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EC number: 627-132-7 | CAS number: 1227096-04-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
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- Particle size distribution (Granulometry)
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- 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
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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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:
- From 02-17-1988 to 03-03-1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Reliability scoring based on 1997 guideline for test n°471
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- EC Number:
- 627-132-7
- Cas Number:
- 1227096-04-9
- Molecular formula:
- No molecular formula
- IUPAC Name:
- N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- Test material form:
- solid
- Remarks:
- resin
- Details on test material:
- - Chemical name: N-decyl-N-methyldecan-1-amine
- EC number: 627-132-7
“Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree by each registrant.”
Constituent 1
Method
- Target gene:
- In Salmonella typhimurium: ability to synthetise histidine after mutation
in E. Coli WP2uvra: ability to synthetise Tryptophane after mutation
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA1537, TA1538, TA98 and TA100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (liver post mitochondrial fraction of rats induced with Aroclor 1254)
- Test concentrations with justification for top dose:
- - First mutagenicity experiment with and without S9 mix: 4, 20, 100, 500, 2500 and 5000 µg/plate
- Second mutagenicity experiment with and without S9 mix: 4, 20, 100, 500, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: see table 1
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- In agar (plate incorporation): first mutagenicity and second mutagenicity tests with or without S9 mix
- Exposure duration: 48h to 72h
SELECTION AGENT (mutation assays): agar containing traces of histidine and biotin, maintained at 45°C for Salmonella strains.
agar containing traces of tryptophan and biotin, maintained at 45°C for Escherichia coli.
NUMBER OF REPLICATIONS: two independent mutagenicity experiments each using three plates/dose-level
DETERMINATION OF CYTOTOXICITY
- Method: the evaluation of the toxicity was based on the decrease in the number of revertant colonies and/or thinning of the bacterial lawn. - Evaluation criteria:
- After incubation for 48 to 72 hour at 37 °C in the dark, colonies were counted
- Statistics:
- No statistical analysis performed
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Tested up to limit concentrations recommended by the test guideline
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Tested up to limit concentrations recommended by the test guideline
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Tested up to limit concentrations recommended by the test guideline
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Tested up to limit concentrations recommended by the test guideline
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Tested up to limit concentrations recommended by the test guideline
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Tested up to limit concentrations recommended by the test guideline
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
- The number of revertants for the vehicle and positive controls were as specified in the acceptance criteria. The study was therefore considered as valid.
- Since the test item was freely soluble and non-toxic in the preliminary test, the highest dose-level was 5000 µg/plate, according to the criteria specified in the international guidelines.
- No precipitate was observed in the petri plates when scoring the revertants at any of the tested dose-levels.
- No toxicity was noted at any dose-level in any strain.
- The test item did not induce any noteworthy increase in the number of revertants, in any of the strains, either with or without S9 mix.
- Table: Detailed results for the two mutagenicity test performed with six bacterial strains for six concentrations of the test Genamin SH301
as well as the vehicle and positive control.
Strain | Compound | First mutagenicity test | Second mutagenicity test | ||||||
Dose level (µg/plate) | S9 mix | Revertant colony count | Dose level (µg/plate) | S9 mix | Revertant colony count | ||||
Mean | Mean | ||||||||
TA 98 | DMSO | 0 | without | 20 | 0 | without | 23 | ||
Genamin SH301 | 4 | without | 20 | 4 | without | 25 | |||
Genamin SH301 | 20 | without | 24 | 20 | without | 23 | |||
Genamin SH301 | 100 | without | 20 | 100 | without | 20 | |||
Genamin SH301 | 500 | without | 23 | 500 | without | 23 | |||
Genamin SH301 | 2500 | without | 21 | 2500 | without | 21 | |||
Genamin SH301 | 5000 | without | 25 | 5000 | without | 29 | |||
2 -nitrofluorene | 2.5 | without | 391 | 2.5 | without | 357 | |||
DMSO | 0 | with | 31 | 0 | with | 29 | |||
Genamin SH301 | 4 | with | 38 | 4 | with | 25 | |||
Genamin SH301 | 20 | with | 31 | 20 | with | 25 | |||
Genamin SH301 | 100 | with | 34 | 100 | with | 29 | |||
Genamin SH301 | 500 | with | 31 | 500 | with | 20 | |||
Genamin SH301 | 2500 | with | 30 | 2500 | with | 29 | |||
Genamin SH301 | 5000 | with | 35 | 5000 | with | 36 | |||
2 -aminoanthracene | 0.5 | with | 390 | 0.5 | with | 441 | |||
Benzo(a)pyrene | 10 | with | 682 | 10 | with | 689 |
Strain | Compound | First mutagenicity test | Second mutagenicity test | ||||||
Dose level (µg/plate) | S9 mix | Revertant colonycount | Dose level (µg/plate) | S9 mix | Revertant colonycount | ||||
Mean | Mean | ||||||||
TA 100 | DMSO | 0 | without | 155 | 0 | without | 180 | ||
Genamin SH301 | 4 | without | 173 | 4 | without | 170 | |||
Genamin SH301 | 20 | without | 174 | 20 | without | 172 | |||
Genamin SH301 | 100 | without | 156 | 100 | without | 167 | |||
Genamin SH301 | 500 | without | 162 | 500 | without | 187 | |||
Genamin SH301 | 2500 | without | 173 | 2500 | without | 200 | |||
Genamin SH301 | 5000 | without | 155 | 5000 | without | 194 | |||
Sodium azide | 1 | without | 613 | 1 | without | 620 | |||
DMSO | 0 | with | 182 | 0 | with | 194 | |||
Genamin SH301 | 4 | with | 168 | 4 | with | 182 | |||
Genamin SH301 | 20 | with | 171 | 20 | with | 171 | |||
Genamin SH301 | 100 | with | 165 | 100 | with | 165 | |||
Genamin SH301 | 500 | with | 168 | 500 | with | 172 | |||
Genamin SH301 | 2500 | with | 172 | 2500 | with | 214 | |||
Genamin SH301 | 5000 | with | 232 | 5000 | with | 230 | |||
2 -aminoanthracene | 0.5 | with | 584 | 0.5 | with | 760 | |||
Benzo(a)pyrene | 10 | with | 621 | 10 | with | 630 |
Strain | Compound | First mutagenicity test | Second mutagenicity test | ||||||
Dose level (µg/plate) | S9 mix | Revertant colony count | Dose level (µg/plate) | S9 mix | Revertant colony count | ||||
Mean | Mean | ||||||||
TA 1537 | DMSO | 0 | without | 9 | 0 | without | 8 | ||
Genamin SH301 | 4 | without | 11 | 4 | without | 8 | |||
Genamin SH301 | 20 | without | 10 | 20 | without | 7 | |||
Genamin SH301 | 100 | without | 8 | 100 | without | 6 | |||
Genamin SH301 | 500 | without | 7 | 500 | without | 9 | |||
Genamin SH301 | 2500 | without | 10 | 2500 | without | 5 | |||
Genamin SH301 | 5000 | without | 10 | 5000 | without | 9 | |||
9-aminoacridine | 50 | without | 146 | 50 | without | 184 | |||
DMSO | 0 | with | 9 | 0 | with | 11 | |||
Genamin SH301 | 4 | with | 9 | 4 | with | 9 | |||
Genamin SH301 | 20 | with | 10 | 20 | with | 7 | |||
Genamin SH301 | 100 | with | 10 | 100 | with | 15 | |||
Genamin SH301 | 500 | with | 9 | 500 | with | 5 | |||
Genamin SH301 | 2500 | with | 7 | 2500 | with | 8 | |||
Genamin SH301 | 5000 | with | 13 | 5000 | with | 10 | |||
2 -aminoanthracene | 1 | with | 98 | 1 | with | 64 | |||
Benzo(a)pyrene | 10 | with | 122 | 10 | with | 116 |
Strain | Compound | First mutagenicity test | Second mutagenicity test | ||||||
Dose level (µg/plate) | S9 mix | Revertant colony count | Dose level (µg/plate) | S9 mix | Revertant colony count | ||||
Mean | Mean | ||||||||
TA 1538 | DMSO | 0 | without | 10 | 0 | without | 10 | ||
Genamin SH301 | 4 | without | 11 | 4 | without | 12 | |||
Genamin SH301 | 20 | without | 16 | 20 | without | 16 | |||
Genamin SH301 | 100 | without | 12 | 100 | without | 9 | |||
Genamin SH301 | 500 | without | 12 | 500 | without | 12 | |||
Genamin SH301 | 2500 | without | 13 | 2500 | without | 14 | |||
Genamin SH301 | 5000 | without | 15 | 5000 | without | 15 | |||
2 -nitrofluorene | 2.5 | without | 468 | 2.5 | without | 397 | |||
DMSO | 0 | with | 15 | 0 | with | 20 | |||
Genamin SH301 | 4 | with | 15 | 4 | with | 17 | |||
Genamin SH301 | 20 | with | 17 | 20 | with | 22 | |||
Genamin SH301 | 100 | with | 22 | 100 | with | 17 | |||
Genamin SH301 | 500 | with | 12 | 500 | with | 21 | |||
Genamin SH301 | 2500 | with | 20 | 2500 | with | 20 | |||
Genamin SH301 | 5000 | with | 21 | 5000 | with | 20 | |||
2 -aminoanthracene | 0.5 | with | 488 | 0.5 | with | 453 | |||
Benzo(a)pyrene | 10 | with | 212 | 10 | with | 194 |
Strain | Compound | First mutagenicity test | Second mutagenicity test | ||||||
Dose level (µg/plate) | S9 mix | Revertant colony count | Dose level (µg/plate) | S9 mix | Revertant colony count | ||||
Mean | Mean | ||||||||
TA 1535 | DMSO | 0 | without | 16 | 0 | without | 11 | ||
Genamin SH301 | 4 | without | 13 | 4 | without | 16 | |||
Genamin SH301 | 20 | without | 17 | 20 | without | 18 | |||
Genamin SH301 | 100 | without | 15 | 100 | without | 15 | |||
Genamin SH301 | 500 | without | 10 | 500 | without | 19 | |||
Genamin SH301 | 2500 | without | 13 | 2500 | without | 17 | |||
Genamin SH301 | 5000 | without | 11 | 5000 | without | 20 | |||
Sodium azide | 1 | without | 388 | 1 | without | 401 | |||
DMSO | 0 | with | 15 | 0 | with | 8 | |||
Genamin SH301 | 4 | with | 9 | 4 | with | 9 | |||
Genamin SH301 | 20 | with | 12 | 20 | with | 5 | |||
Genamin SH301 | 100 | with | 12 | 100 | with | 11 | |||
Genamin SH301 | 500 | with | 8 | 500 | with | 6 | |||
Genamin SH301 | 2500 | with | 12 | 2500 | with | 10 | |||
Genamin SH301 | 5000 | with | 15 | 5000 | with | 12 | |||
2 -aminoanthracene | 1 | with | 169 | 1 | with | 139 | |||
Benzo(a)pyrene | 10 | with | 19 | 10 | with | 17 |
Strain | Compound | First mutagenicity test | Second mutagenicity test | ||||||
Dose level (µg/plate) | S9 mix | Revertant colony count | Dose level (µg/plate) | S9 mix | Revertant colony count | ||||
Mean | Mean | ||||||||
WP2uvrA | DMSO | 0 | without | 80 | 0 | without | 99 | ||
Genamin SH301 | 4 | without | 87 | 4 | without | 99 | |||
Genamin SH301 | 20 | without | 80 | 20 | without | 93 | |||
Genamin SH301 | 100 | without | 81 | 100 | without | 106 | |||
Genamin SH301 | 500 | without | 73 | 500 | without | 112 | |||
Genamin SH301 | 2500 | without | 73 | 2500 | without | 110 | |||
Genamin SH301 | 5000 | without | 89 | 5000 | without | 117 | |||
MNNG | 2.5 | without | 277 | 2.5 | without | 316 | |||
DMSO | 0 | with | 89 | 0 | with | 90 | |||
Genamin SH301 | 4 | with | 85 | 4 | with | 91 | |||
Genamin SH301 | 20 | with | 90 | 20 | with | 87 | |||
Genamin SH301 | 100 | with | 85 | 100 | with | 86 | |||
Genamin SH301 | 500 | with | 93 | 500 | with | 104 | |||
Genamin SH301 | 2500 | with | 81 | 2500 | with | 88 | |||
Genamin SH301 | 5000 | with | 86 | 5000 | with | 99 | |||
2 -aminoanthracene | 10 | with | 458 | 10 | with | 318 | |||
Benzo(a)pyrene | 10 | with | 125 | 10 | with | 159 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under these experimental conditions, no noteworthy increase in the number of revertants was observed towards all the strains used, both with and without S9 mix. Genamin SH301 did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and Escherichia Coli WP2uvrA. - Executive summary:
The potential of Genamin SH 301 to induce reverse mutation in bacteria was assessed using five strains of Salmonella typhimurium and Escherichia coli Wp2uvrA according to a method comparable to OECD guideline 471. The study was conducted in compliance with the principles of Good Laboratory Practice.
A preliminary toxicity test was performed to define the dose-levels of Genamin SH 301 to be used for the mutagenicity study. The test item was then tested in two independent experiments, both with and without a metabolic activation system, the S9 mix, prepared from a liver post-mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254.
Both experiments were performed according to the direct plate incorporation method.
The five strains of bacteriaSalmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 1538 were exposed to the following dose-levels of Genamin SH 301 (three plates/dose-level):
- 4, 20, 100, 500, 2500 and 5000 µg/plate, for the first and the second mutagenicity experiments with and without S9 mix,
After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored. The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid.
No precipitate was observed in the petri plates when scoring the revertants at all dose-levels.
No toxicity was noted towards all the strains used, both with and without S9 mix.
The test item did not induce any significant increase in the number of revertants, both with or without S9 mix, in any of the five strains of Salmonella typhimurium and Escherichia coli WP2uvrA.
Under these experimental conditions Genamin SH 301 did not show any mutagenic activity in the bacterial reverse mutation test .
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