Registration Dossier
Registration Dossier
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EC number: 278-928-2 | CAS number: 78491-02-8
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well reported study performed under GLP and using a standard study design for determining acute toxicity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: classical LD50 test method
- Principles of method if other than guideline:
- Following a preliminary test, 5 groups of mice were dosed at different test dosages and observed for 14 days.
- GLP compliance:
- yes
- Limit test:
- no
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:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Bodyweight 18-25g (fasted, pretreatment).
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Remarks:
- (deionised)
- Details on exposure:
- Single ip injection at a dose volume of 10 ml/kg.
- Doses:
- Rangefinder: 500, 1600, 3200, 5000 mg/kg
LD50 determination: 630,1000, 1600, 2500, 3200 mg/kg. - No. of animals per sex per dose:
- Rangefinder: 2 males, 2 females
LD50 determination: 5 males, 5 females. - Control animals:
- no
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 312 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 666 - 2 155
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 664 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 981 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 493 - 1 373
- Mortality:
- Rangefinder:
500 1600 3200 5000 dosage, mg/kg
0/2 1/2 1/2 2/2 deaths.
LD50 determination:
630 1000 1600 2500 3200 dosage, mg/kg
1/5 2/5 2/5 4/5 5/5 male deaths
2/5 4/5 4/5 4/5 5/5 female deaths - Clinical signs:
- Observed signs included abnormalities of movement and posture, ataxia and tremors.
- Gross pathology:
- No significant lesions observed in surviving animals.
Applicant's summary and conclusion
- Conclusions:
- Acute LD50 in the mouse after ip administration was determined to be 981 mg/kg (combined sexes). Some indication of sex-related difference in acute toxicity was reported.
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