metabolic Activation (-S9) |
||||
TA 1537 |
TA 1535 |
TA 98 |
TA 100 |
TA 102 |
||
NC (0.00) |
R1 |
7 |
15 |
26 |
126 |
260 |
R2 |
6 |
13 |
23 |
123 |
252 |
|
R3 |
7 |
13 |
22 |
120 |
248 |
|
T1 (0.002) |
R1 |
4 |
10 |
21 |
108 |
232 |
R2 |
5 |
13 |
23 |
102 |
228 |
|
R3 |
5 |
11 |
19 |
104 |
236 |
|
T2 (0.005) |
R1 |
4 |
14 |
18 |
106 |
234 |
R2 |
4 |
11 |
20 |
112 |
230 |
|
R3 |
4 |
12 |
23 |
110 |
242 |
|
T3 (0.016) |
R1 |
5 |
13 |
24 |
114 |
248 |
R2 |
6 |
14 |
22 |
108 |
240 |
|
R3 |
4 |
12 |
19 |
111 |
252 |
|
T4 ((0.050) |
R1 |
6 |
13 |
23 |
114 |
250 |
R2 |
5 |
13 |
24 |
116 |
254 |
|
R3 |
5 |
14 |
20 |
120 |
246 |
|
T5 (0.158) |
R1 |
6 |
14 |
24 |
123 |
258 |
R2 |
6 |
14 |
23 |
120 |
248 |
|
R3 |
5 |
13 |
25 |
121 |
250 |
|
PC |
R1 |
180 |
1168 |
890 |
1248 |
1552 |
R2 |
178 |
1184 |
924 |
1280 |
1520 |
|
R3 |
182 |
1216 |
916 |
1304 |
1568 |
NC= Negative Control,T =Test concentration (T5: Highest, T1: Lowest), R= Replicate
PC= Positive
control 2-Aminoanthracene
[2.5μg/plate]: TA 1537, TA1535, TA98, TA100
2-Aminoanthracene [10μg/plate]:TA
102 Sodium azide
[10μg/plate]: TA 1535, TA
100,
4-Nitro-o-phenylenediamine: TA 1537[50μg/plate] TA 98[10μg/plate] Methyl methanesulfonate [4μl/plate]: TA 102
TABLE 4 - MEAN REVERTANT COUNT IN PLATE INCORPORATION METHOD (TRIALI)
Dose (mg/plate) |
In the presence of Metabolic Activation (+S9) |
|||||||||
TA 1537 |
TA 1535 |
TA 98 |
TA 100 |
TA 102 |
||||||
MEAN |
SD |
MEAN |
SD |
MEAN |
SD |
MEAN |
SD |
MEAN |
SD |
|
NC (0.00) |
7.00 |
1.00 |
15.00 |
1.00 |
22.33 |
2.52 |
122.00 |
3.61 |
270.67 |
10.07 |
T1 (0.002) |
4.67 |
0.58 |
11.33 |
1.53 |
17.67 |
1.15 |
108.67 |
3.06 |
237.33 |
5.03 |
T2 (0.005) |
4.33 |
0.58 |
12.67 |
0.58 |
21.33 |
1.53 |
110.00 |
2.00 |
246.67 |
6.11 |
T3 (0.016) |
5.00 |
1.00 |
13.00 |
1.00 |
17.33 |
1.15 |
110.67 |
3.06 |
256.00 |
7.02 |
T4 (0.050) |
5.33 |
0.58 |
13.67 |
1.53 |
21.00 |
2.00 |
109.33 |
4.16 |
260.67 |
8.00 |
T5 (0.158) |
5.67 |
0.58 |
14.33 |
0.58 |
17.33 |
0.58 |
100.00 |
4.00 |
264.67 |
6.11 |
PC |
174.67 |
9.87 |
474.67 |
20.53 |
1210.00 |
31.05 |
1600.00 |
16.00 |
1344.00 |
36.66 |
Dose (mg/plate) |
In the Absence of Metabolic Activation (-S9) |
|||||||||
TA 1537 |
TA 1535 |
TA 98 |
TA 100 |
TA 102 |
||||||
MEAN |
SD |
MEAN |
SD |
MEAN |
SD |
MEAN |
SD |
MEAN |
SD |
|
NC (0.00) |
6.67 |
0.58 |
14.33 |
1.53 |
21.00 |
2.65 |
121.33 |
3.06 |
266.00 |
9.17 |
T1 (0.002) |
4.67 |
0.58 |
12.33 |
1.53 |
17.67 |
1.15 |
109.00 |
2.65 |
236.00 |
4.00 |
T2 (0.005) |
5.00 |
1.00 |
13.67 |
1.15 |
19.00 |
1.00 |
104.67 |
3.06 |
242.00 |
4.00 |
T3 (0.016) |
5.33 |
0.58 |
14.33 |
0.58 |
20.33 |
1.53 |
107.33 |
6.11 |
242.67 |
8.33 |
T4 (0.050) |
5.67 |
0.58 |
13.00 |
1.00 |
18.67 |
2.08 |
115.33 |
3.06 |
255.33 |
6.11 |
T5 (0.158) |
6.00 |
0.00 |
14.67 |
0.58 |
16.67 |
1.53 |
100.00 |
2.00 |
256.00 |
4.00 |
PC |
174.67 |
5.03 |
1312.00 |
36.66 |
986.67 |
24.44 |
1130.67 |
40.27 |
1850.67 |
33.31 |
NC= Negative Control,T =Test concentration (T5: Highest, T1: Lowest),SD= Standard Deviation
PC= Positive control
2-Aminoanthracene [2.5μg/plate]: TA 1537, TA 1535, TA 98, TA 100 Methyl methanesulfonate [4μl/plate]: TA 102
2-Aminoanthracene [10μg/plate]:TA 102
Sodium azide [10μg/plate]: TA 1535, TA 100
4-Nitro-o-phenylenediamine: TA 1537[50μg/plate], TA 98 [10μg/plate]
TABLE 5 - MEAN REVERTANT COUNT IN PRE-INCUBATION METHOD (TRIAL II)
Dose (mg/plate) |
In the presence of Metabolic Activation (+S9) |
|||||||||
TA 1537 |
TA 1535 |
TA 98 |
TA 100 |
TA 102 |
||||||
MEAN |
SD |
MEAN |
SD |
MEAN |
SD |
MEAN |
SD |
MEAN |
SD |
|
NC (0.00) |
7.00 |
1.00 |
14.33 |
1.53 |
25.33 |
2.52 |
125.00 |
2.65 |
263.33 |
7.57 |
T1 (0.002) |
4.67 |
0.58 |
11.33 |
1.53 |
19.67 |
0.58 |
119.67 |
1.53 |
237.33 |
7.02 |
T2 (0.005) |
4.33 |
0.58 |
12.33 |
0.58 |
22.67 |
1.53 |
122.33 |
2.08 |
245.33 |
5.03 |
T3 (0.016) |
5.33 |
0.58 |
13.00 |
2.65 |
23.33 |
3.79 |
122.00 |
3.00 |
246.00 |
8.00 |
T4 (0.050) |
5.67 |
0.58 |
13.33 |
1.53 |
24.00 |
1.00 |
123.67 |
0.58 |
251.33 |
4.16 |
T5 (0.158) |
6.33 |
0.58 |
14.33 |
0.58 |
24.33 |
2.08 |
123.67 |
1.15 |
260.67 |
3.06 |
PC |
172.00 |
9.17 |
413.33 |
30.55 |
1362.67 |
20.13 |
1472.00 |
32.00 |
1698.67 |
16.65 |
Dose (mg/plate) |
In the Absence of Metabolic Activation (-S9) |
|||||||||
TA 1537 |
TA 1535 |
TA 98 |
TA 100 |
TA 102 |
||||||
MEAN |
SD |
MEAN |
SD |
MEAN |
SD |
MEAN |
SD |
MEAN |
SD |
|
NC (0.00) |
6.67 |
0.58 |
13.67 |
1.15 |
23.67 |
2.08 |
123.00 |
3.00 |
253.33 |
6.11 |
T1 (0.002) |
4.67 |
0.58 |
11.33 |
1.53 |
21.00 |
2.00 |
104.67 |
3.06 |
232.00 |
4.00 |
T2 (0.005) |
4.00 |
0.00 |
12.33 |
1.53 |
20.33 |
2.52 |
109.33 |
3.06 |
235.33 |
6.11 |
T3 (0.016) |
5.00 |
1.00 |
13.00 |
1.00 |
21.67 |
2.52 |
111.00 |
3.00 |
246.67 |
6.11 |
T4 (0.050) |
5.33 |
0.58 |
13.33 |
0.58 |
22.33 |
2.08 |
116.67 |
3.06 |
250.00 |
4.00 |
T5 (0.158) |
5.67 |
0.58 |
13.67 |
0.58 |
24.00 |
1.00 |
121.33 |
1.53 |
252.00 |
5.29 |
PC |
180.00 |
2.00 |
1189.33 |
24.44 |
910.00 |
17.78 |
1277.33 |
28.10 |
1546.67 |
24.44 |
NC= Negative Control, T =Test concentration (T5: Highest, T1: Lowest),SD= Standard Deviation
PC= Positive control
2-Aminoanthracene [2.5μg/plate]: TA 1537, TA 1535, TA 98, TA 100
2-Aminoanthracene [10μg/plate]: TA 102
Sodium azide [10μg/plate]: TA 1535, TA 100
4-Nitro-o-phenylenediamine: TA 1537[50μg/plate] TA 98[10μg/plate]
Methyl methanesulfonate: [4μl/plate]: TA 102
Applicant's summary and conclusion
- Conclusions:
- The test chemical did not induce gene mutations by base pair changes or frame shifts in the genome of the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.
- Executive summary:
Ames assay was performed to investigate the potential of Sodium 2-hydroxybenzoate (CAS No. 54-21-7) to induce gene mutations in comparison to negative control according to the plate incorporation test (Trial I) and the pre-incubation test (Trial II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the negative, positive controls was tested in triplicate. Based on the solubility and precipitation test results eight different concentrations viz., 0.0 (NC), 0.002, 0.005, 0.016, 0.050, 0.158, 0.501, 1.582 and 5 mg/plate were selected for pre-experiment.
Based on the pre-experiment results, the test item was tested with the following concentrations 0.0 (NC), 0.002, 0.005, 0.016, 0.050 and 0.158 mg/plate for main study, both in the presence of metabolic activation (+S9) and in the absence of metabolic activation (-S9).
No substantial increase in revertant colony numbers in any of the tester strains were observed following treatment with Sodium 2-hydroxybenzoate (CAS No. 54-21-7) at any dose level in both the confirmatory trials, neither in the presence nor in the absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. The spontaneous reversion rates in the negative, positive controls are within the range of our historical data.
The positive controls used for various strains showed a distinct increase in induced revertant colonies in both the methods i.e. Plate incorporation method and Pre-incubation method.
In conclusion, it is stated that during the described mutagenicity test and under the experimental conditions reported, the test item Sodium 2-hydroxybenzoate (CAS No. 54-21-7) did not induce gene mutations by base pair changes or frame shifts in the genome of the strains used.
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