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EC number: 256-260-2 | CAS number: 46235-93-2
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9/19/2001-10/3/2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: Japan 59 NohSan Notification No. 4200, Acute Oral Toxicity Study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-(3-oxazolidinyl)ethyl methacrylate
- EC Number:
- 256-260-2
- EC Name:
- 2-(3-oxazolidinyl)ethyl methacrylate
- Cas Number:
- 46235-93-2
- Molecular formula:
- C9H15NO3
- IUPAC Name:
- 2-(1,3-oxazolidin-3-yl)ethyl 2-methylprop-2-enoate
- Test material form:
- liquid
- Remarks:
- yellow
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Adult male and female Crl:CDaBR rats were obtained from Charles River Laboratories, Raleigh, NC. Upon arrival, all animals were examined for physical abnormalities and quarantinedlacclimated for approximately one week. The animals were individually housed in suspended stainless steel cages (18x34x20cm) with wire mesh fronts and bottoms. Cages were suspended above absorbent-paper pan liners, which were changed 3 times a week. Throughout the test period, all rats had free access to water (via automatic watering) purified by reverse osmosis and PMI Certified Rodent Diet 5002(C) (Purina Mills Inc., Richmond, IN). The animal room was environmentally controlled with controls set to maintain a temperature of approximately 23°C and a relative humidity range of 30-70%. The temperature and relative humidity were monitored 24 hrs a day. During the study, the average daily temperature was approximately 22°C and the average daily relative humidity ranged from 44 to 54%. Any excursions beyond these ranges were minimal and did not affect the integrity of the study. Temperature and relative humidity remained in compliance with acceptable ranges defined in the "Guide for the Care and Use of Laboratory Animals" ISBN No. 0-309-05377-3, Revised 1996. The light cycle was automatically controlled, 12 hrs on and 12 hrs off.
Prior to treatment, rats were selected from a healthy stock population, assigned to the study group using a computer-generated sequence of random numbers, identified by uniquely numbered ear tags, and fasted overnight. At the time they were dosed, the males were approximately 8 weeks old and the females were approximately 9 weeks old. The fasted body weights ranged from 208 to 242 g for males and from 182 to 201 g for females.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The undiluted test substance was was administered to male and female rats at 250, 750 or 1250 mgkg body weight. Dose was calculated on an "as is" basis; no adjustment was made for percent active ingredient. No analytical verification of the dosing solution was performed since the test substance was administered undiluted.
- Doses:
- 250, 750, and 1250 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- All animals were observed for signs of ill health, or reaction to treatment at approximately 1,2 and 4 hrs after dosing and once daily thereafter for 14 days. Body weights were recorded on day 0 (prior to dosing) and on days 7 and 14. Decedents were necropsied as they were found. Surviving rats were euthanized on day 14 and necropsied. Necropsy consisted of a gross examination of organs in situ.
- Statistics:
- The mortality incidences of males and females were compared across doses with a categorical data modeling procedure using SAS CATMOD (SAS Institute Inc. SAS User's Guide: Statistics, Version 6 Edition, p 405-517. Cary, NC: SAS Institute Inc., 1990). The criterion of statistical significance was 0.05. Since the results did not indicate a significant difference between the mortality responses across dose groups for males and females, the LD50 was calculated on the pooled (male and female combined data) mortality incidences at each dose.
The LD5o and slope were calculated from the logarithm of the doses and the incidences of mortality using a SAS PROBIT procedure (SAS Institute Inc. SAS User's Guide: Statistics, Version 6 Edition, p 1324-1350. Cary, NC: SAS Institute Inc., 1990) based on the method of D.J. Finney (Probit Analysis, Third Edition, London: Cambridge University Press, 1971). The procedure was unable to determine the 95% confidence limits.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 763 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two male and 2 female animals at 750 mg/kg died by day 3 and all rats at 1250 mg/kg died by day 1.
- Clinical signs:
- other: No clinical signs of toxicity were noted in males at 250 mglkg during the 14-day observation period. Scant feces was noted in females at 250 mglkg on day 1 only. Numerous clinical signs of toxicity were noted in males and/or females at 750 and/or 1250 mg/
- Gross pathology:
- Necropsy of the decedents in both sexes at 750 and 1250 mg/kg revealed numerous gastrointestinal changes. These included: stomach: distended, thickened, contains clear fluid, glandular portion reddened and/or sloughing, contains gelatinous material and intestine reddened. Carcass autolysis was also noted. Necropsy of the survivors at 250 mg/kg (both sexes) and 750 mg/kg (males) revealed no gross changes. One female survivor at 750 mg/kg was found with stomach wall thickened.
- Other findings:
- The acute oral LD50 in male and female rats was 763 mg/kg. The log probit slope of the dose-mortality data (probit incidence versus log dose) was 7.72 in this study.
Any other information on results incl. tables
Table 1. Mortality
Dose (mg/kg) | 250 | 750 | 1250 |
Males | 0/5 | 2/5 | 5/5 |
Females | 0/5 | 2/5 | 5/5 |
Combined sexes | 0/10 | 4/10 | 10/10 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral LD50 for OXEMA in male and female rats was 763 mg/kg bw.
- Executive summary:
The acute oral toxicity of Monomer OXEMA was assessed in Crl: CD®BR rats. Three groups of five male and five female rats/groups were gavaged with the test substance, as received, at 250,750 or 1250 mg/kg body weight. Two male and 2 female animals at 750 mg/kg died by day 3 and all rats at 1250 mg/kg died by day 1. No clinical signs of toxicity were noted in males at 250 mg/kg during the 14-day observation period. Scant feces were noted in females at 250 mg/kg on day 1 only. Numerous clinical signs of toxicity were noted in males and/or females at
750 and/or 1250 mg/kg. These included: soft, scant/no feces, red or tan stained muzzle, passiveness, ataxia, yellow/brown stained anogenital area, and red-stained eyes. These clinical signs were evident beginning on day 0 and continued through day 5. Body weight gain among survivors in both sexes at 750 mg/kg was decreased (32-39%) when compared to historical control values. There was no treatment related effect on body weight gain among both sexes at 250 mg/kg. Necropsy of the decedents in both sexes at 750 and 1250 mg/kg revealed numerous gastrointestinal changes. Necropsy of the survivors at 250 mg/kg (both sexes) and 750 mg/kg (males) revealed no gross changes. One female survivor at 750 mg/kg was found with stomach wall thickened. The acute oral LD50 for OXEMA in male and female rats was 763 mg/kg.
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