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EC number: 602-891-7 | CAS number: 122731-59-3
- Life Cycle description
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- Endpoint summary
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation (Bacterial reverse muation assay/AMES test, GLP): negative with and without metabolic activation
[Schering AG, Report No. AL91; 1996-06-06]
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:
- August 1995
- 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:
- adopted May 26, 1983
- Principles of method if other than guideline:
- plate incorporation method
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine gene locus
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system: S9-liver mix
- source of S9: CCR
- method of preparation of S9 mix: The S9 liver microsomal fraction was obtained from the livers of 8 - 12 weeks old male Wistar rats, strain HanIbm (BRL, CH-4414 Füllinsdorf, weight approx. 220 - 320 g) which received a single i.p. injection of 500 mg/kg b.w. Aroclor 1254 (Antechnika, D-76275 Ettlingen, F.R.G.) in olive oil 5 days previously. After cervical dislocation the livers of the animals were removed, washed in 150 mM KCI and homogenised. The homogenate, was diluted 1+3 in KCI and centrifuged at 9,000 g for
10 minutes at 4° C. A stock of the supernatant containing the microsomes was frozen in ampoules of 2, 3 or 5 mL and stored at -80° C. Small numbers of the ampoules are kept at -20° C for up to several weeks before use.
- concentration or volume of S9 mix and S9 in the final culture medium: The standardisation of the protein content was made using the analysis kit of Bio-Rad Laboratories, D-80939 Mtinchen: Bio-Rad protein assay, Catalogue 500 000 6. The protein concentration in the S9 preparation was 30.6 mg/mL (lot 250795). The amount of S9 supernatant was 15% v/v.
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): The metabolic activity of the S9 preparation was checked with benzo (a) pyrene. - Test concentrations with justification for top dose:
- 33.3, 100.0; 333.3; 1000.0; 2500.0; and 5000.0 ~g/plate
- Vehicle / solvent:
- DMSo, aqua dest.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without S9-mix: NaN3; 4-NOPD, MMS; with S9-mix: 2-AA
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: one
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48 h
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: background growth inhibition - Rationale for test conditions:
- According to OECD test guideline
- Evaluation criteria:
- A test article is considered positive if either a dose related increase in the number of revertants or a biological relevant increase for at least one test concentration is induced.
A test article producing neither a dose related increase in the number of revertants nor a biological relevant positive response at any one of the test points is considered non-mutagenic in this system.
A significant response is described as follows:
A test article is considered mutagenic if the number of reversions is at least twice the spontaneous reversion rate in strains TA 100 and TA 102 or thrice on TA 1535, TA 1537, and TA 98. Also, a dose-dependent increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the test article regardless whether the highest dose induced the criteria described above or not. - Key result
- Species / strain:
- other: TA 98, TA 100, TA 102, TA 1535, TA 1537
- 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
- Conclusions:
- Tamip diacetate is not genotoxic under the conditions of this test system and therefore classification is not required.
- Executive summary:
Tamip diacetate (ZK 91248) did not show any mutagenic potential in a bacterial reverse mutation assay with S. typhymurium (TA 1535, TA 100, TA 1537, TA 102, TA 98) when tested up to 5.0 mg/plate in the absense and presense of intrinsic metabolic activation (liver mix from Aroclor 1254 -treated rats).
Reference
TA1535 / without S9 | ||||||
Concentration mg/plate | Plate | Revertants/plate | ||||
1 | 2 | 3 | Mean | s.d. | Factor* | |
Negative control | 16 | 12 | 13 | 14 | 2.1 |
|
Solvent control | 11 | 14 | 15 | 13 | 2.1 | 1.0 |
Positive control# | 866 | 653 | 891 | 803 | 130.8 | 60.3 |
33.3 | 16 | 15 | 14 | 15 | 1.0 | 1.1 |
100.0 | 9 | 11 | 14 | 11 | 2.5 | 0.9 |
333.3 | 13 | 13 | 12 | 13 | 0.6 | 1.0 |
1000.0 | 10 | 7 | 15 | 11 | 4.0 | 0.8 |
2500.0 | 7 | 12 | 17 | 12 | 5.0 | 0.9 |
5000.0 | 11 | 8 | 16 | 12 | 4.0 | 0.9 |
TA1535 / with S9 | ||||||
Concentration mg/plate | Plate | Revertants/plate | ||||
1 | 2 | 3 | Mean | s.d. | Factor* | |
Negative control | 18 | 16 | 16 | 17 | 1.2 |
|
Solvent control | 19 | 19 | 20 | 19 | 0.6 | 1.0 |
Positive control## | 302 | 232 | 236 | 257 | 39.3 | 13.3 |
33.3 | 12 | 19 | 10 | 14 | 4.7 | 0.7 |
100.0 | 12 | 13 | 10 | 12 | 1.5 | 0.6 |
333.3 | 19 | 19 | 8 | 15 | 6.4 | 0.8 |
1000.0 | 18 | 17 | 14 | 16 | 2.1 | 0.8 |
2500.0 | 18 | 20 | 15 | 18 | 2.5 | 0.9 |
5000.0 | 10 | 18 | 19 | 16 | 4.9 | 0.8 |
#= sodium azide 10 µg/plate; ##= 2-aminoanthracene 2.5 µg/plate | ||||||
TA 1537 without S9 | ||||||
Concentration mg/plate | Plate | Revertants/plate | ||||
1 | 2 | 3 | Mean | s.d. | Factor* | |
Negative control | 13 | 18 | 19 | 17 | 3.2 |
|
Solvent control | 12 | 10 | 19 | 14 | 4.7 | 1.0 |
Positive control# | 55 | 62 | 58 | 58 | 3.5 | 4.3 |
33.3 | 13 | 13 | 10 | 12 | 1.7 | 0.9 |
100.0 | 15 | 14 | 19 | 16 | 2.6 | 1.2 |
333.3 | 9 | 13 | 12 | 11 | 2.1 | 0.8 |
1000.0 | 7 | 14 | 17 | 13 | 5.1 | 0.9 |
2500.0 | 14 | 15 | 10 | 13 | 2.6 | 1.0 |
5000.0 | 16 | 18 | 14 | 16 | 2.0 | 1.2 |
TA 1537 with S9 | ||||||
Concentration mg/plate | Plate | Revertants/plate | ||||
1 | 2 | 3 | Mean | s.d. | Factor* | |
Negative control | 10 | 17 | 16 | 14 | 3.8 |
|
Solvent control | 18 | 17 | 17 | 17 | 0.6 | 1.0 |
Positive control## | 100 | 100 | 96 | 99 | 2.3 | 5.7 |
33.3 | 21 | 15 | 19 | 18 | 3.1 | 1.1 |
100.0 | 16 | 18 | 13 | 16 | 2.5 | 0.9 |
333.3 | 14 | 17 | 18 | 16 | 2.1 | 0.9 |
1000.0 | 16 | 13 | 16 | 15 | 1.7 | 0.9 |
2500.0 | 15 | 14 | 10 | 13 | 2.6 | 0.8 |
5000.0 | 18 | 20 | 24 | 21 | 3.1 | 1.2 |
#= 4-nitro-o-phenylene-diamine 10 µg/plate; ##= 2-aminoanthracene 2.5 µg/plate | ||||||
TA 98 without S9 | ||||||
Concentration mg/plate | Plate | Revertants/plate | ||||
1 | 2 | 3 | Mean | s.d. | Factor* | |
Negative control | 38 | 39 | 44 | 40 | 3.2 |
|
Solvent control | 40 | 43 | 51 | 45 | 5.7 | 1.0 |
Positive control# | 171 | 191 | 166 | 176 | 13.2 | 3.9 |
33.3 | 51 | 74 | 53 | 59 | 12.7 | 1.3 |
100.0 | 51 | 58 | 73 | 61 | 11.2 | 1.4 |
333.3 | 59 | 43 | 52 | 51 | 8.0 | 1.1 |
1000.0 | 53 | 55 | 53 | 54 | 1.2 | 1.2 |
2500.0 | 40 | 51 | - | 46 | 7.8 | 1.0 |
5000.0 | 55 | 48 | - | 52 | 4.9 | 1.2 |
TA 98 with S9 | ||||||
Concentration mg/plate | Plate | Revertants/plate | ||||
1 | 2 | 3 | Mean | s.d. | Factor* | |
Negative control | 46 | 53 | 63 | 54* | 8.5 |
|
Solvent control | 62 | 66 | 75 | 68* | 6.7 | 1.0 |
Positive control## | 537 | 656 | 609 | 601 | 59.9 | 8.9 |
33.3 | 47 | 43 | 63 | 51 | 10.6 | 0.8 |
100.0 | 48 | 49 | 41 | 46 | 4.4 | 0.7 |
333.3 | 42 | 48 | 53 | 48 | 5.5 | 0.7 |
1000.0 | 63 | 56 | 53 | 57 | 5.1 | 0.8 |
2500.0 | 60 | 64 | 59 | 61 | 2.6 | 0.9 |
5000.0 | 60 | 73 | 71 | 68 | 7.0 | 1.0 |
#= 4-nitro-o-phenylene-diamine 10 µg/plate; ##= 2-aminoanthracene 2.5 µg/plate; * These numbers of revertants are above the eorresponding values of the historieal eontrol | ||||||
TA 100 without S9 | ||||||
Concentration mg/plate | Plate | Revertants/plate |
|
|
|
|
| 1 | 2 | 3 | Mean | s.d. | Factor* |
Negative control | 168 | 155 | 172 | 165 | 8.9 |
|
Solvent control | 168 | 178 | 173 | 173 | 5.0 | 1.0 |
Positive control# | 966 | 1030 | 1012 | 1003 | 33.0 | 5.8 |
33.3 | 145 | 143 | 189 | 159 | 26.0 | 0.9 |
100.0 | 147 | 134 | 163 | 148 | 14.5 | 0.9 |
333.3 | 133 | 119 | 165 | 139 | 23.6 | 0.8 |
1000.0 | 134 | 131 | 124 | 130 | 5.1 | 0.7 |
2500.0 | 123 | 130 | 131 | 138 | 4.4 | 0.7 |
5000.0 | 138 | 146 | 140 | 141 | 4.2 | 0.8 |
TA 100 with S9 | ||||||
Concentration mg/plate | Plate | Revertants/plate | ||||
1 | 2 | 3 | Mean | s.d. | Factor* | |
Negative control | 181 | 184 | 199 | 188 | 9.6 |
|
Solvent control | 168 | 201 | 178 | 182 | 16.9 | 1.0 |
Positive control## | 1138 | 1326 | 1417 | 1294 | 142.3 | 7.1 |
33.3 | 177 | 200 | 166 | 181 | 17.3 | 1.0 |
100.0 | 159 | 187 | 177 | 174 | 14.2 | 1.0 |
333.3 | 135 | 153 | 156 | 148 | 11.4 | 0.8 |
1000.0 | 164 | 159 | 165 | 163 | 3.2 | 0.9 |
2500.0 | 155 | 158 | 153 | 155 | 2.5 | 0.9 |
5000.0 | 167 | 172 | 155 | 165 | 8.7 | 0.9 |
#= sodium azide 10 µg/plate; ##= 2-aminoanthracene 2.5 µg/plate | ||||||
TA 102 without S9 | ||||||
Concentration mg/plate | Plate | Revertants/plate | ||||
1 | 2 | 3 | Mean | s.d. | Factor* | |
Negative control | 216 | 251 | 257 | 241 | 22.1 |
|
Solvent control | 272 | 277 | 302 | 284 | 16.1 | 1.0 |
Positive control# | 899 | 745 | 1201 | 948 | 232.0 | 3.3 |
33.3 | 287 | 296 | 307 | 297 | 10.0 | 1.0 |
100.0 | 320 | 335 | 326 | 327 | 7.5 | 1.2 |
333.3 | 305 | 339 | 310 | 318 | 18.4 | 1.1 |
1000.0 | 272 | 297 | 312 | 294 | 20.2 | 1.0 |
2500.0 | 153 | 193 | 187 | 178 | 21.6 | 0.6 |
5000.0 | 191 | 192 | 195 | 193 | 2.1 | 0.7 |
TA 102 with S9 | ||||||
Concentration mg/plate | Plate | Revertants/plate | ||||
1 | 2 | 3 | Mean | s.d. | Factor* | |
Negative control | 327 | 351 | 343 | 340* | 12.2 |
|
Solvent control | 341 | 368 | 345 | 351* | 14.6 | 1.0 |
Positive control## | 1469 | 1524 | 1468 | 1487 | 32.0 | 4.2 |
33.3 | 351 | 355 | 381 | 362 | 16.3 | 1.0 |
100.0 | 373 | 381 | 372 | 375 | 4.9 | 1.1 |
333.3 | 375 | 364 | 378 | 372 | 7.4 | 1.1 |
1000.0 | 389 | 388 | 418 | 398 | 17.0 | 1.1 |
2500.0 | 210 | 233 | 209 | 217 | 13.6 | 0.6 |
5000.0 | 222 | 221 | 212 | 218 | 5.5 | 0.6 |
#= methyl methane sulfonate 5 µL/plate; ##= 2-aminoanthracene 2.5 µg/plate | ||||||
* enhancement factor = Sum revertants/concentration test article/ sum revertants/ solvent control |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Tamip diacetate (ZK 91248) did not show any mutagenic potential in a bacterial reverse mutation assay with S. typhymurium (TA 1535, TA 100, TA 1537, TA 102, TA 98) when tested up to 5.0 mg/plate in the absense and presense of intrinsic metabolic activation (liver mix from Aroclor 1254 -treated rats) (Schering AG, Report No. AL91; 1996-06-06)
Justification for classification or non-classification
Tamip diacetate (ZK 91248) was tested in a standard genotoxicity test and did not show any genotoxic potential. Thus, there is no sufficient evidence available to classify Tamip diacetate as genotoxic.
Classification according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP) is not required.
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