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EC number: 216-630-6 | CAS number: 1631-25-0
- 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:
- 22 February and 16 April 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Healthy male and female 5-week-old Crj:CD (SD) rats (weight: 120 to 150 g in males and 110 to 145 g in females) were used (10 animals in a group, total 50 each of males and females). A 0.5 (w/v) % suspension of the sample in water containing 7.5 (w/v)% of gum arabic was given to the animals by oral gavage using gastric tube. Animals were observed for general symptoms for 14 days. The LD50 was calculated from the number of survivals and deaths using Bliss's probit model. A preliminary study had been conducted for the sample administration and determined the maximum dose of 44.4 mL/kg. The lower 4 dose levels of 35.5 mL/kg, 28.4 mL/kg, 22.7 mL/kg, and 18.2 mL/kg were selected from the maximum dose at a common ratio of 1.25.
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1-cyclohexyl-1H-pyrrole-2,5-dione
- EC Number:
- 216-630-6
- EC Name:
- 1-cyclohexyl-1H-pyrrole-2,5-dione
- Cas Number:
- 1631-25-0
- Molecular formula:
- C10H13NO2
- IUPAC Name:
- 1-cyclohexyl-2,5-dihydro-1H-pyrrole-2,5-dione
- Test material form:
- solid: flakes
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: A suspension of the sample in water containing gum arabic.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: A 0.5% w/v suspension of the sample in water containing 7.5% w/v of gum arabic
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 35.5 mL/kg, 28.4 mL/kg, 22.7 mL/kg, and 18.2 mL/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Results and discussion
- Preliminary study:
- A preliminary study had been conducted for the sample administration and determined the maximum dose of 44.4 mL/kg.
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 130.3 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 118.5 - <= 142.2
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 130.5 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 118.6 - <= 143.5
- Mortality:
- Death occurred from 3 hours after dosing in higher dose groups.
- Clinical signs:
- other: Decreased locomotory activity was observed from a few minutes after dosing across the dose levels.
- Gross pathology:
- Subsequent necropsy of animals that survived for 14 days showed mild hypertrophy of the spleen among major organs.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Under the conditions of this study it was found that 1-cyclohexyl-1H-pyrrole-2,5-dione should be classified as Acute toxicity cat 3 (oral).
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