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Diss Factsheets
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EC number: 254-372-6 | CAS number: 39236-46-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- 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 using a standard HRIPT method with a large volunteer panel, containing sufficient information to form reliable conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Human repeat insult patch test with 200 volunteers.
- GLP compliance:
- no
- Remarks:
- Pre-GLP study
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:
- White powder
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- other: informed consent contract signed
- Subjects:
- 200 individuals selected from local population.
- Clinical history:
- Absence of skin disease capable of confusing skin reactions was confirmed.
- Controls:
- Not required
- Route of administration:
- dermal
- Details on study design:
- Discs moistened with an aqueous 10% solution of test substance placed on upper arm sites and covered with occlusive tape. Dressings removed after 24h, test sites scored for reaction. Unless reaction seen, test applications repeated at the same site 24-48h later. A total of 15 applications made in this way (Monday - Wednesday - Friday each week for 5 consecutive weeks).
After a 2-week rest period, each volunteer was challenged using the same dermal patch procedure, and skin reactions were scored on patch removal plus 24 a d 48h later.
Results and discussion
- Results of examinations:
- No visible skin reactions were observed in any of the 200 volunteers tested, either following any of the 15 induction treatments or after challenge.
Any other information on results incl. tables
Based on the complete absence of effect in 200 volunteers, the report predicts with 95% certainty that 98.17% of a general human population will not be sensitised by repeated skin application of the test substance.
Applicant's summary and conclusion
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.