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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed under 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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
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:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Male New Zealand White rabbits from Harlan UK Ltd, Bicester (HsdIf:NZW strain).
- Age at study initiation: 12 to 13 weeks old.
- Weight at study initiation: 2.2 to 2.5 kg
- Housing:Individually housed in cages.
- Diet (e.g. ad libitum):Global Diet 2930C (Harlan Teklad, Bicester, 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: 7 to 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):15 to 21 degrees C
- Humidity (%):Humidity did not fall below the limit specified in the protocol (45%).
- Air changes (per hr):15 to 20
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From 14 February 2012 to 28 February 2012.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):500 mg
VEHICLE
- Amount(s) applied (volume or weight with unit):none - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 15 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: A 30 x 20 mm area on the closely clipped dorsum.
- % coverage:100%
- Type of wrap if used: none
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lightly brushed clean of any solid residues and swabbed with moist cotton wool.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema & eschar Grade
No erythema 0
Very slight erythema 1
Well-defined erythema 2
Moderate erythema 3
Severe erythema (beet redness) or eschar formation preventing reading of erythema 4
Oedema Grade
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (edges raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond the dermal test site) 4
The scores for erythema and oedema at the 24 and 72 hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test article.
Primary Irritation Index Classification of Irritancy
0 Non irritant
>0 to 2 Mild irritant
>2 to 5 Moderate irritant
>5 to 8 Severe irritant
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- ca. 0.5
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.333
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- other: very slight erythema in one animal
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.333
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- other: very slight erythema in one animal
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.667
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- other: well-defined erythema in one animal
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - Very slight erythema was noted at one treated skin site at 24 and 48 hours after patch removal. Well-defined erythema was noted at this site 72 hours after patch removal with very slight erythema and fissuring present on Day 8. No evidence of skin irritation was noted at this treated skin site on Day 15.
- No evidence of skin irritation was noted at the other two treated skin sites during the observation period.
Any other information on results incl. tables
Table1
Individual dermal reactions
Animal number, sex, initial body weight and final body weight |
Dermal reaction |
Observation time after removal of patches |
||||||
Imm |
1 hour |
24 hours |
48 hours |
72 hours |
7 days |
14 days |
||
4M |
Erythema/Eschar formation |
0 |
0 |
1 |
1 |
2 |
1 |
0 |
Oedema formation |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Other |
- |
- |
- |
- |
- |
FS |
- |
|
5M |
Erythema/Eschar formation |
N/A |
0 |
0 |
0 |
0 |
N/A |
N/A |
Oedema formation |
N/A |
0 |
0 |
0 |
0 |
N/A |
N/A |
|
Other |
N/A |
- |
- |
- |
- |
N/A |
N/A |
|
6M |
Erythema/Eschar formation |
N/A |
0 |
0 |
0 |
0 |
N/A |
N/A |
Oedema formation |
N/A |
0 |
0 |
0 |
0 |
N/A |
N/A |
|
Other |
N/A |
- |
- |
- |
- |
N/A |
N/A |
|
Sum of 24 and 72 hour readings (S) |
: |
3 |
||||||
Primary Irritation Index (S/6) |
: |
3/6 = 0.5 |
||||||
Classification |
: |
MILD IRRITANT |
Key:
Imm Immediately after removal of patch
FS Fissuring
N/A Not applicable
Table 2
Individual Daily and Mean Scores for Dermal Irritation Following 4 Hour
Exposure
Dermal reaction |
Observation Time |
Individual Scores � Rabbit Number and Sex |
|
||
4M |
5M |
6M |
|||
Erythema/Eschar Formation |
24 Hours |
1 |
0 |
0 |
|
48 Hours |
1 |
0 |
0 |
||
72 Hours |
2 |
0 |
0 |
||
Total |
4 |
0 |
0 |
||
Mean Score |
1.3 |
0.0 |
0.0 |
||
Oedema Formation |
24 Hours |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
||
72 Hours |
0 |
0 |
0 |
||
Total |
0 |
0 |
0 |
||
Mean Score |
0.0 |
0.0 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test article produced a primary irritation index of 0.5 and was classified as a MILD IRRITANT to rabbit skin according to the Draize classification
scheme. The test article did not meet the criteria for classification as irritant or corrosive according to the Globally Harmonized System of
Classification and Labelling of Chemicals (GHS).
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