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EC number: 434-800-1 | CAS number: 121776-33-8
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 82-2 (Repeated Dose Dermal Toxicity -21/28 Days)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 434-800-1
- EC Name:
- -
- Cas Number:
- 121776-33-8
- Molecular formula:
- C11H13CL2NO3
- IUPAC Name:
- 2,2-dichloro-1-[5-(furan-2-yl)-2,2-dimethyl-1,3-oxazolidin-3-yl]ethan-1-one
- Reference substance name:
- 3-(Dichloroacetyl)-5-(2-furanyl)-2,2-dimethyloxazolidine
- IUPAC Name:
- 3-(Dichloroacetyl)-5-(2-furanyl)-2,2-dimethyloxazolidine
- Test material form:
- other: Brown particles
- Details on test material:
- - Name of test material (as cited in study report): MON 13900
- Physical state: Brown particles
- Purity: 96.4%
- Lot/batch No.: DAY-8912-1370T
- Vapor pressure: 5 x 10-6 Torr
- Octanol/water partition coefficient: 2.67
- Date received: June 22, 1990
Constituent 1
Constituent 2
Test animals
- Species:
- other: Albino rat
- Strain:
- other: Sprague-Dawley (CD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Charles River Breeding Laboratory, Portage, MI
Sex and numbers: Males, 32; females, 32
Age at study start: Approx 8 wk
Weight range at study start: Males-90.3-329.9 g; females-178.9-209.1 g
All rats were housed one per cage. Information on the temperature and humidity of the animal room was not provided. However, the study authors stated that animal housing and husbandry were in accordance with the provisions of the “Guide to the Care and Use of Laboratory Animals.” Animals were identified by an individual eartag and a barcoded cage card. The animal room was supplied daily with 12 h of light. The rats were acclimated to laboratory conditions for approx 27 d prior to dosing. Purina Certified Rodent Chow #5002 and tap water were provided ad libitum throughout the predose and dosing periods. Rats were assigned into groups according to weight via computer-generated randomization.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Neat test substance was dermally applied under occlusion to a shaved area (approx 25 cm2) on each animal’s back. The shaved area comprised approximately 10% of the total body surface. The shaved area was covered with a gauze patch and occlusive dressing.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 21 d
- Frequency of treatment:
- 6 h/d, 5 d/wk
Doses / concentrations
- Remarks:
- Doses / Concentrations:
25, 250, and 1000 mg/kg bw/day
Basis:
nominal per unit area
- No. of animals per sex per dose:
- 8/sex/dose
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: Based on a previous range-finding study; the range-finding study reported no observed effect level (NOELs) of 500 mg/kg bw/day for males and 1000 mg/kg bw/day for females. The low observed effect level (LOEL) for males was 750 mg/kg bw/day based on a dose-related increase in the incidence of liver foci; a LOEL was not established for females. Liver foci were observed during the macroscopic pathology examination.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily for mortality and moribundity
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Twice daily for clinical signs of toxicity
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: Throughout the study period
BODY WEIGHT AND FOOD CONSUMPTION: Yes
- Time schedule for examinations: Once weekly
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes
URINALYSIS: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- General observations: No mortalities occurred during the study. There were no treatment-related signs of dermal irritation or clinical indications of systemic toxicity. No effects were observed on body weight or food consumption.
Haematology and clinical chemistry: There were no alterations in haematological parameters that were considered toxicologically significant. Blood urea nitrogen (BUN) was slightly, but significantly increased (128% of control mean value) in females from the 1000 mg/kg/day group.
Gross pathology, organ weights and histopathology: No treatment-related changes in gross pathology, organ weights or histopathology were observed
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- dermal irritation
- Dose descriptor:
- NOEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical biochemistry
- haematology
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- clinical biochemistry
- haematology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the NOEL of MON 13900 for the local effects was > 1,000 mg/kg bw/day for males and females. The NOEL for systemic toxicity was determined to be 250 mg/kg bw/day for females and > 1,000 mg/kg bw /day for males.
- Executive summary:
A study was conducted to evaluate the subchronic toxic effects of MON 13900 when administered by the dermal route in Sprague-Dawley rats. The study was performed according to the EPA Guideline OPP 82-2 in compliance with GLP.
The test substance was administered dermally to three groups of rats at dose levels of 25, 250 and 1,000 mg/kg bw/day. No mortalities occurred during the study. There were no treatment-related signs of dermal irritation or clinical indications of systemic toxicity. No effects were observed on body weight or food consumption. There were no alterations in haematological parameters that were considered toxicologically significant. Blood urea nitrogen (BUN) was slightly, but significantly increased (128% of control mean value) in females from the 1,000 mg/kg bw/day group. No treatment-related changes in gross pathology, organ weights or histopathology were observed.
Under the test conditions, the NOEL of the test substance for the local effects was > 1,000 mg/kg bw/day for males and females. The NOEL for systemic toxicity was determined to be 250 mg/kg bw/day for females and > 1,000 mg/kg bw /day for males.
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