Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-645-2 | CAS number: 85-98-3
- 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:
- 18.4. - 25.4.2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 1,3-diethyldiphenylurea
- EC Number:
- 201-645-2
- EC Name:
- 1,3-diethyldiphenylurea
- Cas Number:
- 85-98-3
- Molecular formula:
- C17H20N2O
- IUPAC Name:
- 1,3-diethyl-1,3-diphenylurea
- Details on test material:
- - Name of test material (as cited in study report): Centralit
- Physical state: white solid powder
- Analytical purity: 99.93%
- Impurities (identity and concentrations): sec. and terc. amines 0.06%, volatile substances 0.01%
- Lot/batch No.: 0271199/B
- Storage condition of test material: the substance was stored in dark, at laboratory conditions
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TOP VELAZ s.r.o., Praha, Czech Republic
- Weight at study initiation: 158-183 g
- Fasting period before study: 20 h
- Housing: 5 animals in one plastic breeding cage VELAZ T4
- Diet (e.g. ad libitum): standard feeding mixture ST-1 ad libitum
- Water (e.g. ad libitum): drinking tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity relative (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12-hour light/12 hour dark
STUDY TIME SCHEDULE
Experimental part of study: 18.4.-25.4. 2001
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- PREPARATION OF APPLICATION FORM
The single volume of administered suspension was 1mL/100 g of animal body weight.
VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 500, 700, 1000, 1500 mg/kg bw
- No. of animals per sex per dose:
- 5 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Mortality: daily
- Body weight recording: before application, on the 8th day of the study and at the end of the study
- Clinical examination: the first day: twice (30 minutes and 3 hours after application), the second day: twice (in the morning and in the afternoon) and daily thereafter for 14 days
- Necropsy of survivors performed: yes - Statistics:
- Numeric value of toxicity was defined by Bliss method, using computer program PROBIT (VUOS 1991).
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 780.9 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 685.5 - 889.6
- Mortality:
- Dose 700 mg/kg
2 animals after 2.15 and 5.5 hrs after application
Dose 1000 mg/kg
4 animals 0.45 hrs after application
Dose 1500 mg/kg
all animals died 0.15 - 04 hrs after application - Clinical signs:
- other: Dose 500 mg/kg 30 minutes after application: Piloerection, skin anaemia, discomfort, excitation, tremor, increased reactivity 2nd day: no clinical changes Dose 700 mg/kg 30 minutes after application: Skin anaemia, discomfort, clonus, torpor, increased re
- Gross pathology:
- Dose 500 mg/kg
Without pathological changes
Dose 700 mg/kg
3 survivors - without pathological changes
2 died animal - skin anaemia, mild lung congestion, intestine anaemia, mild liver, congestion, heart-block in systole (probably consequence of abdominal muscules contraction)
Dose 1000 mg/kg
Mild lung congestion, stomach anaemia, flatulence, intestine anaemia, liver congestion
Dose 1500 mg/kg
Mild lung congestion, mild intestine anaemia, liver congestion
Any other information on results incl. tables
-
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance CENTRALIT is according to results of acute oral toxicity classified as harmful.
The test substance caused clinical signs of intoxication – increase neuro-muscles irritability resulted in spasm. Pathological findings were insignificant. - Executive summary:
The aim of the study was to investigate acute toxic effects of the test substance Centralit, after a single oral administration to Wistar rats (females only). Result follows in test protocol No. 0127 (March, the 3rd, 2001), when after performing of limit test, higher sensitivity for females was found out.
The testing was performed according to Regulation of Ministry of health of the Czech Republic No. 251/1998 Sb., the Method B.1: Acute Oral Toxicity (per os). This method corresponds with the guideline OECD No. 401 (1987).
According to the study results, the value of LD50 (oral) for female rats is 780.9 mg/kg of body weight.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.