Registration Dossier
Registration Dossier
Diss Factsheets
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: 202-394-1 | CAS number: 95-14-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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
- Sensitisation
- 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

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guidance study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,2,3-Benzotriazole
- IUPAC Name:
- 1,2,3-Benzotriazole
- Reference substance name:
- Benzotriazole
- EC Number:
- 202-394-1
- EC Name:
- Benzotriazole
- Cas Number:
- 95-14-7
- Molecular formula:
- C6H5N3
- IUPAC Name:
- benzotriazole
- Test material form:
- other: needles
- Details on test material:
- - Name of test material (as cited in study report): 1,2,3-Benzotriazole
- Physical state: solid
- Analytical purity: 99.87 %
- Lot/batch No.: 111254 / 112649
- Expiration date of the lot/batch: Nov. 2012
- Storage condition of test material: 20 +- 5°C
Constituent 1
Constituent 2
Method
- Target gene:
- his-
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102, TA1535
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- first experiment
50/150/500/1501/5003 µg/plate
second experiment
313/625/1250/2500/5000 µg/plate - Vehicle / solvent:
- Dimethylsulfoxide (DMSO)
DMSO is chosen because 1H-benzotriazole is completly soluble and the vehicle does not have any effects on the viability of the bacetria.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylenediamine; 2-Amino-anthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) with and without preincubation
DURATION
- Preincubation period: 20 min
NUMBER OF REPLICATIONS: 4 - Evaluation criteria:
- The colonies were counted visually.
The increase factor f(I) of revertant induction and the absolute number ov refertants were calculated.
If a significant, reproducible increase of revertant colonies (f(I) > 2) can be observed, 1H-benzotriazole is considered mutagenic. - Statistics:
- mean values and standard deviations of each treatment, solvent control and positive control are calculated. Calculations were performed with unrounded values
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA:
The negative, vehicle and positive controls were compared to historical data and
found to be in the range of this data. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table: Mean revertants first experiment
Strain | TA97a | TA98 | TA100 | TA102 | TA1535 | ||||||
Induction | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
H2O | Mean | 118 | 121 | 15 | 19 | 90 | 101 | 145 | 144 | 16 | 17 |
sd | 8 | 6 | 3 | 2 | 9 | 9 | 9 | 20 | 3 | 2 | |
DMSO | Mean | 126 | 121 | 19 | 20 | 97 | 94 | 127 | 140 | 17 | 15 |
sd | 9 | 7 | 3 | 3 | 12 | 14 | 9 | 8 | 2 | 3 | |
Positive controls | Mean | 563 | 562 | 236 | 220 | 452 | 470 | 583 | 631 | 193 | 186 |
sd | 69 | 37 | 34 | 12 | 41 | 26 | 102 | 66 | 13 | 14 | |
f(I) | 4.47 | 4.64 | 12.42 | 11.00 | 5.02 | 5.00 | 4.59 | 4.51 | 12.06 | 12.40 | |
5003 µg/pl. | Mean | 107 | 125 | 18 | 15 | 99 | 102 | 149 | 141 | 16 | 14 |
sd | 5 | 4 | 2 | 4 | 18 | 6 | 10 | 9 | 5 | 1 | |
f(I) | 0.85 | 1.03 | 0.95 | 0.75 | 1.02 | 1.09 | 1.17 | 1.01 | 0.94 | 0.93 | |
1501 µg/pl. | Mean | 123 | 124 | 17 | 16 | 103 | 103 | 143 | 146 | 17 | 17 |
sd | 10 | 5 | 2 | 4 | 11 | 7 | 7 | 7 | 3 | 2 | |
f(I) | 0.98 | 1.02 | 0.89 | 0.80 | 1.06 | 1.10 | 1.13 | 1.04 | 1.00 | 1.13 | |
500 µg/pl. | Mean | 120 | 118 | 15 | 16 | 89 | 110 | 139 | 130 | 15 | 14 |
sd | 5 | 10 | 5 | 1 | 8 | 3 | 16 | 11 | 4 | 1 | |
f(I) | 0.95 | 0.98 | 0.79 | 0.80 | 0.92 | 1.17 | 1.09 | 0.93 | 0.88 | 0.93 | |
150 µg/pl. | Mean | 116 | 121 | 14 | 18 | 88 | 101 | 136 | 141 | 15 | 15 |
sd | 3 | 7 | 1 | 3 | 21 | 10 | 5 | 11 | 2 | 1 | |
f(I) | 0.92 | 1.00 | 0.74 | 0.90 | 0.91 | 1.07 | 1.07 | 1.01 | 0.88 | 1.00 | |
50 µg/pl. | Mean | 119 | 108 | 16 | 20 | 83 | 97 | 137 | 128 | 15 | 15 |
sd | 5 | 7 | 3 | 3 | 19 | 6 | 4 | 15 | 2 | 2 | |
f(I) | 0.94 | 0.89 | 0.84 | 1.00 | 0.86 | 1.03 | 1.08 | 0.91 | 0.88 | 1.00 |
Table: Mean revertants second experiment
Strain | TA97a | TA98 | TA100 | TA102 | TA1535 | ||||||
Induction | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
H2O | Mean | 118 | 117 | 15 | 15 | 100 | 87 | 166 | 153 | 16 | 15 |
sd | 4 | 3 | 3 | 1 | 8 | 10 | 14 | 11 | 2 | 2 | |
DMSO | Mean | 117 | 115 | 18 | 16 | 98 | 96 | 149 | 154 | 18 | 16 |
sd | 3 | 6 | 3 | 1 | 3 | 3 | 23 | 7 | 3 | 2 | |
Positive controls | Mean | 517 | 592 | 217 | 222 | 416 | 473 | 621 | 611 | 210 | 241 |
sd | 71 | 13 | 12 | 15 | 38 | 26 | 25 | 43 | 10 | 13 | |
f(I) | 4.42 | 5.15 | 12.06 | 13.88 | 4.16 | 4.93 | 4.17 | 3.97 | 13.13 | 15.06 | |
5002 µg/pl. | Mean | 104 | 112 | 15 | 14 | 95 | 93 | 139 | 146 | 15 | 14 |
sd | 7 | 7 | 2 | 3 | 7 | 7 | 12 | 5 | 2 | 3 | |
f(I) | 0.89 | 0.97 | 0.83 | 0.88 | 0.97 | 0.97 | 0.93 | 0.95 | 0.83 | 0.88 | |
2501 µg/pl. | Mean | 112 | 113 | 14 | 15 | 84 | 79 | 145 | 157 | 15 | 13 |
sd | 3 | 3 | 3 | 3 | 8 | 9 | 5 | 16 | 2 | 1 | |
f(I) | 0.96 | 0.98 | 0.78 | 0.94 | 0.86 | 0.82 | 0.97 | 1.02 | 0.83 | 0.81 | |
1251 µg/pl. | Mean | 117 | 109 | 14 | 16 | 82 | 79 | 143 | 150 | 17 | 16 |
sd | 4 | 6 | 2 | 2 | 8 | 6 | 11 | 16 | 4 | 4 | |
f(I) | 1.00 | 0.95 | 0.78 | 1.00 | 0.84 | 0.82 | 0.96 | 0.97 | 0.94 | 1.00 | |
626 µg/pl. | Mean | 116 | 116 | 15 | 17 | 92 | 87 | 156 | 157 | 15 | 15 |
sd | 4 | 4 | 1 | 3 | 16 | 9 | 14 | 12 | 2 | 3 | |
f(I) | 0.99 | 1.01 | 0.83 | 1.06 | 0.94 | 0.91 | 1.05 | 1.02 | 0.83 | 0.94 | |
313 µg/pl. | Mean | 115 | 114 | 14 | 17 | 85 | 85 | 146 | 151 | 16 | 14 |
sd | 2 | 2 | 2 | 3 | 11 | 7 | 5 | 8 | 2 | 2 | |
f(I) | 0.98 | 0.99 | 0.78 | 1.06 | 0.87 | 0.89 | 0.98 | 0.98 | 0.89 | 0.88 |
Applicant's summary and conclusion
- Conclusions:
- 1H-benzotriazole did not show mutagenic effects in the two conducted experiments.
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.
