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EC number: 222-048-3 | CAS number: 3327-22-8
- 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
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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:
- 1984-01-12 to 1984-04-02
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline, with acceptable restrictions. The restrictions were: the range of strains does not comply with the current guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Annex V Method 431
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (3-chloro-2-hydroxypropyl)trimethylammonium chloride
- EC Number:
- 222-048-3
- EC Name:
- (3-chloro-2-hydroxypropyl)trimethylammonium chloride
- Cas Number:
- 3327-22-8
- Molecular formula:
- C6H15ClNO.Cl
- IUPAC Name:
- 3-chloro-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride
- Details on test material:
- - Name of test material (as cited in study report): 3-chlor-2-hydroxypropyltrimethyl-ammonium chloride
- Physical state: solid
- Analytical purity: dry: 94.59%, humid: 65.51%
- Lot/batch No.: 0201
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- ranging from 1.58 - 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: bidest water
- Justification for choice of solvent/vehicle: none given in test report
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 100 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1535 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 TA 100 TA 1537 TA 1538 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-nitrosoguanidine
- Remarks:
- TA 98 100 1535 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- all strains with activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- TA 98 TA100 TA 1537 TA 1538 with activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation);
DURATION
- Exposure duration: 3 days
NUMBER OF REPLICATIONS: triplicate
DETERMINATION OF CYTOTOXICITY
- Method: other: relative survival rate: comparison of number of revertants in presence and absence of prototrophic bacterai (spontaneous revertants of TA 1573 (RTA))
OTHER: To avoid any light effects on the test compound, all experimentation was performed under yellow light. - Evaluation criteria:
- A positive result is a reproducible dose effect with a 2-fold increase in the number of revertants over controls in at least one strain. A 1.5-fold increase is the criterion for a positive result in strain TA 100.
- Statistics:
- The number of revertants was counted with a Fischer 880 counter unless precipitation had occurred. Mean number of revertants per plate was calculated.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- dose dependent
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- at highest dose
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- at two highest doses tested
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: none reported
- The pH value is not reported
- Other confounding effects: none reported
COMPARISON WITH HISTORICAL CONTROL DATA: none given in study report
ADDITIONAL INFORMATION ON CYTOTOXICITY: neither quantitative nor qualitative evidence of cytotoxic effects was observed
Any other information on results incl. tables
Table 1: Dose range-finding study Relative survival rate
- |
Without activation |
With activation |
||||
Conc. |
TA1537 |
TA1537 + RTA |
Relative survival rate |
TA1537 |
TA1537 + RTA |
Relative survival rate |
0* |
6 |
190 |
1.00 |
16 |
226 |
1.00 |
1.58 |
8 |
214 |
1.12 |
16 |
236 |
1.05 |
5 |
7 |
197 |
1.03 |
14 |
219 |
0.90 |
15.8 |
10 |
205 |
1.06 |
14 |
206 |
0.91 |
50 |
10 |
202 |
1.04 |
15 |
235 |
1.05 |
158 |
8 |
197 |
1.03 |
13 |
224 |
1.00 |
500 |
8 |
204 |
1.07 |
17 |
237 |
1.05 |
1580 |
13 |
233 |
1.20 |
13 |
232 |
1.04 |
5000 |
17 |
214 |
1.07 |
17 |
232 |
1.02 |
*solvent control with water
RTA: spontaneous revertants of TA 1573
Table 2: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
- |
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
18 |
29 |
no |
185 |
153 |
no |
15 |
10 |
no |
1.58 |
23 |
30 |
no |
182 |
116 |
no |
20 |
9 |
no |
5 |
23 |
30 |
no |
185 |
138 |
no |
17 |
12 |
no |
15.8 |
22 |
28 |
no |
198 |
145 |
no |
19 |
9 |
no |
50 |
23 |
30 |
no |
204 |
147 |
no |
13 |
15 |
no |
158 |
26 |
30 |
no |
185 |
141 |
no |
21 |
14 |
no |
500 |
34 |
31 |
no |
162 |
183 |
no |
28 |
18 |
no |
1580 |
30 |
30 |
no |
178 |
158 |
no |
40 |
21 |
no |
5000 |
39 |
28 |
no |
175 |
168 |
no |
68 |
41 |
no |
Positive control 1 |
462 |
75 |
no |
305 |
256 |
no |
- |
82 |
no |
Positive control 2 |
166 |
208 |
no |
281 |
532 |
no |
227 |
- |
no |
*solvent control with water
Table 3 Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
- |
TA1537 |
TA1538 |
||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
6 |
16 |
no |
14 |
21 |
no |
1.58 |
8 |
16 |
no |
18 |
20 |
no |
5 |
7 |
14 |
no |
12 |
16 |
no |
15.8 |
10 |
14 |
no |
23 |
18 |
no |
50 |
10 |
15 |
no |
21 |
21 |
no |
158 |
8 |
13 |
no |
12 |
17 |
no |
500 |
8 |
17 |
no |
16 |
19 |
no |
1580 |
13 |
13 |
no |
15 |
18 |
no |
5000 |
17 |
17 |
no |
14 |
18 |
no |
Positive control 1 |
569 |
168 |
no |
- |
76 |
no |
Positive control 2 |
122 |
106 |
no |
835 |
103 |
no |
*solvent control with water
Table 4: Experiment 2 Repeat of strain TA 1537 Number of revertants per plate (mean of 3 plates)
- |
TA100 |
|
Conc. |
- MA |
Cytotoxic |
0* |
20 |
no |
1.58 |
19 |
no |
5 |
24 |
no |
15.8 |
26 |
no |
50 |
28 |
no |
158 |
25 |
no |
500 |
36 |
no |
1580 |
46 |
no |
5000 |
80 |
no |
Positive control |
781 |
no |
*solvent control with water
Applicant's summary and conclusion
- Conclusions:
- (3-Chloro-2-hydroxypropyl)trimethylammonium chloride was tested in OECD 471 under GLP. A dose-dependant increase in the number of revertants was observed in Salmonella typhimurium TA1535 both with and without activation. An increase in the number of revertants was also seen in strain TA 98 in the absence of activation at the highest dose tested, and in TA 1537 without activation at the two highest doses tested. It was concluded that the test substance is mutagenic under the conditions of the test.
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