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EC number: 629-716-7 | CAS number: 1211950-04-7
- 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
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Diamine quaternised C16-18, C18 unsaturated, was tested in three in-vitro genotoxicity studies to current OECD/EU protocol and carried out to GLP with a well-defined test substance. All three tests were negative.
Link to relevant study records
- 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:
- 2010 -03-22 till 2010-04-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/ß-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment I and II without S9 mix: 0.03; 0.1; 0.3; 1; 3; 10; 33; and 100 µg/plate
Experiment I and II with S9 mix: 0.3; 1; 3; 10; 33; 100; 250; and 500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:DMSO
- Justification for choice of solvent/vehicle: better than others - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide; 4-nitro-o-phenylene-diamine; methyl methane sulfonate, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: iplate incorporation; preincubation;
DURATION
- Preincubation period: 1 hour
- Exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 plates
DETERMINATION OF CYTOTOXICITY
A reduction in the number of spontaneous revertants (below the induction factor of 0.5) or a clearing of the bacterial background lawn.
- Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and TA 102) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
- 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
- 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:
- valid
- 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:
- valid
- 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:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation:
The test item precipitated in the overlay agar on the incubated in the pre-experiment at 2500 µg/plate and 5000 µg/plate in the absence of metabolic activation and from 1000 µg/plate up to 5000 µg/plate in the presence of metabolic activation. In Experiment I and II precipitation of the test item was observed from 100 µg/plate to 500 µg/plate in the presence of metabolic activation. The undissolved particles of the test item had no influence on the data recording.
- Other confounding effects:
COMPARISON WITH HISTORICAL CONTROL DATA: performed
ADDITIONAL INFORMATION ON CYTOTOXICITY:
following concentrations (µg/plate):
Strain Pre- Experiment Experiment I Experiment II
without S9 mix with S9 mix without S9 mix with S9 mix without S9 mix with S9 mix
TA 1535 10 - 5000 100 - 5000 10 - 100 100 - 500 10 - 100 100 - 500
TA 1537 10 - 5000 100 - 5000 33 - 100 250 - 500 10 - 100 100 - 500
TA 98 10 - 5000 100 - 5000 33 - 100 250 - 500 10 - 100 100 - 500
TA 100 10 - 5000 100 - 5000 10 - 100 / 10 - 100 100 - 500
TA 102 10 - 5000 100 - 5000 10 - 100 / 10 - 100 100 - 500
/ = no reduced background growth
Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at the following concentrations (µg/plate):
Strain Pre- Experiment Experiment I Experiment II
without S9 mix with S9 mix without S9 mix with S9 mix without S9 mix with S9 mix
TA 1535 33 - 5000 333 - 5000 33 - 100 250 - 500 10 - 100 250 - 500
TA 1537 33 - 5000 333 - 5000 33 - 100 250 - 500 10 - 100 250 - 500
TA 98 33 - 5000 333 - 5000 100 250 - 500 33 - 100 250 - 500
TA 100 33 - 5000 333 - 5000 33 - 100 250 - 500 33 - 100 100 - 500
TA 102 33 - 5000 333 - 5000 33 - 100 250 - 500 10 - 100 250 - 500 - Remarks on result:
- other: other: reverse mutation assay
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, N, N, N´,N´,N´´-Pentamethyl-N-tallowalkyl- 1,3- propanediammonium chloride is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay. - Executive summary:
The test item N, N, N´,N´,N´´-Pentamethyl-N-tallowalkyl- 1,3- propanediammonium chloride was assessed for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and TA 102.
The assay was performed with and without liver microsomal activation. Each concentration and the controls, were tested in triplicate. Due to strong toxic effects in the pre-experiment, the plate incorporation was repeated (reported as experiment I). Due to contamination of bacteria suspension of strains TA 1537 and TA 98 in experiment I, this part was repeated under identical conditions (reported as part of experiment I). The test item was tested at the following concentrations:
Pre-Experiment: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment I and II without S9 mix: 0.03; 0.1; 0.3; 1; 3; 10; 33; and 100 µg/plate
Experiment I and II with S9 mix: 0.3; 1; 3; 10; 33; 100; 250; and 500 µg/plateThe plates incubated with the test item showed reduced background growth at the following concentrations (µg/plate):
Strain
Pre- Experiment
Experiment I
Experiment II
without S9 mix
with S9 mix
without S9 mix
with S9 mix
without S9 mix
with S9 mix
TA 1535
10 - 5000
100 - 5000
10 - 100
100 - 500
10 - 100
100 - 500
TA 1537
10 - 5000
100 - 5000
33 - 100
250 - 500
10 - 100
100 - 500
TA 98
10 - 5000
100 - 5000
33 - 100
250 - 500
10 - 100
100 - 500
TA 100
10 - 5000
100 - 5000
10 - 100
/
10 - 100
100 - 500
TA 102
10 - 5000
100 - 5000
10 - 100
/
10 - 100
100 - 500
/ = no reduced background growth
Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at the following concentrations (µg/plate):
Strain
Pre- Experiment
Experiment I
Experiment II
without S9 mix
with S9 mix
without S9 mix
with S9 mix
without S9 mix
with S9 mix
TA 1535
33 - 5000
333 - 5000
33 - 100
250 - 500
10 - 100
250 - 500
TA 1537
33 - 5000
333 - 5000
33 - 100
250 - 500
10 - 100
250 - 500
TA 98
33 - 5000
333 - 5000
100
250 - 500
33 - 100
250 - 500
TA 100
33 - 5000
333 - 5000
33 - 100
250 - 500
33 - 100
100 - 500
TA 102
33 - 5000
333 - 5000
33 - 100
250 - 500
10 - 100
250 - 500
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with N, N, N´,N´,N´´-Pentamethyl-N-tallowalkyl- 1,3- propanediammonium chloride at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix).
Reference
Summary of Results Pre-Experiment
Study Name: 1302501 |
Study Code: Harlan CCR 1302501 |
Experiment: 1302501 VV Plate |
Date Plated: 22/03/2010 |
Assay Conditions: |
Date Counted: 25/03/2010 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
Revertant Colony Counts (Mean ±SD) |
|||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
||||
Without Activation |
DMSO |
15 ± 6 |
14 ± 3 |
25 ± 5 |
158 ± 12 |
444 ± 14 |
||
Untreated |
13 ± 3 |
19 ± 7 |
24 ± 5 |
173 ± 13 |
416 ± 27 |
|||
N, N, N´,N´,N´´- |
3 µg |
10 ± 3 |
16 ± 1 |
25 ± 6 |
157 ± 11 |
364 ± 21 |
||
Pentamethyl-N- |
10 µg |
9 ± 3R |
14 ± 4R |
25 ± 5R |
110 ± 7R |
364 ± 39R |
||
tallowalkyl- 1,3- |
33 µg |
4 ± 1M R |
1 ± 2M R |
1 ± 1M R |
4 ± 3M R |
37 ± 3M R |
||
propanediammonium |
100 µg |
0 ± 0M R |
0 ± 0M R |
0 ± 0M R |
0 ± 0M R |
0 ± 0M R |
||
chloride |
333 µg |
0 ± 0M R |
0 ± 0M R |
0 ± 0M R |
0 ± 0M R |
0 ± 0M R |
||
1000 µg |
0 ± 0M R |
0 ± 0M R |
0 ± 0M R |
0 ± 0M R |
0 ± 0M R |
|||
2500 µg |
0 ± 0M R P |
0 ± 0M R P |
0 ± 0M R P |
0 ± 0M R P |
0 ± 0M R P |
|||
5000 µg |
0 ± 0M R P |
0 ± 0M R P |
0 ± 0M R P |
0 ± 0M R P |
0 ± 0M R P |
|||
NaN3 |
10 µg |
1734 ± 53 |
1887 ± 122 |
|||||
4-NOPD |
10 µg |
346 ± 17 |
||||||
4-NOPD |
50 µg |
71 ± 5 |
||||||
MMS |
3.0 µL |
2258 ± 210 |
||||||
With Activation |
DMSO |
17 ± 4 |
22 ± 1 |
31 ± 3 |
165 ± 20 |
586 ± 35 |
||
Untreated |
18 ± 3 |
19 ± 2 |
43 ± 7 |
177 ± 15 |
538 ± 66 |
|||
N, N, N´,N´,N´´- |
3 µg |
15 ± 3 |
23 ± 4 |
38 ± 8 |
161 ± 7 |
519 ± 14 |
||
Pentamethyl-N- |
10 µg |
15 ± 5 |
23 ± 5 |
35 ± 7 |
179 ± 9 |
567 ± 40 |
||
tallowalkyl- 1,3- |
33 µg |
13 ± 4 |
30 ± 6 |
41 ± 10 |
182 ± 3 |
595 ± 12 |
||
propanediammonium |
100 µg |
12 ± 4R |
19 ± 5R |
29 ± 7R |
53 ± 30R |
363 ± 39R |
||
chloride |
333 µg |
0 ± 0M R |
0 ± 0M R |
0 ± 0M R |
0 ± 0M R |
0 ± 0M R |
||
1000 µg |
0 ± 0M R P |
0 ± 0M R P |
0 ± 0M R P |
0 ± 0M R P |
0 ± 0M R P |
|||
2500 µg |
0 ± 0M R P |
0 ± 0M R P |
0 ± 0M R P |
0 ± 0M R P |
0 ± 0M R P |
|||
5000 µg |
0 ± 0M R P |
0 ± 0M R P |
0 ± 0M R P |
0 ± 0M R P |
0 ± 0M R P |
|||
2-AA |
2.5 µg |
500 ± 45 |
503 ± 50 |
2133 ± 551 |
4080 ± 219 |
|||
2-AA |
10.0 µg |
2397 ± 57 |
||||||
Key to Positive Controls |
Key to Plate Postfix Codes |
||
NaN3 2-AA MMS 4-NOPD |
sodium azide 2-aminoanthracene methyl methane sulfonate 4-nitro-o-phenylene-diamine |
R M P |
Reduced background growth Manual count Precipitate |
Summary of Results Experiment I
Study Name: 1302501 |
Study Code: Harlan CCR 1302501 |
Experiment: 1302501 HV1 Pre |
Date Plated: 13/04/2010 / 21/04/2010* |
Assay Conditions: |
Date Counted: 16/04/2010 / 28/04/2010* |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
Revertant Colony Counts (Mean ±SD) |
|||||
TA 1535 |
TA 1537* |
TA 98* |
TA 100 |
TA 102 |
||||
Without Activation |
DMSO |
17 ± 1 |
15 ± 6 |
35 ± 3 |
131 ± 9 |
447 ± 8 |
||
Untreated |
15 ± 4 |
8 ± 1 |
33 ± 5 |
132 ± 9 |
479 ± 24 |
|||
N, N, N´,N´,N´´- |
0.03 µg |
19 ± 4 |
13 ± 3 |
28 ± 1 |
135 ± 4 |
459 ± 44 |
||
Pentamethyl-N- |
0.1 µg |
16 ± 1 |
14 ± 4 |
35 ± 7 |
137 ± 11 |
437 ± 15 |
||
tallowalkyl- 1,3- |
0.3 µg |
17 ± 3 |
10 ± 5 |
26 ± 6 |
140 ± 4 |
427 ± 14 |
||
propanediammonium |
1µg |
15 ± 1 |
12 ± 3 |
30 ± 3 |
136 ± 7 |
428 ± 18 |
||
chloride |
3 µg |
21 ± 5 |
12 ± 4 |
28 ± 7 |
134 ± 7 |
451 ± 7 |
||
10 µg |
18 ± 2R |
11 ± 5 |
27 ± 3 |
99 ± 7R |
390 ± 13R |
|||
33 µg |
3 ± 1M R |
4 ± 1M R |
16 ± 3R |
3 ± 2M R |
16 ± 3M R |
|||
100 µg |
0 ± 0M R |
1 ± 2M R |
1 ± 1M R |
0 ± 0M R |
0 ± 0M R |
|||
NaN3 |
10 µg |
1929 ± 133 |
338 ± 28 |
2065 ± 35 |
||||
4-NOPD |
10 µg |
|||||||
4-NOPD |
50 µg |
82 ± 2 |
||||||
MMS |
3.0 µL |
4677 ± 818 |
||||||
With Activation |
DMSO |
22 ± 2 |
19 ± 7 |
47 ± 6 |
143 ± 8 |
563 ± 117 |
||
Untreated |
16 ± 6 |
29 ± 0 |
47 ± 10 |
166 ± 26 |
555 ± 31 |
|||
N, N, N´,N´,N´´- |
0.3 µg |
17 ± 4 |
22 ± 6 |
49 ± 10 |
136 ± 10 |
514 ± 29 |
||
Pentamethyl-N- |
1 µg |
19 ± 5 |
24 ± 2 |
38 ± 6 |
152 ± 7 |
540 ± 43 |
||
tallowalkyl- 1,3- |
3 µg |
24 ± 8 |
13 ± 6 |
43 ± 5 |
148 ± 9 |
519 ± 27 |
||
propanediammonium |
10 µg |
15 ± 2 |
21 ± 3 |
41 ± 8 |
140 ± 18 |
485 ± 29 |
||
chloride |
33 µg |
19 ± 2 |
21 ± 5 |
41 ± 9 |
149 ± 14 |
510 ± 18 |
||
100 µg |
18 ± 5R P |
12 ± 5P |
36 ± 3P |
147 ± 17P |
418 ± 45P |
|||
250 µg |
0 ± 1P R M |
6 ± 2M R P |
5 ± 4P M R |
0 ± 0P M |
20 ± 5P M |
|||
500 µg |
0 ± 0P M R |
0 ± 0M R P |
0 ± 0P M R |
0 ± 0P M |
0 ± 0P M |
|||
2-AA |
2.5 µg |
550 ± 40 |
482 ± 5 |
2251 ± 25 |
2911 ± 77 |
|||
2-AA |
10.0 µg |
2905 ± 190 |
||||||
Key to Positive Controls |
Key to Plate Postfix Codes |
||
NaN3 2-AA MMS 4-NOPD |
sodium azide 2-aminoanthracene methyl methane sulfonate 4-nitro-o-phenylene-diamine |
R M P |
Reduced background growth Manual count Precipitate |
* = repeated experiment
Summary of Results Experiment II
Study Name: 1302501 |
Study Code: Harlan CCR 1302501 |
Experiment: 1302501 HV2 Pre |
Date Plated: 22/04/2010 |
Assay Conditions: |
Date Counted: 28/04/2010 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
Revertant Colony Counts (Mean ±SD) |
|||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
||||
Without Activation |
DMSO |
16 ± 6 |
11 ± 2 |
30 ± 9 |
122 ± 3 |
310 ± 2 |
||
Untreated |
15 ± 2 |
14 ± 1 |
28 ± 2 |
138 ± 10 |
337 ± 10 |
|||
N, N, N´,N´,N´´- |
0.03 µg |
14 ± 4 |
11 ± 3 |
28 ± 8 |
117 ± 9 |
313 ± 25 |
||
Pentamethyl-N- |
0.1 µg |
17 ± 5 |
12 ± 4 |
27 ± 6 |
108 ± 6 |
326 ± 13 |
||
tallowalkyl- 1,3- |
0.3 µg |
15 ± 2 |
12 ± 5 |
28 ± 6 |
111 ± 4 |
317 ± 8 |
||
propanediammonium |
1 µg |
16 ± 5 |
11 ± 3 |
32 ± 3 |
112 ± 3 |
329 ± 21 |
||
chloride |
3 µg |
14 ± 1 |
11 ± 3 |
24 ± 4 |
95 ± 23 |
310 ± 18 |
||
10 µg |
5 ± 3R |
4 ± 1R |
14 ± 3R |
63 ± 18R |
66 ± 4R M |
|||
33 µg |
0 ± 1R M |
3 ± 1M R |
9 ± 1M R |
0 ± 0M R |
62 ± 13M R |
|||
100 µg |
0 ± 0M R |
0 ± 0M R |
0 ± 0M R |
0 ± 0M R |
12 ± 2M R |
|||
NaN3 |
10 µg |
1706 ± 27 |
1760 ± 170 |
|||||
4-NOPD |
10 µg |
464 ± 20 |
||||||
4-NOPD |
50 µg |
81 ± 6 |
||||||
MMS |
3.0 µL |
2302 ± 36 |
||||||
With Activation |
DMSO |
19 ± 4 |
23 ± 6 |
42 ± 7 |
129 ± 8 |
376 ± 19 |
||
Untreated |
20 ± 3 |
20 ± 5 |
53 ± 8 |
139 ± 17 |
403 ± 41 |
|||
N, N, N´,N´,N´´- |
0.3 µg |
19 ± 3 |
16 ± 1 |
38 ± 11 |
111 ± 2 |
355 ± 42 |
||
Pentamethyl-N- |
1 µg |
21 ± 6 |
20 ± 3 |
43 ± 5 |
114 ± 7 |
453 ± 53 |
||
tallowalkyl- 1,3- |
3 µg |
17 ± 3 |
21 ± 6 |
38 ± 3 |
130 ± 2 |
429 ± 49 |
||
propanediammonium |
10 µg |
20 ± 4 |
21 ± 1 |
37 ± 4 |
132 ± 12 |
447 ± 55 |
||
chloride |
33 µg |
18 ± 3 |
24 ± 2 |
44 ± 3 |
147 ± 10 |
397 ± 32 |
||
100 µg |
18 ± 3P R |
12 ± 4P R |
42 ± 3P R |
48 ± 4P R |
284 ± 22P R |
|||
250 µg |
4 ± 2P M R |
9 ± 2P M R |
12 ± 3P M R |
16 ± 5P M R |
29 ± 9P M R |
|||
500 µg |
0 ± 0P M R |
0 ± 0P M R |
0 ± 1P M R |
0 ± 0P M R |
14 ± 4P M R |
|||
2-AA |
2.5 µg |
372 ± 12 |
415 ± 4 |
1859 ± 10 |
2546 ± 58 |
|||
2-AA |
10.0 µg |
2027 ± 265 |
||||||
Key to Positive Controls |
Key to Plate Postfix Codes |
||
NaN3 2-AA MMS 4-NOPD |
sodium azide 2-aminoanthracene methyl methane sulfonate 4-nitro-o-phenylene-diamine |
R M P |
Reduced background growth Manual count Precipitate |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vitro:
Diamine quaternised C16-18, C18 unsaturated, was tested for genetic toxicity in three in vitro tests. In a bacterial reverse mutation assay the substance was not mutagenic with or without S9 mix. In addition, the substance was tested in a chromosomal aberration test in human lymphocytes and was found to be not clastogenic. The test item did not induce structural chromosomal aberrations in human lymphocytes in vitro. Further, the test item did not induce mutations in the mouse lymphoma thymidine kinase locus assay using the cell line L5178Y in the absence and presence of metabolic activation. Therefore, the test substance is not mutagenic in the TK mutation test.
Justification for selection of genetic toxicity endpoint
For each endpoint, bacterial mutagenicity, mammalian mutagenicity and mammalian clastogenicity, a recent guideline and GLP compliant study is available.
Justification for classification or non-classification
All tests were to current protocols carried out to GLP and with a clearly defined and described test substance. Based on these results it can be concluded that Diamine quaternised C16-18, C18 -unsaturated, is not to be expected to be a genotoxic hazard to human health.
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