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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames test (OECD 471): negative with S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538 and E. coli WP2 uvrA with and without metabolic activation
Ames test (OECD 471): negative with S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538 with and without metabolic activation
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Aug - 23 Sep 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his operon (for S. typhimurium strains)
trp operon (for E. coli strain) - Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital/β-naphthoflavone
- Test concentrations with justification for top dose:
- Pre-experiment: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate with and without metabolic activation.
The pre-experiment is reported as Experiment I.
Experiment II: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate with and without metabolic activation. - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative nontoxicity to bacteria. - Untreated negative controls:
- yes
- Remarks:
- untreated controls
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine (4-NOPD), 2-aminoanthracene (2-AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) (Experiment I); preincubation (Experiment II)
DURATION
- Preincubation period: 1 h
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiment
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn - Evaluation criteria:
- A test item is considered as a mutagenic if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding 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 and solvent controls such an increase is not considered biologically relevant. - Statistics:
- Mean values and standard deviations were calculated.
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- but tested up to the precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test item precipitated in the overlay agar in the test tubes at 5000 µg/plate with and without S9 mix and in Experiment II from 2500 to 5000 µg/plate with S9 mix. Precipitation of the test item in the overlay agar on the incubated agar plates was observed in Experiment I at 5000 µg/plate. The undissolved particles had no influence on the data recording.
RANGE-FINDING/SCREENING STUDIES: The pre-experiment is reported as Experiment I (all strains were tested in the pre-experiment).
ADDITIONAL INFORMATION ON CYTOTOXICITY: The plates incubated with the test item showed reduced background growth in strains TA 1537, TA 98 and TA 100 with and without metabolic activation. Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in strain TA 1537 with metabolic activation (experiment 2) and in strains TA 98 and TA 100 with and without metabolic activation (experiment 2 and experiment 1 and 2. respectively). Please refer to table 3 and 4. - Conclusions:
- Under the conditions of the conducted test the substance was not mutagenic in any of the five strains (TA 1535, TA 1537, TA 98, TA 100 and WP2 uvrA) tested with and without metabolic activation.
- Executive summary:
The mutagenicity of the test item was studied with five mutant strains of Salmonella typhimurium
(TA 1535, TA 1537, TA 98, TA 100 and WP2 uvrA) with and without metabolic activation according to OECD 471 under GLP conditions. Under the conditions of the conducted test the substance was not mutagenic in any of the five strains (TA 1535, TA 1537, TA 98, TA 100 and WP2 uvrA) tested with and without metabolic activation.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 18 Sep - 06 Oct 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The substance was not tested in E. coli WP2 strains or S. thyphimurium TA102.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- yes
- Remarks:
- test strain with an AT base pair at the primary reversion site missing
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his operon
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium 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 (500 mg/kg bw i.p.)
- Test concentrations with justification for top dose:
- Experiment 1 and 2
50, 150, 500, 1500 and 5000 µg/plate with and without metabolic activation. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethylsulphoxide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethylsulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene (2-AA)
- Remarks:
- +S9: 2-AA (0.5 µg/plate TA535, TA1538, TA98 and TA100; 1 µg/plate TA1537); -S9: NaN3 (1 µg/plate, TA1535 and TA1535); 2-NF (1 µg/plate, TA98, TA1538); 9-AA (20 µg/plate, TA1537)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: microcolony growth - Evaluation criteria:
- A test substance was considered as a mutagen if there was:
i) for S. typhimurium strains TA1535, TA1537, TA1538 and TA98, at least a doubling of the mean concurrent vehicle control values at some concentration of the test substances and, for S. typhimurium strain TA100, a 1.5-fold increase over the control value. If the mean colony count on the vehicle control plates was less than 10 then a value of 10 was assumed for assessment purposes. In such cases a minimum count of 20 was required before a significant mutagenic response was identified.
ii) a dose-related response, although at high dose levels this relationship could be inverted because of, for example, (1) toxicity to the bacteria, (2) specific toxicity to mutants and (3) inhibition of foreign compound metabolising enzymes where mutagens require metabolic activation by the liver.
iii) a reproducible effect in independent tests. - Statistics:
- Mean values and standard deviations were calculated.
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 1500 µg/plate in +S9 and -S9 (exp. 1 and 2) +S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 1500 µg/plate in -S9 and +S9 (exp. 1)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 1500 µg/plate in -S9 (exp. 1) -S9; starting at 5000 µg/plate in+ S9 (exp. 2)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 1500 µg/plate in -S9 (exp.1 and 2); starting at 1500 µg/plate in +S9 (exp 2) and at 5000 µg/plate in +S9 (exp. 1)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test substance was noted.
RANGE-FINDING/SCREENING STUDIES: A toxicity test using strain TA100 was performed in the presence and absence of S9 mix to establish suitable dose levels for the mutation tests. One plate for each of the following concentrations was used: 50, 150, 500, 1500 and 5000 µg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: The vehicle control values were within the normal ranges experienced in this laboratory and reported in the literature with these strains of S. typhimurium. The results obtained with the positive control substances were within the normal ranges expected for each bacterial strain and metabolic activation condition.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Toxicity to bacteria was noted at doses of 1500 and 5000 µg/plate, in the absence of S9 mix, in strains TA1537, TA1538, TA98 and TA100 (exp. 2). In the presence of S9 mix, toxicity to the bacteria was observed in strains TA1537 and TA100 at 5000 µg/plate and in strain TA1538 at dose levels of 1500 and 5000 µg/plate. - Conclusions:
- Under the conditions of the conducted test the substance was not mutagenic in any of the five strains (TA1535, TA1537, TA1538, TA98 and TA100) tested with and without metabolic activation.
- Executive summary:
The mutagenicity of the test item was studied with five mutant strains of Salmonella typhimurium
(TA 1535, TA 1537, TA 1538, TA 98 and TA 100) with and without metabolic activation according to OECD 471 under GLP conditions. Under the conditions of the conducted test the substance was not mutagenic in any of the five strains (
TA 1535, TA 1537, TA 1538, TA 98 and TA 10) tested with and without metabolic activation.
Referenceopen allclose all
Table 1. Test results of main test 1 (plate incorporation).
With or without S9-Mix |
Test substance concentration [μg/plate] |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA1535 |
TA100 |
WP2 uvrA |
TA1537 |
TA98 |
||
- |
0 (DMSO) |
11 ± 3 |
154 ± 16 |
35 ± 1 |
9 ± 1 |
26 ± 6 |
- |
0 |
13 ± 3 |
172 ± 9 |
38 ± 5 |
14 ± 0 |
23 ± 4 |
- |
3 |
12 ± 2 |
160 ± 23 |
38 ± 6 |
9 ± 2 |
26 ± 4 |
- |
10 |
12 ± 3 |
167 ± 16 |
43 ± 3 |
8 ± 3 |
25 ± 2 |
- |
33 |
10 ± 2 |
161 ± 8 |
41 ± 10 |
8 ± 2 |
25 ± 3 |
- |
100 |
9 ± 1 |
138 ± 24 |
38 ± 3 |
9 ± 1 |
21 ± 7 |
- |
333 |
9 ± 1 |
56 ± 7R |
39 ± 10 |
9 ± 3R |
31 ± 2R |
- |
1000 |
8 ± 2 |
55 ± 4R |
37 ± 9 |
6 ± 2R |
27 ± 4R |
- |
2500 |
7 ± 2 |
54 ± 12R |
37 ± 6 |
5 ± 2R |
25 ± 5R |
- |
5000 |
10 ± 4P |
63 ± 8P,R |
33 ± 4P |
5 ± 2P,R |
20 ± 5P,R |
Positive controls, –S9 |
Name |
NaN3 |
NaN3 |
MMS |
4-NOPD |
4-NOPD |
Concentration [μg/plate] |
10 |
10 |
2.0 µL |
50 |
10 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1136 ± 68 |
2125 ± 126 |
829 ± 40 |
78 ± 6 |
336 ± 30 |
|
+ |
0 (DMSO) |
11 ± 3 |
141 ± 7 |
48 ± 5 |
14 ± 2 |
30 ± 3 |
+ |
0 |
11 ± 4 |
170 ± 2 |
56 ± 11 |
13 ± 1 |
27 ± 4 |
+ |
3 |
11 ± 1 |
142 ± 11 |
49 ± 7 |
13 ± 2 |
30 ± 3 |
+ |
10 |
11 ± 4 |
171 ± 19 |
47 ± 5 |
11 ± 3 |
32 ± 2 |
+ |
33 |
10 ± 5 |
139 ± 14 |
43 ± 3 |
11 ± 2 |
37 ± 9 |
+ |
100 |
9 ± 3 |
150 ± 17 |
50 ± 5 |
13 ± 2 |
36 ± 2 |
+ |
333 |
7 ± 1 |
119 ± 24 |
46 ± 8 |
15 ± 1 |
32 ± 3 |
+ |
1000 |
9 ± 3 |
38 ± 3R |
43 ± 8 |
12 ± 1M,R |
29 ± 6R |
+ |
2500 |
10 ± 4 |
33 ± 2M,R |
46 ± 2 |
13 ± 1M,R |
23 ± 2R |
+ |
5000 |
12 ± 2P |
29 ± 2P,M,R |
37 ± 6P |
13 ± 2P,M,R |
16 ± 2P,M,R |
Positive controls, +S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentration [μg/plate] |
2.5 |
2.5 |
10 |
2.5 |
2.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
348 ± 19 |
3985 ± 50 |
384 ± 50 |
197 ± 5 |
4320 ± 413 |
|
NaN3: sodium azide
4-NOPD: 4-nitro-o-phenylene-diamine
MMS: methylmethanesulfonate
2-AA: 2-aminoanthracene
M: manual count
P: precipitate
R: reduced background growth
Table 2. Test results of main test 2 (preincubation).
With or without S9-Mix |
Test substance concentration [μg/plate] |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA1535 |
TA100 |
WP2 uvrA |
TA1537 |
TA98 |
||
- |
0 (DMSO) |
12 ± 3 |
143 ± 9 |
36 ± 6 |
8 ± 2 |
30 ± 10 |
- |
0 |
10 ± 3 |
201 ± 2 |
39 ± 3 |
7 ± 3 |
26 ± 9 |
- |
3 |
10 ± 5 |
141 ± 3 |
43 ± 4 |
7 ± 1 |
22 ± 3 |
- |
10 |
11 ± 5 |
132 ± 21 |
47 ± 4 |
7 ± 2 |
26 ± 2 |
- |
33 |
9 ± 1 |
152 ± 10 |
39 ± 7 |
9 ± 2 |
28 ± 3 |
- |
100 |
10 ± 3 |
54 ± 10 |
38 ± 6 |
7 ± 2 |
22 ± 2 |
- |
333 |
10 ± 3 |
58 ± 10 |
24 ± 2 |
9 ± 2 |
16 ± 1 |
- |
1000 |
9 ± 1 |
56 ± 8 |
41 ± 1 |
8 ± 1 |
7 ± 3M,R |
- |
2500 |
13 ± 4 |
55 ± 3 |
28 ± 10 |
10 ± 2 |
6 ± 2M,R |
- |
5000 |
7 ± 3 |
38 ± 11M,R |
37 ± 10 |
6 ± 0R |
5 ± 2M,R |
Positive controls, –S9 |
Name |
NaN3 |
NaN3 |
MMS |
4-NOPD |
4-NOPD |
Concentration [μg/plate] |
10 |
10 |
2.0 µL |
50 |
10 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
905 ± 35 |
2051 ± 72 |
671 ± 107 |
79 ± 8 |
374 ± 50 |
|
+ |
0 (DMSO) |
12 ± 2 |
115 ± 8 |
47 ± 9 |
9 ± 3 |
36 ± 2 |
+ |
0 |
9 ± 4 |
190 ± 29 |
59 ± 11 |
11 ± 3 |
32 ± 7 |
+ |
3 |
12 ± 2 |
126 ± 34 |
51 ± 5 |
12 ± 2 |
34 ± 11 |
+ |
10 |
8 ± 2 |
119 ± 21 |
53 ± 6 |
13 ± 1 |
37 ± 11 |
+ |
33 |
13 ± 1 |
128 ± 11 |
52 ± 10 |
11 ± 2 |
36 ± 7 |
+ |
100 |
13 ± 2 |
110 ± 18 |
54 ± 8 |
9 ± 5 |
43 ± 9 |
+ |
333 |
13 ± 3 |
64 ± 18 |
56 ± 17 |
13 ± 2 |
40 ± 11 |
+ |
1000 |
7 ± 3 |
42 ± 6 |
57 ± 16 |
13 ± 1 |
33 ± 8 |
+ |
2500 |
8 ± 2 |
22 ± 9M,R |
43 ± 4 |
8 ± 2M,R |
13 ± 2M,R |
+ |
5000 |
13 ± 1 |
2 ± 2M,R |
45 ± 4 |
4 ± 2M,R |
5 ± 1M,R |
Positive controls, +S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentration [μg/plate] |
2.5 |
2.5 |
10 |
2.5 |
2.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
367 ± 24 |
3181 ± 117 |
421 ± 12 |
185 ± 12 |
3909 ± 258 |
|
NaN3: sodium azide
4-NOPD: 4-nitro-o-phenylene-diamine
MMS: methylmethanesulfonate
2-AA: 2-aminoanthracene
M: manual count
R: reduced background growth
Table 1. Test results of experiment 1 (plate incorporation).
With or without S9-Mix |
Test substance concentration [μg/plate] |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA1535 |
TA100 |
TA1538 |
TA98 |
TA1537 |
||
– |
0 (DMSO) |
8 ± 4 |
89 ± 14 |
13 ± 4 |
20 ± 2 |
10 ± 1 |
– |
50 |
11 ± 5 |
81 ± 15 |
9 ± 3 |
18 ± 2 |
9 ±2 |
– |
150 |
12 ± 3 |
81 ± 17 |
12 ± 4 |
15 ± 7 |
9 ± 3 |
– |
500 |
10 ± 2 |
86 ± 13 |
9 ± 3 |
19 ± 5 |
7 ± 1 |
– |
1500 |
6 ± 2 |
82 ± 7# |
8 ± 2# |
15 ± 4# |
12 ± 5# |
– |
5000 |
7 ± 2 |
74 ± 18# |
9 ± 3# |
19 ±4# |
11 ± 1# |
Positive controls, –S9 |
Name |
NaN3 |
NaN3 |
2-NF |
2-NF |
9-AA |
Concentration [μg/plate] |
1 |
1 |
1 |
1 |
20 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
76 ± 19 |
422 ± 33 |
186 ± 28 |
142 ± 3 |
54 ± 14 |
|
+ |
0 (DMSO) |
12 ± 2 |
95 ± 8 |
19 ± 2 |
29 ± 2 |
8 ± 2 |
+ |
50 |
10 ± 2 |
86 ± 5 |
20 ± 7 |
23 ± 6 |
11 ± 2 |
+ |
150 |
10 ± 5 |
81 ± 11 |
14 ± 4 |
22 ± 3 |
8 ± 3 |
+ |
500 |
10 ± 3 |
100 ± 9 |
12 ± 2 |
27 ± 3 |
13 ± 6 |
+ |
1500 |
9 ± 3 |
98 ± 4 |
17 ± 3# |
23 ± 5 |
9 ± 3 |
+ |
5000 |
10 ± 2 |
96 ± 12# |
17 ± 4# |
24 ± 5 |
10 ± 2# |
Positive controls, +S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentration [μg/plate] |
0.5 |
0.5 |
0.5 |
0.5 |
1 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
46 ± 11 |
183± 26 |
75 ± 8 |
114 ± 8 |
36 ± 9 |
|
DMSO: dimethylsulphoxide
NaN3: sodium azide
2-AA: 2-aminoanthracene
9-AA: 9-aminoacridine
2-NF: 2-nitrofluorene
#: thin lawn of microcolonies (i.e. toxicity)
Table 2. Test results of experiment 2 (plate incorporation).
With or without S9-Mix |
Test substance concentration [μg/plate] |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA1535 |
TA100 |
TA1538 |
TA98 |
TA1537 |
||
– |
0 (DMSO) |
8 ± 3 |
110 ± 10 |
19 ± 1 |
28 ± 10 |
9 ± 2 |
– |
50 |
10 ± 3 |
108 ± 11 |
16 ± 2 |
21 ± 1 |
8 ± 1 |
– |
150 |
10 ± 2 |
92 ± 15 |
15 ± 3 |
27 ± 2 |
7 ± 1 |
– |
500 |
7 ± 2 |
75 ± 10 |
16 ± 4 |
26 ± 3 |
8 ± 1 |
– |
1500 |
9 ± 5 |
94 ± 12# |
15 ± 5 |
23 ± 4# |
8 ± 2# |
– |
5000 |
8 ± 3 |
84 ± 7# |
16 ± 1 |
25 ± 4# |
7 ± 0# |
Positive controls, –S9 |
Name |
NaN3 |
NaN3 |
2-NF |
2-NF |
9-AA |
Concentration [μg/plate] |
1 |
1 |
1 |
1 |
20 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
174 ± 20 |
627 ± 52 |
209 ± 11 |
186 ± 14 |
177 ± 13 |
|
+ |
0 (DMSO) |
7 ± 2 |
101 ± 11 |
22 ± 3 |
35 ± 4 |
8 ± 1 |
+ |
50 |
10 ± 2 |
101 ± 12 |
21 ± 2 |
30 ± 1 |
8 ± 1 |
+ |
150 |
9 ± 4 |
118 ± 4 |
19 ± 6 |
30 ± 8 |
7 ± 2 |
+ |
500 |
11 ± 3 |
104 ± 7 |
23 ± 3 |
25 ± 5 |
8 ± 0 |
+ |
1500 |
13 ± 1 |
100 ± 10 |
24 ± 1# |
29 ± 2 |
9 ± 1 |
+ |
5000 |
8 ± 3 |
107 ± 11# |
23 ± 3# |
36 ± 4 |
7 ± 2# |
Positive controls, +S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentration [μg/plate] |
0.5 |
0.5 |
0.5 |
0.5 |
1 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
76 ± 19 |
189 ± 9 |
105 ± 2 |
142 ± 40 |
39 ± 3 |
|
DMSO: dimethylsulphoxide
NaN3: sodium azide
2-AA: 2-aminoanthracene
9-AA: 9-aminoacridine
2-NF: 2-nitrofluorene
#: thin lawn of microcolonies (i.e. toxicity)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A bacterial gene mutation assay with the test substance was performed in accordance to OECD Guideline 471 and in compliance with GLP (2015). In this study the substance was not mutagenic in any of the five strains (TA 1535, TA 1537, TA 98, TA 100 and WP2 uvr A) tested with and without metabolic activation up to 5000 µg/plate.
An additional bacterial gene mutation assay with the test substance was performed similar to OECD Guideline 471 and in compliance with GLP (1985). In this study the substance was not mutagenic in any of the five strains (TA 1535, 1537, TA 1538, TA 98 and TA 100) tested with and without metabolic activation up to 5000 µg/plate.
Justification for classification or non-classification
The available experimental data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the available data on genetic toxicity, the test item is not classified according to Regulation (EC) 1272/2008 (CLP), as amended for the eighth time in regulation (EU) No 2016/918.
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