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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Potassium carbamoylcarbamate
- EC Number:
- 247-728-7
- EC Name:
- Potassium carbamoylcarbamate
- Cas Number:
- 26479-35-6
- Molecular formula:
- C2H3KN2O3
- IUPAC Name:
- potassium N-carbamoylcarbamate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: particulates
- Details on test material:
- - Name of test material (as cited in study report):Potassium Allophonate
- Physical state:powder
- Analytical purity:83.8%
1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:Nulliparous, non-pregnant female CBA/CaCrl strain mice obtained from Charles River (UK) Ltd, Margate.
- Age at study initiation: 8 to 10 weeks old.
- Weight at study initiation: 15 to 20 g
- Housing:Group housed during acclimatisation and individually housed from Day –1 in cages.
- 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.
- Acclimation period: 8 to 15 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 17 January 2012 To 31 January 2012
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0, 10%, 25%, 50% w/v
- No. of animals per dose:
- 5
- Details on study design:
RANGE FINDING TESTS: A preliminary screening test was performed with one mouse. The mouse was treated by daily application of 25 µL of the test
article at the maximum suitable concentration (50% w/v in DMSO) to the dorsal surface of each ear for three consecutive days (Days 1, 2 and 3). The mouse was observed daily for five days from the initiation of treatment. Any signs of toxicity or irritation during this period were recorded.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:3
- Exposure period: 24 hours
- Site:Outer aspect of both auditory pinnae.
- Frequency of applications:once daily
- Duration:Once daily on Days 1, 2 and 3.
- Concentrations: 0.25 mL/pinna
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge:1
- Site: Tail vein injection.
- Concentrations:0.25 mL phosphate buffered saline incorporating 20 μCi of 3HTdR.
- Evaluation (hr after challenge):5 hours- Positive control substance(s):
- other: α-hexylcinnamaldehyde formulated at a concentration of 25% in acetone / olive oil (4:1 v/v)
Results and discussion
- Positive control results:
- The positive control article produced a Stimulation Index of 4.49.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Variability:
- 599 +/- 196.1 DPM
- Test group / Remarks:
- Vehicle control
- Remarks on result:
- other: Control parameter
- Key result
- Parameter:
- SI
- Value:
- 0.55
- Variability:
- 330 +/- 138.7 DPM
- Test group / Remarks:
- 10% in DMSO
- Key result
- Parameter:
- SI
- Value:
- 1.22
- Variability:
- 730 +/-565.8 DPM
- Test group / Remarks:
- 25% in DMSO
- Key result
- Parameter:
- SI
- Value:
- 0.67
- Variability:
- 401 +/- 126.5 DPM
- Test group / Remarks:
- 50% in DMSO
- Key result
- Parameter:
- SI
- Value:
- 4.49
- Variability:
- 2693 +/- 1860.1 DPM
- Test group / Remarks:
- Positive control
Any other information on results incl. tables
Individual DPMs and Stimulation Index (SI)
Concentration (%w/v) in DMSO |
Group |
Animal |
DPM/ |
Mean DPM/animal |
Stimulation Index (SI)a |
Vehicle |
1 |
49 |
506 |
599 |
NA |
50 |
509 |
||||
51 |
941 |
||||
52 |
458 |
||||
53 |
583 |
||||
10 |
2 |
54 |
146 |
330 |
0.55 |
55 |
313 |
||||
56 |
421 |
||||
57 |
265 |
||||
58 |
504 |
||||
25 |
3 |
59 |
711 |
730 |
1.22 |
60 |
790 |
||||
61 |
186 |
||||
62 |
328 |
||||
63 |
1635 |
||||
50 |
4 |
64 |
389 |
401 |
0.67 |
65 |
285 |
||||
66 |
521 |
||||
67 |
540 |
||||
68 |
272 |
||||
Positive control |
5 |
69 |
1308 |
2693 |
4.49 |
70 |
1715 |
||||
71 |
1619 |
||||
72 |
3013 |
||||
73 |
5809 |
Key
DMSO dimethyl sulphoxide
NA = Not applicable
a= Stimulation Index of 3.0 or greater indicates a positive result
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The Local Lymph Node Assay demonstrated that Potassium Allophonate does not have the potential to cause skin sensitisation.
The test article did not meet the criteria for classification as a sensitiser according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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