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Diss Factsheets
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EC number: 271-898-1 | CAS number: 68611-64-3
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-06-24 2008-07-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The GLP study was conducted according to an internationally accepted guideline. All study parameters are based on the specific guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Urea, reaction products with formaldehyde
- EC Number:
- 271-898-1
- EC Name:
- Urea, reaction products with formaldehyde
- Cas Number:
- 68611-64-3
- Molecular formula:
- not available
- IUPAC Name:
- Urea, reaction products with formaldehyde
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Approximately 24 hours before application the fur on the dorsal area of the trunk was removed by close clipping (area 6 x 6 cm). Only animals with healthy intact skin were used. After clipping the fur the animals were weighed.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Rabbits were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
- Number of animals:
- 3
- Details on study design:
- The test substance in the dose of 0.5 g was applied on intact skin and then it was covered by gauze patch, foil and cellulose cotton and held in place with non-irritating tape -Spotaplast. At the end of each exposure period the patch was removed and remaining sample was washed with water.
In initial test three patches were applied sequentially to one animal. The first patch was removed after three minutes. No serious skin reaction was observed, so the second patch was applied for one hour. The observations at this stage indicated that exposure can humanely be allowed to extend to four hours, so the third patch was applied for four hours. After removing the patch, a response was graded. Because no corrosive or irritant effect was observed after a 4-hour exposure, the response was verified in confirmatory test using two additional animals, cach with one patch for an exposure period of 4 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No skin irritation was caused by 4-hour exposure to Weikoform (Urea, reaction products with formaldehyde).
- Executive summary:
The test substance, Weikoform (Urea, reaction products with formaldehyde), was tested in the study for acute dermal irritation/corrosion. Rabbits (New Zealand Albino breed) were used for the test. Fest was performed according to Method B.4 - Acute Toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008. Three rabbits were exposed to 0.5 g of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at 1, 24,48 and 72 hours after exposure. At first the test substance was applied on the skin of one rabbit (test animal No. 7). Rabbit No. 7 was investigated 3 minutes, 1 hour and 4 hours after application of the test substance. No symptoms of irritation were observed on the skin. In confirmatory test, two others rabbits (rabbit No. 8 and No. 9) were used with 4-hour exposition period. No evidence of a corrosive effect or symptoms of irritation were observed on the skin. No skin irritation was caused by 4-hour exposure to Weikoform (Urea, reaction products with formaldehyde). No other signs of intoxication were observed.
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