Registration Dossier
Registration Dossier
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EC number: 278-928-2 | CAS number: 78491-02-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported study performed under GLP and using 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 870.1200 (Acute Dermal 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:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Bodyweights 2.1-3.0 kg males, 2.3-2.4 kg females pre-test.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Remarks:
- patch and test material moistened with distilled water (0.2 ml)
- Details on dermal exposure:
- Moistened test substance applied to previously clipped test sites (dorsal skin, ca. 10% of body surface area) then covered with gauze, plastic sheet and tape.
- Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- not required
- Details on study design:
- Dressings removed after 24h and test sites subsequently washed with distilled water. Test sites observed 1, 7 and 14 days post-treatment. Animals observed 1, 2 and 4h post-treatment, then daily up to 14 days.
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: No deaths occurred and no significant evidence of systemic toxicity was observed.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: One day after treatment, 2 females showed minor (grade 1) skin reactions at test sites; in one of these, the reactions persisted to day 7. No clear indications of systemic toxicity was observed (only sporadic observations of reduced faecal production were
- Gross pathology:
- No abnormal observations were reported at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Low dermal toxicity was recorded in this study: acute dermal LD50 in the rabbit >2000 mg/kg.
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