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EC number: 204-436-4 | CAS number: 120-93-4
- 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
Carcinogenicity
Administrative data
Description of key information
The substance was not carcinogenic in the oral study in rats and not carcinogenic in the gavage study in mice.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Remarks:
- other: gavage and oral feed (see: doses)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, acceptable for assessment. Restrictions: survival and food intake (and thus quantitative availability of test substance) not specified.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Two F1 hybrid stocks of mice were used: strains (C57BL/6xC3H/Anf)F1 and (C57BL/6xAKR)F1. 18 animals per sex per strain received the test compound via gavage during weaning (day 7-28) and consecutively via the diet until 18 months of age. During gavage a maximum tolerated dose of 215 mg/kg bw/d (derived from zero mortality after 19 daily doses) in 0.5 % gelatine was administered. During the dietary phase, animals received 646 ppm (= ca. 80 mg/kg bw/day) via unrestricted consumption of feed (concentration calculated according to the weight and food consumption of 4-week old mice). Negative and positive control groups were run simultaneously. After 18 months mice were sacrificed and gross pathological and histological examinations were performed.
- GLP compliance:
- not specified
- Species:
- mouse
- Strain:
- other: see "details on test animals and environmental conditions"
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: "specific pathogen-free" mice were obtained from Cumberland View Farms, Clinton, Tennessee, to establish a breeding colony.
- Strain: Females of a C57BL/6 strain were mated with C3H/Anf or AKR males to obtain (C57BL/6 x C3H/Anf)F1 and C57BL/6 x AKR)F1, the two F1 hybrid stocks used.
- Age at study initiation: 7 days
- Housing: 6 animals per cage
- Diet: ad libitum - Route of administration:
- other: gavage and oral feed (see: doses)
- Vehicle:
- other: 0.5% gelatin during gavage
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 18 months
- Frequency of treatment:
- Gavage: daily
Dietary period: continuously - Post exposure period:
- None
- Dose / conc.:
- 215 mg/kg bw/day (actual dose received)
- Remarks:
- during gavage (day 7-28)
- Dose / conc.:
- 646 ppm
- Remarks:
- ca. 80 mg/kg bw/day; during dietary exposure (>28 days)
- No. of animals per sex per dose:
- 18 mice per sex per strain
- Control animals:
- yes, concurrent no treatment
- yes, concurrent vehicle
- other: positive control: ethyl carbamate
- Observations and examinations performed and frequency:
- The postmortem procedure included an external examination and a thorough examination of thoracic and abdominal cavities, with histologic examination of major organs and of all grossly visible lesions.
- Details on results:
- Exposure to ethylene urea during the examination period (gavage plus dietary) caused no significant increase in tumors.
Though the test design does not meet current standards completely, the negative result at the high dose for almost lifetime gives evidence of no cancerogenic potential of the test substance on oral application in mice: no positive result is expected when another test is repeated (comp. McGregor et al., 1994). Ambiguities: survival, food intake and thus quantitative availability of test substance, not specified. - Key result
- Dose descriptor:
- other: No increase in tumours observed
- Effect level:
- >= 80 - <= 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Exposure to ethylene urea during the examination period (gavage plus dietary) caused no significant increase in tumors.
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, acceptable for assessment Restrictions: limited number of animals, limited documentation.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Two groups of 6 female rats received a diet containing 0.1% 2-imidazolidinone for 150 days. One of the groups in addition received 0.12% sodium nitrite via the drinking water. At the end of the exposure period animals were weighed and gross pathology and histopathology were examined.
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- SIV 50
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ivanovas, Kisslegg/Allgäu
- Weight at study initiation: 120 g
- Diet: ad libitum
- Water: ad libitum - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 150 days
- Frequency of treatment:
- Continuous
- Dose / conc.:
- 0.1 other: % in feed
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- Post-exposure period: none
- Details on results:
- All animals survived, no tumors occurred, while in the group additionally treated with nitrite all animals died, suffering carcinomas (5 nephroblastomas, 1 squamous cell carcinoma).
Because of the low number of animals applied it is not possible to conclude whether 2-imidazolidinone is carcinogenic or not, but the combination with nitrite provides clear evidence of tumor generation. - Key result
- Dose descriptor:
- other: No tumours observed
- Effect level:
- 1 000 ppm
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: All animals survived, no tumors occurred, while in the group additionally treated with nitrite all animals died, suffering carcinomas (5 nephroblastomas, 1 squamous cell carcinoma).
Referenceopen allclose all
Justification for classification or non-classification
Classification, Labelling, and Packaging
Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on carcinogenicity, the test item is not classified
according to Regulation (EC) No 1272/2008 (CLP).
Additional information
The induction of malignant tumors in rats was tested by oral administration of the test substance (Sander, 1971). Two groups of 6 female rats each received for 150 days standard diet, which contained 2-Imidazolidine (0.1%). One group got, in addition, drinking water with 0.12% sodium nitrite. All animals survived, no tumors occurred, while in the group additionally treated with nitrite all animals died, suffering carcinomas (5 nephroblastomas, 1 squamous cell carcinoma).
The tumorigenicity of the test substance was tested by continuous oral administration to both sexes of two hybrid strains of mice, started at the age of 7 days (Innes, 1969). 18 animals per sex per strain received the test compound via gavage during weaning (day 7-28) and consecutively via the diet until 18 month of age. Maximal tolerated doses were given. Exposure to the test substance during the examination period (gavage plus dietary) caused no significant increase in tumors.
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