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EC number: 227-285-6 | CAS number: 5763-44-0
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetrahydrocyclopenta[c]pyrrole-1,3(2H,3aH)-dione
- EC Number:
- 227-285-6
- EC Name:
- Tetrahydrocyclopenta[c]pyrrole-1,3(2H,3aH)-dione
- Cas Number:
- 5763-44-0
- Molecular formula:
- C7H9NO2
- IUPAC Name:
- 4,5,6,6a-tetrahydro-3aH-cyclopenta[c]pyrrole-1,3-dione
- Test material form:
- solid: flakes
- Details on test material:
- - Name of test material (as cited in study report): 852 IMIDE ( = tetrahydrocyclopenta[c]pyrrole-1,3(2H,3aH)-dione)
- Substance type: solid
- Physical state: flakes
- Storage condition of test material: stable under normal storage conditions
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- test system recognized by international guidelines as the recommended system
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: 160 grams for males and 125 grams for females
- Housing:cages with sterilized sawdust as bedding material and paper as cage enrichment.
- Diet (e.g. ad libitum):free access to pelleted rodent diet
- Water (e.g. ad libitum): free access to tap-water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3°C
- Humidity (%): 40-70
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
GAVAGE PREPARATION
- method : using a plastic feeding tube.
- frequency : once daily, 7 days/week approx. the same time each day (max 6 hours difference betwwen the earliest and latest dose)
- Storage temperature of food: at ambient temperature
VEHICLE
propylene glycol
- Amount of vehicle (if gavage): 5 ml/kg bw. - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- at least 28 days.
- Frequency of treatment:
- once daily, 7 days/week.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
30 mg/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
130 mg/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
600 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: issued of a dose range finding study performed by NOTOX before the start of these experimentation. (see attached document n°2)
- Rationale for animal assignment (if not random):randomized - Positive control:
- no.
Examinations
- Observations and examinations performed and frequency:
- mortality/viability : at least twice daily
clinical signs
CAGE SIDE OBSERVATIONS: No data
- Time schedule:
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations:weekly
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes / weekly
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations:
- Dose groups that were examined:
HAEMATOLOGY: Yes
- Time schedule for collection of blood: under anaesthesia, immedialtely prior to scheduled post mortem examination
- Anaesthetic used for blood collection: Yes (isoflurane)
- Animals fasted: No data
- How many animals:40
- Parameters checked in table [1] were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood:under anaesthesia, immedialtely prior to scheduled post mortem examination
- Animals fasted: No data
- How many animals:40
- Parameters checked in table [1] were examined.
URINALYSIS: No data
- Time schedule for collection of urine:
- Metabolism cages used for collection of urine: Yes / No / No data
- Animals fasted: Yes / No / No data
- Parameters checked in table [No.?] were examined.
NEUROBEHAVIOURAL EXAMINATION: Yes / No / No data
- Time schedule for examinations:during week 4 of treatment
- Dose groups that were examined: all the groups
- Battery of functions tested: sensory activity; grip strength ; motor activity ;
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
for both, see the attached document n°3
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- hunched posture and piloerection at a dose of 600 mg/kg
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- hunched posture and piloerection at a dose of 600 mg/kg
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- at a dose of 600 mg/kg
- Food efficiency:
- no effects observed
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- ALAT + cholesterol, at a dose of 600 mg/kg
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- inrease of motor activity, at a dose of 600 mg/kg
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- higher liver weight, at a dose of 600 mg/kg.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced size of prostate, at a dose of 600 mg/kg
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 130 mg/kg bw/day (nominal)
- Based on:
- test mat. (total fraction)
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The combined occurence of observed changes was considered warranted to set the NO OBSERVED ADVERSE EFFECT LEVEL (NOAEL) for 852 IMIDE ( = tetrahydrocyclopenta[c]pyrrole-1,3(2H,3aH)-dione) at 130 mg/kg.
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