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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- 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 ChemicaIs 6, 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:
- other: 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
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Details on test animals or test system and environmental conditions:
- - Sex: male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- Males: 43 days (starting 14 days before mating)
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.
- Premating exposure period: 14 days
- Duration of test: 41 -52 days
- Post-exposure period: 1 day
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Details on maternal toxic effects:
The compound had no effects on reproductive parameteres such as the mating index, the fertility index, numbers of corpora Iutea or implantations, the implantation index, the delivery index, the gestation index, gestation length or parturition.
Significant adverse effects were observed in animals of the 1000 mg/kg/day group, especially in females. These adverse effects observed in females were as follows:
- 3 females out of 12 died.
- By the observation, late onset of twitching, chronic convulsion, suppression of body weight gain and a decrease in food consumption in lactation period were observed.
- By the histopathological examination, the degeneration of nerve fibers in the brain and the spinal cord, and the hyperplasia of the mucosa in gastric tract, the oedema and inflammatory ceII infiltration in the forestomach, and the atrophy of the thymus were revealed. Also the increases in the weight of the kidney and the adrenals without histopathological changes were observed.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- mortality
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
On examination of neonates, the 1000 mg/kg dose was associated with a decrease in body weight and a low viability index. There were no significant differences in the number of offspring or live offspring, the sex ratio or the live birth index. All pups of three dams of the 1000 mg/kg group, died during the lactation period. No abnormalities ascribable to the compound were found for external features, clinical signs or necropsy findings for the offspring.
Effect levels (fetuses)
- 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:
- fetal/pup body weight changes
- changes in litter size and weights
- changes in postnatal survival
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Reproductive parameters:
Dose (mg/kg) |
0 |
40 |
200 |
1000 |
No. of pairs examined |
12 |
12 |
12 |
10 |
No of pairs with successful mating |
12 |
12 |
11 |
10 |
Mating index (%) |
100.0 |
100.0 |
91.7 |
100.0 |
No. of pregnant females |
12 |
12 |
11 |
9 |
Fertility index (%) |
100.0 |
100.0 |
100.0 |
90.0 |
Pairing days until mating (mean ± SD) |
2.5 ± 1.0 |
3.1 ± 1.0 |
3.9 ± 3.0 |
2.8 ± 1.0 |
No. of estrous stages without mating (mean ± SD) |
0.0 ± 0.0 |
0.0 ± 0.0 |
0.1 ± 0.3 |
0.0 ± 0.0 |
Mating index (%) = (No. of pairs with successful mating / No. of pais examined) x 100
Fertility index (%) = (No. of prgnant animals / No. of pairs with successful mating) x 100
_
Developmental parameters:
Dose (mg/kg) |
0 |
40 |
200 |
1000 |
No. of females examined |
12 |
12 |
11 |
8 |
Live birth index (%) |
98.03 ± 4.52 |
100.00 ± 0.00 |
93.18 ± 22.61 |
89.06 ± 12.64 |
No. of live pups on day 0 (mean) |
14.3 +/-1.6 |
15.5 +/-1.2 |
13.1 +/-5.1 |
11.0 +/-3.7 |
No. of live pups on day 4 (mean) |
14.0 +/-1.5 |
45.5 +/-1.2 |
14.0 +/-3.7 |
7.8 /-4.2 |
Body weight of pups on day 0 (g) |
||||
Male (mean ± SD) |
7.2 ± 0.4 |
6.6 ± 0.4 |
6.9 ± 0.7 |
6.4 ± 1.1* |
Female (mean ± SD) |
6.8 ± 0.6 |
6.3 ± 0.5 |
6.5 ± 0.7 |
6.0 ± 0.9* |
Body weight of pups on day 4 (g) |
||||
Male (mean ± SD) |
11.1 ± 1.1 |
10.4 ± 0.9 |
10.8 ± 2.0 |
10.2 ± 2.5 |
Female (mean ± SD) |
10.7 ± 1.3 |
9.8 ± 1.0 |
10.4 ± 2.0 |
9.8 ± 1.8 |
* = Significantly different from control; p<0.05
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the NOAEL for the reproductive/developmental toxicity is considered to be 200 mg/kg/day. A lower body weight gain and a lower viability index were observed in the pups from females of the 1000 mg/kg/day group.
- Executive summary:
The study was performed according to OECD TG 422 in compliance with GLP.
SD (Crj: CD) rats received gavage doses of 0 (vehicle; corn oil), 40, 200 and 1000 mg/kg/day, for males starting from 14 days before mating for 43 days and in females from 14 days before mating to day 3 of lactation. The female animals were sacrificed on day 4 of lactation.
There were no effects on the reproductive parameters such as the mating index, the fertility index, the number of corpora lutea or implantations, the implantation index, the delivery index, the gestation index and the gestation length or the parturition. Three females in the 1000 mg/kg/day group, however, lost all of their pups during the lactation period. Females in the 1000 mg/kg/day group showed the following adverse effects in the repeated oral dose test: death of 3 animals out of 12, late onset of twitching, chronic convulsion, the suppression of body weight gain, degeneration of nerve fibers in the brain and spinal cord, hyperplasia of the mucosa in die gastric tract, oedema and inflammatory cell infiltration in the forestomach, atrophy of the thymus, increase in the weight of the kidneys and the adrenals without histopathological changes.
The pups from the females in the 1000 mg/kg/day group showed lower body weights, and the viability index of the pups was decreased due to maternal nursery activity. By external inspection, no abnomalities were found.
Conclusion: Under the conditions of this study, the NOAEL for the reproductive/developmental toxicity is considered to be 200 mg/kg/day.
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