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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 27 November 1991 to 14 January 1992.
- 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 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 84/449/EEC
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Mansion, Kent, U.K.
- Age at study initiation: approximately five to eight weeks old
- Weight at study initiation: the males weighed 140 - 178g and the females 131 - 170g
- Fasting period before study: overnight fast immediately before dosing and for approximately two hours after dosing
- Housing: groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.; free access throughout the study
- Water (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.; free access throughout the study
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 52-65%
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage):10 ml/kg
- Lot/batch no. (if required): 1s2002
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Range-finding study: 1
Main study: 5 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 30 min, 1h, 2h and 4 h after dosing and subsequently once daily for 14 days
- Frequency of observations and weighing: Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.
- At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- Data evaluations included the relationship, if any, between the animals' exposure to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.
Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made.
The results were interpreted according to the Commission Directive 83/467/EEC which adapts Council Directive 67/548/EEC on the regulations relating to the classification, packaging and labelling of dangerous substances (see Table 1 below). Test materials with acute oral LD 50 values greater than 2000 mg/kg require no symbol and risk phrase.
Results and discussion
- Preliminary study:
- A range-finding study was performed to determine a dosing regime. 1 male and 1 female rat were administered 10 ml/kg substance (dose level: 2000 mg/kg).
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
Deaths and overt signs of toxicity were recorded 30 min, 1h, 2h and 4 h after dosing and then daily for five days.
Individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes. No necropsies were performed.
Based on the results of the preliminary range-finding study, the dose level of 2000 mg/kg bodyweight was selected for the main study.
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
Table 2. Individual bodyweights and weekly bodyweight gain in the main study in the rats
Dose Level mg/kg |
Animal Number & Sex |
Bodyweight (g) at Day 0 7 14 |
Bodyweight Gain (g) During week 1 2 |
|||
2000 |
505 Male |
178 |
265 |
327 |
87 |
62 |
506 Male |
161 |
221 |
297 |
60 |
76 |
|
507 Male |
166 |
249 |
310 |
83 |
61 |
|
508 Male |
140 |
209 |
262 |
69 |
53 |
|
509 Male |
155 |
233 |
285 |
78 |
52 |
|
510 Female |
170 |
225 |
260 |
55 |
35 |
|
511 Female |
131 |
186 |
202 |
55 |
16 |
|
512 Female |
141 |
215 |
245 |
74 |
30 |
|
513 Female |
132 |
172 |
190 |
40 |
18 |
|
514 Female |
140 |
172 |
196 |
32 |
24 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of (1,4,5,6-Tetrahydro-4,6-dioxopyrimidin-2-yl)cyanamide in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
A study was performed to assess the acute oral toxicity of the (1,4,5,6-Tetrahydro-4,6-dioxopyrimidin-2-yl)cyanamide in the Sprague-Dawley strain rat according to guideline OECD 401 of 1981 and Method B1 of Commission Directive 84/449/EEC. Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a suspension in distilled water B.P. at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination. There were no deaths, no signs of systemic toxicity nor abnormalities noted at necropsy. The acute oral median lethal dose (LD50) of (1,4,5,6-Tetrahydro-4,6-dioxopyrimidin-2-yl)cyanamide in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.
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