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EC number: 247-728-7 | CAS number: 26479-35-6
- 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:
- 14 days
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to GLP/OECD guideline without deficiency.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- 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
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- Potassium carbamoylcarbamate
- EC Number:
- 247-728-7
- EC Name:
- Potassium carbamoylcarbamate
- Cas Number:
- 26479-35-6
- Molecular formula:
- C2H4N2O3.K
- IUPAC Name:
- potassium N-carbamoylcarbamate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):Potassium Allophonate
- Physical state:powder
- Analytical purity:83.8%
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HsdHan: WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Male and female (nulliparous, non-pregnant) HsdHan:WIST strain rats.
- Age at study initiation: Approximately 9 to 10 weeks old on Day 1.
- Weight at study initiation: Range of 185 g to 310 g.
- Housing: During the acclimatisation period, four rats of the same sex were group caged. From the day prior to dosing (Day –1), each rat was
individually housed in a similar cage. After completion of the Day 3 observations animals allocated to the main study were returned to group housing.
- Diet (e.g. ad libitum):SQC(E) Rat and Mouse Maintenance Diet No 1, from Special Diets Services Ltd, Witham, UK was freely available to the animals at all times.
- Water (e.g. ad libitum):Mains water was provided, ad libitum, via cage-mounted water bottles. The water had been periodically analysed for specific contaminants.
- Acclimation period:The condition of the animals was assessed daily throughout the acclimatisation period of 7 to 14 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 to 24 degrees C
- Humidity (%):45% to 65%
- Air changes (per hr): 15 to 20
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From 11 January 2012 to 01 February 2012.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Electric clippers were used to remove all hair from the dorsum on the day before dosing. The dermal test site was an area of at least 10% of the total body surface on the clipped dorsum of the rat. The total surface area (cm2) for each animal was calculated according to the largest animal in each
group using the following formula:
Surface area (cm2) = K x body weight (g)2/3 (where K = 9)
Individual dose weights (mg) were calculated from the body weights of the rats on the morning of dosing (Day 1).
The test article was spread as uniformly as possible over the dermal test site. The test article was moistened with purified water in order to maximise dermal contact. A dense gauze patch was placed over the treated skin and retained in place by an elasticated, open-weave, adhesive compression
bandage. This was wrapped securely around the torso of the animal. The dressing was removed approximately 24 hours after application. The
dermal test site of each rat was lightly brushed clean of any solid residues and swabbed with water-moistened cotton wool before the animal was
returned to the holding cage. - Duration of exposure:
- 24 hours
- Doses:
- 2000mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were examined at the beginning and end of the working day throughout the acclimatisation
and study periods to ensure they were in good health.Animals were weighed on Day 1 (day before dosing) and on Days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs were recorded immediately post dose, at approximately 15 and 30
minutes post dose, hourly between 1 and 4 hours post dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. - Statistics:
- none
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no apparent clinical signs of reaction to treatment.
- Gross pathology:
- No macroscopic changes were noted at necropsy.
- Other findings:
- Well defined erythema was noted at the treatment sites of three males and two females on removal of the dressings at the end of the exposure
period. No other dermal reactions were noted.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The acute median lethal dermal dose of Potassium Allophonate to rats was found to exceed 2000 mg/kg.
The test material was considered to have no significant acute toxic risk in respect of its acute dermal toxicity and did not meet the criteria for
classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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