Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 605-140-1 | CAS number: 158237-07-1
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:
- 17-27 May, 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 26 May 1983
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-5-oxo-4,5-dihydro-1H-1,2,3,4-tetrazole-1-carboxamide
- EC Number:
- 605-140-1
- Cas Number:
- 158237-07-1
- Molecular formula:
- C16H20ClN5O2
- IUPAC Name:
- 4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-5-oxo-4,5-dihydro-1H-1,2,3,4-tetrazole-1-carboxamide
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium) and trp operon (for E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and 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 male SD rats treated with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- First experiment: 313, 625, 1250, 2500 and 5000 µg/plate with and without metabolic activation (tested up to the recommended maximum concentration)
Second experiment: 313, 625, 1250, 2500 and 5000 µg/plate with and without metabolic activation (tested up to the recommended maximum concentration) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 2-Aminoanthracene (2-AA); 2-(2-Furyl)-3-(5-nitro- 2-furyl) acrylamide (AF-2);
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: observation of bacterial growth inhibition - Rationale for test conditions:
- based on the results of a previous study.
- Evaluation criteria:
- If more than two fold and dose-related increase in revertant colonies were observed as compared with the solvent control, it was evaluated as positive in terms of mutagenicity.
- Statistics:
- Mean numbers of the revertant colonies of each concentration of each test system was calculated and compared to that of the solvent control.
Results and discussion
Test resultsopen allclose all
- 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:
- no cytotoxicity
- 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:
- no cytotoxicity
- 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:
- no cytotoxicity
- Remarks:
- a slight decrease in bacterial growth was detected in the 1st experiment without S9 (colony numbers reduced to up to 84% of the respective vehicle control in a dose-dependent manner)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:
No relevant effect on bacterial growth was observed in any strain at any test concentration (a slight effect on bacterial growth was observed in the 1st experiment in tester strain TA 100 without metabolic activation)
Any other information on results incl. tables
Table 1: The result of the first experiment (without S-9)
Compound |
S-9 Mix |
concentration |
TA 100 |
TA 1535 |
WP2 uvra |
TA 98 |
TA 1537 |
DMSO |
- |
0 |
94 98 84 (92) |
13 12 10 (12) |
13 16 7 (12) |
16 17 17 (17) |
7 5 5 (6) |
Test substance |
- |
5000 |
62 84 86 (77) |
5 7 8 (7) |
16 20 25 (20) |
15 15 19 (16) |
5 8 7 (7) |
|
- |
2500 |
88 81 80 (83) |
5 6 5 (5) |
15 12 13 (13) |
17 15 23 (18) |
9 7 6 (7) |
|
- |
1250 |
84 86 80 (83) |
7 4 6 (6) |
10 9 10 (10) |
18 23 19 (20) |
6 8 5 (6) |
|
- |
625 |
85 96 74 (85) |
4 6 9 (6) |
10 12 10 (11) |
19 11 25 (18) |
6 5 4 (5) |
|
- |
313 |
88 100 82 (90) |
8 5 8 ( 6) |
7 13 15 (12) |
16 18 23 (19) |
6 7 8 (7) |
Positive control |
- |
|
412a) 357 379 (383) |
175b) 172 182 (176) |
184a) 194 197 (192) |
362c) 303 333 (333) |
379d) 441 392 (404) |
( ) : mean
a) AF-2: 0.01 µg/plate; b) NaN3: 0.5 µg/plate; c) AF-2: 0.1 µg/plate; d) 9-AA: 80 µg/plate
Table 2: The result of the first experiment (with S-9)
Compound |
S-9 Mix (10%) |
concentration |
TA 100 |
TA 1535 |
WP2 uvra |
TA 98 |
TA 1537 |
DMSO |
+ |
0 |
84 90 96 (90) |
10 8 5 (8) |
19 16 25 (20) |
26 28 29 (28) |
13 12 11 (12)
|
Test substance |
+ |
5000 |
90 99 92 (94) |
6 3 5 (5) |
16 14 14 (15) |
20 19 17 (19) |
6 7 4 (6) |
|
+ |
2500 |
89 83 85 (86) |
11 8 9 (9) |
25 10 17 (17) |
28 22 30 (27) |
6 5 8 (6) |
|
+ |
1250 |
100 94 72 (89) |
3 5 6 (5) |
13 18 15 (15) |
31 26 19 (25) |
7 6 7 (7) |
|
+ |
625 |
86 90 67 (81) |
5 7 9 (7) |
18 17 13 (16) |
19 32 34 (28) |
9 5 5 (6) |
|
+ |
313 |
95 88 82 (88) |
7 5 9 (7) |
18 19 20 (19) |
31 29 36 (32) |
8 5 9 (7) |
Positive control |
+ |
|
407 e) 451 477 (445) |
176 f) 192 186 (185) |
219 g) 315 304 (303) |
188 h) 192 196 (192) |
70 f) 78 83 (77) |
( ) : mean
e) 2-AA: 1.0 µg/plate; f) 2-AA: 2.0 µg/plate; g) 2-AA: 10.0 µg/plate; h) 2-AA: 0.5 µg/plate
Table 3: The result of the second experiment (without S-9)
Compound |
S-9 Mix |
concentration |
TA 100 |
TA 1535 |
WP2 uvra |
TA 98 |
TA 1537 |
DMSO |
- |
0 |
91 84 89 (88) |
9 14 15 (13) |
13 16 14 (14) |
34 28 31 (31) |
16 9 8 (11) |
Test substance |
- |
5000 |
89 77 81 (82) |
11 7 12 (10) |
11 10 16 (12) |
27 35 30 (31) |
16 10 13 (13)
|
|
- |
2500 |
84 90 90 (88) |
13 15 10 (13) |
13 11 14 (13) |
25 30 30 (28) |
4 14 12 (10) |
|
- |
1250 |
73 86 82 (80) |
7 14 15 (12) |
9 13 10 (11) |
26 23 29 (26) |
12 9 7 (9) |
|
- |
625 |
89 94 95 (93) |
15 10 7 (11) |
10 10 12 (11) |
34 26 24 (28) |
7 10 10 (9) |
|
- |
313 |
93 87 84 (88) |
10 10 9 (10) |
14 13 8 (12) |
23 31 34 (29) |
11 14 11 (12) |
Positive control |
- |
|
387a) 402 424 (404) |
155b) 177 163 (165) |
147a) 160 158 (155) |
436C) 440 448 (441) |
463d) 478 442 (461) |
( ) : mean
a) AF-2: 0.01 µg/plate; b) NaN3: 0.5 µg/plate; c) AF-2: 0.1 µg/plate; d) 9-AA: 80 µg/plate
Table 4: The result of the second experiment (with S-9)
Compound |
S-9 Mix (10%) |
concentration |
TA 100 |
TA 1535 |
WP2 uvra |
TA 98 |
TA 1537 |
DMSO |
+ |
0 |
98 93 96 (96) |
11 14 11 (12) |
13 16 22 (17) |
36 39 40 (38) |
10 9 10 (10) |
Test substance |
+ |
5000 |
90 81 88 (86) |
11 16 15 (14) |
18 16 24 (19) |
37 35 27 (33) |
7 11 12 (10) |
|
+ |
2500 |
101 87 90 (93) |
11 7 13 (10) |
12 16 23 (17) |
31 37 40 (36) |
7 10 15 (11) |
|
+ |
1250 |
89 88 82 (86) |
14 15 12 (14) |
18 10 17 (15) |
34 33 40 (36) |
12 8 13 (11) |
|
+ |
625 |
79 80 83 (81) |
11 14 8 (11) |
13 17 22 (17) |
27 31 40 (33) |
8 10 12 (10) |
|
+ |
313 |
81 94 86 (87) |
11 12 12 (12) |
20 15 16 (17) |
27 29 37 (31) |
10 6 10 (9) |
Positive control |
+
|
|
455e) 398 404 (419) |
115f) 151 122 (129) |
287g) 278 265 (277) |
179h) 185 162 (175) |
79f) 72 83 (78) |
( ) : mean
e) 2-AA: 1.0 µg/plate; f) 2-AA: 2.0 µg/plate; g) 2-AA: 10.0 µg/plate; h) 2-AA: 0.5 µg/plate
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the conducted test the substance was not mutagenic in any of the five tester strains (TA 98, TA 100, TA 1535, TA 1537 and WP2 uvrA) tested with and without metabolic activation up to 5000 µg/plate.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
