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EC number: 610-945-6 | CAS number: 53037-34-6
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 12, 2012 - December 12, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Oligomerisation reaction products of glyoxal and urea.
- EC Number:
- 610-945-6
- Cas Number:
- 53037-34-6
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).
- IUPAC Name:
- Oligomerisation reaction products of glyoxal and urea.
- Details on test material:
- - Name of test material (as cited in study report): NOPCOTE 1661
- Physical state: Clear, light yellow solution
- Purity: 46%
- Lot/batch No.: 79389
- Expiration date of the lot/batch: 11 January 2013
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld.- Age at study initiation: Young adult rats.- Weight at study initiation: Males: 231-242 g, Females: 213-234 g- Housing: Individual caging.- Diet (e.g. ad libitum): Ad libitum.- Water (e.g. ad libitum): Ad libitum.- Acclimation period: 6 days.ENVIRONMENTAL CONDITIONS- Temperature (°C): 20.6 – 25°C.- Humidity (%): 30 - 54 %.- Air changes (per hr): 15-20 air exchanges/hour .- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE- Area of exposure: back of the animals.- % coverage: 10% of the total body.- Type of wrap if used: Sterile gauze pads were placed on the skin to cover the test item. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours.REMOVAL OF TEST SUBSTANCE- Washing (if done): The area of skin treated with the test item was washed with water of body temperature.- Time after start of exposure: 24 hoursTEST MATERIAL- Concentration: Purity factor of 2.18 to the dry content of the test item was used
- Duration of exposure:
- 24 hour
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days- Frequency of observations and weighing: Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. - Necropsy of survivors performed: Yes, gross macroscopic examination was performed on all animals at the end of the 2-week observation period (Day 14).
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Administration of the test item did not cause mortality.
- Clinical signs:
- other: No clinical signs were observed after treatment or during the 14 day observation period.
- Gross pathology:
- No macroscopic effects were observed at necropsy.
- Other findings:
- Local dermal signs: Multifocal erythema in different diameters from 2 – 4 mm was noted in 4/5 males and 3/5 females which was reversible within 72 hours. In case of one male, a wound covered with scab later was observed from Day 2 to Day 9. Yellow discoloration of the fur was observed at the outskirt of the exposed surface in 5/5 males and 5/5 females.
Any other information on results incl. tables
Experimental results are included in the tables which contains the document attached ("Attached background material").
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 value of the test substance was >2000 mg/kg bw in male and female rats.
- Executive summary:
The acute dermal toxicity of test substance was performed according to OECD 402 Guideline and EU B.3 Method in male and female rats. A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied under semi-occlusive conditions as supplied as a single dermal 24-hour exposure followed by a 14‑day observation period. No treatment related effects were observed on mortality, clinical signs, body weight and necropsy. Multifocal erythema in different diameters were noted which were reversible within 72 hours. In case of one male, a wound covered with scab later was observed from day 2 to 9. Yellow discoloration of the fur was observed at the outskirt of the exposed surface in all animals. The acute dermal median lethal dose (LD50) of the test substance was found to be higher than 2000 mg/kg bw in male and female rats.
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