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EC number: 931-275-3 | CAS number: 1125503-33-4
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-03-13 to 2002-03-28
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [See concordance under 1.1. of the CSR]
- IUPAC Name:
- [See concordance under 1.1. of the CSR]
- Details on test material:
- - name of testsubstance used in report: Praepagen HY
- Physical state: yellowish, liquid
- Batch No.: ESDB 01 496
- active ingrdient /purity: Fattyalkyl dimethylhydroxyethylammonium chloride/ ca. 40% in water
- Expiration date of the lot/batch: 2003-07-19
- Storage condition of test material: room temperature (20°C)
- pH: 5.5 - 8.5 (20°C, 10g/L)
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Periodically checked for karyotype stability: yes - Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Periodically checked for karyotype stability: yes - Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 97
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Periodically checked for karyotype stability: yes - Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Periodically checked for karyotype stability: yes - Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Periodically checked for karyotype stability: yes - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Postmitochondrial (S9) fraction from livers of male wistar rats, induced with Phenobarbital (i.p.) and ß-Naphtoflavon orally.
- Test concentrations with justification for top dose:
- 1. Study:
all strains (±S9) : 0.005- 0.016 - 0.05 - 0.16 - 0.5 (mg/plate)
2. Study:
TA 97a, TA 100 (±S9), TA 98, TA 102, TA 1535 (-S9): 0.0016 - 0.005- 0.016 - 0.05 - 0.16 (mg/plate)
TA 98, TA 102, TA 1535 (+S9): 0.016 - 0.05 - 0.16 - 0.5 - 1.6 (mg/plate)
Negative controls tested with aqua bidest. - Vehicle / solvent:
- aqua bidest
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ICR 191
- Remarks:
- positive control in TA 97a (-S9)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2- Aminoanthracen
- Remarks:
- positive control in TA 97a, TA 98, TA 100, TA 1535 (+S9)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cumene hydroperoxide
- Remarks:
- positive control in TA 102 (–S9)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylendiamine
- Remarks:
- positive control in TA 98 (– S9)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Nitrofurantoine
- Remarks:
- positive control in TA 100 (– S9)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Sodiumazide
- Remarks:
- positive control inTA 1535 (– S9)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua bidest
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Danthron
- Remarks:
- positive control in TA 102 (+S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation);
- Two independent studies were conducted
- Exposure duration: 48h
- NUMBER OF REPLICATIONS: 3 replicates per concentration level and control - Evaluation criteria:
- Reduced background lawn is regarded to be a cytotoxic effect. Plates with reduced background lawn were not included into evaluation.
Mean values and standard deviations were calculated from colonies per plate of three replicates.
Induction rate = revertant colonies of test item divided by revertant colonies of the control.
The test item is to be interpretated mutagenic if there is a concentration effect relationship and the induction rate is ≥ 2. - Statistics:
- The arithmetic mean value and the standard deviation were calculated out of three replicates of the revertant colony plates
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 97, TA 98, TA 100, TA 1535, TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Based on the results of a preliminary test (non GLP) the test concentrations have been selected.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Mutagenic and Cytotoxic Effects of the Test Item Praepagen HY
Strain |
S9 |
TestedConcentrationRange[mg/plate] |
Lowest Mutagenic Concentration [mg/plate] |
Lowest Cytotoxic Concentration [mg/plate] |
TA 97a |
- |
0.0016 – 0.5 |
none |
0.5 |
+ |
0.0016 – 0.5 |
none |
0.16 |
|
TA 98 |
- |
0.0016 – 0.5 |
none |
0.5 |
+ |
0.005 – 1.6 |
none |
1.6 |
|
TA 100 |
- |
0.0016 – 0.5 |
none |
0.5 |
+ |
0.0016 – 0.5 |
none |
0.5 |
|
TA 102 |
- |
0.0016 – 0.5 |
none |
0.16 |
+ |
0.005 – 1.6 |
none |
1.6 |
|
TA 1535 |
- |
0.0016 – 0.5 |
none |
0.5 |
+ |
0.005 – 1.6 |
none |
1.6 |
Table 2: Summary of mean number of revertants (mean of 3 plates) in Salmonella typhimurium strains with and without metabolic activation
Experiment I |
||||||||||
Concentration |
TA1535 |
TA102 |
TA100 |
TA98 |
TA97a |
|||||
[mg/plate] |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
Control |
24 |
12 |
322 |
382 |
123 |
133 |
22 |
24 |
234 |
275 |
0.5 |
n.c. |
10 |
n.c. |
353 |
n.c. |
n.c. |
n.c. |
29. |
n.c. |
n.c. |
0.16 |
22 |
13 |
333 |
450 |
74 |
101 |
40 |
40 |
211 |
238 |
0.05 |
30 |
15 |
325 |
480 |
126 |
113 |
45 |
35 |
278 |
276 |
0.016 |
29 |
15 |
397 |
457 |
131 |
100 |
42 |
35 |
277 |
259 |
0.005 |
29 |
13 |
344 |
461 |
133 |
100 |
32 |
34 |
263 |
233 |
Experiment II |
||||||||||
|
TA1535 |
TA102 |
TA100 |
TA98 |
TA97a |
|||||
|
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
Control |
25 |
13 |
389 |
501 |
117 |
112 |
25 |
30 |
260 |
277 |
1.6 |
— |
n.c. |
— |
n.c. |
— |
— |
— |
— |
— |
— |
0.5 |
— |
10 |
— |
203 |
— |
— |
— |
— |
— |
— |
0.16 |
17 |
10 |
198 |
346 |
57 |
129 |
28 |
n.c. |
100 |
n.c. |
0.05 |
12 |
11 |
315 |
333 |
53 |
102 |
31 |
15 |
219 |
121 |
0.016 |
25 |
14 |
273 |
364 |
122 |
110 |
34 |
33 |
232 |
226 |
0.005 |
16 |
— |
218 |
— |
72 |
100 |
21 |
35 |
231 |
205 |
0.0016 |
30 |
— |
339 |
— |
115 |
93 |
28 |
32 |
116 |
136 |
n.c.= not counted, due to reduced background lawn; — = concentration not tested
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study the test item was found to have no mutagenic effects on Salmonella typhimurium strains TA 97a, TA 100, TA 98, TA 102, TA 1535 with (+) and without (-) the metabolic activation system S9 from Wistar rats at concentrations up to 0.5mg/plate.
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