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EC number: 604-714-9 | CAS number: 149968-48-9
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 5 April 2005 to 19 December 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed similarly to the OECD guideline 471 and is in compliance with the Japanese GLP. The test was performed on a very similar structure (saturated chain instead of an insaturated chain).
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Minister of Labor Standard 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 of JMOL on June 2, 1997)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
- Remarks:
- Minister of Labor Standard based on the industrial safety and health Law Article 34-3 Paragraph 2 (Notification No. 76 of JMOL on September 1, 1988) and Notification on partial revision of the standard (Notification No. 13 of JMOL on March 29, 2000)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Docosanamide,N-[3-(dimethylamino)propyl]-
- IUPAC Name:
- Docosanamide,N-[3-(dimethylamino)propyl]-
- 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
- Test material form:
- other: white granular solid
- Details on test material:
- - Name of test material (as cited in study report):N-[3-(dimethylamino)propyl]docosanamide, other name: AMIDET APA-22
- Stability under test conditions: stable in room temperature
- Storage condition of test material: in room temperature, shield from light
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine gene for S. typhimurium, tryphtophan locus for E. coli WP2 uvrA
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction prepared from rat liver homogenates that had been treated with phenobarbital and 5,6-benzoflavone. S9 fraction purchased from Kikkoman Corporation (Japan). Cofactor for S9 mix was purchased from Roche Diagnostics K.K. (lot 732).
- Test concentrations with justification for top dose:
- Preliminary test: 5; 20; 78; 313; 1250 and 5000 µg/plate
Main test: 39, 78, 156, 313, 625, 1250, 2500 and 5000 µg/plate in the absence of metabolic activation
313, 625, 1250, 2500 and 5000 µg/plate in the presence of metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: tetrahydrofuran
- Justification for choice of solvent/vehicle: In a solubility test, distilled water and three different organic solvents of dimethylsulfoxide (DMSO), acetone and tetrahydrofuran, were used. The concentration of the test susbstance when distilled water and DMSO were used was set at 50mg/mL, and the concentration was set at 100 mg/mL for acetone and 250 mg/mL for tetrahydrofuran. The test substance dissolved in tetrahydrofuran by the treatment of sonic waves. The test substance suspended in acetone, but uniform dispersion was not obtained though treatment by supersonic waves was done. On the other hand, the response of the test substance such as exothermic reaction was not recognized in any solvents. Therefore, the test substance was thought stable in these solvents. But the test substance could not disperse in distilled water and DMSO though the treatment by supersonic waves was done.
From these results, tetrahydrofuran was used as the solvent by the reason that it could obtain solution, and the test substance is judged stable. It was confirmed previously that the solvent did not cause bad influence to growth of the bacterial strains and metabolism of drug-metabolizing enzymes.
Controls
- Untreated negative controls:
- yes
- Remarks:
- sterility test with: S9 mix, 0.1M Phosphate buffer, nutrient broth No.2 and the test substance solution of the maximum concentration.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- tetrahydrofuran
- 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, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation (with and without metabolic activation)
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hours
SELECTION AGENT (mutation assays): not applicable
NUMBER OF REPLICATIONS: 2 plates/dose, 2 independant experiments (named Preliminary and main study)
NUMBER OF CELLS EVALUATED: not applicable
DETERMINATION OF CYTOTOXICITY
- Method: toxic effect was examined with a stereoscopic microscope. - Evaluation criteria:
- Negative and positive control data were compared to the laboratory historical control data (mean +/- 2SD).
Acceptance criteria:
when the experiment satisfies the following criteria, it was judged that the test result was obtained from the test of the appropriate procedure.
1) The growth of the contaminant in the test materials, such as Nutrient broth, the test substance solution of the highest concentration, S9 Mix, sodium phosphate buffer are not detected from the result of the sterility test.
2) the negative control values satisfy the acceptance criteria
3) the positive control values satisfy acceptance criteria. And the number of the revertant colonies of the positive control increases two-fold or more compared with the negative control.
Judgment of the test results:
the test substance was judged positive for mutagenic activity when clear dose-related increase in the number of the revertant colonies and two-fold or more increase in the number of revertant colonies compared with the negative control were observed with reappearance. - Statistics:
- no statistics analysis was used for evaluation of the test results.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- See details in Tables 7.6.1/1 to 7.6.1/4
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In TA1535, TA1537, TA98 and TA100 in the absence of metabolic activation, see below for more details and in Tables 7.6.1/1 to 7.6.1/4.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: not applicabe
- Precipitation: in the preliminary test, the precipitation of the test substance was detected at the dose of 313 µg/plate or more in both the presence and absence of metabolic activation, but it did not have a bad influence on the observation of the revertant colonies. In the main test, precipitation of the test substance was detected in the absence of metabolic activation at the dose of 156 µg/plate or more and in the presence of metabolic activation at the dose of 313 µg/plate or more.
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES: the preliminary reverse mutation test was performed to determine the most favorable dose levels of the test substance in the reverse mutation test at each of the bacterial strain. Cytotoxicity was observed in S. typhimurium TA98; TA100, TA1535 and TA1537 in the absence of metabolic activation at the dose of 1250 µg/plate or more. Based on the foregoing results, the maximum dose of the main reverse mutation test was set at 1250 µg/plate and a total of six different dose levels with factor 2 from the maximum dose were employed. The maximum dose levels of the main test of the other bacterial strains were set at 5000 µg/plate and a total of five different dose levels with factor 2 from the maximum dose was employed as toxic effect of the test substance was not detected.
COMPARISON WITH HISTORICAL CONTROL DATA: the numbers of the revertant colonies of the negative control and the positive control were within the range of the standard value of the historical data in the laboratory. Furthemore, all positive controls give an two-fold increase or more in the number of the revertant colonies compared with the negaive control with all bacterial strains. The test can be considered therefore as valid.
ADDITIONAL INFORMATION ON CYTOTOXICITY: the test substance showed toxic effects in the strains TA1535 and TA1537 in the absence of the metabolic activation at the dose of 625 µg/plate or more. Similar toxic effects were observed in the strains TA98 and TA100 in the absence of metabolic activation at the dose of 1250 µg/plate or more. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 7.6.1/1:Number of revertants per plate in the absence of metabolic activation in the preliminary test
Test item Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
WP2 uvrA |
Mean$ |
Mean$ |
Mean$ |
Mean$ |
Mean$ |
|
0 |
10 |
9 |
25 |
129 |
22 |
5 |
8 |
8 |
22 |
132 |
23 |
20 |
10 |
7 |
22 |
134 |
27 |
78 |
9 |
10 |
30 |
130 |
24 |
313 |
8# |
9# |
26# |
121# |
20# |
1250 |
6*# |
3*# |
7*# |
56*# |
21# |
5000 |
5*# |
3*# |
11*# |
62*# |
21# |
Positive control** |
482 |
385 |
507 |
602 |
123 |
$: Mean of duplicate
*: Toxic effect of the test substance was observed
# : Precipitation was observed
**Mutagens positive controls:
- NaN3(0.5 µg/plate) in TA1535 strain
- 9AA (80 µg/plate) in TA1537 strain
- AF-2 (0.01 µg/plate) in TA 100 and WP2 uvrA strains
- AF-2 (0.1 µg/plate) in TA 98 strain
Table 7.6.1/12: Number of revertants per plate in the presence of metabolic activation (S9 mix) in the preliminary test
Test item Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
WP2 uvrA |
Mean$ |
Mean$ |
Mean$ |
Mean$ |
Mean$ |
|
0 |
11 |
10 |
31 |
142 |
25 |
5 |
9 |
9 |
34 |
141 |
26 |
20 |
9 |
9 |
35 |
153 |
25 |
78 |
9 |
7 |
32 |
145 |
20 |
313 |
10# |
8# |
30# |
145# |
25# |
1250 |
8# |
10# |
30# |
140# |
21# |
5000 |
10# |
9# |
30# |
126# |
20# |
Positive control** |
240 |
85 |
384 |
1068 |
941 |
$: Mean of duplicate
# : Precipitation was observed
**Mutagens positive controls:
- 2AA (2 µg/plate) in TA1535 strain
- 2AA (10 µg/plate) in WP2 uvrA strain
-B[a]P (5 µg/plate) in TA100; TA98 and TA1537 strains
Table 7.6.1/3: Number of revertants per plate in the absence of metabolic activation in the main test
Test item Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
WP2 uvrA |
Mean$ |
Mean$ |
Mean$ |
Mean$ |
Mean$ |
|
0 |
9 |
7 |
29 |
132 |
26 |
39 |
7 |
7 |
23 |
124 |
- |
78 |
8 |
8 |
29 |
117 |
- |
156 |
8# |
7# |
28# |
137# |
- |
313 |
8# |
7# |
29# |
116# |
22# |
625 |
7*# |
6*# |
27# |
102# |
26# |
1250 |
2*# |
2*# |
22*# |
71*# |
25# |
2500 |
- |
- |
- |
- |
23# |
5000 |
- |
- |
- |
- |
23# |
Positive control** |
484 |
430 |
554 |
465 |
127 |
$: Mean of duplicate
*: Toxic effect of the test substance was observed
# : Precipitation was observed
**Mutagens positive controls:
- NaN3(0.5 µg/plate) in TA1535 strain
- 9AA (80 µg/plate) in TA1537 strain
- AF-2 (0.01 µg/plate) in TA 100 and WP2 uvrA strains
- AF-2 (0.1 µg/plate) in TA 98 strain
Table 7.6.1/4: Number of revertants per plate in the presence of metabolic activation (S9 mix) in the main test
Test item Concentration |
TA 1535 |
TA1537 |
TA 98 |
TA 100 |
WP2 uvrA |
Mean$ |
Mean$ |
Mean$ |
Mean$ |
Mean$ |
|
0 |
9 |
7 |
28 |
139 |
25 |
313 |
10# |
8# |
32# |
144# |
25# |
625 |
9# |
8# |
36# |
142# |
26# |
1250 |
9# |
9# |
34# |
146# |
21# |
2500 |
8# |
7# |
32# |
137# |
25# |
5000 |
9# |
7# |
29# |
140# |
25# |
Positive control** |
220 |
91 |
334 |
1044 |
898 |
$: Mean of duplicate
# : Précipitation was observed
**Mutagens positive controls:
- 2AA (2 µg/plate) in TA1535 strain
- 2AA (10 µg/plate) in WP2 uvrA strain
- B[a]P (5µg/plate) in TA100, TA98 and TA1537 strains
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the test conditions, N-[3-(dimethylamino)propyl]docosanamide is not mutagenic in S. typhimurium and E. coli in the absence and presence of metabolic activation. - Executive summary:
In a reverse gene mutation assay in bacteria, performed similarly to the OECD No.471 guideline and in compliance with the Japanese GLP, N-[3-(dimethylamino)propyl]docosanamide (named also as Amidet APA-22) (purity of 99.1%) diluted in tetrahydrofuran was tested inS. typhimuriumTA1535, TA1537, TA100, TA98 strains and E. coli WP2 uvrA strain in the presence and the absence of mammalian metabolic activation (S9) using the preincubation method. Five known mutagens (Sodium azide (NaN3); 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2); 9-aminoacridine (9AA), 2-aminoanthracene (2AA) and benzoapyrene (B[a]P)) were used to check the sensitivity of the test system. They gave appropriate response, therefore the test was considered as valid.
In the preliminary assay the test item was used in the presence and absence of metabolic activation at the following concentrations: 0; 5; 20; 78; 313; 1250 and 5000 µg/plate (duplicate). Cytotoxicity was observed in S. typhimurium TA98; TA100, TA1535 and TA1537 in the absence of metabolic activation at the dose of 1250 µg/plate or more. The maximum dose of the main reverse mutation test was thus set at 1250 µg/plate and a total of six different dose levels with factor 2 from the maximum dose were employed. The maximum dose levels of the main test of the other bacterial strains were set at 5000 µg/plate and a total of five different dose levels with factor 2 from the maximum dose was employed as toxic effect of the test substance was not detected.
In the main assay the test item was used at the following concentration: 38; 78; 156; 313; 625 and 1250 in S. typhimurium TA100, TA1535, TA98 and TA1537 in the absence of metabolic activation; 313; 625; 1250; 2500 and 5000 µg/plate in E. coli WP2 uvrA and 313; 625; 1250; 2500 and 5000 µg/plate in all strains in the presence of metabolic activation (duplicate). The test substance showed toxic effects in the strains S. typhimurium TA1535 and TA1537 in the absence of the metabolic activation at the dose of 625 µg/plate or more. Similar toxic effects were observed in the strains TA98 and TA100 in the absence of metabolic activation at the dose of 1250 µg/plate or more.
A precipitation of the test substance was observed in both experiments but it did not have a bad influence on the observation of the revertant colonies.
In both experiments, there was no increase of the number of revertant colonies compared to the vehicle control. Therefore, under the test conditions, N-[3-(dimethylamino)propyl]docosanamide did not show any mutagenic activity in the bacterial reverse mutation test using Salmonella typhimurium and E. coli. This study is considered as acceptable as it satisfied the criteria of the OECD Guideline No. 471.
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