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EC number: 225-795-3 | CAS number: 5081-87-8
- 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:
- 2006-03-28 to 2006-04-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, GLP-compliant study performed according to OECD Guideline 423 and EU Method B.1 tris. No deviations were recorded.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-(2-chloroethyl)(1H,3H)quinazoline-2,4-dione
- EC Number:
- 225-795-3
- EC Name:
- 3-(2-chloroethyl)(1H,3H)quinazoline-2,4-dione
- Cas Number:
- 5081-87-8
- Molecular formula:
- C10H9ClN2O2
- IUPAC Name:
- 3-(2-CHLOROETHYL)QUINAZOLINE-2,4(1H,3H)-DIONE
- Details on test material:
- - Name of test material (as cited in study report): T1201 (3-(2-chloroethyl)-2,4(1H, 3H)-quinazolinedione; CAS no. 5081-87-8)
- Substance type: no data
- Physical state: white solid
- Analytical purity: 100%
- Impurities (identity and concentrations): not applicable
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: 00464885 RT001201G1A251
- Expiration date of the lot/batch: unknown; is excluded from the statement of compliance
- Stability under test conditions: unknown in PEG 300
- Storage condition of test material: at room temperature (20 +/- 5 °C), light protected
- Stability of test item: stable under storage conditions
- Other: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HanRCC:WIST (SPF) from RCC Ltd., Laboratory Animal Services CH-4414 Fullinsdorf / Switzerland
- Age when treated: 12 weeks
- Weight at study initiation: ranged between 186 to 196 grams
- Fasting period before study: 18 hours (access to water was permitted. Food was provided again approx 3 hours after dosing.
- Housing: standard laboratory conditions, in groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland)
- Diet (e.g. ad libitum): ad libitum, pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 001/06 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland)
- Water (e.g. ad libitum): ad libitum, community tap water from Fullinsdorf
- Acclimation period: 5 days, under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 22 +/- 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 2006-04-04 To: 2006-04-18 (1st 2000 mg/kg treatment)
From: 2006-04-06 To: 2006-04-20 (2nd 2000 mg/kg treatment)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Justification for choice of vehicle: PEG 300 was found to be a suitable vehicle. The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. This formulation trial is excluded from the GLP statement of compliance.
- Lot/batch no. (if required): 120471944705164
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: 10mL/kg
DOSAGE PREPARATION (if unusual): Dose levels are in terms of the test item as supplied by the sponsor. The dose formulations were made shortly before each dosing occasion using a magnetic stirrer and a spatula as homogenizers. The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data - Doses:
- - one dose: 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females per group; 2 groups
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
Observation: during the acclimatization period, and the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1
(with the clinical signs) and twice daily during days 2-15
Weighing: on days 1 (prior to test), 8, and 15
- Necropsy of survivors performed: yes. All animals were killed at the end of the observation period by carbon dioxide asphyxiation and discarded after macroscopic examinations were perforemd. No organs or tissues were retained.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: no data - Statistics:
- No statistical analysis was used
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: result of two tests
- Mortality:
- No deaths occurred during the study
- Clinical signs:
- Slightly ruffled fur was noted in three animals at the 2- and 3-hour reading and persisted in one animal until the 5-hour reading.
- Body weight:
- The body weights of the animals were within the range commonly recorded for this strain and age.
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
- Other findings:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of T1201 after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat) greater than 2000 mg/kg body weight. Therefore, the substance is considered not to be classified.
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