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EC number: 235-546-0 | CAS number: 12270-13-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Genotoxicity of the test item was assessed in an in vitro testing battery under GLP (OECD 471, OECD 473 and OECD 476). Substance specific data was available for one test (OECD 467). Thus, additional data from the structural analogue (chloride salt) of the target substance was used in a read-across approach. Details on the read-across rational are provided in section 13.
The source substance was not genotoxic in an OECD 473 in vitro chromosome aberration test, but was tested positive in a bacterial reverse mutation assay (OECD 471). In an in vitro mammalian mutagenicity test (OECD 476) the target substance was tested negative.
Based on the result of the higher tier mammalian cell assay for mutagenicity (OECD 476) and the overall evaluation of the available data in a weight-of-evidence approach the target substance is considered to be non-mutagenic.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1995-11-29 to 1996-03-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- adopted April 4, 1984
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
- Target gene:
- HPRT
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- MEDIA USED: MEM with 10% FCS (complete medium)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- The test concentrations were based on the results from a pre-test.
In the main study the following concentrations of the test article were evaluated:
Experiment 1:
without S9 mix: 1.0, 3.0, 10.0, 30.0, 60.0 and 100.0 µg/mL
with S9 mix: .0, 3.0, 10.0, 30.0, 100.0 and 300 µg/mL
Experiment II:
without S9 mix: 1.0, 3.0, 10.0, 30.0, 40.0 and 50.0 µg/mL
with S9 mix: 1.0, 3.0, 10.0, 20.0, 30.0 and 40.0 µg/mL - Vehicle / solvent:
- - vehicle/solvent used: the test item was dissolved in aqua bidest. The final concentration of the vehicle in the culture medium did not exceed 10% v/v.
- Justification for choice of solvent/vehicle: The solvent was chosen according to its solubility properties - Untreated negative controls:
- yes
- Remarks:
- MEM medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without S9, final concentration 0.6 mg/mL
- Untreated negative controls:
- yes
- Remarks:
- MEM medium plus S9 mix
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest plus S9 mix
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- with S9, final concentration 3.85 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 24 hours
- Exposure duration: 4 hours (short time exposure, Experiment I with and without metabolic activation)
- Expression time (cells in growth medium): 6-7 days (subcultured after 3 days)
- Selection time (if incubation with a selection agent): 7 days
- Fixation time (start of exposure up to fixation or harvest of cells): 14-16 days
SELECTION AGENT (mutation assays): 6-Thioguanine
NUMBER OF REPLICATIONS: one culture per test group (expression period), five flasks per culture per test group (selection period)
DETERMINATION OF CYTOTOXICITY
- Methods: Cloning efficiency - Rationale for test conditions:
- according to OECD test guideline 476
- Evaluation criteria:
- A test article is classified as positive if it induces either a concentration-related increase of the mutant frequency or a reproducible and positive response for one of the test points. A test article producing neither a concentration- related increase of the mutant frequency nor a reproducible positive response at any of the test points is considered non-mutagenic in this system. A significant response is described as follows: The test article is classified as mutagenic if it induces a reproducible mutation frequency that is at least three times higher than the spontaneous mutation frequency in the experiment at one or more of the concentrations.
The test article is classified as mutagenic if there is a reproducible concentration-related increase of the mutation frequency. Such evaluation may be considered also in the case that a threefold increase of the mutant frequency is not observed. However, in a case by case evaluation this decision depends on the level of the corresponding negative control data. If there is by chance a low spontaneous mutation rate in the range normally found (0 - 45 mutants per 10^6 cells) a concentration-related increase of the mutations within this range has to be discussed. - Statistics:
- Since the distribution of mutant cells does not follow known statistical models, an adequate statistical method is not available.
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- 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:
- The study was performed in two independent main experiments, using identical procedures, with and without liver microsomal activation. Strong toxic effects occurred at concentrations of 30 µg/mL and above without and 10 µg/mL and above with metabolic activation. In the second experiment several closely spaced concentrations of the test article were chosen to cover the threshold of toxicity. No precipitation of the test article occurred up to the maximal concentration. In the presence and absence of metabolic activation the cloning efficiency of the cells was reduced down to almost zero at the highest concentrations tested. In the mass-cultures of the larger flasks these toxic effects were less striking. The range of the controls was not exceeded in any of the test groups with or without metabolic activation. Furthermore, there was no indication of any concentration dependent increase of the number of colonies below the threshold of biological relevance. In both experiments of this study (with and without S9 mix) the range of the negative controls was from 5.0 up to 17.5 mutant colonies per 10^6 cells; the range of the groups treated with the test article was from 3.0 up to 15.2 mutant colonies per 10^6 cells. EMS (0.6 mg/mL) and DMBA (3.85 µg/mL) were used as positive controls and showed a distinct increase in induced mutant colonies. In conclusion, it can be stated that in this mutagenicity assay and under the experimental conditions reported the test article did not induce gene mutations at the HPRT locus in V79 cells.
- Conclusions:
- In this mutagenicity assay and under the experimental conditions reported the test article did not induce gene mutations at the HPRT locus in V79 cells.
- Executive summary:
In a mammalian cell HPRT gene mutation assay, V79 cells cultured in vitro were exposed to the test item in aqua bidest at concentrations of 1.0, 3.0, 10.0, 30.0, 60.0 and 100.0 µg/mL in the absence of mammalian metabolic activation and at concentrations of 1.0, 3.0, 10.0, 30.0, 100.0 and 300 µg/mL in the presence of S9 (experiment I). Strong toxic effects occurred at concentrations of 30.0 µg/mL and above without and at 10.0 µg/mL and above with metabolic activation. Thus, in a second experiment several closely spaced concentrations of the test article were chosen to cover the threshold of toxicity (1.0, 3.0, 10.0, 30.0, 40.0 and 50.0 µg/mL (without S9) and 1.0, 3.0, 10.0, 20.0, 30.0 and 40.0 (with S9)). The following concentrations were evaluated for mutagenicity: 1.0, 3.0, 10.0 and 30.0 µg/mL in the presence and absence of mammalian metabolic activation (experiment I) and for experiment II concentrations of 1.0, 10.0, 40.0 and 50.0 µg/mL (without S9) and 1.0, 10.0, 30.0 and 40.0 µg/mL with metabolic activation. The positive controls did induce the appropriate response. There was no evidence of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 476 for in vitro mutagenicity (mammalian forward gene mutation) data.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- For justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Distinct toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation. All plates incubated with the test article showed reduced background growth starting at concentrations as low as 33.3 µg/plate in some of the strains. Substantial increases in revertant colony numbers were observed following treatment with the test item with and without metabolic activation in all strains used. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article induced gene mutations by base pair changes and frameshifts in the genome of the strains TA 1535, TA 1537, TA 98, and TA
100. Therefore, the test item is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay. - Executive summary:
In a reverse gene mutation assay in bacteria, strains TA 1535, TA 100, TA 1537, TA 98 of S. typhimurium were exposed to the test item (90% purity) in water at concentrations of 33.3, 100, 333.3, 1000, 2500 and 5000 µg/plate (experiment I) and at concentrations of 33.3, 66.6, 100, 166.6, 333.3 and 1000 µg/plate (experiment II) in the presence and absence of mammalian metabolic activation. Strains TA 1535 and TA 1537 were additionally tested in at concentrations of 3.3, 10, 33.3, 66.6, 100 and 166.6 µg/plate (experiment IIa). The test item was tested up to the limit concentration (5000 µg/plate). Due to overlapping toxic effects, the number of revertants was reduced at the higher concentrations in the strains TA 1535, TA 1537, and TA 100 in experiments I, II and IIa. The positive controls induced the appropriate responses in the corresponding strains. Substantial increases in revertant colony numbers were observed following treatment with the test item with and without metabolic activation in all strains used. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article induced gene mutations by base pair changes and frameshifts in the genome of the strains TA 1535, TA 1537, TA 98, and TA 100. Therefore, the test item is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay. This study is classified as acceptable. The study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
This information is used in a read-across approach in the assessment of the target substance.
For justification of read-across please refer to the attached read-across report (see IUCLID section 13).
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1995-06-14 to 1995-08-30
- 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
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine locus
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Nutrient medium: 8 g Merck Nutrient Broth and 5 g NaCl per liter,
Selective Agar: 2.0 % Vogel-Bonner-Glucose-Minimal agar was used as selective agar,
Overlay Agar: 6.0 g Merck Agar Agar, 6.0 g NaCl, 10.5 mg L-Histidine, 12.2 mg Biotin per liter. - Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver microsomal fraction
- Test concentrations with justification for top dose:
- According to the results of the pre-experiment the concentrations applied in the main experiments were chosen:
Experiment I: 33.3, 100, 333.3, 1000, 2500 and 5000 µg/plate
Experiment II: 33.3, 66.6, 100, 166.6, 333.3 and 1000 µg/plate
Experiment IIa (strains TA 1535 and TA 1537): 3.3, 10.0, 33.3, 66.6, 100.0 and 166.6 µg/plate - Vehicle / solvent:
- On the day of the experiment, the test article was dissolved in aqua bidest. The solvent was chosen because of its solubility properties.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9, TA 1535 and TA 100, 10 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-NOPD
- Remarks:
- without S9, TA 1537 and TA 98, 10 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9, all strains, 2.5 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours at 37 °C
NUMBER OF REPLICATIONS: 3 plates/strain/dose level
DETERMINATION OF CYTOTOXICITY: Toxicity of the test article can be evidenced by a reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn.
ACCEPTED CONDITIONS FOR EVALUATION:
- corresponding background growth on both negative and test plates
- normal range of spontaneous reversion rates - Rationale for test conditions:
- N.A.
- Evaluation criteria:
- A test article is considered positive if either a dose related and/or reproducible increase in the number of revertants or a significant and reproducible increase for at least one test concentration is induced. A test article producing neither a dose related nor reproducible increase in the number of revertants nor a significant and reproducible 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 strain TA 100 or thrice on TA 1535, TA 1537, and TA 98. Also, a dose-dependent and reproducible 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.
- Statistics:
- According to international guidelines a statistical evaluation of the results is recommended. However, no evaluated statistical procedure can be recommended for analysis of data from the bacterial assays at this time.
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Distinct toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation. All plates incubated with the test article showed reduced background growth starting at concentrations as low as 33.3 µg/plate in some of the strains. Substantial increases in revertant colony numbers were observed following treatment with the test item with and without metabolic activation in all strains used. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article induced gene mutations by base pair changes and frameshifts in the genome of the strains TA 1535, TA 1537, TA 98, and TA
100. Therefore, the test item is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay. - Executive summary:
In a reverse gene mutation assay in bacteria, strains TA 1535, TA 100, TA 1537, TA 98 of S. typhimurium were exposed to the test item (90% purity) in water at concentrations of 33.3, 100, 333.3, 1000, 2500 and 5000 µg/plate (experiment I) and at concentrations of 33.3, 66.6, 100, 166.6, 333.3 and 1000 µg/plate (experiment II) in the presence and absence of mammalian metabolic activation. Strains TA 1535 and TA 1537 were additionally tested in at concentrations of 3.3, 10, 33.3, 66.6, 100 and 166.6 µg/plate (experiment IIa). The test item was tested up to the limit concentration (5000 µg/plate). Due to overlapping toxic effects, the number of revertants was reduced at the higher concentrations in the strains TA 1535, TA 1537, and TA 100 in experiments I, II and IIa. The positive controls induced the appropriate responses in the corresponding strains. Substantial increases in revertant colony numbers were observed following treatment with the test item with and without metabolic activation in all strains used. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article induced gene mutations by base pair changes and frameshifts in the genome of the strains TA 1535, TA 1537, TA 98, and TA 100. Therefore, the test item is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay. This study is classified as acceptable. The study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
Referenceopen allclose all
| Table 1: Pre-test: Determination of Toxicity | |||||
| Concentration µg/mL | extinction mean plus standard deviation | % of control | |||
| without S9 | |||||
| Blanc | 0.163 +/- 0.021 | / | |||
| Negative control | 1.067 +/- 0.045 | 102.92 | |||
| Solvent control | 1.041 +/-0.063 | 100 | |||
| 30 | 0.853 +/- 0.055 | 78.52 | |||
| 50 | 0.604 +/- 0.085 | 50.21 | |||
| 100 | 0.439 +/- 0.029 | 31.39 | |||
| 300 | 0.307 +/- 0.021 | 16.34 | |||
| 500 | 0.210 +/- 0.009 | 5.31 | |||
| 1000 | 0.191 +/- 0.005 | 3.22 | |||
| 3000 | 0.193 +/- 0.006 | 3.35 | |||
| 5000 | 0.194 +/- 0.004 | 3.52 | |||
| with S9 mix | |||||
| Blanc | 0.140 +/- 0.034 | / | |||
| Negative control | 1.177 +/- 0.043 | 101.87 | |||
| Solvent control | 1.158 +/- 0.042 | 100 | |||
| 30 | 1.129 +/- 0.063 | 97.12 | |||
| 50 | 0.903 +/- 0.175 | 74.95 | |||
| 100 | 0.322 +/- 0.018 | 17.85 | |||
| 300 | 0.538 +/- 0.015 | 39.12 | |||
| 500 | 0.464 +/- 0.049 | 31.84 | |||
| 1000 | 0.206 +/- 0.024 | 6.49 | |||
| 3000 | 0.187 +/- 0.004 | 4.66 | |||
| 5000 | 0.187 +/- 0.008 | 4.62 | |||
| Table 1: Summary of Results without S9 mix | |||||||||||||
| Revertants/plate | |||||||||||||
| mean from three plates | |||||||||||||
| Concentration µg/plate |
TA 1535 | TA 1537 | TA 98 | TA 100 | TA 1535 | TA 1537 | |||||||
| I | II | I | II | I | II | I | II | IIa | Iia | ||||
| Negative Control | 17 | 17 | 5 | 13 | 44 | 30 | 141 | 125 | 16 | 10 | |||
| Solvent Control | 15 | 14 | 7 | 14 | 43 | 41 | 149 | 126 | 15 | 11 | |||
| Positive Control | 360 | 843 | 37 | 47 | 279 | 146 | 870 | 767 | 537 | 50 | |||
| 3.3 | / | / | / | / | / | / | / | / | 19 | 8 | |||
| 10 | / | / | / | / | / | / | / | / | 43 | 15 | |||
| 33.3 | 21 | 34 | 16 | 30 | 35 | 53 | 718 | 775 | 28 | 27 | |||
| 66.6 | / | 17 | / | 31 | / | 173 | / | 1083 | 9 | 12 | |||
| 100 | 7 | 9 | 26 | 23 | 72 | 161 | 303 | 1086 | 6 | 20 | |||
| 166.6 | / | 6 | / | 12 | / | 92 | / | 245 | 6 | 12 | |||
| 333.3 | 0 | 3 | 6 | 19 | 54 | 195 | 895 | 272 | / | / | |||
| 1000 | 0 | 3 | 0 | 3 | 38 | 127 | 230 | 42 | / | / | |||
| 2500 | 0 | / | 0 | / | 26 | / | 76 | / | / | / | |||
| 5000 | 10 | / | 0 | / | 30 | / | 65 | / | / | / | |||
/= not performed
| Table 2: Summary of Results with S9 mix | |||||||||||||
| Revertants/plate | |||||||||||||
| mean from three plates | |||||||||||||
| Concentration µg/plate |
TA 1535 | TA 1537 | TA 98 | TA 100 | TA 1535 | TA 1537 | |||||||
| I | II | I | II | I | II | I | II | IIa | Iia | ||||
| Negative Control | 16 | 19 | 6 | 21 | 48 | 43 | 147 | 149 | 12 | 16 | |||
| Solvent Control | 20 | 16 | 7 | 18 | 50 | 46 | 155 | 168 | 15 | 19 | |||
| Positive Control | 221 | 372 | 261 | 149 | 629 | 849 | 899 | 1209 | 206 | 126 | |||
| 3.3 | / | / | / | / | / | / | / | / | 17 | 19 | |||
| 10 | / | / | / | / | / | / | / | / | 20 | 21 | |||
| 33.3 | 47 | 70 | 26 | 35 | 51 | 158 | 192 | 209 | 74 | 38 | |||
| 66.6 | / | 63 | / | 37 | / | 129 | / | 318 | 17 | 39 | |||
| 100 | 12 | 13 | 15 | 38 | 39 | 176 | 308 | 428 | 12 | 41 | |||
| 166.6 | / | 7 | / | 13 | / | 280 | / | 620 | 8 | 17 | |||
| 333.3 | 0 | 4 | 7 | 11 | 52 | 284 | 472 | 444 | / | / | |||
| 1000 | 0 | 1 | 0 | 10 | 44 | 311 | 293 | 164 | / | / | |||
| 2500 | 0 | / | 0 | / | 23 | / | 176 | / | / | / | |||
| 5000 | 0 | / | 0 | / | 26 | / | 181 | / | / | / | |||
| Table 1: Summary of Results without S9 mix | |||||||||||||
| Revertants/plate | |||||||||||||
| mean from three plates | |||||||||||||
| Concentration µg/plate |
TA 1535 | TA 1537 | TA 98 | TA 100 | TA 1535 | TA 1537 | |||||||
| I | II | I | II | I | II | I | II | IIa | Iia | ||||
| Negative Control | 17 | 17 | 5 | 13 | 44 | 30 | 141 | 125 | 16 | 10 | |||
| Solvent Control | 15 | 14 | 7 | 14 | 43 | 41 | 149 | 126 | 15 | 11 | |||
| Positive Control | 360 | 843 | 37 | 47 | 279 | 146 | 870 | 767 | 537 | 50 | |||
| 3.3 | / | / | / | / | / | / | / | / | 19 | 8 | |||
| 10 | / | / | / | / | / | / | / | / | 43 | 15 | |||
| 33.3 | 21 | 34 | 16 | 30 | 35 | 53 | 718 | 775 | 28 | 27 | |||
| 66.6 | / | 17 | / | 31 | / | 173 | / | 1083 | 9 | 12 | |||
| 100 | 7 | 9 | 26 | 23 | 72 | 161 | 303 | 1086 | 6 | 20 | |||
| 166.6 | / | 6 | / | 12 | / | 92 | / | 245 | 6 | 12 | |||
| 333.3 | 0 | 3 | 6 | 19 | 54 | 195 | 895 | 272 | / | / | |||
| 1000 | 0 | 3 | 0 | 3 | 38 | 127 | 230 | 42 | / | / | |||
| 2500 | 0 | / | 0 | / | 26 | / | 76 | / | / | / | |||
| 5000 | 10 | / | 0 | / | 30 | / | 65 | / | / | / | |||
/= not performed
| Table 2: Summary of Results with S9 mix | |||||||||||||
| Revertants/plate | |||||||||||||
| mean from three plates | |||||||||||||
| Concentration µg/plate |
TA 1535 | TA 1537 | TA 98 | TA 100 | TA 1535 | TA 1537 | |||||||
| I | II | I | II | I | II | I | II | IIa | Iia | ||||
| Negative Control | 16 | 19 | 6 | 21 | 48 | 43 | 147 | 149 | 12 | 16 | |||
| Solvent Control | 20 | 16 | 7 | 18 | 50 | 46 | 155 | 168 | 15 | 19 | |||
| Positive Control | 221 | 372 | 261 | 149 | 629 | 849 | 899 | 1209 | 206 | 126 | |||
| 3.3 | / | / | / | / | / | / | / | / | 17 | 19 | |||
| 10 | / | / | / | / | / | / | / | / | 20 | 21 | |||
| 33.3 | 47 | 70 | 26 | 35 | 51 | 158 | 192 | 209 | 74 | 38 | |||
| 66.6 | / | 63 | / | 37 | / | 129 | / | 318 | 17 | 39 | |||
| 100 | 12 | 13 | 15 | 38 | 39 | 176 | 308 | 428 | 12 | 41 | |||
| 166.6 | / | 7 | / | 13 | / | 280 | / | 620 | 8 | 17 | |||
| 333.3 | 0 | 4 | 7 | 11 | 52 | 284 | 472 | 444 | / | / | |||
| 1000 | 0 | 1 | 0 | 10 | 44 | 311 | 293 | 164 | / | / | |||
| 2500 | 0 | / | 0 | / | 23 | / | 176 | / | / | / | |||
| 5000 | 0 | / | 0 | / | 26 | / | 181 | / | / | / | |||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Only limited data was available for the target substance. Thus, available data from the chloride version of the test item was used in a read-across approach. For justification of read-across please refer to the read-across report attached to IUCLID section 13.
Genotoxicity of the test item was assessed in an in vitro testing battery under GLP (OECD 471, OECD 473 and OECD 476). The source substance was not genotoxic in an OECD 473 in vitro chromosome aberration test, but was tested positive in a bacterial reverse mutation assay (OECD 471). In an in vitro mammalian mutagenicity test (OECD 476) the target substance was tested negative. Based on the result of the higher tier mammalian cell assay for mutagenicity (OECD 476) and the overall evaluation of the available data in a weight-of-evidence approach the target substance is considered to be non-mutagenic.
Justification for classification or non-classification
Based on the available data on the test item an on a suitable read-across partner, the target substance does not warrant classification for mutagenicity.
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.
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