Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 278-928-2 | CAS number: 78491-02-8
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Adequately reported study using a standard test method and a relatively large number of human volunteers.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
- Type of sensitisation studied:
- skin
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Human repeat insult patch test (9 RIPT method)
- GLP compliance:
- not specified
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
Method
- Type of population:
- general
- Ethical approval:
- not applicable
- Remarks:
- Informed consent obtained (review board review not required)
- Subjects:
- 19 males, 90 females aged 18 to 68 years showing no physical or dermatological condition which would preclude testing were enrolled in testing. 12 discontinued participation for reasons unrelated to the study, leaving 97.
- Clinical history:
- No data
- Controls:
- Distilled, deionised water vehicle control included.
- Route of administration:
- dermal
- Details on study design:
- Induction phase:
- test sites cleaned with 70% isopropyl alcohol and allowed to dry
- 9 drops (approximately 0.3 ml) of an aqueous 0.5% solution of test substance applied to 2cm square occlusive patches
- one patch applied to each test subject (adjacent to spinal line of the upper back)
- subjects told to remove patches after 24h
- test sites inspected after 24 or 48h rest period (according to day of patch application), immediately prior to re-patching
- a total of 9 patches applied/subject.
Challenge phase:
- 12-18 days after last induction treatment, test sites inspected and challenge patches applied to virgin test sites
- challenge sites inspected after 24, 48 and 72h.
Rechallenge for one subject:
- 1 subject showing reactions at challenge was rechallenged 8 weeks later.
Solvent controls:
- patched as for test solution, but using deionised distilled water.
Results and discussion
- Results of examinations:
- Solvent control sites:
scattered, transient minimal to mild responses seen in 3/97 subjects.
Test solution induction:
- one subject (no. 29) showed mild or moderate reaction after 5 of the 9 induction treatments
- no other reactions were seen.
Test solution challenge:
- subject 29 showed faint erythema at the 48h reading, becoming mild at 72h. This had reduced to a faint response after 144h
- no other reactions were seen.
Any other information on results incl. tables
Rechallenge of subject 29 produced no skin reactions. It was concluded that the earlier responses of this subject reflected a cumulative irritation reaction rather than a sensitisation response.
Applicant's summary and conclusion
- Conclusions:
- In this study, 1/97 human volunteers showed a cumulative irritation response (maximally moderate erythema) to repeated dermal application of a 0.5% solution of test substance. No evidence of sensitisation was seen.
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.