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EC number: 223-228-4 | CAS number: 3775-90-4
- 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)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation. Peer-reviewed database.
Data source
Referenceopen allclose all
- Reference Type:
- other: summary report
- Title:
- Unnamed
- Year:
- 1 998
- Reference Type:
- secondary source
- Title:
- MHW, Japan (1998) Ministry of Health and Welfare, Toxicity Testing Reports of Environmental Chemicals vol. 6, p 539-568
- Author:
- Ministry of Health and Welfare, Japan
- Year:
- 2 003
- Bibliographic source:
- cited in: OECD SIDS, 2-Dimethylaminoethylmethacrylate, CAS No: 2867-47-2, 07/2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-dimethylaminoethyl methacrylate
- EC Number:
- 220-688-8
- EC Name:
- 2-dimethylaminoethyl methacrylate
- Cas Number:
- 2867-47-2
- Molecular formula:
- C8H15NO2
- IUPAC Name:
- 2-(dimethylamino)ethyl methacrylate
- Details on test material:
- - Purity: 99.9%
- Supplier: Sanyo-Kasei Co.
Constituent 1
- Specific details on test material used for the study:
- Test substance 99.9% purity, Sanyo-Kasei. Co
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Details on species / strain selection:
- Rats supplied by Charles River Japan
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were purchased at 7 weeks of age. After quarantine and acclimatisation for 7 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Males: 43 days
Females: from 14 days before mating to day 3 of lactation (41 -52 days) - Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 (Vehicle), 40, 200, 1000 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: As the LD50 value of > 2000 mg/kg was known, a preliminary test to decide the highest dose level at 30, 100, 300, and 1000 mg/kg/day for 14 days was conducted. At 1000 mg/kg/day, decrease of body weight in males and suppression of body weight increase in females were observed. Then the highest dose level for the test was set at 1000 mg/kg/day.
- Post-exposure period: 1 day
Results and discussion
Results of examinations
- Details on results:
- MALES:
At 1000 mg/kg/day, no deaths occured. Clinical observations revealed late onset of twitching, chronic convulsion and suppression of body weight gain. The histopathological examinations revealed a degeneration of nerve fibers in the brain and spinal cord, hyperplasia of the mucosa, edema and inflammatory cell infiltration in the forestomach and increased kidney and liver weights without histopathological correlates. Hematological and blood chemical examinations revealed a slight increase in BUN and slight anemic changes such as decreases in erythrocyte counts, hemoglobin concentration and hematocrit value, associated with a significant increase in reticulocyte ratio.
At 200 mg/kg/day, no adverse effects except for slight anemic changes such as decrease in hemoglobin concentration and hematocrit value with
increase in reticulocyte ratio were observed. However, the severities of these slight anemic changes were considered toxicologically insignificant.
At 40 mg/kg/day, no effects were observed.
FEMALES:
At 1000 mg/kg/day, 3 females out of 12 died. By clinical observations, late onset of twitching, chronic convulsion, suppression of body weight gain and a decrease in food consumption during lactation period were observed. Histopathological examinations revealed a degeneration of nerve fibers in
the brain and the spinal cord, a hyperplasia of the mucosa in the gastric tract, edema and inflammatory cell infiltrations in the forestomach, and an atrophy of the thymus. Also the increases in the weight of the kidney and the adrenals without histopathological changes were observed.
At 200 mg/kg/day no effects were observed.
At 40 mg/kg/day no effects were observed.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- haematology
- histopathology: non-neoplastic
- mortality
- neuropathology
- Dose descriptor:
- NOEL
- Effect level:
- 40 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- haematology
- neuropathology
- Dose descriptor:
- NOEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- mortality
- neuropathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Hematological examination results in male rats (mean ± SD):
Dose mg/kg) |
0 |
200 |
1000 |
No. of males |
12 |
12 |
11 |
RBC (10000/µl) |
881.7 ± 43.6 |
859.8 ± 36.7 |
821.6 ± 34.1** |
Hematocrit (%) |
46.73 ± 2.45 |
44.84 ± 1.26* |
41.72 ± 1.97** |
Hemoglobin (g/dL) |
15.91 ± 0.69 |
15.28 ± 0.40* |
14.24 ± 0.74** |
Reticulocytes (‰) |
17.81 ± 2.61 |
21.56 ± 3.57* |
24.84 ± 3.75** |
* = p<0.05, ** = p<0.01
_
Major histopathological findings in male rats:
Dose (mg/kg) |
0 |
200 |
1000 |
No. of males |
12 |
12 |
11 |
Findings in stomach: |
|||
Slight dilatation, gastric gland |
0 |
0 |
0 |
Slight edema |
0 |
0 |
7** |
Slight hyperplasia, squamous, forestomach diffuse |
0 |
0 |
11** |
Slight inflammatory cell infiltration, forestomach |
0 |
0 |
10** |
Slight ulcer, forestomach |
0 |
0 |
0 |
Slight ulcer, glandular stomach |
0 |
0 |
0 |
Findings in brain: |
|||
Slight degeneration, nerve fiber |
0 |
0 |
3 |
Findings in spinal cord: |
|||
Slight degeneration, nerve fiber |
0 |
0 |
8** |
** = p<0.01
_
Major histopathological findings in female rats:
Dose (mg/kg) |
0 |
200 |
1000 |
||
Surviving |
Deada) |
Surviving |
Deadb) |
||
No. of females |
11 |
1 |
12 |
9 |
3 |
Findings in stomach: |
|||||
Slight dilatation, gastric gland |
0 |
0 |
0 |
0 |
0/2 |
Slight edema |
0 |
0 |
0 |
2 |
1/2 |
Slight hyperplasia, squamous, forestomach diffuse |
0 |
0 |
0 |
9** |
2/2 |
Slight inflammatory cell infiltration, forestomach |
0 |
0 |
0 |
5** |
1/2 |
Slight ulcer, forestomach |
0 |
0 |
0 |
1 |
0/2 |
Slight ulcer, glandular stomach |
0 |
0 |
0 |
0 |
1/2 |
Findings in brain: |
|||||
Slight degeneration, nerve fiber |
0 |
0 |
0 |
4 |
0 |
Findings in spinal cord: |
|||||
Slight degeneration, nerve fiber |
0 |
0 |
0 |
6** |
0 |
a) One female died of dystocia at gestation day 23
b) Dead animals were observed at days 26 and 38 after administration
** = p<0.01
Applicant's summary and conclusion
- Conclusions:
- According to this study, the NOAEL for oral (gavage) repeated dose toxicity in rats is considered to be 200 mg/kg/day for both sexes. The NOELs for repeated dose toxicity are considered to be 40 mg/kg/day for males and 200 mg/kg/day for females.
- Executive summary:
The test substance was studied for oral (gavage) toxicity in rats in an OECD combined repeated dose and reproductive/developmental toxicity screening test at doses of 0, 40, 200 and 1000 mg/kg/day. The study was conducted in compliance with GLP.
Three females died in the 1000 mg/kg group. Soiled tail, twitching, chronic convulsion and suppression of body weight gain in both sexes, and a decrease in food consumption in females were also observed in the late period of administration in this group. Histopathological examination revealed degeneration of nerve fibers in the brain and spinal cord, and hyperplasia of the mucosa, edema and inflammatory cell infiltration in the forestomach in both sexes, and atrophy of the thymus in females in the 1000 mg/kg group. Increases in organ weights without histopathological changes were observed for the kidneys of both sexes, the livers of males, and the
adrenals of females in this group. BUN was slightly increased in males in the same group. Slight anemic changes were observed in males of the 200 and 1000 mg/kg groups.
Conclusion: According to this study, the NOAEL for oral (gavage) repeated dose toxicity in rats is considered to be 200 mg/kg/day for both sexes. The NOELs for repeated dose toxicity are considered to be 40 mg/kg/day for males and 200 mg/kg/day for females.
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