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EC number: 259-467-6 | CAS number: 55067-10-2
- 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:
- From 5 December 1991 to 8 December 1991.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 84/449/EEC
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (1,4,5,6-tetrahydro-4,6-dioxopyrimidin-2-yl)cyanamide
- EC Number:
- 259-467-6
- EC Name:
- (1,4,5,6-tetrahydro-4,6-dioxopyrimidin-2-yl)cyanamide
- Cas Number:
- 55067-10-2
- Molecular formula:
- C5H4N4O2
- IUPAC Name:
- (1,4,5,6-tetrahydro-4,6-dioxopyrimidin-2-yl)cyanamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Test material: CYDI ((1,4,5,6-Tetrahydro-4,6-dioxopyrimidin-2-yl)cyanamide)
Description: Off-white powder
Storage: In original container at room temperature
Molecular formula: C5H4N4O2
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Description: off-white powder
- Sponsor's identification: CYDI
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Container: white plastic jar (x2)
- Data relating to the identity, purity and stability of the test material are the responsibility of the sponsor.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.28 - 2.43 kg
- Housing: individual housing in suspended metal cages
- Diet (e.g. ad libitum): Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol; free access was allowed throughout the study
- Water (e.g. ad libitum): Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol; free access was allowed throughout the study
- Acclimation period: five days each animal
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21°C
- Humidity (%): 37-47%
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): continuous 12 hours light and 12 hours of darkness
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- A quantity of 0.5g of the test material, moistened with 0.6 ml of distilled water, was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48 and 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation
SCORING SYSTEM:
- Method of calculation: according to the scale from Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics". See Table 1.
INTERPRETATION OF THE RESULTS:
- 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 6 to give the primary irritation index of the test material. The test material was classified according to the sceme displayed in Table 2 below.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant in absence of reaction
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant in absence of reaction
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant in absence of reaction
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant in absence of reaction
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant in absence of reaction
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1h, 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant in absence of reaction
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No adverse dermal reactions were noted during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material was classified as non-irritant to rabbit skin according to EEC labelling regulations.
- Executive summary:
A study was performed to assess the irritancy potential of the test material (1,4,5,6-Tetrahydro-4,6-dioxopyrimidin-2-yl)cyanamide to the skin of the New Zealand white rabbit. The method used followed that described in the OECD guideline no. 404 and Method B4 in Commission Directive 84/449/EEC. A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced no adverse dermal reactions. The test material produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material was also classified as non-irritant according to EEC labelling regulations.
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