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EC number: 219-989-7 | CAS number: 2592-95-2
- 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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from SSS study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Bacterial Reverse Mutation Test of test substance in Salmonella typhimurium Tester Strains by Plate incorporation method, was conducted as per OECD guideline No. 471.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-hydroxybenzotriazole
- EC Number:
- 219-989-7
- EC Name:
- 1-hydroxybenzotriazole
- Cas Number:
- 2592-95-2
- Molecular formula:
- C6H5N3O
- IUPAC Name:
- 1H-1,2,3-benzotriazol-1-ol
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): 1-hydroxybenzotriazole- Molecular formula : C6H5N3O- Molecular weight : 135.126 g/mol- Substance type:Organic- Physical state:Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of the test material: 1-hydroxybenzotriazol
- Molecular formula: C6H5N3O
- Molecular weight: 135.126 g/mol
- Substance type: Organic
- Smiles: On1nnc2ccccc12
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: Tester Strains Genotypes Tester Strains his Mutation Additional Mutations Plasmid Repair LPS TA98 hisD3052 uvrB rfa pKM101 TA100 hisG46 uvrB rfa PKM101 TA1535 hisG46 uvrB rfa - TA1537 hisC3076 uvrB rfa - TA102 hisG428 - rfa pKM101 and pAQ1
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 - induced rat liver Microsomal enzymes (S9 homogenate)
- Test concentrations with justification for top dose:
- Trial 1: 0, 312.5, 625, 1250, 2500 and 5000 µg/plate
Trial 2: 0, 128, 320, 800, 2000 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Based on the solubility test dimethyl sulfoxide (Make: Sigma, Lot no.: BCBR0695V for preliminary cytotoxicity assay and Fischer scientific, Lot no.: 1967260517 for Main assay) was selected as a vehicle for the study.
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2- Aminoanthracene (TA1537, TA1535, TA102, TA100 and TA98; Without S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): No data
DURATION
- Preincubation period: No data
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: Triplicate
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: No data
NUMBER OF CELLS EVALUATED: No data
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): No data
CRITERIA FOR MICRONUCLEUS IDENTIFICATION: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: Yes, bacterial cell growth was observed
- Any supplementary information relevant to cytotoxicity: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Methods, such as kinetochore antibody binding, to characterize whether micronuclei contain whole or fragmented chromosomes (if applicable): No data
- OTHER: No data - Rationale for test conditions:
- The Bacterial reverse mutation assay is considered acceptable if the following criteria are met:
- Regular background growth in the solvent control
- The positive control substances must produce a significant increase in revertant colony frequencies
- The spontaneous reversion rates in the solvent control must be in the range of the historical data. - Evaluation criteria:
- Criteria for a Positive response:
• Tester Strains TA98, TA100 and TA102 : For a test item to be considered positive, it must produce at least a 2–fold increase in the mean revertants per plate of at least one of these tester strains over the mean revertants per plate of the appropriate vehicle control. This increase in the mean number of revertants per plate must be accompanied by a dose response (minimum of 2 to 3 concentrations) to increasing concentrations of the test item.
• Tester Strains TA1537 and TA1535 : For a test item to be considered positive, it must produce at least a 3–fold increase in the mean revertants per plate of at least one of these tester strains over the mean revertants per plate of the appropriate vehicle control. This increase in the mean number of revertants per plate must be accompanied by a dose response (minimum of 2 to 3 concentrations) to increasing concentrations of the test item.
Criteria For a Negative Response:
A test item for which the results do not meet the above criteria is considered non-mutagenic in this test. - Statistics:
- No formal hypothesis testing was performed to analyse the data.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Definition of acceptable cells for analysis: No data
- Other confounding effects: No data
RANGE-FINDING/SCREENING STUDIES: In the cytotoxicity study, the experiment was performed using tester strains TA98 and TA100 in the absence and presence of metabolic activation (5% v/v S9 mix) using plate incorporation method. Eight concentrations of test item were tested in triplicate plates along with vehicle and positive controls. The preliminary cytotoxicity assay was performed at the test concentrations of 0, 39.0625, 78.125, 156.25, 312.5, 625, 1250, 2500 and 5000 µg/plate both in the presence (5 % v/v S9 mix) and absence of a metabolic activation system along with vehicle and positive controls.
CYTOKINESIS BLOCK (if used)
- Distribution of mono-, bi- and multi-nucleated cells: No data
NUMBER OF CELLS WITH MICRONUCLEI
- Number of cells for each treated and control culture: No data
- Indication whether binucleate or mononucleate where appropriate: No data
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: Yes
- Negative (solvent/vehicle) historical control data: Yes
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: Bacterial cell growth
- Other observations when applicable: normal growth was observed in the cytotoxicity assay - Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Summary Tables
Table 1
Revertant Colonies - Cytotoxicity Test
Test Concentration (µg/plate) |
TA 98 |
TA 100 |
||||||
+ S9 |
- S9 |
+ S9 |
- S9 |
|||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
VC |
29.67 |
1.53 |
24.67 |
2.08 |
133.33 |
7.37 |
138.33 |
7.51 |
39.0625 |
28.33 |
2.08 |
24.33 |
1.53 |
129.00 |
4.36 |
137.33 |
7.09 |
78.125 |
27.33 |
2.52 |
23.67 |
1.53 |
131.67 |
6.66 |
134.00 |
2.00 |
156.25 |
26.33 |
2.52 |
23.00 |
1.00 |
130.00 |
6.56 |
133.33 |
6.66 |
312.5 |
27.00 |
4.36 |
21.33 |
3.06 |
128.33 |
3.51 |
131.33 |
2.52 |
625 |
26.00 |
5.57 |
23.33 |
3.06 |
125.33 |
9.45 |
130.00 |
7.81 |
1250 |
25.67 |
4.73 |
22.00 |
2.00 |
123.33 |
5.51 |
128.00 |
6.24 |
2500 |
25.33 |
4.04 |
21.67 |
3.51 |
123.00 |
14.73 |
127.00 |
6.08 |
5000 |
26.67 |
2.52 |
19.33 |
3.51 |
118.67 |
3.51 |
124.00 |
8.72 |
PC |
450.67 |
42.72 |
394.67 |
11.68 |
891.67 |
10.50 |
875.67 |
22.19 |
Key: SD = Standard Deviation, µg = Microgram, VC = Vehicle Control, PC = Positive Control,
+ S9 = Presence of S9, - S9 = Absence of S9, S9 = Rat liver Homogenate at 9000g.
Table 2
Revertant Colonies – Trial I
Plate Incorporation Method [Absence of metabolic activation (-S9)] |
||||||||||
Test Concentration (µg/plate) |
TA 1537 |
TA 1535 |
TA 102 |
TA 98 |
TA 100 |
|||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
VC |
10.67 |
5.51 |
14.67 |
2.52 |
223.67 |
2.52 |
24.67 |
2.08 |
138.33 |
7.51 |
312.5 |
5.00 |
2.00 |
13.00 |
2.65 |
220.33 |
3.21 |
21.33 |
3.06 |
131.33 |
2.52 |
625 |
7.67 |
2.08 |
13.33 |
1.15 |
218.00 |
6.24 |
23.33 |
3.06 |
130.00 |
7.81 |
1250 |
7.00 |
1.00 |
11.33 |
4.16 |
218.33 |
6.03 |
22.00 |
2.00 |
128.00 |
6.24 |
2500 |
7.33 |
1.53 |
8.00 |
2.00 |
215.67 |
5.69 |
21.67 |
3.51 |
127.00 |
6.08 |
5000 |
6.33 |
2.31 |
12.67 |
2.52 |
213.33 |
5.51 |
19.33 |
3.51 |
124.00 |
8.72 |
PC |
216.33 |
23.35 |
315.33 |
20.84 |
922.33 |
11.02 |
394.67 |
11.68 |
875.67 |
22.19 |
PC 2Aa |
NA |
NA |
14.00 |
2.00 |
NA |
NA |
NA |
NA |
NA |
NA |
Plate Incorporation Method [Presence of metabolic activation (+S9 5% v/v S9 Mix)] |
||||||||||
Test Concentration (µg/plate) |
TA 1537 |
TA 1535 |
TA 102 |
TA 98 |
TA 100 |
|||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
VC |
6.33 |
1.53 |
15.33 |
2.08 |
228.00 |
4.58 |
29.67 |
1.53 |
133.33 |
7.37 |
312.5 |
6.00 |
2.65 |
14.00 |
2.00 |
225.33 |
3.21 |
27.00 |
4.36 |
128.33 |
3.51 |
625 |
5.33 |
0.58 |
13.00 |
2.00 |
224.33 |
8.33 |
26.00 |
5.57 |
125.33 |
9.45 |
1250 |
9.33 |
2.08 |
14.33 |
2.52 |
218.67 |
6.03 |
25.67 |
4.73 |
123.33 |
5.51 |
2500 |
9.33 |
1.53 |
13.67 |
2.08 |
222.00 |
7.81 |
25.33 |
4.04 |
123.00 |
14.73 |
5000 |
8.67 |
4.51 |
13.33 |
2.08 |
217.00 |
6.00 |
26.67 |
2.52 |
118.67 |
3.51 |
PC |
254.00 |
11.79 |
369.67 |
16.26 |
968.67 |
15.95 |
450.67 |
42.72 |
891.67 |
10.50 |
Key: SD = Standard Deviation, µg = Microgram, VC = Vehicle Control, PC = Positive Control,
+ S9 = Presence of S9, - S9 = Absence of S9, S9 = Rat liver Homogenate at 9000g,PC 2Aa = S9 Efficiency check in absence of metabolic activation with 2 Aminoanthracene, NA = Not Applicable.
Table 3
Revertant Colonies -Trial II
Plate Incorporation Method [Presence of metabolic activation (+S9 10% v/v S9 Mix)] |
||||||||||
Test Concentration (µg/plate) |
TA 1537 |
TA 1535 |
TA 102 |
TA 98 |
TA 100 |
|||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
VC |
9.33 |
0.58 |
13.67 |
0.58 |
254.67 |
25.74 |
28.33 |
2.52 |
135.33 |
11.68 |
128 |
7.00 |
1.73 |
12.33 |
1.53 |
253.67 |
25.01 |
27.33 |
3.21 |
131.67 |
2.08 |
320 |
6.33 |
1.53 |
11.67 |
2.08 |
250.33 |
12.86 |
26.33 |
4.51 |
134.67 |
8.08 |
800 |
7.67 |
1.15 |
10.00 |
1.00 |
248.67 |
7.02 |
27.33 |
1.15 |
131.67 |
6.51 |
2000 |
6.67 |
1.15 |
11.33 |
1.15 |
234.00 |
8.19 |
26.33 |
1.53 |
129.67 |
4.73 |
5000 |
6.00 |
1.00 |
10.33 |
1.15 |
231.33 |
11.68 |
25.00 |
1.00 |
125.33 |
7.02 |
PC |
243.67 |
7.09 |
350.67 |
7.57 |
901.00 |
20.66 |
445.33 |
9.07 |
873.67 |
27.57 |
PC 2Aa |
NA |
NA |
17.33 |
1.53 |
NA |
NA |
NA |
NA |
NA |
NA |
Key: SD = Standard Deviation, µg =
Microgram, VC = Vehicle Control, PC = Positive
Control, + S9 = Presence of S9, S9 = Rat liver
Homogenate at 9000g,PC 2Aa = S9 Efficiency check
in absence of metabolic activation with 2 Aminoanthracene, NA
= Not Applicable.
Table
4 Fold Increase
Trial I - Presence of metabolic activation (+S9 5% v/v S9 Mix) |
||||||||||
Test Concentration (µg/plate) |
TA 1537 |
TA 1535 |
TA 102 |
TA 98 |
TA 100 |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
312.5 |
0.47 |
0.95 |
0.89 |
0.91 |
0.99 |
0.99 |
0.86 |
0.91 |
0.95 |
0.96 |
625 |
0.72 |
0.84 |
0.91 |
0.85 |
0.97 |
0.98 |
0.95 |
0.88 |
0.94 |
0.94 |
1250 |
0.66 |
1.47 |
0.77 |
0.93 |
0.98 |
0.96 |
0.89 |
0.87 |
0.93 |
0.93 |
2500 |
0.69 |
1.47 |
0.55 |
0.89 |
0.96 |
0.97 |
0.88 |
0.85 |
0.92 |
0.92 |
5000 |
0.59 |
1.37 |
0.86 |
0.87 |
0.95 |
0.95 |
0.78 |
0.90 |
0.90 |
0.89 |
PC |
20.28 |
40.11 |
21.50 |
24.11 |
4.12 |
4.25 |
16.00 |
15.19 |
6.33 |
6.69 |
Trial II – Presence of metabolic activation (+S910% v/v S9 mix)
Test Concentration (µg/plate) |
TA1537 |
TA1535 |
TA 100 |
TA 102 |
TA 98 |
128 |
0.75 |
0.90 |
0.97 |
1.00 |
0.96 |
320 |
0.68 |
0.85 |
1.00 |
0.98 |
0.93 |
800 |
0.82 |
0.73 |
0.97 |
0.98 |
0.96 |
2000 |
0.71 |
0.83 |
0.96 |
0.92 |
0.93 |
5000 |
0.64 |
0.76 |
0.93 |
0.91 |
0.88 |
PC |
26.11 |
25.66 |
6.46 |
3.54 |
15.72 |
Key: µg = Microgram, PC = Positive Control
Table 5
Tester Strain Genotype Confirmation
Selective Media Plates |
Details of Observation in Tester Strains |
||||
TA1537 |
TA1535 |
TA98 |
TA100 |
TA102 |
|
Crystal Violet (rfamarker) |
Zone of Inhibition |
Zone of Inhibition |
Zone of Inhibition |
Zone of Inhibition |
Zone of Inhibition |
Ampicillin (pKM101 Plasmid) |
No Growth Observed |
No Growth Observed |
Growth Observed |
Growth Observed |
Growth Observed |
Tetracycline (pAQ1 Plasmid) |
No Growth Observed |
No Growth Observed |
No Growth Observed |
No Growth Observed |
Growth Observed |
Histidine Dependence |
No Growth Observed |
No Growth Observed |
No Growth Observed |
No Growth Observed |
No Growth Observed |
Biotin Dependence |
No Growth Observed |
No Growth Observed |
No Growth Observed |
No Growth Observed |
Growth Observed |
Histidine-Biotin Dependence |
Growth Observed |
Growth Observed |
Growth Observed |
Growth Observed |
Growth Observed |
UvrB |
No Growth Observed |
No Growth Observed |
No Growth Observed |
No Growth Observed |
Growth Observed |
Applicant's summary and conclusion
- Conclusions:
- Test substance is non-mutagenic as it did not induce (point) gene mutations at histidine locus by base pair changes or frame-shift in the presence and absence of metabolic activation system in all five tester strains of Salmonella typhimurium TA1537, TA1535, TA98, TA100 and TA102.
- Executive summary:
Bacterial Reverse Mutation Test of test substance in Salmonella typhimurium Tester Strains by Plate incorporation method, was conducted at sa-FORD (Sanctuary for Research and Development), Maharashtra, India. This study was performed as per OECD guideline No. 471. Based on the solubility test, dimethyl sulfoxide was selected as a vehicle for the test item in the study. The Study was performed to evaluate the mutagenic potential of1-hydroxybenzotriazole (CAS no. 2592-95-2) using Salmonella typhimurium tester strains TA1537, TA1535, TA98, TA100 and TA102 in Trial I (with 5 % v/v S9 mix and without metabolic activation) and Trial II (10% v/v S9 mix) along with vehicle (DMSO) and positive control in triplicates. Following concentrations were used for the respective trials: Trial I: 0, 312.5, 625, 1250, 2500 and 5000 µg/plate and Trial II: 0, 128, 320, 800, 2000 and 5000 µg/plate. Trial I was performed at five test concentrations (factor 2) both in the presence (5 % v/v S9 mix) and absence of metabolic activation system along with vehicle and the positive control. There was no increase in the number of revertant colonies up to the tested concentration of 5000 µg/plate both in the presence (5% v/v S9 mix) and absence of metabolic activation, when compared to the vehicle control. Trial II was conducted to confirm the negative results observed in Trial I. For the negative confirmation, the test item concentration was modified with a spacing factor of 2.5 and concentration of metabolic activation (S9 fraction) was increased to 10% v/v. Trial II was conducted with all the tester strains along with vehicle and positive control only in the presence of metabolic activation system. There was no increase in the number of revertant colonies up to the tested concentration of 5000 µg/plate in the presence (10 % v/v S9 mix) of metabolic activation, when compared to the vehicle control. The spontaneous revertant colonies of the vehicle control were within the acceptable range of historical control data of all the tester strains. The positive controls used in the study exhibited significant increase in the mean number of revertant colonies as compared to vehicle control respective to their strains, indicating the sensitivity of the test system to specific mutagens. On the basis of the results of this study, it is concluded that test substance is non-mutagenic as it did not induce (point) gene mutations at histidine locus by base pair changes or frame-shift in the presence or absence of metabolic activation system in all the five tester strains of Salmonella typhimurium TA1537, TA1535, TA98, TA100 and TA102.
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