Registration Dossier
Registration Dossier
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EC number: 223-032-9 | CAS number: 3699-54-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Near-guideline study, available as unpusblished report, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-(2-hydroxyethyl)imidazolidin-2-one
- EC Number:
- 223-032-9
- EC Name:
- 1-(2-hydroxyethyl)imidazolidin-2-one
- Cas Number:
- 3699-54-5
- Molecular formula:
- C5H10N2O2
- IUPAC Name:
- 1-(2-hydroxyethyl)imidazolidin-2-one
- Details on test material:
- - Name of test material: Hydroxyethylethylene urea
- CAS No.: 3699-54-5
- Appearance: white, solid, crystalline melt
- Purity: > 98%
- Impurities: urea < 1%, water < 1%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, D7950 Biberach, FRG
- Weight at study initiation: animals of comparable weight (+- 20% of the mean weight)
- Fasting period before study: 16 hrs before administration
- Housing: stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG), 5 animals per cage
- Diet (ad libitum): Kliba-labordiaet 343, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (ad libitum): tap water
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 /12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- - vehicle: aqua dest
- justification for choice of vehicle: aqueous formulation corresponds to the physiological medium - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: recording of signs and symptons several times on the day of administration. At least once each workday. Check for moribund and dead animals twice each workday and once on holidays
- Necropsy of survivors performed: yes
- Other examinations performed: body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality.
- Clinical signs:
- other: No abnormalities.
- Gross pathology:
- No pathologic findings noted.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
