Registration Dossier
Registration Dossier
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: 200-300-3 | CAS number: 56-93-9
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No dates listed in report
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to guideline and/or standard method but was non-GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Benzyltrimethylammonium chloride
- EC Number:
- 200-300-3
- EC Name:
- Benzyltrimethylammonium chloride
- Cas Number:
- 56-93-9
- Molecular formula:
- C10H16N.Cl
- IUPAC Name:
- benzyltrimethylazanium chloride
- Details on test material:
- Benzyltrimethylammonium chloride was obtained from Fluka Chemical Corporation (Ronkonkoma, NY) in one lot (306793/1). Information on the identity, purity, and stability of the bulk chemical was provided by the manufacturer; identity was confirmed by the study laboratory. Reports on analyses performed in support of the benzyltrimethylammonium chloride studies are on file at the National Institute of Environmental Health Sciences.
The manufacturer identified the chemical, an off-white to yellow crystalline powder, as benzyltrimethylammonium chloride by nuclear magnetic resonance spectroscopy. The purity of lot 306793/1, determined by argentometric titration, was 100.4% or greater. The study laboratory confirmed the identity of the chemical with infrared spectroscopy. The spectrum was consistent with a literature reference for benzyltrimethylammonium bromide (Aldrich, 1990).
Based on the manufacturers stability information, the bulk chemical was stored at room temperature in sealed containers flushed with nitrogen to expel moisture.
Reference
Aldrich Catalog/Handbook of Fine Chemicals 1990-1991 (1990), p. 146. Aldrich Chemical Company, Inc., Milwaukee, WI.
Constituent 1
Method
- Target gene:
- Histidiine dependent strain of bacteria used to detect point mutations.
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA97, TA98, TA100, and TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver
- Test concentrations with justification for top dose:
- 0, 100, 333, 1000, 3333 and 10,000 ug/plate
- Vehicle / solvent:
- Not specified in report, probably water.
- Details on test system and experimental conditions:
- Benzyltrimethylammonium chloride was sent to the laboratory as a coded aliquot from Radian Corporation (Austin, TX). It was incubated with the Salmonella typhimurium tester strains TA97, TA98, TA100, and TA1535, either in buffer or S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver) for 20 minutes at 37 C. Top agar supplemented with L-histidine and d-biotin was added, and the contents of the tubes were mixed and poured onto the surfaces of minimal glucose agar plates. Histidine-independent mutant
colonies arising on these plates were counted following incubation for 2 days at 37 C.
Each trial consisted of triplicate plates of concurrent positive and negative controls and five doses of benzyltrimethylammonium chloride. In the absence of toxicity, 10,000 µg/plate was selected as the high dose. - Evaluation criteria:
- In this assay, a positive response is defined as a reproducible, dose-related increase in histidine-independent (revertant) colonies in any one strain/activation combination. An equivocal response is defined as an increase in revertants that is not dose related, is not reproducible, or is not of sufficient magnitude to support a determination of mutagenicity. A negative response is obtained when no increase in revertant colonies is observed following chemical treatment. There is no minimum percentage or fold increase required for a chemical to be judged positive or weakly positive.
- Statistics:
- Means and Standard Deviations were calculated.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA97, TA98, TA100, or TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At the two highest doses tested.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- Benzyltrimethylammonium chloride (100 to 10,000 µg/plate) was not mutagenic in Salmonella typhimurium strain TA97, TA98, TA100, or TA1535 with or without induced rat or hamster liver S9 metabolic activation enzymes (Table 1). Slight toxicity was noted at the two highest concentrations tested in all four strains.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1 Mutagenicity of Benzyltrimethylammonium Chloride in Salmonella typhimurium
| Revertants/plate b | ||||||
| Dose | -S9 | + hamster S9 | + rat S9 | |||
| (µg/plate) | Trial 1 | Trial 2 | Trial 1 | Trial 2 | Trial 1 | Trial 2 |
| Strain TA100 | ||||||
| 0 | 122 + 8.2 | 122 + 9.2 | 116 + 7.0 | 119 + 11.0 | 84 + 6.6 | 147 + 9.6 |
| 100 | 119 + 12.7 | 128 + 3.7 | 102 + 1.2 | 130 + 4.9 | 105 + 7.1 | 128 + 7.1 |
| 333 | 115 + 6.9 | 118 + 14.2 | 110 + 3.5 | 115 + 9.0 | 89 + 6.9 | 128 + 3.4 |
| 1000 | 116 + 11.7 | 116 + 8.2 | 107 + 8.1 | 113 + 5.7 | 104 + 8.7 | 136 + 2.5 |
| 3333 | 121 + 9.0c | 122 + 2.4 | 99 + 3.0 | 135 + 2.9c | 102 + 8.7 | 138 + 3.8 |
| 10,000 | 65 + 3.7c | 104 + 4.4c | 103 + 13.5c | 109 + 6.4c | 91 + 7.8 | 113 + 7.2c |
| Positive controld | 1389 + 22.6 | 1485 + 4.8 | 1125 + 21.5 | 2231 + 35.7 | 1883 + 33.0 | 702 + 16.7 |
| Strain TA1535 | ||||||
| 0 | 31 + 3.0 | 29 + 0.9 | 9 + 0.9 | 14 + 0.9 | 9 + 1.7 | 12 + 2.3 |
| 100 | 29 + 0.7 | 30 + 1.0 | 11 + 3.8 | 8 + 1.0 | 10 + 1.9 | 13 + 0.0 |
| 333 | 25 + 0.9 | 26 + 4.4 | 13 + 2.3 | 12 + 1.5 | 10 + 1.5 | 15 + 2.0 |
| 1000 | 28 + 1.5 | 37 + 2.2 | 9 + 1.2 | 10 + 1.7 | 11 + 0.7 | 11 + 0.7 |
| 3333 | 28 + 3.0c | 27 + 2.7 | 9 + 0.9 | 12 + 3.5 | 9 + 3.8 | 13 + 1.2 |
| 10,000 | 22 + 4.8c | 21 + 1.5c | 9 + 1.5c | 12 + 0.6 | 11 + 1.5c | 11 + 2.3 |
| Positive control | 1051 + 8.7 | 1095 + 18.9 | 127 + 9.0 | 323 + 17.8 | 117 + 5.0 | 130 + 13.9 |
| Strain TA97 | ||||||
| 0 | 104 + 8.4 | 121 + 3.5 | 140 + 4.1 | 170 + 8.8 | 113 + 9.7 | 181 + 5.5 |
| 100 | 113 + 7.0 | 110 + 7.4 | 143 + 0.3 | 158 + 8.8 | 126 + 12.1 | 181 + 4.2 |
| 333 | 99 + 0.9 | 114 + 3.6 | 144 + 8.0 | 156 + 1.9 | 124 + 3.5 | 155 + 9.2 |
| 1000 | 112 + 8.3 | 128 + 5.5 | 139 + 6.9 | 165 + 6.1 | 133 + 5.3 | 168 + 11.1 |
| 3333 | 95 + 2.1c | 128 + 2.9 | 130 + 7.1 | 152 + 6.0c | 129 + 2.2 | 167 + 6.4 |
| 10,000 | 92 + 5.2c | 100 + 5.6c | 131 + 2.2c | 172 + 7.8c | 110 + 4.6c | 174 + 12.8 |
| Positive control | 1626 + 161.0 | 722 + 9.3 | 511 + 17.2 | 1452 + 23.1 | 763 + 36.3 | 691 + 13.3 |
| Strain TA98 | ||||||
| 0 | 19 + 4.1 | 16 + 0.6 | 39 + 2.6 | 35 + 2.7 | 32 + 5.5 | 31 + 5.8 |
| 100 | 14 + 1.5 | 14 + 1.7 | 37 + 3.4 | 27 + 4.4 | 31 + 1.2 | 29 + 0.9 |
| 333 | 16 + 2.1 | 19 + 4.1 | 32 + 3.2 | 31 + 2.8 | 30 + 1.3 | 34 + 2.6 |
| 1000 | 17 + 2.0 | 17 + 2.4 | 36 + 2.1 | 34 + 1.2 | 35 + 1.7 | 30 + 5.8 |
| 3333 | 19 + 1.2c | 16 + 1.5 | 33 + 5.5 | 30 + 3.5 | 38 + 2.2 | 35 + 2.2 |
| 10,000 | 14 + 1.0c | 19 + 3.5c | 34 + 1.2 | 28 + 1.8 | 31 + 3.8 | 36 + 1.7c |
| Positive control | 1246 + 69.5 | 1848 + 57.8 | 1205 + 26.9 | 2210 + 28.6 | 1401 + 30.6 | 659 + 32.9 |
b Revertants are presented as mean ± standard error from three plates.
c Slight toxicity
d The positive controls in the absence of metabolic activation were sodium azide (TA100 and TA1535), 9-aminoacridine (TA97), and 4-nitro-o-phenylenediamine (TA98). The positive control for metabolic activation with all strains was 2-aminoanthracene.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Benzyltrimethylammonium chloride was not mutagenic in Salmonella typhimurium strains TA97, TA98, TA100, and TA1535, with or without S9 metabolic activation enzymes. - Executive summary:
Benzyltrimethylammonium chloride was not mutagenic in Salmonella typhimurium strains TA97, TA98, TA100, and TA1535, with or without S9 metabolic activation enzymes.
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.
