Registration Dossier
Registration Dossier
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EC number: 254-372-6 | CAS number: 39236-46-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Brief report of a study using a standard test method: no information on adverse reactions other than death, but sufficient to conclude an LD50 value.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Classical acute oral LD50 test using groups of 3 males, 2 females.
- GLP compliance:
- no
- Remarks:
- Pre-GLP study
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]
- EC Number:
- 254-372-6
- EC Name:
- N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]
- Cas Number:
- 39236-46-9
- Molecular formula:
- C11H16N8O8
- IUPAC Name:
- N',N'''-methylenebis{1-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea}
- Test material form:
- other: tested as aqueous 25% solution
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sherman - Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Single oral dose after 24h starvation period.
- Doses:
- Volumes of 25% solution equivalent to 3.15, 4.0, 5.0, 6.25 and 7.9 g test substance/kg.
- No. of animals per sex per dose:
- 3 males, 2 females.
- Control animals:
- no
- Details on study design:
- Animals observed for 14 days post-dose.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 200 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- >= 4 200 - <= 6 400
- Remarks on result:
- other: Dosages expressed in terms of active ingredient in the 25% solution tested.
- Mortality:
- All rats dosed at 7900 mg/kg died; no other deaths occurred.
- Clinical signs:
- other: No information given
- Gross pathology:
- Not evaluated
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- An oral LD50 value of 5200 mg/kg was determined in this study.
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