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EC number: 205-352-0 | CAS number: 139-08-2
- 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:
- key study
- Study period:
- From February 28, 2001 to March 26, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Quaternary ammonium compounds, benzyl C12-C16 (even numbered) -alkyldimethyl chlorides
- Molecular formula:
- C12-14H25-29-(CH3)2-C6H5-N.CL
- IUPAC Name:
- Quaternary ammonium compounds, benzyl C12-C16 (even numbered) -alkyldimethyl chlorides
Constituent 1
- Specific details on test material used for the study:
- - Physical state: Clear liquid
- Analytical purity: >93%
- Impurities (identity and concentrations): 0.8% Free Amine + Amine hydrochloride and ≤ 0.1% AAS
- Lot/batch No.: DEGE001033
- Expiration date of the lot/batch: January 2002
- Stability under test conditions: The test substance is hydrolytically and photolytically stable under the conditions of this study and has been shown to be stable in aqueous, alcohol and alcohol/aqueous solutions for extended periods, e.g. at least five years under standard laboratory conditions.
- Storage condition of test material: Room temperature in the dark
- pH (1% water): 6.5
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbitone/β-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Preliminary toxicity study: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate (With and without metabolic activation)
Main Experiment: Experiment 1 & 2: 0.15, 0.5, 1.5, 5, 15 and 50 µg/plate (With and without metabolic activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Sterile distilled water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- (concurrent untreated)
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- other: Nitroquinoline-1-oxide (4NQO)
- Remarks:
- Without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2AA)
- Remarks:
- With metabolic activation
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- With metabolic activation
- Positive controls:
- yes
- Positive control substance:
- other: 1,8-Dihydroxyanthraquinone (DANTHRON)
- Remarks:
- With metabolic activation
- Details on test system and experimental conditions:
- Method of application: In agar (direct plate incorporation)
Number of replications: Triplicates - Evaluation criteria:
- The test substance was considered positive in the test system if the following criteria were met:
The test substance should have induced a reproducible, dose-related and statistically significant increase in the revertant count in at least one strain of bacteria.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - The test substance caused a visible reduction in the growth of the bacterial background lawn to all of the tester strains both with and without S9-mix beginning at 15µg/plate. The sensitivity of the bacterial tester strains to the toxicity of the test substance varied slightly between experiment number, strain type and exposures with or without S9-mix. The test substance was, therefore, tested up to the toxic limit. No test substance precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
- No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test substance, either with or without metabolic activation.
- All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains.
Any other information on results incl. tables
Table 1. Cytotoxicity (Number of revertant colonies)
|
|
Test substance concentration (µg/plate) |
||||||||||
With/ Without S9-mix |
Strain |
0 |
0.15 |
0.5 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
Without |
TA100 |
91 |
91 |
81 |
83 |
64 |
17S |
0T |
0T |
0T |
0T |
0T |
With |
TA100 |
97 |
105 |
103 |
103 |
83 |
50S |
0T |
0T |
0T |
0T |
0T |
S=sparse bacterial background lawn
T= toxic, no bacterial lawn
Table 2. Genotoxicity (Mean number of revertant colonies)
Strain |
TA100 |
TA1535 |
TA102 |
TA98 |
TA1537 |
||||||
Test substance concentration (mg/plate) |
|
|
|
|
|
||||||
With S9 |
|
|
|
|
|
||||||
+ve control type (concentration (mg/plate)) |
2AA (1) |
2AA (2) |
DAN (10) |
BP (5) |
2AA (2) |
||||||
Test number |
1 |
2 |
1 |
2 |
1 |
2 |
1 |
2 |
1 |
2 |
|
+ve control |
1772 |
2317 |
287 |
135 |
886 |
723 |
229 |
251 |
582 |
336 |
|
-ve control |
143 |
137 |
17 |
17 |
349 |
308 |
36 |
25 |
12 |
22 |
|
0.15 |
129 |
137 |
13 |
13 |
357 |
315 |
26 |
24 |
13 |
18 |
|
0.5 |
134 |
11 |
10 |
14 |
346 |
313 |
33 |
25 |
15 |
14 |
|
1.5 |
129 |
127 |
15 |
14 |
373 |
307 |
32 |
26 |
16 |
14 |
|
5 |
142 |
143 |
10 |
13 |
369 |
341 |
32 |
23 |
17 |
16 |
|
15 |
132 |
0 |
12 |
2 |
363 |
151 |
37 |
11 |
17 |
6 |
|
50 |
28 |
0 |
10 |
0 |
276 |
0 |
22 |
0 |
10 |
0 |
|
Without S9 |
|
|
|
|
|
||||||
+ve control type (concentration (mg/plate)) |
ENNG (3) |
ENNG (5) |
MMC (0.5) |
4NQO (0.2) |
9AA (80) |
||||||
Test number |
1 |
2 |
1 |
2 |
1 |
2 |
1 |
2 |
1 |
2 |
|
+ve control |
621 |
464 |
603 |
430 |
854 |
961 |
142 |
126 |
656 |
716 |
|
-ve control |
153 |
134 |
12 |
18 |
316 |
336 |
38 |
22 |
16 |
17 |
|
0.15 |
150 |
123 |
13 |
15 |
340 |
308 |
29 |
18 |
18 |
19 |
|
0.5 |
132 |
114 |
11 |
21 |
331 |
339 |
30 |
18 |
17 |
18 |
|
1.5 |
154 |
111 |
19 |
16 |
339 |
232 |
25 |
14 |
15 |
11 |
|
5 |
145 |
111 |
9 |
10 |
326 |
325 |
28 |
19 |
12 |
18 |
|
15 |
84 |
0 |
11 |
0 |
320 |
0 |
23 |
0 |
0 |
0 |
|
50 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance was found to be non-mutagenic in Ames test with and without metabolic activation.
- Executive summary:
A study was conducted to determine the in vitro genetic toxicity of the test substance, C12 -16 ADBAC, according to OECD Guideline 471, EU Method B13/14 and US EPA OPPTS 850.5100 (Ames test), in compliance with GLP. The mutagenic potential was investigated in Salmonella typhimurium strains A1535, TA1537, TA102, TA98 and TA100 with and without metabolic activation. Six dose levels of the test substance for each bacterial strain were tested in triplicate with and without a metabolic activation system. The dose range was determined in a preliminary toxicity assay and was 0.15 to 50 µg/plate in the first experiment. The experiment was repeated on a separate day using the same dose range, fresh cultures of the bacterial strains and fresh test substance formulations. Additional dose levels were included in both experiments to allow for test substance-induced toxicity and to ensure there were a minimum of four non-toxic doses plated out. The vehicle (sterile distilled water) control plates produced counts of revertant colonies within the normal range. All the positive control chemicals used in the test produced marked increases in the frequency of revertant colonies, both with and without the S9 -mix. No test substance precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix. No significant increase in the frequency of revertant colonies was recorded for any of the bacterial strains with any dose of the test substance, either with or without metabolic activation. Under the study conditions, the test substance was found to be non-mutagenic in Ames test with and without metabolic activation (Thompson, 2001).
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