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EC number: 273-453-7 | CAS number: 68966-86-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Mutagenicity refers to the induction of permanent transmissible changes in the amount or structure of genetic material of cells or organisms. The Bacterial Reverse Mutation Test (OECD 471, EU B.13/14) is required to fulfil Annex VII information requirements on mutagenicity.
In thein vitrostudy in mammalian cells, the mutagenicity of the test item was tested in five mutant strains ofSalmonella typhimurium(TA1535, TA1537, TA98, TA100 and TA102) at concentrations of 5 - 5000 µg/plate, in the presence or absence of S9. Under the test conditions, the test item did not present any cytotoxic or mutagenic properties in the Bacterial Reverse Mutation Test, which detects gain of function point mutations and frameshiftsin vitro.
Link to relevant study records
- Endpoint:
- genetic toxicity in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Annex VII Section 8.4 of the REACH regulations requires the conduct of an appropriate in vitro gene mutation study. The OECD471 reverse mutation assay in bacteria (Ames test) is considered to complete fulfil the requirements for this assessment of mutagenicity
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Liver homogenates from Spargue-Dawley male rats with Aroclor 1254
- Test concentrations with justification for top dose:
- Presence of S9; 15, 50, 150, 500 and 1500 μg/plate
Absence of S9; 15, 50, 150, 500 and 1500 μg/plate
Top dose based on results of the initial toxicity test - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Not reported - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Remarks:
- Experiment AM002031 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- Experimeny AM002031 with metabolic activation and Experiment AM002032 with metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- mitomycin C
- Remarks:
- Experiment AM002032 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- Remarks:
- Experiment AM002033 with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): 0.1 mL bacteria
DURATION
- Preincubation period: 11 - 12 hours
- Exposure duration: 48 to 72 hours
- Expression time (cells in growth medium): 48 to 72 hours
- Selection time (if incubation with a selection agent): Not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): Not applicable
NUMBER OF REPLICATIONS: 3
Plates were kept in the dark for 48 to 72 hours at 37.5 ºC
NUMBER OF CELLS EVALUATED: 1.3 x 10^9 to 2.7 x 10^9
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: Micrscopic evaluation of revertants
- Any supplementary information relevant to cytotoxicity: None reported
OTHER EXAMINATIONS: None reported - Rationale for test conditions:
- Following standard guidelines
- Evaluation criteria:
- The number of revertant colonies on the plates, with and without the test compound, were compared to evaluate mutagenicity. A reduction in the number of revertant colonies and/or a diminution of the background lawn was taken as an indication of bacteriotoxicity. If there was concern about the nature of colonies scored as revertants and when positive mutagenic results are obtained, the genotype of revertant colonies were spot-checked by picking and streaking on histidine free plates.
- Statistics:
- None reported
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Not mutagenic
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Not mutagenic
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Not mutagenic
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Not mutagenic
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Not mutagenic
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: None reported
- Effects of osmolality: None reported
- Evaporation from medium: None reported
- Water solubility: None reported
- Precipitation: None reported
- Definition of acceptable cells for analysis: Not reported
- Other confounding effects: None reported
RANGE-FINDING/SCREENING STUDIES: Performed but results not reported
CYTOKINESIS BLOCK (if used)
- Distribution of mono-, bi- and multi-nucleated cells: Not applicable
NUMBER OF CELLS WITH MICRONUCLEI
- Number of cells for each treated and control culture: 1.3 x 10^9 to 2.9 x 10^9
- Indication whether binucleate or mononucleate where appropriate: Not applicable
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: strain, mutagen (concentration of mutagen in μg/plate), mean of revertants per plate (minimum/maximum). The data of test without S9 are: TA1535, NaN3 (0.7), 348176 (208/659); TA1537, 9-AA (50), 265±106 (133/479); TA98, 2-NF (2.5), 406+95 (98/556); TA100, NaN3 (0.7), 379±57 (287/491); TA102, Mitotnycin C (0.15) 703±188 (369/997). The data of the tests with lot KH2202 of S9 are: TA1535, 2-AA (0.9), 130+34 (62/153); TA1537, 2-AA (1.7), 237148 (165/255); TA98, 2-AA (0.8), 624±138 (368/754); TA100, 2-AA (0.8), 600-1191 (202/764); TA102, 2-AA (0.9), 5341117 (349/636). Additional data of the tests with lot KI-12202 of S9 are: TA100, B(a)P (5.0), 719123 (701/752); TA102, B(a)P (5.0), 427119 (406/442).
- Negative (solvent/vehicle) historical control data: See table below
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: Revertent colonies
- Other observations when applicable: None reported - Conclusions:
- In the concentration range investigated, the test item did not induce a significant increase in the mutation frequency of the tester strains in the presence and absence of a metabolic activation system. Therefore under the experimental conditions the test item was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 in the presence and absence of a metabolizing system.
- Executive summary:
The test item was investigated in an Ames test with Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 in the presence and absence of a metabolizing system at a range of concentrations of 5 to 5000 μg/plate following the OECD 471 guideline. In the concentration range investigated, the test item did not induce a significant increase in the mutation frequency of the tester strains in the presence and absence of a metabolic activation system. Therefore under the experimental conditions the test item was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 in the presence and absence of a metabolizing system.
The test is a GLP compliant, guideline experimental study available as an unpublished study reported, deemed reliable without restrictions, and therefore adequate for use as a supporting study.
Reference
Table 1: Induction of revertants in S. typhimurium by the test item in the absente of a metabolizing system. (Experiment AM00203 1)
Substance | Concentration (μg/plate) | S9 | Number of revertants per plate | ||||||||||||||
TA98 | TA100 | TA102 | TA1535 | TA1537 | |||||||||||||
Counts | Mean | SD | Counts | Mean | SD | Counts | Mean | SD | Counts | Mean | SD | Counts | Mean | SD | |||
Control | 0 | - | 49 | 55 | 6 | 101 | 110 | 8 | 203 | 234 | 23 | 19 | 13 | 6 | 4 | 7 | 3 |
55 | 118 | 245 | 11 | 9 | |||||||||||||
62 | 110 | 253 | 8 | 7 | |||||||||||||
Solvent Control | 0 | - | 58 | 57 | 7 | 97 | 98 | 2 | 252 | 256 | 6 | 15 | 13 | 3 | 9 | 10 | 2 |
63 | 97 | 252 | 12 | 9 | |||||||||||||
49 | 99 | 263 | 11 | 12 | |||||||||||||
Test item | 5 | - | 104 | 97 | 6 | 11 | 12 | 2 | 8 | 9 | 2 | ||||||
93 | 14 | 11 | |||||||||||||||
93 | 11 | 8 | |||||||||||||||
Test item | 15 | - | 44 | 48 | 4 | 106 | 104 | 3 | 239 | 234 | 11 | 16 | 13 | 3 | 12 | 9 | 3 |
49 | 101 | 220 | 12 | 6 | |||||||||||||
52 | 105 | 244 | 12 | 10 | |||||||||||||
Test item | 50 | - | 57 | 54 | 3 | 107 | 95 | 13 | 242 | 249 | 18 | 12 | 10 | 3 | 9 | 8 | 3 |
51 | 99 | 272 | 9 | 5 | |||||||||||||
55 | 79 | 232 | 8 | 10 | |||||||||||||
Test item | 150 | - | 33 | 32 | 3 | 84 | 95 | 9 | 230 | 227 | 8 | 11 | 9 | 2 | 4 | 4 T | 1 |
33 | 99 | 233 | 9 | 4 | |||||||||||||
29 | 101 | 217 | 8 | 5 | |||||||||||||
Test item | 500 | - | 29 | 29 T | 5 | 71 | 66 T | 10 | 195 | 226 | 23 | 10 | 12 | 3 | 6 | 3 T | 3 |
25 | 74 | 236 | 12 | 3 | |||||||||||||
34 | 54 | 246 | 15 | 1 | |||||||||||||
Test item | 1500 | - | 23 | 25 T | 5 | 212 | 212 | 3 | |||||||||
22 | 215 | ||||||||||||||||
30 | 210 | ||||||||||||||||
NaN3 | 0.7 | - | 341 | 369 | 21 | 372 | 404 | 23 | |||||||||
380 | 421 | ||||||||||||||||
385 | 418 | ||||||||||||||||
2 -NF | 2.5 | - | 410 | 428 | 14 | ||||||||||||
433 | |||||||||||||||||
440 | |||||||||||||||||
9 -AA | 50 | - | 283 | 247 | 85 | ||||||||||||
327 | |||||||||||||||||
131 | |||||||||||||||||
Mitomycin C | 0.15 | - | 534 | 604 | 53 | ||||||||||||
658 | |||||||||||||||||
620 |
- : without S9-mix; SD: standard deviation; T: bacteriotoxic; solvent control: DMSO, 50 pl/plate; 2-NF: 2-nitrofluorene; 9-AA: 9-aminoacridine;
titer of bacterial suspensions (viable cells/ml), TA98: 2.2x10^9 (232,262,178), TA100: 2.8x10^9 ( 262,304,264), TA102: 3.2x10^9 (364,280,310), TA1535: 2.9x10^9 (286,316,278), TA1537: 1.3x10^9 (128,138)
Table 2: Induction of revertants in S. typhimurium by Tricyclate in the presence of a metabolizing system. (Experiment AM002031)
Substance | Concentration (μg/plate) | S9 | Number of revertants per plate | ||||||||||||||
TA98 | TA100 | TA102 | TA1535 | TA1537 | |||||||||||||
Counts | Mean | SD | Counts | Mean | SD | Counts | Mean | SD | Counts | Mean | SD | Counts | Mean | SD | |||
Control | 0 | + | 32 | 37 | 7 | 112 | 109 | 6 | 249 | 262 | 10 | 11 | 11 |
3 |
13 |
11 |
2 |
|
|
|
34 |
|
|
114 |
|
|
268 |
|
|
14 |
|
|
10 |
|
|
|
|
|
46 |
|
|
102 |
|
|
269 |
|
|
9 |
|
|
11 |
|
|
Solvent Control |
0 |
+ |
35 |
42 |
8 |
103 |
103 |
0 |
276 |
270 |
6 |
9 |
10 |
2 |
13 |
12 |
3 |
|
|
|
52 |
|
|
103 |
|
|
264 |
|
|
9 |
|
|
10 |
|
|
|
|
|
39 |
|
|
103 |
|
|
270 |
|
|
11 |
|
|
14 |
|
|
Test item |
15 |
+ |
48 |
45 |
7 |
100 |
98 |
5 |
228 |
244 |
14 |
10 |
9 |
1 |
14 |
12 |
3 |
|
|
|
37 |
|
|
101 |
|
|
246 |
|
|
9 |
|
|
12 |
|
|
|
|
|
50 |
|
|
92 |
|
|
259 |
|
|
9 |
|
|
10 |
|
|
Test item |
50 |
+ |
38 |
39 |
2 |
89 |
102 |
11 |
238 |
259 |
16 |
9 |
10 |
3 |
15 |
16 |
3 |
|
|
|
40 |
|
|
113 |
|
|
271 |
|
|
13 |
|
|
18 |
|
|
|
|
|
38 |
|
|
105 |
|
|
267 |
|
|
9 |
|
|
14 |
|
|
Test item |
150 |
+ |
37 |
35 |
3 |
93 |
97 |
5 |
247 |
227 |
19 |
10 |
8 |
3 |
10 |
12 |
4 |
|
|
|
32 |
|
|
95 |
|
|
229 |
|
|
5 |
|
|
10 |
|
|
|
|
|
36 |
|
|
103 |
|
|
204 |
|
|
9 |
|
|
16 |
|
|
Test item |
500 |
+ |
38 |
35 |
3 |
59 |
73 |
11 |
238 |
240 |
3 |
5 |
5 |
2 |
10 |
6 |
3 |
|
|
|
34 |
|
|
82 |
|
|
239 |
|
|
4 |
|
|
6 |
|
|
|
|
|
32 |
|
|
77 |
|
|
242 |
|
|
6 |
|
|
8 |
|
|
Test item |
1500 |
+ |
34 |
34 |
5 |
25 |
27 T |
4 |
209 |
208 |
10 |
7 |
8 |
1 |
9 |
6 T |
5 |
|
|
|
40 |
|
|
32 |
|
|
219 |
|
|
8 |
|
|
8 |
|
|
|
|
|
29 |
|
|
25 |
|
|
197 |
|
|
8 |
|
|
1 |
|
|
2-AA |
0.8 |
+ |
588 |
643 |
45 |
872 |
859 |
10 |
|
|
|
|
|
|
|
|
|
|
|
|
644 |
|
|
854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
696 |
|
|
852 |
|
|
|
|
|
|
|
|
|
|
|
2 -AA |
0.9 |
+ |
|
|
|
|
|
|
415 |
397 |
16 |
141 |
160 |
15 |
|
|
|
|
|
|
|
|
|
|
|
|
378 |
|
|
167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
398 |
|
|
172 |
|
|
|
|
|
2 -AA |
1.7 |
+ |
|
|
|
|
|
|
|
|
|
|
|
|
272 |
302 |
22 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
318 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
315 |
|
|
+: with S9-mix: SD: standard deviation; T: bacteriotoxic; solvent control: DMSO, 50 pliplate; 2-AA: 2-aminoanthracene; titer of bacterial suspensions (viable cells/m1), TA98: 2.2x10^9 (232,262,178), TA100: 2.8x10^9 (262,304,264), TA102: 3.2x10^9 (364,280,310), TA1535: 2.9x1^9 (286,316,278), TA1537: 1.3x10^9 ( 128,138)
Table 3: Induction of revertants in S. typhimurium by the test item in the absente of a metabolizing system. (Experiment AM002032)
Substance | Concentration (μg/plate) | Number of revertants per plate | ||||||||
TA100 | TA102 | TA1535 | ||||||||
Counts | Mean | SD | Counts | Mean | SD | Counts | Mean | SD | ||
Control | 0 | 94 | 101 | 8 | 220 | 255 | 26 | 20 | 15 | 5 |
98 | 267 | 10 | ||||||||
111 | 279 | 14 | ||||||||
Solvent control | 0 | 108 | 101 | 6 | 248 | 255 | 6 | 11 | 15 | 4 |
100 | 256 | 19 | ||||||||
96 | 261 | 15 | ||||||||
Test item | 5 | 81 | 92 | 10 | ||||||
92 | ||||||||||
102 | ||||||||||
Test item | 15 | 99 | 89 | 8 | 15 | 12 | 3 | |||
81 | 10 | |||||||||
88 | 10 | |||||||||
Test item | 50 | 109 | 94 | 12 | 238 | 241 | 5 | 9 | 11 | 3 |
84 | 247 | 11 | ||||||||
89 | 239 | 14 | ||||||||
Test item | 150 | 84 | 92 | 8 | 252 | 255 | 17 | 15 | 14 | 3 |
91 | 236 | 15 | ||||||||
102 | 276 | 11 | ||||||||
Test item | 500 | 61 | 53 T | 7 | 222 | 198 | 22 | 9 | 13 | 4 |
46 | 202 | 15 | ||||||||
51 | 171 | 14 | ||||||||
Test item | 1500 | 174 | 167 T | 6 | 9 | 10 | 1 | |||
165 | 10 | |||||||||
162 | 10 | |||||||||
Test item | 5000 | 133 | 140 T | 21 | 5 | 6 T | 2 | |||
168 | 5 | |||||||||
120 | 7 | |||||||||
NaN3 | 0.7 | 398 | 354 | 33 | 346 | 387 | 31 | |||
323 | 398 | |||||||||
341 | 417 | |||||||||
Mitomycin C | 0.15 | 659 | 743 | 61 | ||||||
774 | ||||||||||
796 |
SD: standard deviation; T: bacteriotoxic; solvent control: DMSO, 50 ul/plate; titer of bacterial suspensions (viable cells/ml), TA100: 2.7x10^9 ( 230,298,270), TA102: 2.5x10^9 ( 243,279,229), TA1535: 2.3x10^9 ( 209,244,235)
Table 3a: Induction of revertants in S. typhimurium by the test item in the absente of a metabolizing system. (Experiment AM002033)
Substance | Concentration (μg/plate) | Number of revertants per plate | |||||
TA98 | TA1537 | ||||||
Counts | Mean | SD | Counts | Mean | SD | ||
Control | 0 | 33 | 44 | 9 | 14 | 12 | 2 |
48 | 12 | ||||||
52 | 11 | ||||||
Solvent control | 0 | 46 | 50 | 6 | 10 | 11 | 2 |
57 | 12 | ||||||
48 | 11 | ||||||
Test item | 1.5 | 52 | 49 | 5 | 11 | 11 | 1 |
52 | 12 | ||||||
43 | 11 | ||||||
Test item | 5 | 47 | 46 | 4 | 7 | 10 | 5 |
48 | 15 | ||||||
42 | 8 | ||||||
Test item | 15 | 40 | 38 | 4 | 11 | 13 | 3 |
40 | 11 | ||||||
33 | 16 | ||||||
Test item | 50 | 33 | 37 | 5 | 9 | 10 | 3 |
36 | 9 | ||||||
42 | 13 | ||||||
Test item | 150 | 38 | 31 T | 7 | 8 | 5 T | 3 |
30 | 6 | ||||||
24 | 2 | ||||||
2 -NF | 2.5 | 386 | 378 | 22 | |||
349 | |||||||
399 | |||||||
2 -NF | 50 | 176 | 174 | 23 | |||
200 | |||||||
147 |
SD: standard deviation; T: bacteriotoxic; solvent control: DMSO, 50 ul/plate; 2-NF: 2-nitrofluorene; 9-AA: 9-aminoacridine; titer of bacterial suspensions (viable cells/ml), TA98: 2.7x10^9 ( 245,298,273), TA1537: 2.5x10^9 (196,308,257)
Table 4: Induction of revertants in S. typhimurium by Tricyclate in the presence of a metabolizing system. (Experiment AM002032)
Substance | Concentration (μg/plate) | S9 | Number of revertants per plate | ||||||||||||||
TA98 | TA100 | TA102 | TA1535 | TA1537 | |||||||||||||
Counts | Mean | SD | Counts | Mean | SD | Counts | Mean | SD | Counts | Mean | SD | Counts | Mean | SD | |||
Control | 0 | + | 43 | 37 | 6 | 104 | 109 | 11 | 237 | 252 | 16 | 9 | 8 | 2 | 11 | 13 | 3 |
32 | 100 | 272 | 7 | 12 | |||||||||||||
36 | 122 | 247 | 7 | 16 | |||||||||||||
Solvent Control | 0 | + | 32 | 35 | 6 | 95 | 97 | 3 | 276 | 273 | 12 | 7 | 9 | 4 | 6 | 11 | 5 |
42 | 95 | 285 | 8 | 17 | |||||||||||||
31 | 100 | 259 | 13 | 11 | |||||||||||||
Test item | 5 | + | 89 | 92 | 3 | 13 | 16 | 3 | |||||||||
93 | 16 | ||||||||||||||||
94 | 18 | ||||||||||||||||
Test item | 15 | + | 107 | 102 | 8 | 10 | 12 | 2 | |||||||||
106 | 13 | ||||||||||||||||
92 | 12 | ||||||||||||||||
Test item | 50 | + | 33 | 38 | 4 | 87 | 88 | 3 | 233 | 250 | 18 | 18 | 11 | 6 | 10 | 15 | 5 |
40 | 91 | 243 | 8 | 17 | |||||||||||||
40 | 87 | 273 | 8 | 18 | |||||||||||||
Test item | 150 | + | 34 | 34 | 4 | 110 | 108 | 3 | 270 | 261 | 23 | 7 | 10 | 4 | 14 | 12 | 3 |
37 | 109 | 231 | 9 | 13 | |||||||||||||
30 | 105 | 282 | 14 | 10 | |||||||||||||
Test item | 500 | + | 31 | 31 | 4 | 78 | 70 | 15 | 260 | 243 | 24 | 11 | 10 | 3 | 12 | 9 | 3 |
27 | 81 | 258 | 8 | 9 | |||||||||||||
34 | 50 | 211 | 12 | 6 | |||||||||||||
Test item | 1500 | + | 25 | 29 | 4 | 210 | 206 | 5 | 6 | 6 T | 1 | ||||||
29 | 207 | 6 | |||||||||||||||
33 | 200 | 7 | |||||||||||||||
Test item | 5000 | + | 31 | 27 T | 6 | 161 | 135 T | 20 | 5 | 5 T | 2 | ||||||
30 | 127 | 4 | |||||||||||||||
20 | 116 | 6 | |||||||||||||||
2 -AA | 0.8 | + | 585 | 541 | 34 | 976 | 911 | 60 | |||||||||
531 | 834 | ||||||||||||||||
507 | 924 | ||||||||||||||||
2 -AA | 0.9 | + | 591 | 658 | 49 | 158 | 171 | 13 | |||||||||
684 | 187 | ||||||||||||||||
699 | 168 | ||||||||||||||||
2 -AA | 1.7 | + | 217 | 246 | 34 | ||||||||||||
292 | |||||||||||||||||
229 |
+: with S9-mix: SD: standard deviation; T: bacteriotoxic; solvent control: DMSO, 50 ul/plate; 2-AA: 2-aminoanthracene; titer of bacterial suspensions (viable cells/ml), TA98: 2.7x10&9 ( 245,298,273), TA100: 2.7x10^9 ( 230,298,270), TA102: 2.5x10^9 ( 243,279,229), TA1535: 2.3x10^9 ( 209,244,235), TA1537: 2.5x10^9 ( 196,308,257)
Table 5: Historic negative control data
Strain | -S9 | +S9 | ||
Spontaneous | Solvent control | Spontaneous | Solvent control | |
TA1535 | 14 ± 6 (10/34) | 14 ± 4 (9/24) | 14 ± 5 (8/19) | 13 ± 4 (8/21) |
TA1537 | 11 ± 4 (7/18) | 11 ± 3 (6/17) | 14 ± 3 (11/21) | 15 ± 4 (11/26) |
TA98 | 33 ± 11 (21/52) | 31 ± 11 (19/60) | 35 ± 11 (16/64) | 36 ± 11 (20/57) |
TA100 | 106 ± 21 (82/147) | 101 ± 19 (81/132) | 103 ± 15 (85/130) | 102 ± 13 (87/122) |
TA102 | 249 ± 29 (198/291) | 251 ± 19 (219/289) | 273 ± 15 (234/330) | 275 ± 28 (238/345) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
The Ames Test (OECD 471) is an intentionally accepted in vitro test method to detect mutagenicity, as described in the Annex to the EU Test Methods (TM) Regulation (Council Regulation (EC) No 440/2008). Conducted according to the aforementioned guideline and GLP, the study passed all validity criteria and was considered to be reliable without restriction (Klimisch 1).
The test item was considered to be non-mutagenic in the in vitro test. Consequently, it can be concluded that the test item does not present genotoxic potential requiring classification or substance specific risk mitigation measures (RMMs).
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