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EC number: 202-903-7 | CAS number: 100-94-7
- 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
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- Nanomaterial pour density
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- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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:
- 15 May 2019 - 07 Jun 2019
- 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:
- 21 Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- Aug 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich -Straße 7, 55116 Mainz
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dibenzyldimethylammonium chloride
- EC Number:
- 202-903-7
- EC Name:
- Dibenzyldimethylammonium chloride
- Cas Number:
- 100-94-7
- Molecular formula:
- C16H20N.Cl
- IUPAC Name:
- dibenzyldimethylammonium chloride
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: 17 Jan 2020
- Physical state / color: solid, white
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature (protect against moisture, under N2).
- Homogeneity: The homogeneity of the test substance was ensured by mixing before preparation of the test substance solutions.
- Storage stability: The stability of the test substance under storage conditions is guaranteed until 17 Jan 2020 as indicated by the sponsor.
- Solubility and stability of the test substance in the solvent/vehicle: This study was performed in an aqueous test system. Due to the use of water (= ultrapure water) as vehicle the verification of the stability of the test substance in the vehicle is not required.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was weighed and topped up with the chosen vehicle to achieve the required concentration of the stock solution. The test substance was dissolved in water. To achieve a clear solution of the test substance in the vehicle, the test substance preparation was shaken thoroughly. The further concentrations were diluted according to the planned doses. All test substance formulations were prepared immediately before use.
FORM AS APPLIED IN THE TEST (if different from that of starting material) : dissolved in water.
Method
- Target gene:
- his, 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:
- Type and composition of metabolic activation system:
S9 mix (supplemented with cofactors) derived from phenobarbital (i.p.) and β-naphthoflavone (orally) induced rat liver.
- source of S9 : prepared by the sponsor.
- method of preparation of S9 mix : At least 5 male Wistar rats [Crl:WI(Han)] (200 - 300 g; Charles River Laboratories Germany GmbH) received 80 mg/kg b.w. phenobarbital i.p. and β-naphthoflavone orally (both supplied
by Sigma-Aldrich, 82024 Taufkirchen, Germany) each on three consecutive days. During this time, the animals were housed in polycarbonate cages: central air conditioning with a fixed range of temperature of 20 - 24°C and a fixed relative humidity of 45 - 65%. The day/night rhythm was 12 hours: light from 6 am to 6 pm and darkness from 6 pm to 6 am. Standardized pelleted feed and drinking water from bottles were available ad libitum. 24 hours after the last administration, the rats were sacrificed, and the livers were prepared using sterile solvents and glassware at a temperature of +4°C. The livers were weighed and washed in a weight-equivalent volume of a 150 mM KCl solution and homogenized in three volumes of KCl solution. After centrifugation of the homogenate at 9000 x g for 10 minutes at +4°C, 5 mL portions of the supernatant (S9 fraction) were stored at -70°C to -80°C. - Test concentrations with justification for top dose:
- 0; 33; 100; 333; 1000; 2750 and 5500 μg/plate (SPT)
0; 33; 100; 333; 1000; 2750 and 5500 μg/plate (PIT)
In agreement with the recommendations of current guidelines 5 mg/plate or 5 μL/plate were generally selected as maximum test dose at least in the 1st Experiment. However, this maximum dose was tested even in the case of relatively insoluble test compounds to detect possible mutagenic impurities. Furthermore, doses > 5 mg/plate or > 5 μL/plate might also be tested in repeat experiments for further clarification/substantiation. In this study, due to the purity of the test substance 5.5 mg/plate was used as top dose in all experiments. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water.
- Justification for choice of solvent/vehicle: Due to the good solubility of the test substance in water, water was used as vehicle.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- other: not applicable
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-aminoanthracene with S9 mix: 2.5 μg/plate for strains TA 1535, TA 100, TA 1537, TA 98. 60 μg/plate for strain: E. coli WP2 uvrA. 4-nitro-o-phenylenediamine without S9 mix: 10 μg/platefor strain: TA 98.
- Remarks:
- Sterility control: Additional plates were treated with soft agar, S9 mix, buffer, vehicle and the test substance but without the addition of tester strains.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
- Cell density at testing: approx. 10^9 cells per mL
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 – 72 hours
DETERMINATION OF CYTOTOXICITY
- Toxicity detected by a
• decrease in the number of revertants (factor ≤ 0.6)
• clearing or diminution of the background lawn (= reduced his- or trp- background growth)
was recorded for all test groups both with and without S9 mix in all experiments. Single values with a factor ≤ 0.6 were not detected as toxicity in low dose groups. - Evaluation criteria:
- Acceptance criteria
Generally, the experiment was considered valid if the following criteria were met:
• The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.
• The sterility controls revealed no indication of bacterial contamination.
• The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies compatible with the range of the historical positive control data or above.
• Fresh bacterial culture containing approximately 109 cells per mL were used.
Assessment criteria
The test substance was considered positive in this assay if the following criteria were met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. at least doubling (bacteria strains with high spontaneous mutation rate, like TA 98, TA 100 and E.coli WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA 1535 and TA 1537) of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance was generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the range of the historical negative control data under all experimental conditions in at least two experiments carried out independently of each other.
Results and discussion
Test resultsopen allclose all
- 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:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Homogeneity: The homogeneity of the test substance was ensured by mixing before preparation of the test substance solutions.
- Precipitation: No precipitation of the test substance was found with and without S9 mix.
HISTORICAL CONTROL DATA
- Negative (solvent/vehicle) historical control data: see table 1
- Positive historical control data: see table 2
Any other information on results incl. tables
Tab. 1: Historical Negative Controls
(based on Sorcerer Counter / Ames Study Mananger System (Sep 2017 - Sep 2018)
Strain |
S9 Mix |
Vehicle |
No. of Plates |
No. of Values |
Min |
Max |
Mean |
SD |
|
|
|
|
|
|
|
|
|
TA 1535 |
Without |
(All) |
315 |
112 |
7 |
19 |
11 |
2.3 |
|
With |
(All) |
318 |
112 |
6 |
21 |
11 |
2.6 |
|
|
|
|
|
|
|
|
|
TA 100 |
Without |
(All) |
318 |
113 |
78 |
140 |
106 |
12.1 |
|
With |
(All) |
327 |
113 |
72 |
135 |
107 |
11.2 |
|
|
|
|
|
|
|
|
|
TA 1537 |
Without |
(All) |
309 |
112 |
4 |
12 |
8 |
1.7 |
|
With |
(All) |
309 |
112 |
5 |
13 |
9 |
1.6 |
|
|
|
|
|
|
|
|
|
TA 98 |
Without |
(All) |
318 |
113 |
12 |
27 |
18 |
2.9 |
|
With |
(All) |
312 |
113 |
18 |
45 |
25 |
4.0 |
|
|
|
|
|
|
|
|
|
E. coli |
Without |
(All) |
306 |
113 |
19 |
38 |
26 |
4.2 |
|
With |
(All) |
306 |
113 |
18 |
40 |
26 |
4.1 |
Tab. 2: Historical Positive Controls
(based on Sorcerer Counter / Ames Study Mananger System (Sep 2017 - Sep 2018)
Strain |
S9 Mix |
Positive control |
No. of Plates |
No. of Values |
Min |
Max |
Mean |
SD |
|
|
|
|
|
|
|
|
|
TA 1535 |
Without |
MNNG |
252 |
88 |
2345 |
7317 |
4484 |
1042.2 |
|
With |
2-AA |
252 |
88 |
50 |
334 |
193 |
53.3 |
|
|
|
|
|
|
|
|
|
TA 100 |
Without |
MNNG |
252 |
88 |
814 |
5801 |
3443 |
1004.7 |
|
With |
2-AA |
258 |
88 |
413 |
2943 |
1563 |
492.8 |
|
|
|
|
|
|
|
|
|
TA 1537 |
Without |
AAC |
246 |
88 |
282 |
1497 |
809 |
237.1 |
|
With |
2-AA |
252 |
88 |
41 |
254 |
108 |
36.8 |
|
|
|
|
|
|
|
|
|
TA 98 |
Without |
NOPD |
252 |
88 |
484 |
1239 |
986 |
141.1 |
|
With |
2-AA |
249 |
88 |
161 |
2347 |
1098 |
379.9 |
|
|
|
|
|
|
|
|
|
E. coli |
Without |
4-NQO |
246 |
88 |
176 |
1931 |
750 |
395.9 |
|
With |
2-AA |
246 |
88 |
66 |
259 |
115 |
45.7 |
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
- Executive summary:
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay.
STRAINS: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA.
DOSE RANGE: 33 μg - 5500 μg/plate (SPT), 33 μg - 5500 μg/plate (PIT).
TEST CONDITIONS: Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats).
SOLUBILITY: No precipitation of the test substance was observed with and without S9 mix.
TOXICITY: A bacteriotoxic effect was occasionally observed depending on the strain and test conditions at and above 2750 μg/plate.
MUTAGENICITY: A relevant increase in the number of his+ or trp+ revertants (factor ≥ 2: TA 100, TA 98 and E.coli WP2 uvrA or factor ≥ 3: TA 1535 and TA 1537) was not observed in the standard plate test or in the preincubation test without S9 mix or after the addition of a metabolizing system.
CONCLUSION: Under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
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.
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