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EC number: 403-140-4 | CAS number: 103694-68-4 MAJANTOL; MAJANTOL R
- 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
- Study period:
- 2019-20-18 to 2019-10-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted July 21, 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- dated May 30, 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-(2,2-dimethyl-3-hydroxypropyl)toluene
- EC Number:
- 403-140-4
- EC Name:
- 3-(2,2-dimethyl-3-hydroxypropyl)toluene
- Cas Number:
- 103694-68-4
- Molecular formula:
- C12H18O
- IUPAC Name:
- 2,2-dimethyl-3-(3-methylphenyl)propan-1-ol
Constituent 1
Method
- Target gene:
- Salmonella typhimurium: histidine (his)
Escherichia coli: tryptophan (trp)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver homogenate (S9) from Phenobarbital/ß-naphtoflavone pretreated rats (protein concentration: 29.3 mg/mL)
Type and composition of metabolic activation system:
- source of S9 : Phenobarbital/β-naphthoflavone induced rat liver S9 (Lot. No.: 060619K)
- method of preparation of S9 mix: according to Ames et al. (1977); appropriate quantity of S9 supernatant thawed and mixed with S9 cofactor solution (final concentration: approx. 10% (v/v))
- volume of S9 mix in the final culture medium: 500 μL
- quality controls of S9: Each batch of S9 was routinely tested for its capability to activate the known mutagens benzo[a]pyrene and 2-aminoanthracene in the Ames test. - Test concentrations with justification for top dose:
- The test item was tested at the following concentrations:
Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
Experiment II:
Strains TA 1535 and WP2 uvrA: 10; 33; 100; 333; 1000; 2500 and 5000 μg/plate
The remaining strains: 3; 10; 33; 100; 333; 1000; and 2500 μg/plate
The top dose for the main experiments was chosen based on the results of the preliminary study. In the pre-experiment the concentration range of the test item was 3 – 5000 μg/plate. The pre-experiment is reported as experiment I. Since toxic effects were observed in experiment I seven concentrations were tested in experiment II. Based on toxicity observed in experiment I the maximum concentration of 5000 μg/plate was reduced to 2500 μg/plate in some strains. The concentration range included two logarithmic decades. - Vehicle / solvent:
- - Solvent used: DMSO (purity > 99%)
- Justification for choice of solvent/vehicle: because of its solubility properties and its relative nontoxicity to the bacteria
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine; 2-aminoanthracene, 2-AA
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments : 2
METHOD OF TREATMENT/ EXPOSURE:
- Pre-experiment for toxicity: in agar (plate incorporation)
- Experiment I: in agar (plate incorporation)
- Experiment II: Preincubation
TREATMENT:
- Preincubation period: 60 minutes
- Exposure duration/duration of treatment: 48 hours
METHODS FOR MEASUREMENTS OF GENOTOXICIY
- Method: Number of revertant colonies - Evaluation criteria:
- A test item was considered as a mutagen if a biologically relevant increase in the number of revertants of twofold or above (strains TA 98, TA 100, and WP2 uvrA) or threefold or above (strains TA 1535 and TA 1537) the spontaneous mutation rate of the corresponding solvent control was observed. A dose dependent increase was considered biologically relevant if the threshold is reached or exceeded at more than one concentration. An increase of revertant colonies equal or above the threshold at only one concentration was judged as biologically relevant if reproduced in an independent second experiment. A dose dependent increase in the number of revertant colonies below the threshold was regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remained within the historical range of negative and solvent controls such an increase was not considered biologically relevant.
- Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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:
- valid
- 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:
- valid
- 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:
- valid
- 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:
- valid
- 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:
- valid
- Additional information on results:
- The test item precipitated in the overlay agar in the test tubes from 2500 to 5000 μg/plate (experiment I) respectively up to the highest investigated dose (experiment II). No precipitation of the test item was observed in the overlay agar on the incubated agar plates. The plates incubated with the test item showed reduced background growth in experiment I in all strains used with and without S9 mix. In experiment II normal background growth was observed on the incubated agar plates.
Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in all strains in the presence and absence of S9 mix.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test item at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Any other information on results incl. tables
Table 1: Summary of Experiment I
Metabolic | Test | Dose Level | Revertant Colony Counts (Mean ± SD) | ||||
TA 1535 | TA 1537 | TA 98 | TA 100 | WP2 uvRA | |||
Without Activation | DMSO |
| 11 ± 2B M | 14 ± 3 | 26 ± 8 | 98 ± 9 | 55 ± 9 |
Untreated |
| 16 ± 3B M | 18 ± 3 | 35 ± 3 | 114 ± 9 | 54 ± 2 | |
Test item | 3 µg | 9 ± 2B M | 14 ± 5 | 35 ± 9 | 97 ± 4 | 51 ± 7 | |
10 µg | 11 ± 2B M | 11 ± 3 | 33 ± 8 | 114 ± 16 | 54 ± 11 | ||
33 µg | 10 ± 1B M | 14 ± 3 | 30 ± 5 | 99 ± 15 | 58 ± 9 | ||
100 µg | 9 ± 2B M | 15 ± 5 | 29 ± 4 | 95 ± 9 | 48 ± 11 | ||
333 µg | 10 ± 3B M | 11 ± 2 | 26 ± 6 | 100 ± 15 | 50 ± 17 | ||
1000 µg | 10 ± 2B M R | 7 ± 2R | 15 ± 4R | 73 ± 15R | 23 ± 6R | ||
2500 µg | 3 ± 2B M R | 1 ± 1R | 5 ± 2M R | 3 ± 1R | 14 ± 1R M | ||
5000 µg | 3 ± 1B M R | 0 ± 0R | 1 ± 1M R | 1 ± 1R | 11 ± 3R M | ||
NaN3 | 10 µg | 1167 ± 49B M |
|
| 1883 ± 136 |
| |
4-NOPD | 10 µg |
|
| 416 ± 6 |
|
| |
4-NOPD | 50 µg |
|
|
|
|
| |
MMS | 2.0 µL |
|
|
|
| 914 ± 104 | |
With Activation | DMSO |
| 11 ± 2B M | 18 ± 3 | 40 ± 3 | 117 ± 11 | 58 ± 4 |
Untreated |
| 11 ± 2B M | 17 ± 6 | 40 ± 11 | 116 ± 11 | 62 ± 5 | |
Test item | 3 µg | 10 ± 3B M | 17 ± 5 | 41 ± 7 | 115 ± 7 | 60 ± 8 | |
10 µg | 10 ± 2B M | 14 ± 7 | 35 ± 7 | 108 ± 19 | 55 ± 5 | ||
33 µg | 11 ± 3B M | 15 ± 4 | 38 ± 6 | 113 ± 7 | 54 ± 4 | ||
100 µg | 11 ± 2B M | 14 ± 4 | 43 ± 8 | 113 ± 7 | 56 ± 7 | ||
333 µg | 12 ± 3B M | 10 ± 3 | 37 ± 6 | 109 ± 6 | 52 ± 7 | ||
1000 µg | 9 ± 1B M R | 4 ± 1R M | 15 ± 2R M | 50 ± 17R | 23 ± 4R | ||
2500 µg | 1 ± 1B M R | 0 ± 1R M | 2 ± 1M R | 3 ± 1R | 11 ± 3R M | ||
5000 µg | 0 ± 1B M R | 0 ± 0R M | 0 ± 1M R | 0 ± 0R | 5 ± 1R M | ||
2-AA | 2.5 µg | 349 ± 47B M | 434 ± 7 | 3097 ± 218 | 3777 ± 163 |
| |
2-AA | 10 µg |
|
|
|
| 3.22 ± 22 |
Key to Positive Controls
NaN3: sodium azide
2-AA: 2-aminoanthracene
4-NOPD: 4-nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
Key to Plate Postfix Codes
R: Reduced background growth
B: Extensive bacterial growth
M: Manual count
Table 2: Summary of Experiment II
Metabolic | Test | Dose Level | Revertant Colony Counts (Mean ± SD) | ||||
TA 1535 | TA 1537 | TA 98 | TA 100 | WP2 uvRA | |||
Without Activation | DMSO |
| 9 ± 3 | 11 ± 4 | 27 ± 7 | 88 ± 5 | 40 ± 6 |
Untreated |
| 14 ± 5 | 16 ± 4 | 25 ± 10 | 102 ± 4 | 44 ± 3 | |
Test item | 3 µg |
| 15 ± 2 | 25 ± 8 | 90 ± 8 |
| |
10 µg | 11 ± 1 | 17 ± 6 | 28 ± 0 | 89 ± 10 | 41 ± 1 | ||
33 µg | 8 ± 2 | 14 ± 7 | 23 ± 2 | 87 ± 10 | 46 ± 6 | ||
100 µg | 10± 2 | 15 ± 5 | 19 ± 6 | 84 ± 20 | 44 ± 3 | ||
333 µg | 12± 5 | 8 ± 4 | 21 ± 3 | 86 ± 12 | 34 ± 3 | ||
1000 µg | 6 ± 1 | 1 ± 1 | 2 ± 0 | 39 ± 6 | 18 ± 5 | ||
2500 µg | 0 ± 1 | 1 ± 1 | 0 ± 1 | 0 ± 0 | 0 ± 0 | ||
5000 µg | 0 ± 0 |
|
|
| 0 ± 0 | ||
NaN3 | 10 µg | 1106 ± 78 |
|
| 1705 ± 146 |
| |
4-NOPD | 10 µg |
|
| 371 ± 7 |
|
| |
4-NOPD | 50 µg |
| 70 ± 11 |
|
|
| |
MMS | 2.0 µL |
|
|
|
| 820 ± 19 | |
With Activation | DMSO |
| 10 ± 0 | 13 ± 3 | 36 ± 6 | 95 ± 7 | 48 ± 5 |
Untreated |
| 12 ± 4 | 19 ± 3 | 44 ± 3 | 100 ± 6 | 59 ± 6 | |
Test item | 3 µg |
| 14 ± 7 | 33 ± 8 | 84 ± 9 |
| |
10 µg | 14 ± 2 | 14 ± 3 | 36 ± 6 | 87 ± 3 | 54 ± 2 | ||
33 µg | 10 ± 1 | 15 ± 1 | 35 ± 9 | 98 ± 12 | 54 ± 9 | ||
100 µg | 14 ± 3 | 15 ± 3 | 39 ± 6 | 99 ± 3 | 54 ± 8 | ||
333 µg | 13 ± 3 | 17 ± 2 | 28 ± 2 | 68 ± 9 | 49 ± 6 | ||
1000 µg | 9 ± 3 | 1 ± 1 | 1 ± 1 | 1 ± 1 | 31 ± 3 | ||
2500 µg | 0 ± 1 | 0 ± 0 | 0 ± 1 | 0 ± 1 | 2 ± 1 | ||
5000 µg | 0 ± 0 |
|
|
| 0 ± 0 | ||
2-AA | 2.5 µg | 331 ± 23 | 314 ± 11 |
| 3166 ± 109 |
| |
2-AA | 10 µg |
|
|
|
| 306 ± 54 |
Key to Positive Controls
NaN3: sodium azide
2-AA:2-aminoanthracene
4-NOPD:4-nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
Applicant's summary and conclusion
- Conclusions:
- The test substance was not mutagenic to Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA in the presence and absence of a metabolizing system.
- Executive summary:
An in vitro reverse mutation assay study (Ames) was conducted under GLP-conditions according to OECD Guideline 471 and EU Method B13/B14 in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA. Two separate Experiments were performed, one as a plate incorporation assay (Experiment I) and a second one as a preincubation assay (Experiment II). All tests were conducted in triplicate and concentrations between 3 μg/plate and 5000 μg/plate were tested. Strains were exposed to the test substance with and without metabolic activation with rat liver S9 mix. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies. Cytotoxicity was observed in all strains in the presence and absence of S9 mix. No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test item at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Therefore it was concluded that the test substance did not induce gene mutations and it was considered to be non-mutagenic.
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