Registration Dossier
Registration Dossier
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EC number: 278-928-2 | CAS number: 78491-02-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported study performed under GLP and following a standard test method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea
- EC Number:
- 278-928-2
- EC Name:
- 1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea
- Cas Number:
- 78491-02-8
- Molecular formula:
- C8H14N4O7
- IUPAC Name:
- 1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Males 257-297g, females 226-255g bodyweight.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- Animals fasted for 16-20h pre-dose.
- Doses:
- 2000 mg/kg only.
- No. of animals per sex per dose:
- 5 males, 5 females
- Details on study design:
- Rats observed 1, 2 and 4h post dose (Day 0), then daily for 14 days (with mortality checks twice daily).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 reported as approximately 2000 mg/kg: 2/5 males and 2/5 females died following administration of this dose.
- Mortality:
- 1 male, 2 females died on the day of dosing. 1 male died the following day.
- Clinical signs:
- other: Diarrhoea and anogenital soiling were seen in all treated animals.
- Gross pathology:
- Abnormalities of the liver, adrenals and gastrointestinal tract were seen in decedents.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the observed mortality following oral administration of 2000 mg/kg, the acute LD50 is concluded to be close to, but above, 2000 mg/kg.
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