Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 254-372-6 | CAS number: 39236-46-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Brief report of a study performed using a standard test method: contains sufficient information to conclude an LC0 value.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US Federal Register 26 (1961) Section 191.10
- 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:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Fine white powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: described as albino rabbits
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No further data available.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Dry powder test material moistened with saline and applied to clipped skin (intact for 2 rabbits/group, abraded to penetrate stratum corneum for 2 rabbits/group) under occlusive dressing.
- Duration of exposure:
- Up to 24h
- Doses:
- 0.5, 1.5, 2.0, 4.0, 8.0 g/kg.
- No. of animals per sex per dose:
- 2 rabbits, skin intact + 2 rabbits, skin abraded per dose. Sex not specified.
- Control animals:
- not required
- Details on study design:
- Animals observed for 14 days after dressing removal.
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD0
- Effect level:
- 8 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths occurred.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: Not reported.
- 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:
- Application of test substance at up to 8000 mg/kg caused no deaths in this study, even when the possibilities for skin penetration were increased by abrasion of the test sites.
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.
