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EC number: 200-644-4 | CAS number: 67-16-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 04 Aug 2006
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Intermediate summary report with no details provided on the materials and methods.
- Deviations:
- not specified
- Principles of method if other than guideline:
- Intermediate summary report with no detail provided on the materials and methods. The main information indicate that the study seems to follow the OECD guidline.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N'-[dithiobis[2-(2-hydroxyethyl)-1-methylvinylene]]bis[N-[(4-amino-2-methyl-5-pyrimidinyl)methyl]formamide
- EC Number:
- 200-644-4
- EC Name:
- N,N'-[dithiobis[2-(2-hydroxyethyl)-1-methylvinylene]]bis[N-[(4-amino-2-methyl-5-pyrimidinyl)methyl]formamide
- Cas Number:
- 67-16-3
- Molecular formula:
- C24H34N8O4S2
- IUPAC Name:
- N,N'-[dithiobis[2-(2-hydroxyethyl)-1-methylvinylene]]bis[N-[(4-amino-2-methyl-5-pyrimidinyl)methyl]formamide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- No detail provided.
Method
- Target gene:
- not specified
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA 7001 to 7006
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Not specified
- Test concentrations with justification for top dose:
- 156 to 5000 µg/ml
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
Results and discussion
Any other information on results incl. tables
Identification of Gédéon database : Amendment N°73 |
|||||||||
Preliminary toxicity assay(on theMixedstrains only, with and without metabolic activation): |
|||||||||
Compound |
Tested Concentrations |
Unit |
|||||||
10036 AMINOET |
0 (DMSO) |
79 |
157 |
313 |
625 |
1250 |
2500 |
5000 (c) |
(µg/ml) |
5007 TDS HYDRATE SEC |
0 (DMSO) |
79 |
157 |
313 |
625 |
1250 |
2500 |
5000 (c) |
(µg/ml) |
3341 UREE |
0 (DMSO) |
79 |
157 |
313 |
625 |
1250 |
2500 |
5000 (c) |
(µg/ml) |
PYRIMIDYL-2',1 PIPERAZINE |
0 (DMSO) |
79 |
157 |
313 |
625 |
1250 |
2500 |
5000 (c) |
(µg/ml) |
9490 S BENZYLOXY PTS |
0 (DMSO) |
79 |
157 |
313 |
625 |
1250 |
2500 |
5000 (c) |
(µg/ml) |
3341 UREE |
0 (DMSO) |
79 |
157 |
313 |
625 |
1250 |
2500 |
5000 (c) |
(µg/ml) |
RESULTS: |
|
|
|
|
|
|
|
|
|
Genotoxicity assay (onMixedandTA98): |
|||||||||
All the criteria for a valid test were met. |
|||||||||
Compound |
Tested Concentrations and Induction Factors (Significance) |
Conclusion |
|||||||
|
+ S9 |
156 |
313 |
625 |
1250 |
2500 |
5000 (c) |
2-AA |
Negative |
10036 AMINOET |
Mixed |
0.5 |
0.5 |
1.0 |
2.0 |
1.3 |
1.3 |
35.0 |
|
Assay 1 |
|
|
|
|
|
|
(**) |
||
|
TA98 |
2.0 |
1.7 |
1.7 |
1.7 |
2.3 |
2.3 |
48.0 |
|
|
|
|
|
|
|
|
(**) |
||
Batch: |
- S9 |
156 |
313 |
625 |
1250 |
2500 |
5000 (c) |
4NQO+2NF |
Negative |
534301/002 |
Mixed |
1.3 |
0.5 |
1.3 |
0.5 |
0.3 |
0.5 |
36.0 |
|
|
|
|
|
|
|
|
(**) |
||
Serie: 10036 |
TA98 |
0.7 |
1.0 |
1.7 |
1.0 |
1.0 |
0.0 |
48.0 |
|
|
|
|
|
|
|
|
(**) |
||
Vehicle: DMSO |
Discussion :No presence of colonies nor changes in the colour of the wells was observed. |
||||||||
Compound |
Tested Concentrations and Induction Factors (Significance) |
Conclusion |
|||||||
|
+ S9 |
156 |
313 |
625 |
1250 |
2500 |
5000 (c) |
2-AA |
Negative |
5007 TDS HYDRATE SEC |
Mixed |
1.3 |
1.7 |
0.7 |
1.0 |
2.0 |
0.7 |
46.3 |
|
Assay 1 |
|
|
|
|
|
|
(**) |
||
|
TA98 |
1.0 |
1.0 |
1.5 |
0.8 |
2.0 |
1.5 |
36.0 |
|
|
|
|
|
|
|
|
(**) |
||
Batch: |
- S9 |
156 |
313 |
625 |
1250 |
2500 |
5000 (c) |
4NQO+2NF |
Negative |
544681/014 |
Mixed |
0.3 |
1.0 |
0.3 |
2.0 |
1.3 |
0.0 |
48.0 |
|
|
|
|
|
|
|
|
(**) |
||
Serie: 5007 |
TA98 |
1.3 |
1.0 |
1.0 |
0.7 |
0.7 |
0.7 |
48.0 |
|
|
|
|
|
|
|
|
(**) |
||
Vehicle: DMSO |
Discussion :No presence of colonies nor changes in the colour of the wells was observed. |
||||||||
Compound |
Tested Concentrations and Induction Factors (Significance) |
Conclusion |
|||||||
|
+ S9 |
20 |
39 |
78 |
156 |
313 |
625 (e) |
2-AA |
Negative |
3341 UREE |
Mixed |
0.9 |
0.9 |
0.7 |
0.7 |
1.0 |
1.1 |
18.7 |
|
Assay 1 |
|
|
|
|
|
|
(**) |
||
|
TA98 |
0.7 |
0.5 |
0.5 |
1.7 |
0.3 |
1.3 |
24.0 |
|
|
|
|
|
|
|
|
(**) |
||
Batch: |
- S9 |
2.6 |
7.8 |
23 |
70 |
209 |
625 (e) |
4NQO+2NF |
Negative |
544641/001 |
Mixed |
0.3 |
1.0 |
0.7 |
0.3 |
0.7 |
0.7 |
47.7 |
|
|
|
|
|
|
|
|
(**) |
||
Serie: 3341 |
TA98 |
2.3 |
2.3 |
2.7 |
0.0 |
0.3 |
0.3 |
48.0 |
|
|
|
|
|
|
|
|
(**) |
||
Vehicle: DMSO |
Discussion :No presence of colonies nor changes in the colour of the wells was observed. |
||||||||
Compound |
Tested Concentrations and Induction Factors (Significance) |
Conclusion |
|
||||||||
|
+ S9 |
156 |
313 |
625 |
1250 |
2500 |
5000 (c) |
2-AA |
Negative |
|
|
PYRIMIDYL-2',1 PIPERAZINE |
Mixed |
0.8 |
0.5 |
0.8 |
1.3 |
0.8 |
2.5 |
34.8 |
|
||
Assay 1 |
|
|
|
|
|
|
(**) |
|
|||
|
TA98 |
1.2 |
0.8 |
1.4 |
0.6 |
0.2 |
1.2 |
28.8 |
|
||
|
|
|
|
|
|
|
(**) |
|
|||
Batch: |
- S9 |
156 |
313 |
625 |
1250 |
2500 |
5000 (c) |
4NQO+2NF |
Negative |
|
|
M02413/001 |
Mixed |
0.7 |
1.3 |
1.7 |
1.3 |
0.7 |
0.7 |
47.7 |
|
||
|
|
|
|
|
|
|
(**) |
|
|||
Serie: 495 |
TA98 |
0.3 |
0.7 |
1.0 |
1.3 |
1.3 |
2.7 |
48.0 |
|
||
|
|
|
|
|
|
|
(**) |
|
|||
Vehicle: DMSO |
Discussion :No presence of colonies nor changes in the colour of the wells was observed. |
|
|||||||||
Compound |
Tested Concentrations and Induction Factors (Significance) |
Conclusion |
|
||||||||
|
+ S9 |
156 |
313 |
625 |
1250 |
2500 |
5000 (c) |
2-AA |
Negative |
|
|
9490 S BENZYLOXY PTS |
Mixed |
0.3 |
0.7 |
1.0 |
2.0 |
1.3 |
1.3 |
43.3 |
|
||
Assay 1 |
|
|
|
|
|
|
(**) |
|
|||
|
TA98 |
1.0 |
1.3 |
1.3 |
1.7 |
3.0 |
1.0 |
48.0 |
|
||
|
|
|
|
|
|
|
(**) |
|
|||
Batch: |
- S9 |
15 |
44 |
133 |
398 |
1193 |
3594 (d) |
4NQO+2NF |
Negative |
|
|
543401/005 |
Mixed |
0.3 |
0.7 |
0.7 |
0.7 |
0.7 |
0.0 |
48.0 |
|
||
|
|
|
|
|
|
|
(**) |
|
|||
Serie: 9490 |
TA98 |
1.3 |
1.3 |
1.5 |
0.8 |
0.3 |
0.0 |
36.0 |
|
||
|
|
|
|
|
|
|
(**) |
|
|||
Vehicle: DMSO |
Discussion :No presence of colonies nor changes in the colour of the wells was observed. |
|
|||||||||
Compound |
Tested Concentrations and Induction Factors (Significance) |
Conclusion |
|
||||||||
|
+ S9 |
7.4 |
22 |
67 |
201 |
603 |
1800 (e) |
2-AA |
Negative |
|
|
3341 UREE |
Mixed |
0.5 |
1.0 |
1.0 |
0.8 |
1.8 |
1.8 |
33.8 |
|
||
Assay 1 |
|
|
|
|
|
|
(**) |
|
|||
|
TA98 |
0.8 |
1.8 |
1.0 |
1.5 |
1.0 |
1.8 |
36.0 |
|
||
|
|
|
|
|
|
|
(**) |
|
|||
Batch: |
- S9 |
7.4 |
22 |
67 |
201 |
603 |
1800 (e) |
4NQO+2NF |
Negative |
|
|
544641/002 |
Mixed |
1.8 |
0.8 |
1.0 |
0.5 |
1.0 |
1.3 |
35.8 |
|
||
|
|
|
|
|
|
|
(**) |
|
|||
Serie: 3341 |
TA98 |
0.8 |
0.8 |
1.5 |
0.8 |
1.5 |
1.5 |
36.0 |
|
||
|
|
|
|
|
|
|
(**) |
|
|||
Vehicle: DMSO |
Discussion :No presence of colonies nor changes in the colour of the wells was observed. |
|
|||||||||
|
(a): highest concentration limited by the solubility in the solvent |
||||||||||
|
(b): highest concentration limited by the available amount of the compound |
||||||||||
|
(c): highest maximum recommended concentration |
||||||||||
|
(d): highest concentration limited by toxicity |
||||||||||
|
(e): highest concentration limited by precipitate |
||||||||||
|
(**): statistical significance (p<0.01) |
||||||||||
|
4NQO: 4-Nitroquinoline N-oxyde (500 ng/ml) |
||||||||||
|
2NF: 2 Nitrofluorene (2000 ng/ml) |
||||||||||
|
2-AA: 2-anthramine (5 µg/ml) |
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|
DMSO : Dimethyl Sulfoxide |
||||||||||
Applicant's summary and conclusion
- Conclusions:
- No presence of colonies nor changes in the colour of the wells was observed.
- Executive summary:
No presence of colonies nor changes in the colour of the wells was observed in an intermediate study report.
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.
