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EC number: 946-742-7 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 05 Apr - 13 May 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- / Guideline study conducted according to the Japanese test guideline reported as "Standard of the Minister of Labor, based on the Industrial Safety and Health Law Article 57-2 Paragraph 1 (Notification No. 77 of JMOL on September 1, 1988) and Notification on partial revision of the standard (Notification No. 67 JMOL on June 2, 1997)", which in principle is similar to OECD TG 471.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Qualifier:
- according to guideline
- Guideline:
- other: Standard of the Minister of Labor, based on the Industrial Safety and Health Law Article 57-2 Paragraph 1 (Notification No. 77 of JMOL on September 1, 1988) and Notification on partial revision of the standard (Notification No. 67 JMOL on June 2, 1997)
- Deviations:
- not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]docosanamide
- EC Number:
- 262-134-8
- EC Name:
- N-[3-(dimethylamino)propyl]docosanamide
- Cas Number:
- 60270-33-9
- Molecular formula:
- C27H56N2O
- IUPAC Name:
- N-[3-(dimethylamino)propyl]docosanamide
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light
- Solubility and stability of the test substance in the solvent/vehicle:stable in dimethylsulfoxid, acetone and tetrahydrofuran
FORM AS APPLIED IN THE TEST: liquid
Method
- Target gene:
- his operon, tryp operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats, treated with 5,6-benzoflavone
- Test concentrations with justification for top dose:
- Based on the results of the range-finding study (all strains; doses applied 5, 20, 78, 313, 1250, 5000 μg/mL), the following concentrations were used in the main experiment:
- 39, 78, 156, 313, 625, 1250 µg/plate (TA strains, without metabolic activation)
- 313, 625, 1250, 2500, 5000 µg/plate (WP2uvrA, with and without metabolic activation, TA strains with metabolic activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: tetrahydrofuran (THF)
- Justification for choice of solvent/vehicle: The solvent was chosen based on its solubility and stability properties.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- THF
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- benzo(a)pyrene
- other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2), 2-Aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
- Cell density at seeding:
in main test
TA100 and TA1535: 2.2 x 10^9
TA98: 3 x 10^9
TA1537: 1.7 x 10^9
WP2uvrA: 6.7 x 10^9
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: duplicate - Evaluation criteria:
- The positive control should show a clear dose-dependend increase of at least two times compared to the negative control (spontaneous reversion rate). The negative and positive control as well as the test item should satisfy the acceptance criteria.
Acceptance criteria
The study was considered valid if:
- the number of revertant colonies of the negative (solvent) and positive controls were in the historical control range in all strains (value ± 2SD)
- no contamination in test material, S9 mix, Sodium phosphate buffer (analysis performed)
- the positive control led to an increase of at least two times compared to the negative control - Statistics:
- No statistical analysis was performed. Mean values were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- number of revertant colonies decreased compared to solvent control starting at 1250 μg/plate without S9 mix (24%)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- number of revertant colonies decreased compared to solvent control starting at 1250 μg/plate without S9 mix (46%)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- number of revertant colonies decreased compared to solvent control starting at 625 μg/plate without S9 mix (22 - 78%)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- number of revertant colonies decreased compared to solvent control starting at 625 μg/plate without S9 mix (14 - 71%)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitate was detected in all examined strains with metabolic activation at all concentration tested and without metabolic activation starting at a concentration of 156 μg/plate (all TA strains) or 313 μg/plate (WP2uvrA).
RANGE-FINDING/SCREENING STUDIES: All bacterial strains showed negative responses over the entire dose range, i.e. no clear dose-dependent increase in the number of revertants of at least two times compared to the negative control. Precipitate was detected in all examined strains with and without metabolic activation starting at 313 μg/plate (for further details see "any other information on results incl tables").
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data:
TA98, -S9: 444 - 679, mean ± SD: 561 ± 58.8
TA98, +S9: 249 - 448, mean ± SD: 349 ± 49.8
TA100, -S9: 398 - 689, mean ± SD: 544 ± 72.8
TA100, +S9: 843 - 1457, mean ± SD: 1150 ± 153.5
TA1535, -S9: 352 - 720, mean ± SD: 536 ± 92.0
TA1535, +S9: 116 - 320, mean ± SD: 218 ± 51.0
TA1537, -S9: 254 - 895, mean ± SD: 574 ± 160.4
TA1537, +S9: 52 - 104, mean ± SD: 78 ± 13.1
WP2uvrA, -S9: 87 - 137, mean ± SD: 107 ± 14.8
WP2uvrA, +S9: 523 - 1101, mean ± SD: 812 ± 144.4
- Negative (solvent/vehicle) historical control data:
TA98, -S9: 15 - 31, mean ± SD: 23 ± 4.0
TA98, +S9: 18 - 40, mean ± SD: 29 ± 5.5
TA100, -S9: 90 - 133, mean ± SD: 111 ± 11
TA100, +S9: 96 - 147, mean ± SD: 122 ± 13
TA1535, -S9: 3 - 14, mean ± SD: 9 ± 2.7
TA1535, +S9: 4 - 14, mean ± SD: 9 ± 2.6
TA1537, -S9: 3 - 12, mean ± SD: 8 ± 2.3
TA1537, +S9: 2 - 15, mean ± SD: 9 ± 3.1
WP2uvrA, -S9: 14 - 33, mean ± SD: 23 ± 4.8
WP2uvrA, +S9: 15 - 35, mean ± SD: 25 ± 5.0
The ranges are calculated as mean ± 2xSD.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: toxic effects were examined with a stereoscopic microscope
Any other information on results incl. tables
Table 1: Summary of test results (Range-finding study, experiment 1, pre-incubation method)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 2 plates) |
|||||
Frameshift type |
Base-pair substitution type |
||||||
TA1537 |
TA98 |
TA100 |
TA1535 |
WP2 uvrA |
|||
– |
Solvent control (THF) |
9 |
25 |
129 |
10 |
22 |
|
5 |
8 |
22 |
132 |
8 |
23 |
||
20 |
7 |
22 |
134 |
10 |
27 |
||
78 |
10 |
30 |
130 |
9 |
24 |
||
313 |
9 P |
26 P |
121 P |
8 P |
20 P |
||
1250 |
3 P T |
7 P T |
56 P T |
6 P T |
21 P |
||
5000 |
3 P T |
11 P T |
62 P T |
5 P T |
21 P |
||
Positive controls (µg/plate) |
9AA |
AF-2 |
AF-2 |
NaN3 |
AF-2 |
||
Mean No. of colonies/plate (average of 2 plates) |
385 |
507 |
602 |
482 |
123 |
||
+ |
Solvent control (THF) |
10 |
31 |
142 |
11 |
25 |
|
5 |
9 |
34 |
141 |
9 |
26 |
||
20 |
9 |
35 |
153 |
9 |
25 |
||
78 |
7 |
32 |
145 |
9 |
20 |
||
313 |
8 P |
30 P |
145 P |
10 P |
25 P |
||
1250 |
10 P |
30 P |
140 P |
8 P |
21 P |
||
5000 |
9 P |
30 P |
126 P |
10 P |
20 P |
||
Positive controls (µg/plate) |
B[α]P |
B[α]P |
B[α]P |
2AA |
2AA |
||
Mean No. of colonies/plate (average of 2 plates) |
85 |
384 |
1068 |
240 |
941 |
THF = tetrahydrofuran
AF-2 = 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
NaN3= sodium azide
9AA = 9-aminoacridine
B[α]P = benzo[α]pyrene
2AA = 2-aminonathracene
P = precipitate
T = toxic effect observed
Table 2: Summary of test results (main study, experiment 2, pre-incubation method)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 2 plates) |
|||||
Frameshift type |
Base-pair substitution type |
||||||
TA1537 |
TA98 |
TA100 |
TA1535 |
WP2 uvrA |
|||
– |
Solvent control (THF) |
7 |
29 |
132 |
9 |
26 |
|
39 |
7 |
23 |
124 |
7 |
- |
||
78 |
8 |
29 |
117 |
8 |
- |
||
156 |
7 P |
28 P |
137 P |
8 P |
- |
||
313 |
7 P |
29 P |
116 P |
8 P |
22 P |
||
625 |
6 P T |
27 P |
102 P |
7 P T |
26 P |
||
1250 |
2 P T |
22 P T |
71 P T |
2 P T |
25 P |
||
2500 |
- |
- |
- |
- |
23 P |
||
5000 |
- |
- |
- |
- |
23 P |
||
Positive controls (µg/plate) |
9AA |
AF-2 |
AF-2 |
NaN3 |
AF-2 |
||
Mean No. of colonies/plate (average of 2 plates) |
430 |
554 |
465 |
484 |
127 |
||
+ |
Solvent control (THF) |
7 |
28 |
139 |
9 |
25 |
|
313 |
8 P |
32 P |
144 P |
10 P |
25 P |
||
625 |
8 P |
36 P |
142 P |
9 P |
26 P |
||
1250 |
9 P |
34 P |
146 P |
9 P |
21 P |
||
2500 |
7 P |
32 P |
137 P |
8 P |
25 P |
||
5000 |
7 P |
29 P |
140 P |
9 P |
25 P |
||
Positive controls (µg/plate) |
B[α]P |
B[α]P |
B[α]P |
2AA |
2AA |
||
Mean No. of colonies/plate (average of 2 plates) |
91 |
334 |
1044 |
220 |
898 |
THF = tetrahydrofuran
AF-2 = 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
NaN3= sodium azide
9AA = 9-aminoacridine
B[α]P = benzo[α]pyrene
2AA = 2-aminonathracene
P = precipitate
T = toxic effect observed
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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