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EC number: 207-396-6 | CAS number: 467-63-0
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
p,p',p"-tris(dimethylamino)trityl alcohol [CAS No. 467-63-0] is non-mutagenic as it does not induce (point) gene mutations by base-pair changes or frameshift in the histidine operon in any of the five tester strains of Salmonella typhimurium (TA1537, TA1535, TA98, TA100 or TA102) neither in the presence nor in the absence of metabolic activation system
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17-August 2021-16-September 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study contains experimental data of the registered substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- OECD Guideline 471. OECD Guideline for Testing of Chemicals - Bacterial Reverse Mutation Test, adopted on 21 July 1997 and corrected on 26 June 2020.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
- Expiration date of the lot/batch:
- Purity test date:
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under storage conditions:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium:
- Reactivity of the test substance with the solvent/vehicle /test medium (if applicable):
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Preparation of a nanomaterial dispersion (incl. dilution):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
INFORMATION ON NANOMATERIALS
- Chemical Composition:
- Density:
- Particle size & distribution:
- Specific surface area:
- Isoelectric point:
- Dissolution (rate):
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
OTHER SPECIFICS
- measurement of pH, osmolality, and precipitate in the culture medium to which the test chemical is added:
- other information: - Target gene:
- Histidine Operon
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Remarks:
- Salmonella typhimurium is a commonly used test system for bacterial reverse mutation studies, and it is recommended by international guidelines ( OECD Guideline 471), and it meets the regulatory requirement of most regulatory agencies
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : S9 was prepared in-housed rom a combination of phenobarbitone and Beta-naphthoflavone-induced rat liver microsomal enzymes (S9 homogenate).
- method of preparation of S9 mix: S9 mix [Cofactors (Cofactor ingredients: D-glucose-6-phosphate, β-NADP, magnesium chloride, potassium chloride, sodium phosphate and Liver homogenate] was prepared prior to use in the study. The post-mitochondrial fraction (liver homogenate) was used at the concentration of 10 % (v/v) in the S9 mix.
- concentration or volume of S9 mix in the final culture medium : 0.5 ml
- quality controls of S9: Efficiency check of S9 was performed during the assay - Test concentrations with justification for top dose:
- Test concentrations: 0.0 (NC), 0.0 (VC), 0.0048828, 0.0097656, 0.01953125, 0.0390625 and 0.078125 mg/plate.
Justification: Test concentrations were selected based on a preliminary cytotoxicity test. This pretest was performed with TA98 and TA100 strains, both in the presence and absence of metabolic activation using the plate incorporation method. The following concentrations were tested in triplicates along with the negative, vehicle and positive controls: 0.0 (NC), 0.0 (VC), 0.0390625, 0.078125, 0.15625, 0.3125, 0.625, 1.25, 2.5 and 5 mg/plate. In both strains, complete inhibition of background lawn with no presence of any revertant colonies were observed at 0.3125 mg/plate, both with and without S9 metabolic activation. A substantial reduction in the number of revertant colonies accompanied by a moderate inhibition of background lawn was observed at 0.15625 mg/plate compared to the vehicle control data. A slight reduction in the number of revertant colonies accompanied by a moderate inhibition of background lawn was observed at 0.078125 mg/plate, both in the presence (10% v/v S9 mix) and absence of metabolic activation compared to vehicle control data. Hence, cconsidering the criteria that the highest test concentration should yield a decrease in the revertant colony count and/or diminution of the background lawn, 0.078125 mg/plate was selected as the highest concentration of the Test Item for the main assay - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (dimethyl sulfoxide)
- Justification for choice of solvent/vehicle: The test Item was found to be insoluble in distilled water (50 mg/ml) and found to be soluble in dimethyl sulfoxide (50 mg/ml). Hence, dimethyl sulfoxide was selected as the vehicle for the study - Untreated negative controls:
- yes
- Remarks:
- Distilled Water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: Triplicate
- Number of independent experiments : Two
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): 1 -2 ×109 bacteria/ml
- Test substance added in medium; in agar (plate incorporation); preincubation; in suspension.
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 20 minutes
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: background growth inhibition.
- Evaluation criteria:
- A Test Item is considered as a mutagen if a biologically relevant increase in the mean number of revertants exceeding the threshold of twice (strains TA98, TA100 and TA102) or thrice (strains TA1535 and TA1537) the colony count of the corresponding solvent control is observed.
A dose-dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
A dose-dependent increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent experiment.
A dose-dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent experiment. - Statistics:
- The mean number of revertant colonies and the standard deviation within the plates for each concentration were compared to the spontaneous reversion rates of the control. Microsoft Office Excel-based calculations were used for descriptive statistical analysis.
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The test Item was found to be insoluble in distilled water (50 mg/ml) - Remarks on result:
- other: No mutagenic potential observed
- Conclusions:
- Based on the results of the present study, it is concluded that p,p',p"-tris(dimethylamino)trityl alcohol [CAS No. 467-63-0] is non-mutagenic as it does not induce (point) gene mutations by base-pair changes or frameshift in the histidine operon in any of the five tester strains of Salmonella typhimurium (TA1537, TA1535, TA98, TA100 or TA102) neither in the presence nor in the absence of metabolic activation system.
- Executive summary:
The ability of the registered substance, p,p’,p”-tris(dimethylamino)trityl alcohol [CAS No. 467-63-0] to induce point mutation and/or frameshift in the histidine operon was tested in five Salmonella typhimurium tester strains (TA1537, TA1535, TA98, TA100 or TA102) in the presence and absence of an exogenous metabolic activation. The S9 fraction was obtained from rats injected with the combination of phenobarbitone and β-naphthoflavone. Test concentrations were selected based on solubility, precipitation and a preliminary cytotoxicity test. The cytotoxicity test was performed with TA98 and TA100 strains, both in the presence and absence of metabolic activation using the plate incorporation method. The following concentrations were tested in triplicates along with the negative, vehicle and positive controls: 0.0 (NC), 0.0 (VC), 0.0390625, 0.078125, 0.15625, 0.3125, 0.625, 1.25, 2.5 and 5 mg/plate. In both strains, complete inhibition of background lawn with no presence of any revertant colonies were observed at 0.3125 mg/plate, both with and without S9 metabolic activation. A substantial reduction in the number of revertant colonies accompanied by a moderate inhibition of background lawn was observed at 0.15625 mg/plate compared to the vehicle control data. A slight reduction in the number of revertant colonies accompanied by a moderate inhibition of background lawn was observed at 0.078125 mg/plate, both in the presence (10% v/v S9 mix) and absence of metabolic activation compared to vehicle control data. Hence, cconsidering the criteria that the highest test concentration should yield a decrease in the revertant colony count and/or diminution of the background lawn, 0.078125 mg/plate was selected as the highest concentration of the Test Item for the main assay, either in the presence or the absence of metabolic activation when compared to the vehicle control data. Hence the following doses were selected for the main test: 0.0 (NC), 0.0 (VC), 0.0048828, 0.0097656, 0.01953125, 0.0390625 and 0.078125 mg/plate. Trial I of the main test was conducted according to the plate incorporation method, both with (10 % v/v S9 mix) and without S9 metabolic activation system using the tester strains TA98, TA100, TA1535, TA1537 and TA102. Trial II was performed to confirm the negative result of Trial I. Trial II was performed according to the preincubation method, both in the presence (10 % v/v S9 mix) and absence of S9 metabolic activation system using the tester strains TA1535, TA1537, TA98, TA100 and TA102. Results: In Trial I, a slight reduction in the revertant count and moderate inhibition in the background lawn was noted at the concentration of 0.078125 mg/plate both in the presence (10% v/v S9 mix) and absence of metabolic activation compared to vehicle control data. There was no increase in the number of revertant colonies or diminution of the background lawn was observed at the concentrations from0.0390625 to 0.00488mg/plate either in the presence (10 % v/v S9 mix) or absence of metabolic activation when compared to the vehicle control data. Furthermore, no trend of an increased number of revertant colonies with increased Test Item concentration was observed. In Trial II, a slight reduction in the revertant count and moderate inhibition in the background lawn was noted at the concentration of 0.078125 mg/plate both in the presence (10% v/v S9 mix) and absence of metabolic activation compared to vehicle control data. There was no increase in the number of revertant colonies or diminution of the background lawn was observed at the concentrations from0.0390625 to 0.0048828mg/plate either in the presence (10 % v/v S9 mix) or absence of metabolic activation when compared to the vehicle control data. Furthermore, no trend of an increased number of revertant colonies with increased dosing of the Test Item was observed. Conclusion: Based on the results of the present study, it is concluded that p,p',p"-tris(dimethylamino)trityl alcohol [CAS No. 467-63-0] is non-mutagenic as it does not induce (point) gene mutations by base-pair changes or frameshift in the histidine operon in any of the five tester strains of Salmonella typhimurium (TA1537, TA1535, TA98, TA100 or TA102) neither in the presence nor in the absence of metabolic activation system. The study was performed according to GLP.
Reference
Table1: Mean Revertant Colony Count – Preliminary Cytotoxicity Assay
Test Item Concentration (mg/plate) |
TA 98 |
TA 100 |
||||||
- S9 |
+ S9 |
- S9 |
+ S9 |
|||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
NC (Distilled water) |
23 (NI) |
1.15 |
23 (NI) |
1.53 |
102 (NI) |
4.00 |
99 (NI) |
3.51 |
VC (Dimethyl sulfoxide) |
22 (NI) |
2.08 |
22 (NI) |
1.53 |
99 (NI) |
4.51 |
95 (NI) |
4.73 |
T1 (0.0390625) |
20 (NI) |
1.53 |
20 (NI) |
2.00 |
90 (NI) |
4.04 |
91 (NI) |
5.69 |
T2 (0.078125) |
16 (MI) |
0.58 |
15 (MI) |
1.53 |
81 (MI) |
2.65 |
79 (MI) |
3.79 |
T3 (0.15625) |
8 (MI) |
1.73 |
8 (MI) |
1.73 |
26 (MI) |
6.00 |
22 (MI) |
4.00 |
T4 (0.3125) |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
T5 (0.625) |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
T6 (1.25) |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
T7 (2.5) |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
T8 (5.0) |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
0 (CI) |
0.00 |
PC |
324 (NI) |
12.50 |
314 (NI) |
11.06 |
676 (NI) |
13.01 |
676 (NI) |
14.42 |
Key: NC = Negative Control, VC = Vehicle control, PC = Positive Control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation, SD = Standard Deviation, T1-T8 = Test Item concentration from lower to higher, NI = No Inhibition, MI = Moderate Inhibition, CI = Complte Inhibition.
Positive Controls:
2-Nitrofluorene |
: |
TA98 (absence of metabolic activation) |
Sodium azide |
: |
TA100 (absence of metabolic activation) |
Benzo[a]pyrene |
: |
TA98 and TA100 (presence of metabolic activation) |
Table2 Mean Revertant Colony Count in Trial I(Plate Incorporation Method)
Absence of metabolic activation |
Presence of metabolic activation (+S9 10% v/v S9 Mix) |
|||||||||||||||||||
Test Item Concentration (mg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
||||||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
NC (Distilled water) |
21 |
2.65 |
102 |
5.00 |
14 |
1.15 |
7 |
1.53 |
227 |
3.51 |
22 |
2.00 |
101 |
2.08 |
12 |
2.08 |
6 |
1.15 |
232 |
8.19 |
VC (Dimethyl sulfoxide) |
20 |
2.52 |
96 |
4.36 |
13 |
2.00 |
6 |
1.53 |
233 |
5.29 |
21 |
2.52 |
99 |
6.81 |
13 |
2.08 |
6 |
1.53 |
233 |
6.66 |
T1 (0.0048828) |
20 |
3.21 |
98 |
4.58 |
12 |
1.73 |
6 |
1.73 |
237 |
5.00 |
20 |
2.52 |
95 |
2.52 |
11 |
1.15 |
6 |
1.73 |
236 |
10.60 |
T2 (0.0097656) |
21 |
2.08 |
98 |
6.11 |
12 |
2.08 |
5 |
0.58 |
230 |
5.03 |
20 |
3.06 |
101 |
3.21 |
13 |
0.58 |
7 |
1.73 |
234 |
10.21 |
T3 (0.01953125) |
21 |
2.52 |
99 |
4.16 |
12 |
1.53 |
4 |
0.58 |
228 |
11.00 |
19 |
1.15 |
95 |
4.04 |
12 |
1.15 |
5 |
1.73 |
229 |
4.51 |
T4 (0.0390625) |
18 |
1.73 |
99 |
3.61 |
11 |
1.15 |
6 |
1.53 |
226 |
6.11 |
20 |
3.00 |
97 |
5.13 |
12 |
2.08 |
7 |
1.53 |
228 |
7.64 |
T5 (0.078125) |
15 |
0.58 |
85 |
3.51 |
9 |
1.15 |
3 |
0.58 |
198 |
8.54 |
17 |
1.73 |
81 |
5.51 |
8 |
0.58 |
3 |
1.15 |
196 |
11.50 |
PC |
323 |
14.01 |
684 |
6.43 |
316 |
14.50 |
191 |
6.51 |
1590 |
17.01 |
306 |
4.58 |
700 |
13.58 |
307 |
6.00 |
193 |
12.34 |
1599 |
17.44 |
Key: NC = Negative Control, VC = Vehicle control, PC = Positive Control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation, SD = Standard Deviation, T1-T5 = Test Item concentration from lower to higher.
Positive Controls:
2-Nitrofluorene |
: |
TA98 (absence of metabolic activation) |
Sodium azide |
: |
TA100 and TA1535 (absence of metabolic activation) |
9-Aminoacridine |
: |
TA1537 (absence of metabolic activation) |
Mitomycin-C |
: |
TA102(absence of metabolic activation) |
Benzo[a]pyrene |
: |
TA98, TA100, TA1535, TA1537 and TA102 (presence of metabolic activation) |
Table3 Mean Revertant Colony Count in Trial II (Preincubation Method)
Absence of metabolic activation |
Presence of metabolic activation (+S9 10% v/v S9 Mix) |
|||||||||||||||||||
Test Item Concentration (mg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
||||||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
NC (Distilled water) |
21 |
2.5 |
102 |
5.51 |
12 |
2.08 |
7 |
1.15 |
235 |
7.55 |
21 |
2.65 |
102 |
5.51 |
13 |
2.00 |
6 |
1.15 |
236 |
5.57 |
VC (Dimethyl sulfoxide) |
19 |
2.5 |
97 |
2.52 |
13 |
1.53 |
6 |
1.15 |
238 |
7.94 |
20 |
2.52 |
96 |
2.65 |
13 |
1.15 |
5 |
1.15 |
229 |
6.43 |
T1 (0.00488828) |
19 |
2.3 |
99 |
7.55 |
12 |
1.15 |
6 |
1.53 |
235 |
6.66 |
23 |
1.15 |
100 |
3.79 |
12 |
1.15 |
6 |
1.73 |
232 |
6.24 |
T2 (0.0097656) |
21 |
3.0 |
101 |
6.11 |
12 |
2.08 |
6 |
1.15 |
234 |
8.96 |
22 |
1.15 |
94 |
4.04 |
11 |
1.00 |
6 |
0.58 |
240 |
6.03 |
T3 (0.01953125) |
19 |
1.2 |
95 |
3.21 |
14 |
1.73 |
7 |
1.73 |
234 |
6.66 |
22 |
1.53 |
94 |
6.03 |
13 |
0.58 |
6 |
1.73 |
226 |
6.03 |
T4 (0.0390625) |
20 |
2.6 |
102 |
4.00 |
11 |
1.53 |
5 |
1.15 |
227 |
9.17 |
19 |
1.15 |
102 |
2.65 |
13 |
2.08 |
6 |
1.53 |
223 |
4.04 |
T5 (0.078125) |
16 |
0.6 |
84 |
4.36 |
9 |
2.08 |
4 |
1.61 |
200 |
8.33 |
17 |
2.31 |
82 |
3.79 |
9 |
1.73 |
3 |
0.58 |
196 |
10.60 |
PC |
335 |
8.0 |
684 |
10.60 |
333 |
9.07 |
203 |
16.01 |
1700 |
29.10 |
335 |
12.29 |
687 |
3.06 |
318 |
8.08 |
204 |
14.29 |
1686 |
11.79 |
Key: NC = Negative Control, VC = Vehicle control, PC = Positive Control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation, SD = Standard Deviation,T1-T5 = Test Item concentration from lower to higher.
Positive Controls:
2-Nitrofluorene |
: |
TA98 (absence of metabolic activation) |
Sodium azide |
: |
TA100 and TA1535 (absence of metabolic activation) |
9-Aminoacridine |
: |
TA1537 (absence of metabolic activation) |
Mitomycin-C |
: |
TA102 (absence of metabolic activation) |
Benzo[a]pyrene |
: |
TA98, TA100, TA1535, TA1537 and TA102 (presence of metabolic activation) |
Table4 Fold Increase
Trial I - Plate Incorporation Method |
Trial II – Preincubation Method |
|||||||||||||||||||
Test Item Concentration (mg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
||||||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
NC (Distilled water) |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
VC (Dimethyl sulfoxide) |
0.94 |
0.94 |
0.94 |
0.98 |
0.95 |
1.08 |
0.95 |
1.12 |
1.03 |
1.01 |
0.94 |
0.97 |
0.95 |
0.93 |
1.08 |
1.03 |
0.95 |
0.94 |
1.01 |
0.97 |
T1 (0.0048828) |
1.03 |
0.98 |
1.02 |
0.96 |
0.92 |
0.85 |
0.95 |
0.95 |
1.02 |
1.01 |
0.97 |
1.11 |
1.02 |
1.05 |
0.88 |
0.93 |
0.89 |
1.13 |
0.99 |
1.01 |
T2 (0.0097656) |
1.05 |
0.98 |
1.02 |
1.01 |
0.95 |
0.95 |
0.84 |
1.11 |
0.99 |
1.00 |
1.09 |
1.07 |
1.04 |
0.99 |
0.93 |
0.83 |
0.89 |
1.19 |
0.98 |
1.05 |
T3 (0.01953125) |
1.05 |
0.94 |
1.03 |
0.95 |
0.90 |
0.88 |
0.68 |
0.79 |
0.98 |
0.98 |
1.00 |
1.08 |
0.98 |
0.98 |
1.05 |
1.00 |
1.11 |
1.13 |
0.98 |
0.99 |
T4 (0.0390625) |
0.92 |
0.97 |
1.03 |
0.98 |
0.87 |
0.93 |
1.00 |
1.05 |
0.97 |
0.98 |
1.03 |
0.95 |
1.06 |
1.06 |
0.85 |
0.95 |
0.84 |
1.06 |
0.95 |
0.98 |
T5 (0.078125) |
0.78 |
0.82 |
0.88 |
0.82 |
0.72 |
0.63 |
0.42 |
0.42 |
0.85 |
0.84 |
0.84 |
0.85 |
0.87 |
0.86 |
0.70 |
0.68 |
0.58 |
0.63 |
0.84 |
0.86 |
PC |
16.41 |
14.81 |
7.13 |
7.04 |
24.33 |
23.03 |
30.11 |
30.53 |
6.82 |
6.85 |
17.34 |
16.48 |
7.08 |
7.18 |
24.95 |
23.88 |
32.11 |
38.19 |
7.14 |
7.37 |
Key: NC = Negative Control, VC = Vehicle control, PC = Positive Control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation, T1-T5 = Test Item concentration from lower to higher.
Table5 S9 Efficiency Check- Summary
Summary of S9 efficiency check |
||||
|
TA100 |
TA1535 |
||
Mean |
SD |
Mean |
SD |
|
VC Dimethyl Sulfoxide (-S9) |
98.67 |
4.51 |
13.00 |
2.00 |
VC Dimethyl Sulfoxide (+S9) |
95.33 |
4.73 |
13.33 |
2.08 |
PC Benzo[a]pyrene (-S9) |
97.67 |
3.51 |
13.33 |
2.08 |
PC Benzo[a]pyrene (+S9) |
676.00 |
14.42 |
307.00 |
6.00 |
Key: VC = Vehicle control, PC = Positive control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation, SD = Standard Deviation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In-vitro Gene mutation study:
The ability of the registered substance, p,p’,p”-tris(dimethylamino)trityl alcohol [CAS No. 467-63-0] to induce point mutation and/or frameshift in the histidine operon was tested in five Salmonella typhimurium tester strains (TA1537, TA1535, TA98, TA100 or TA102) in the presence and absence of an exogenous metabolic activation. The S9 fraction was obtained from rats injected with the combination of phenobarbitone and β-naphthoflavone. Test concentrations were selected based on solubility, precipitation and a preliminary cytotoxicity test. The cytotoxicity test was performed with TA98 and TA100 strains, both in the presence and absence of metabolic activation using the plate incorporation method. The following concentrations were tested in triplicates along with the negative, vehicle and positive controls: 0.0 (NC), 0.0 (VC), 0.0390625, 0.078125, 0.15625, 0.3125, 0.625, 1.25, 2.5 and 5 mg/plate. In both strains, complete inhibition of background lawn with no presence of any revertant colonies were observed at 0.3125 mg/plate, both with and without S9 metabolic activation. A substantial reduction in the number of revertant colonies accompanied by a moderate inhibition of background lawn was observed at 0.15625 mg/plate compared to the vehicle control data. A slight reduction in the number of revertant colonies accompanied by a moderate inhibition of background lawn was observed at 0.078125 mg/plate, both in the presence (10% v/v S9 mix) and absence of metabolic activation compared to vehicle control data. Hence, cconsidering the criteria that the highest test concentration should yield a decrease in the revertant colony count and/or diminution of the background lawn, 0.078125 mg/plate was selected as the highest concentration of the Test Item for the main assay, either in the presence or the absence of metabolic activation when compared to the vehicle control data. Hence the following doses were selected for the main test: 0.0 (NC), 0.0 (VC), 0.0048828, 0.0097656, 0.01953125, 0.0390625 and 0.078125 mg/plate. Trial I of the main test was conducted according to the plate incorporation method, both with (10 % v/v S9 mix) and without S9 metabolic activation system using the tester strains TA98, TA100, TA1535, TA1537 and TA102. Trial II was performed to confirm the negative result of Trial I. Trial II was performed according to the preincubation method, both in the presence (10 % v/v S9 mix) and absence of S9 metabolic activation system using the tester strains TA1535, TA1537, TA98, TA100 and TA102. Results: In Trial I, a slight reduction in the revertant count and moderate inhibition in the background lawn was noted at the concentration of 0.078125 mg/plate both in the presence (10% v/v S9 mix) and absence of metabolic activation compared to vehicle control data. There was no increase in the number of revertant colonies or diminution of the background lawn was observed at the concentrations from0.0390625 to 0.00488mg/plate either in the presence (10 % v/v S9 mix) or absence of metabolic activation when compared to the vehicle control data. Furthermore, no trend of an increased number of revertant colonies with increased Test Item concentration was observed. In Trial II, a slight reduction in the revertant count and moderate inhibition in the background lawn was noted at the concentration of 0.078125 mg/plate both in the presence (10% v/v S9 mix) and absence of metabolic activation compared to vehicle control data. There was no increase in the number of revertant colonies or diminution of the background lawn was observed at the concentrations from0.0390625 to 0.0048828mg/plate either in the presence (10 % v/v S9 mix) or absence of metabolic activation when compared to the vehicle control data. Furthermore, no trend of an increased number of revertant colonies with increased dosing of the Test Item was observed. Conclusion: Based on the results of the present study, it is concluded that p,p',p"-tris(dimethylamino)trityl alcohol [CAS No. 467-63-0] is non-mutagenic as it does not induce (point) gene mutations by base-pair changes or frameshift in the histidine operon in any of the five tester strains of Salmonella typhimurium (TA1537, TA1535, TA98, TA100 or TA102) neither in the presence nor in the absence of metabolic activation system.The study was performed according to GLP.
Justification for classification or non-classification
p,p',p"-tris(dimethylamino)trityl alcohol [CAS No. 467-63-0] is non-mutagenic as it did not induce (point) gene mutations by base-pair changes or frameshift in the histidine operon in any of the five tester strains of Salmonella typhimurium (TA1537, TA1535, TA98, TA100 or TA102) neither in the presence nor in the absence of metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
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