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EC number: 700-726-4 | CAS number: 1369499-44-4
- 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:
- 27 Feb - 24 Jun 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- (5Z)-5-(2-methylpropylidene)imidazolidine-2,4-dione
- EC Number:
- 700-726-4
- Cas Number:
- 1369499-44-4
- Molecular formula:
- C7H10N2O2
- IUPAC Name:
- (5Z)-5-(2-methylpropylidene)imidazolidine-2,4-dione
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD / Crl: CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: males approx. 6 weeks, females approx. 7 weeks
- Weight at study initiation: males 192-201 g, females 180-188 g
- Fasting period before study: feeding was discontinued approx. 16 hours before administration
- Housing: 2-3 animals/cage
- Diet: ad libitum (ssniff® R/M-H V1530, ssniff Spezialdiäten GmbH, D-59494 Soest, Germany)
- Water: ad libitum (tap water)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17.03.2003 To: 10.04.2003
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.8% aqueous hydroxypropylmethylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL in 0.8% aqueous hydroxypropylmethylcellulose gel
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg b.w. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: before and immediately, at 5, 15, 30 and 60 min, as well as at 3, 6 and 24 hours and 14 days after administration
- Observations on mortality were made at least once daily; the time of death was recorded as precisely as possible
- Observations on clinical signs: changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system, somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Individual body weights were recorded before administration of the substance and thereafter in weekly intervals up to the end of the study, and at death; changes in weight were calculated and recorded
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy ; all gross pathological changes were recorded; no histopathology was carried out as no macroscopical findings were noted at autopsy; autopsy and macroscopic inspection of animals which died prematurely were carried out as soon as possible after exitus
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1 of 3 male and 1 of 3 female animals died prematurely within 24 hours after dosing.
- Clinical signs:
- other: Slightly to moderately reduced motility, slight to moderate ataxia, slight to moderate dyspnoea, ptosis.
- Gross pathology:
- No macroscopical findings were noted at autopsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The oral LD50 value of the test material in male and female rats was determined to be >2000 mg/kg bw. One male and one female animals died prematurely within 24 hours after dosing.
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