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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9/19/2001-10/16/2001
- 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 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Qualifier:
- according to guideline
- Guideline:
- other: Japan 59 NohSan Notification No. 4200, Acute Dermal Toxicity Study
- 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:CD®BR rats were obtained from Charles River Laboratories, Raleigh, NC. Upon arrival, all animals were examined for physical abnormalities and quarantined/acclimated for approximately one week. The animals were individually housed in suspended stainless steel cages (18x34x20 cm) 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 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.
On the day prior to treatment, rats were selected from a healthy stock population, assigned to the study group using a computer-generated sequence of random numbers and identified by uniquely numbered ear tags. At the time they were dosed, the males were approximately 8 weeks old and the females were approximately 9 weeks old. The body weights ranged from 236 to 274 g for males and from 204 to 244 g for females.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Approximately 24 hrs prior to the application of the test substance, the hair around the entire trunk between the flank and shoulders was shaved closely with electric clippers. The test substance, undiluted, was applied topically to the shaved intact skin (target of 10% body surface area) of five male and five female rats at 2000, 1200 or 400 mg/kg body weight. Dose was calculated on an "as is" basis; no adjustment was made for percent active ingredient. The entire trunk of each animal was wrapped in a polyethylene sheet covered with Elastoplast® (Beiersdorf, Inc., Norwalk, CT) and PEG®(Becton-Dickinson Co., Franklin Lakes, NJ) elastic bandages and secured in place with adhesive tape.
The test substance remained in contact on the skin of each animal for 24 hrs. Each cuff was removed after the 24-hr exposure period, and the application site was wiped with paper towels saturated with tap water. The application site was blotted dry with paper towels, and the approximate dimensions of the contact area of the test substance were determined.
Each animal was fitted with a cardboard collar to prevent preening of the application site. The collar was worn throughout the 14-day observation period.
After dermal application, the test substance covered an area approximately 6 cm x 6 cm. - Duration of exposure:
- 24
- Doses:
- 400, 1200, 2000 mg/kg
- 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 LDso was calculated on the pooled (male and female combined data) mortality incidences at each dose.
The LD50, 95% confidence limits; and slope were calculated from the logarithm of the doses and the incidences of mortality using a SAS PR OBIT 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 ).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 641 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- ca. 1 115 - ca. 3 663
- Mortality:
- Three males and 4 females at 2000 mg/kg and 2 females at 1200 mg/kg died by day 2. No deaths occurred in either sex at 400 mg/kg.
- Clinical signs:
- other: Scant or no feces was observed in both sexes at 2000 mg/kg on days 1 and 2. Ataxia and passiveness were seen in both sexes at 2000 mg/kg and in one female at 1200 mg/kg on day 1. There were no clinical signs of systemic toxicity noted in either sex at 400
- Gross pathology:
- Necropsy of the decedents in both sexes at 2000 mg/kg revealed carcass autolysis and gastrointestinal changes which included stomach: contains black material, glandular portion reddened, and intestine: reddened or blackened. Two females at 1200 mg/kg revealed carcass autolysis only. Necropsy of survivors revealed no gross observations.
- Other findings:
- The acute dermal LD50 in male and female rats is 1641 mg/kg with 95% confidence limits of 1115 to 3 663. The log probit slope of the dose-mortality data (probit incidence versus log dose) was 4.89 in this study.
Any other information on results incl. tables
Table 1: Male Mortality
Dose (mg/kg bw) | Died | Comments |
400 | 0/5 | |
1200 | 0/5 | |
2000 | 3/5 | All died on day 1. |
Table 2: Female Mortality
Dose (mg/kg bw) | Died | Comments |
400 | 0/5 | |
1200 | 2/5 | Animals died on days 1 and 2. |
2000 | 4/5 | Animals died on days 1 (n=3) and 2 (n=1). |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute dermal toxicity of OXEMA was assessed in Crl:CD®BR rats. The test substance was applied to the shaved intact skin of five male and five female rats at 2000, 1200 or 400 mg/kg body weight. The application sites were occluded for 24 hrs. After the 24-hr exposure, the application sites were wiped with paper towels saturated with tap water and blotted dry with paper towels.
Three males and four females died at 2000 mg/kg and two females died at 1200 mg/kg. Scant or no feces was noted in both sexes on days 1 and 2. Ataxia and passiveness were seen in both sexes at 2000 mg/kg and in one female at 1200 mg/kg on day 1. There were no clinical signs of systemic toxicity noted in either sex at 400 or in males at 1200 mg/kg. Signs of skin irritation (i.e., edema, erythema, pocketing edema, eschar, blanching, dark areas, scabs, sloughing and desiccation) were observed in both sexes at all levels beginning on day 1 and continued through the day 14 observation period. Body weight gain over the 14-day observation period was decreased (10-71 %) in both sexes at all levels when compared to historical control data. Necropsy of the decedents in both sexes at 2000 mg/kg revealed gastrointestinal changes. Necropsy of decedents at 1200 mg/kg showed no treatment-related changes. Necropsy of survivors revealed no gross observations. The acute dermal LD50 in male and female rats for OXEMA is 1641 mg/kg with 95% confidence limits of 1115 to 3663. - Executive summary:
The acute dermal toxicity of OXEMA was assessed in Crl:CD®BR rats. The test substance was applied to the shaved intact skin of five male and five female rats at 2000, 1200 or 400 mg/kg body weight. The application sites were occluded for 24 hrs. After the 24-hr exposure, the application sites were wiped with paper towels saturated with tap water and blotted dry with paper towels.
Three males and four females died at 2000 mg/kg and two females died at 1200 mg/kg. Scant or no feces was noted in both sexes on days 1 and 2. Ataxia and passiveness were seen in both sexes at 2000 mg/kg and in one female at 1200 mg/kg on day 1. There were no clinical signs of systemic toxicity noted in either sex at 400 or in males at 1200 mg/kg. Signs of skin irritation (i.e., edema, erythema, pocketing edema, eschar, blanching, dark areas, scabs, sloughing and desiccation) were observed in both sexes at all levels beginning on day 1 and continued through the day 14 observation period. Body weight gain over the 14-day observation period was decreased (10-71 %) in both sexes at all levels when compared to historical control data. Necropsy of the decedents in both sexes at 2000 mg/kg revealed gastrointestinal changes. Necropsy of decedents at 1200 mg/kg showed no treatment-related changes. Necropsy of survivors revealed no gross observations. The acute dermal LD50 in male and female rats for OXEMA is 1641 mg/kg with 95% confidence limits of 1115 to 3663.
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