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EC number: 686-822-6 | CAS number: 1200-09-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-08-08 to 2008-09-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD test guideline 471
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- 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:
- 10% liver S9 in standard co-factors
- Test concentrations with justification for top dose:
- - Preliminary Toxicity Test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
- Mutation Test-Experiment 1 and 2: 1.5, 5, 15, 50, 150, 500 and 1500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- mitomycin C
- other: 1,8-Dihydroxyanthraquinone, 2-Aminoanthracene
- Remarks:
- The first four chemicals are positive controlsin the absence of S9. The last three are non-mutagenic in the absence of S9.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
- Method: by the background bacterial lawn - Evaluation criteria:
- The test material will be considered mutagenic (positive) in the test system if
- dose-related increase in revertant frequency over the dose range is tested and/or
- a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation is determined - Statistics:
- Standard deviation
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- 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
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: Toxic effects (no bacterial background lawn) and precipitate was observed 5000 µg/plate on the strain of Salmonella used (TA 100)
COMPARISON WITH HISTORICAL CONTROL DATA: yes - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The substance was considered to be non-mutagenic under the conditions of this test.
Reference
Table 1: Spontaneous Mutation Rates (Concurrent Negative Controls)
Mean numbers of revertant colonies per plate |
||||
Base-pair substitution type |
Frameshift type |
|||
TA 100 |
TA 1535 |
TA 102 |
TA 98 |
TA 1537 |
Experiment 1 |
||||
109 |
17 |
278 |
14 |
19 |
Experiment 2 |
||||
68 |
24 |
213 |
18 |
17 |
Table 2: Experiment 1 - Without Metabolic Activation
Test substance concentration (µg/plate) |
Mean numbers of revertant colonies per plate (standard deviation) |
||||
|
Base-pair substitution type |
Frameshift type |
|||
|
TA 100 |
TA 1535 |
TA 102 |
TA 98 |
TA 1537 |
0 |
89 (5.8) |
21 (4.6) |
265 (24.8) |
21 (6.0) |
15 (2.3) |
1.5 |
94 (2.0) |
24 (4.9) |
279 (6.6) |
19 (4.7) |
14 (1.5) |
5 |
74 (2.5) |
23 (5.5) |
288 (10.5) |
22 (4.0) |
18 (2.6) |
15 |
87 (7.1) |
17 (7.0) |
275 (17.2) |
15 (6.5) |
14 (1.7) |
50 |
77 (7.2) |
17 (0.6) |
269 (12.3) |
18 (3.5) |
17 (2.5) |
150 |
94 (6.5) |
24 (3.8) |
273 (2.3) |
15 (2.3) |
13 (1.2) |
500 |
0 V (0.00) |
23 (5.6) |
0 V (0.00) |
0 V (0.00) |
0 V (0.00) |
1500 |
0 T (0.00) |
0 V (0.0) |
0 T (0.00) |
0 T (0.00) |
0 T (0.00) |
Positive controls |
|||||
Name |
ENNG |
ENNG |
MMC |
4NQO |
9AA |
Concentration (µg/plate) |
3 |
5 |
0.5 |
0.5 |
80 |
Mean no. colonies per plate |
375 (121.9) |
252 (6.4) |
1055 (112.4) |
149 (7.8) |
595 (85.4) |
Table 3: Experiment 1 - With Metabolic Activation
Test substance concentration (µg/plate) |
Mean numbers of revertant colonies per plate (standard deviation) |
||||
|
Base-pair substitution type |
Frameshift type |
|||
|
TA 100 |
TA 1535 |
TA 102 |
TA 98 |
TA 1537 |
0 |
94 (7.2) |
13 (1.0) |
240 (7.5) |
21 (4.5) |
20 (0.6) |
1.5 |
80 (14.6) |
10 (1.5) |
238 (23.5) |
25 (2.6) |
18 (3.6) |
5 |
100 (15.0) |
14 (3.2) |
231 (45.3) |
28 (1.5) |
14 (2.0) |
15 |
83 (6.5) |
14 (1.7) |
253 (25.7) |
29 (3.0) |
14 (2.6) |
50 |
84 (19.6) |
14 (2.6) |
266 (9.5) |
23 (3.1) |
12 (5.6) |
150 |
78 (4.7) |
8 (2.6) |
264 (6.1) |
24 (7.6) |
16 (6.7) |
500 |
59 S (11.5) |
0 V (0.00) |
180 S (5.0) |
12 (1.5) |
6 S (1.0) |
1500 |
0 T (0.00) |
0 T (0.00) |
0 T (0.00) |
0 T (0.00) |
0 T (0.00) |
Positive controls |
|||||
Name |
2AA |
2AA |
DAN |
BP |
2AA |
Concentration (µg/plate) |
1 |
2 |
10 |
5 |
2 |
Mean no. colonies per plate |
966 (18.0) |
277 (62.2) |
807 (128.3) |
287 (53.6) |
237 (72.7) |
Table 4: Experiment 2 -Without Metabolic Activation
Test substance concentration (µg/plate) |
Mean numbers of revertant colonies per plate (standard deviation) |
||||
|
Base-pair substitution type |
Frameshift type |
|||
|
TA 100 |
TA 1535 |
TA 102 |
TA 98 |
TA 1537 |
0 |
85 (3.6) |
25 (4.4) |
267 (43.2) |
14 (4.7) |
13 (5.2) |
1.5 |
83 (6.4) |
25 (1.5) |
232 (27.8) |
13 (0.6) |
13 (3.5) |
5 |
75 (7.8) |
19 (6.2) |
251 (3.6) |
13 (3.2) |
14 (3.0) |
15 |
68 (7.0) |
21 (10.0) |
226 (19.1) |
15 (2.3) |
15 (3.5) |
50 |
74 (14.0) |
22 (5.0) |
231 (16.6) |
16 (2.0) |
17 (4.0) |
150 |
68 (10.1) |
23 (4.2) |
214 (21.2) |
13 (4.0) |
10 (1.0) |
500 |
0 T (0.00) |
0 T (0.00) |
0 V (0.00) |
0 V (0.00) |
0 T (0.00) |
1500 |
0 T (0.00) |
0 T (0.00) |
0 T (0.00) |
0 T (0.00) |
0 T (0.00) |
Positive controls |
|||||
Name |
ENNG |
ENNG |
MMC |
4NQO |
9AA |
Concentration (µg/plate) |
3 |
5 |
0.5 |
0.2 |
80 |
Mean no. colonies per plate |
359 (10.4) |
98 (16.8) |
848 (236.2) |
102 (9.7) |
821 (278.5) |
Table 5: Experiment 2- With Metabolic Activation
Test substance concentration (µg/plate) |
Mean numbers of revertant colonies per plate (standard deviation) |
||||
|
Base-pair substitution type |
Frameshift type |
|||
|
TA 100 |
TA 1535 |
TA 102 |
TA 98 |
TA 1537 |
0 |
73 (4.7) |
18 (3.5) |
243 (28.7) |
22 (1.2) |
16 (1.2) |
1.5 |
72 (4.4) |
13 (6.7) |
243 (9.5) |
14 (4.2) |
9 (3.2) |
5 |
77 (11.8) |
11 (2.1) |
240 (20.6) |
17 (3.5) |
16 (3.2) |
15 |
75 (3.1) |
14 (2.1) |
268 (8.1) |
19 (6.7) |
11 (2.0) |
50 |
71 (5.6) |
9 (0.6) |
270 (11.4) |
16 (4.2) |
10 (4.4) |
150 |
57 (7.1) |
11 (2.9) |
262 (10.6) |
18 (2.1) |
6 (1.7) |
500 |
0 V (0.00) |
0 V (0.00) |
191 S (32.3) |
8 V (13.3) |
4 S (4.4) |
1500 |
0 T (0.00) |
0 T (0.00) |
0 T (0.00) |
0 T (0.00) |
0 T (0.00) |
Positive controls |
|||||
Name |
2AA |
2AA |
DAN |
BP |
2AA |
Concentration (µg/plate) |
1 |
2 |
10 |
5 |
2 |
Mean no. colonies per plate |
1289 (230.9) |
277 (81.8) |
736 (165.6) |
327 (20.4) |
180 (25.9) |
ENNG N-ethyl-N´-nitro-N-nitrosoguanidine
4NQO 4 -Nitroquinoline-1 -oxide
9AA 9 -Aminoacridine
MMC Mitomycin C
2AA 2 -Aminoanthracene
BP Benzo(a)pyrene
DAN 1,8 -Dihydroxyanthraquinone
S Sparse bacterial background lawn
T Toxic, no bacterial background lawn
V Very weak bacterial background lawn
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for selection of genetic toxicity endpoint
GLP study according to OECD test guideline 471.
Justification for classification or non-classification
Based on the results in the OECD 471 Ames test, the substance is not considered to be mutagenic according to Regulation (EC) No 1272/2008.
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