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EC number: 226-002-3 | CAS number: 5205-93-6
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Standard NTP protocol, according to international standad procedures.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: according to standard NTP test protocol for Micronucleus test
- Principles of method if other than guideline:
- Bone marrow assays
Rat and mouse bone marrow micronucleus tests typically employ 1 to 3 treatments of the chemical under study; treatments are administered at 24 hr.intervals, and there are normally 5 male animals per treatment group. Doses extend up to the maximum tolerated dose. The route of administration in these short-term tests is usually either intraperitoneal injection or oral gavage. Based on the cell cycle and maturation times of the erythrocytes,
harvesting of the bone marrow usually occurs 24 hours after the last dosing; this interval is indicated in the data tables as "sample collection time." At that time, about 50% of the erythrocytes in the bone marrow are immature, newly formed erythrocytes, and these are the cell types that are checked
for presence of micronuclei. The animals are euthanized by CO2 inhalation and the femurs are removed.
The bone marrow is flushed from the femurs and spread onto slides. The slides are air-dried, fixed, and stained with a fluorescent DNA-specific stain that easily illuminates any micronuclei that may be present. Typically, 2000 polychromatic erythrocytes (PCEs, reticulocytes; immature erythrocytes) are scored per animal for frequency of micronucleated cells in each of 5 animals per dose group. In addition, the percentage of PCEs among the total erythrocyte population in the bone marrow is scored for each dose group as an indicator of chemical-induced toxicity. In non-treated healthy mice
and rats, the %PCE in bone marrow is usually around 50-60%. If a chemical interferes with the production of erythrocytes in the bone marrow, then the %PCE in the bone marrow may decline from the typical normal level. Conversely, if erythrocyte production is stimulated by chemical exposure, then a higher percentage of immature erythrocytes may be observed.
As part of these bone marrow micronucleus tests measuring induction of chromosomal changes after short-term exposures to potentially mutagenic agents, peripheral blood samples are sometimes taken, usually about 48 hr after treatment. This sample collection time is based on cell cycle and
erythrocyte maturation data, as well as the timing of erythrocyte translocation from the bone marrow compartment to the peripheral circulation.
Thus, in these instances, although micronuclei are induced in erythrocytes in the bone marrow, it is the circulating erythrocyte population that is
analyzed. In these cases, 2000 PCE are analyzed for frequency of micronucleated cells, as described above, but 1000 erythrocytes are scored for
determination of %PCE, since the percentage of PCE in blood is only around 3-5% in a healthy animal. - GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]methacrylamide
- EC Number:
- 226-002-3
- EC Name:
- N-[3-(dimethylamino)propyl]methacrylamide
- Cas Number:
- 5205-93-6
- Molecular formula:
- C9H18N2O
- IUPAC Name:
- N-[3-(dimethylamino)propyl]-2-methylacrylamide
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2-Propenamide, N-(3-(dimethylamino)propyl)-2-methyl-
- Substance type: organic
- Physical state at room temperature: liquid
- Analytical purity: no data
- Isomers composition: not applicable
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: Stability in water: Several days at room temperature, refrigerated and in the freezer
- Storage condition of test material: no data
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- No data.
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- PREPARATION OF DOSING: No data
DIET PREPARATION
- Rate of preparation of diet (frequency): no data
- Mixing appropriate amounts with (Type of food): no data
- Storage temperature of food: no data - Duration of treatment / exposure:
- Sample collection time (time after the last dosing): 24 hours
- Frequency of treatment:
- GAV x 4, 4 Days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 250.25, 500.5, 1000.1 mg/kg
Basis:
no data
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s):
- Route of administration: no data
- Doses / concentrations: 25.25 mg/kg
Examinations
- Tissues and cell types examined:
- Erythrocytes in the bone marrow of the femurs.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Doses extend up to the maximum tolerated dose.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
Based on the cell cycle and maturation times of the erythrocytes, harvesting of the bone marrow usually occurs 24 hours after the last dosing; this
interval is indicated in the data tables as "sample collection time." At that time, about 50% of the erythrocytes in the bone marrow are immature,
newly formed erythrocytes, and these are the cell types that are checked for presence of micronuclei. The animals are euthanized by CO2
inhalation and the femurs are removed.
DETAILS OF SLIDE PREPARATION:
The bone marrow is flushed from the femurs and spread onto slides. The slides are air-dried, fixed, and stained with a fluorescent DNA-specific stain that easily illuminates any micronuclei that may be present.
METHOD OF ANALYSIS:
Typically, 2000 polychromatic erythrocytes (PCEs, reticulocytes; immature erythrocytes) are scored per animal for frequency of micronucleated cells
in each of 5 animals per dose group. In addition, the percentage of PCEs among the total erythrocyte population in the bone marrow is scored for
each dose group as an indicator of chemical-induced toxicity. In non-treated healthy mice and rats, the %PCE in bone marrow is usually around
50-60%. If a chemical interferes with the production of erythrocytes in the bone marrow, then the %PCE in the bone marrow may decline from the
typical normal level. Conversely, if erythrocyte production is stimulated by chemical exposure, then a higher percentage of immature erythrocytes
may be observed. - Evaluation criteria:
- Data are typically presented as the mean number of micronucleated cells per 1,000 cells for each treatment group. A positive trend test is one in
which the P value is equal to or less than 0.025. For the micronucleus frequency in any dose group to be considered significantly elevated over the
control group, the P value must be equal to or less than 0.025 divided by the number of chemical-treatment groups. Thus, if the number of treated
groups is 3, then the required pairwise P value is 0.008. This adjustment in the pairwise P value is a correction for multiple comparisons of the same
data. In the short-term studies, tests that give positive results are repeated to confirm the response.
Factors that must be considered in analyzing micronucleus test data include number of animals per dose group (a minimum of 3 is required), dose
levels and number of doses administered, route of administration, tissue and cell type analyzed, sample time (interval between last dosing and
harvesting of cells for analysis), frequencies of micronucleated cells in the negative and positive controls, and the results of the statistical analyses.
The final conclusion for a micronucleus test is determined by considering the results of statistical analyses, the reproducibility of any observed
effects, and the magnitude and biological significance of those effects. - Statistics:
- A formal statistical analysis of the data is performed that includes a trend test, to determine if there is an overall increase across all doses in the
frequency of cells containing micronuclei, and a pairwise comparison of each dose group to the corresponding control, to see if any one dose group
is statistically different from the control group in frequency of micronucleated cells.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- At 1000.1 mg/kg 2/5 male mice died.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Peripheral Blood
Study ID | Result | Route | |
---|---|---|---|
Male | Female | ||
F89655 | Negative | Not Tested | Gavage |
Start Date | Sample Collection Time | Sex | Dosing Regimen |
---|---|---|---|
10/17/2006 | 24 Hours | Male | GAV x 4, 4 Days |
Dose
mg/kg |
Animal
Number |
Polychromatic Erythrocytes
Trend P = 0.098 |
Normochromatic Erythrocytes
Trend P = 0.008 |
||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
No. Examined | Total MN Cells | Percent PCE |
MN Cells
per 1000 |
No. Examined | Total MN Cells | Percent NCE |
MN Cells
per 1000 |
||||
Vehicle Control | SALN | 0 |
1 | 20000 | 66 | 2.0 | 3.3 | 997553 | 1288 | 98.0 | 1.3 |
0 |
2 | 20000 | 46 | 2.1 | 2.3 | 938193 | 1175 | 97.9 | 1.3 | ||
0 |
3 | 20000 | 46 | 2.3 | 2.3 | 844520 | 1139 | 97.7 | 1.3 | ||
0 |
4 | 20000 | 52 | 1.9 | 2.6 | 1031948 | 1488 | 98.1 | 1.4 | ||
0 |
5 | 20000 | 40 | 1.8 | 2.0 | 1089692 | 1413 | 98.2 | 1.3 | ||
Average ± SEM | 2.0 ± 0.1 | 2.5 ± 0.2 | 98.0 ± 0.1 | 1.3 ± 0.0 | |||||||
Test Chemical | 250.25 |
10 | 20000 | 48 | 2.4 | 2.4 | 825749 | 1085 | 97.6 | 1.3 | |
250.25 |
6 | 20000 | 31 | 2.1 | 1.6 | 945000 | 1276 | 97.9 | 1.4 | ||
250.25 |
7 | 20000 | 45 | 2.0 | 2.3 | 971457 | 1269 | 98.0 | 1.3 | ||
250.25 |
8 | 20000 | 38 | 2.2 | 1.9 | 871415 | 1097 | 97.8 | 1.3 | ||
250.25 |
9 | 20000 | 43 | 2.0 | 2.2 | 980310 | 1142 | 98.0 | 1.2 | ||
Average ± SEM | 2.1 ± 0.1 | 2.1 ± 0.1 | 97.9 ± 0.1 | 1.3 ± 0.0 | |||||||
Pairwise P: | 0.927 | Pairwise P: | 0.880 | ||||||||
Test Chemical | 500.5 |
11 | 20000 | 45 | 1.8 | 2.3 | 1104561 | 1417 | 98.2 | 1.3 | |
500.5 |
12 | 20000 | 47 | 2.0 | 2.4 | 964836 | 1269 | 98.0 | 1.3 | ||
500.5 |
13 | 20000 | 54 | 2.3 | 2.7 | 838304 | 1122 | 97.7 | 1.3 | ||
500.5 |
14 | 20000 | 60 | 2.3 | 3.0 | 860037 | 1114 | 97.7 | 1.3 | ||
500.5 |
15 | 20000 | 54 | 2.3 | 2.7 | 852628 | 1107 | 97.7 | 1.3 | ||
Average ± SEM | 2.1 ± 0.1 | 2.6 ± 0.1 | 97.9 ± 0.1 | 1.3 ± 0.0 | |||||||
Pairwise P: | 0.380 | Pairwise P: | 0.698 | ||||||||
Test Chemical | 1000.1 |
16 | 20000 | 79 | 1.7 | 4.0 | 1142650 | 1746 | 98.3 | 1.5 | |
1000.1 |
17 | 20000 | 40 | 1.8 | 2.0 | 1071652 | 1481 | 98.2 | 1.4 | ||
1000.1 |
18d | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0.0 | ||
1000.1 |
19d | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0.0 | ||
1000.1 |
20 | 20000 | 50 | 2.0 | 2.5 | 987243 | 1356 | 98.0 | 1.4 | ||
Average ± SEM | 1.8 ± 0.1 | 2.8 ± 0.6 | 98.2 ± 0.1 | 1.4 ± 0.1 | |||||||
Pairwise P: | 0.205 | Pairwise P: | 0.013 | ||||||||
Positive Control | CPA | 25.25 |
21 | 20000 | 370 | 1.3 | 18.5 | 1542690 | 2236 | 98.7 | 1.4 |
25.25 |
22 | 20000 | 488 | 0.2 | 24.4 | 10459899 | 17103 | 99.8 | 1.6 | ||
25.25 |
23 | 20000 | 327 | 0.8 | 16.4 | 2547208 | 4126 | 99.2 | 1.6 | ||
25.25 |
24 | 20000 | 425 | 0.8 | 21.3 | 2584665 | 4476 | 99.2 | 1.7 | ||
25.25 |
25 | 20000 | 363 | 0.8 | 18.2 | 2469715 | 4302 | 99.2 | 1.7 | ||
Average ± SEM | 0.8 ± 0.2 | 19.7 ± 1.4 | 99.2 ± 0.2 | 1.6 ± 0.1 | |||||||
d= dead
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
In conclusion, it can be stated that during the decribed mutagenicity test and under the experimental conditions reported, the test article did not
induce gene mutations in the erythrocytes of the bone marrow tested.
Therefore, N-Dimethylaminopropyl methacrylamide has to be judged as nonmutagenic up to 500 mg/kg according to the Micronucleus test results. - Executive summary:
In a B6C3F1 mouse bone marrow micronucleus assay (standard NTP protocol), (number of anmials: 5 per dose group. male only) were treated by oral gavage with 2 -Propenamide, N-(3 -(dimethylamino)propyl)-2 -methyl- (Purity: no data) at doses of 0, 250.25, 500.5, 1000.1mg/kg bw. Bone marrow cells were harvested at 24 hr after last dosing. The vehicle was SALN. The mice were exposed by gavage x 4, 4 days, treatments were administed at 24 hr. intervals.
There were signs of toxicity at the highest dose group (1000.1 mg/kg) during the study. 2/5 test animals die
Dimethylaminopropyl methacrylate was tested at an adequate dose based on maximum tolerated dose. The positive control induced the appropriate response. There was not a significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow after any treatment time.This study is classified as acceptable. This study satisfies the requirement for bone marrow micronucleus assay (standard NTP protocol) for in vivo cytogenetic mutagenicity data.
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