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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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Read-across from a Klimisch 3 study performed on a close structural analogue which is manufactured in the same way (reaction of formaldehyde with a modified urea) and reacts with water in the same way (hydrolysis releasing formaldehyde) as the registered substance. Although this study was performed under GLP and following a standard test method, the report has major deficiencies. The test material was an aqueous 50% solution and the report conclusion cites LC50 values for such a solution but tabulated data suggest exposure concentrations used for LC50 calculation are for active ingredient. Additionally, the reported very high humidity in test chambers which could affect crystallisation of solid material from aerosol, making the gravimetric analsysi of test atmospheres unreliable. Finally, the whole-body exposure employed is likely to have incurred intake via ingestion (grooming) and even perhaps dermal contact, since test material was reported on the fur at all test concentrations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-3 (Acute inhalation toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Diazolidinyl urea
- IUPAC Name:
- Diazolidinyl urea
- 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
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Bodyweights at start of test: males 204-252g, females 201-237g. Individually caged during exposure.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- 4.5h
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gravimetric analysis with particle size measurement
- Duration of exposure:
- 4.5 h
- Concentrations:
- Preliminary test: 5.01 mg/l
Definitive test: 0.53, 1.20, 1.98 mg/l - No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Details on study design:
- During test exposure, rats were observed every 15 minutes for 1h, then every 30 minutes. Following exposure, rats were examined at least once daily.
Results and discussion
- Preliminary study:
- Exposure at 5.01 mg/l caused 100% mortality within 4 days.
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 1.35 mg/L air
- Based on:
- test mat.
- 95% CL:
- 1.03 - 1.76
- Exp. duration:
- 4.5 h
- Remarks on result:
- other: This corresponds to an LD50 for the test substance itself (active ingredient in the tested solution) of 0.675 mg/l
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 1.25 mg/L air
- Based on:
- test mat.
- 95% CL:
- 1.02 - 1.54
- Exp. duration:
- 4.5 h
- Remarks on result:
- other: This corresponds to an LD50 for the test substance itself (active ingredient in the tested solution) of 0.625 mg/l
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 1.3 mg/L air
- Based on:
- test mat.
- 95% CL:
- 0.99 - 1.71
- Exp. duration:
- 4.5 h
- Remarks on result:
- other: This corresponds to an LD50 for the test substance itself (active ingredient in the tested solution) of 0.65 mg/l
- Mortality:
- 0.53 mg/l: no mortality
1.20 mg/l: 40% mortality by day 2
1.98 mg/l: 90% mortality by day 3 - Clinical signs:
- other: 0.53 mg/l: signs included lethargy, hunched posture, irregular respiration during exposure and (hunched posture, irregular respiration) for 2 subsequent days 1.20 mg/l: signs included lethargy, hunched posture, irregular respiration during exposure. Subs
- Gross pathology:
- Necropsy of decedents revealed distension and discoloration of the gastrointestinal tract plus reddening of the lungs.
Any other information on results incl. tables
Exposure at 0.53 mg/l produced only transient clinical signs: animals recovered by day, gained weight and showed no gross abnormalities at necropsy. 0.53 mg/l (corresponding to 0.27 mg registered substance/l) is therefore considered a 4.5h NOAEC.
Test atmospheres:
- 0.53 +/- 0.05 mg/l, mass median aerodynamic diameter ca. 2.9 microns (ca. 7% <1 micron, 53% <3 microns)
- 1.20 +/- 0.13 mg/l: mass median aerodynamic diameter ca. 2.5 microns (ca. 8% <1 micron, 61% <3 microns)
- 1.98 +/- 0.14 mg/l: mass median aerodynamic diameter ca. 2.4 microns (ca. 7% <1 micron, 66% <3 microns)
- 5.01 +/- 0.24 mg/l: mass median aerodynamic diameter ca. 2.6 microns (ca. 7% <1 micron, 60% <3 microns)
Applicant's summary and conclusion
- Interpretation of results:
- toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- From this study an acute inhalation LC50 of 0.65 mg/l can be concluded for the tested anaolgue. Based on the close similarity of both chemical structure and properties, it is predicted that the registered substance would give a similar result in this assay.
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