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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
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EC number: 690-928-8 | CAS number: 39992-90-0
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-04-09 to 2001-04-25
- 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:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]
- EC Number:
- 241-523-6
- EC Name:
- N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]
- Cas Number:
- 17526-94-2
- Molecular formula:
- C13H20N4O2
- IUPAC Name:
- 3-[3-(dimethylcarbamoylamino)-4-methylphenyl]-1,1-dimethylurea
- Reference substance name:
- 3-[3-(dimethylcarbamoylamino)-2-methylphenyl]-1,1-dimethylurea
- Cas Number:
- 17607-23-7
- Molecular formula:
- C13H20N4O2
- IUPAC Name:
- 3-[3-(dimethylcarbamoylamino)-2-methylphenyl]-1,1-dimethylurea
- Reference substance name:
- unknown
- IUPAC Name:
- unknown
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- solid
Constituent 1
impurity 1
impurity 2
impurity 3
- Specific details on test material used for the study:
- - Substance type: organic
- Physical state: colourless solid
- Analytical purity: 100%
- Purity test date: 01 March 2000
- Lot/batch No.: 0232 07
- Expiration date of the lot/batch: March 2003
- Storage condition of test material: store dry in closed containers
- Other: stable at dry storage conditions for at least 2 years
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: no data
- Weight at study initiation: Body weight at the commencement of the study: male 150- 168 g and female 142- 160 g. 3 male and 3 female animals were used.
- Fasting period before study: Prior to administration of the test item animals were fasted by withholding food overnight. Following the period of fasting the animals were weighed and the test item was administered. Then the food was withheld for a further 3-4hours.
- Housing: The animals were barrier maintained (semi-barrier) in air conditioned rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 55+/-10%
- Air changes (per hr): 10x per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1%
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg TDI-Urone in 1 % Carboxymethylcellulose (CMC, Sigma, Lot-No. 36H0738) ad 10 ml
- Amount of vehicle (if gavage): 10 ml/kg body weight
- Justification for choice of vehicle:The vehicle was chosen due to its non-toxic characteristics.
- Lot/batch no. (if required): 36H0738
- Purity: no data - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for 14 days after dosing. The animals were weighed prior to first application and once a week thereafter. A careful clinical examination was made twice a day on the day of dosing and once a day thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- none
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- As none of the animals died the LD0 is >2000 mg/kg body weight.
- Clinical signs:
- other: No clinical signs of toxicity were observed throughout the observation period.
- Gross pathology:
- Necropsy revealed an acute injection of blood vessels in all animals in fue abdominal region. This finding is due to euthanasia with an overdose of pentobarbital injected intraperitoneally.
- Other findings:
- no other findings
Any other information on results incl. tables
Table1: Bodyweight gain
Animal No. |
Day 0 |
Day 7 |
Day 14 |
|
male |
1 |
150 |
188 |
229 |
2 |
168 |
215 |
256 |
|
3 |
160 |
210 |
240 |
|
female |
1 |
142 |
158 |
170 |
2 |
146 |
159 |
180 |
|
3 |
160 |
169 |
184 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of TDI-Urone was established to be > 2000 mg/kg body weight. As none of the animals died the corresponding LD0 is > 2000 mg/kg bw. Thus, TDI-Urone is practically nontoxic.
- Executive summary:
In an acute oral toxicity study according to OECD 423, groups of 3 male and 3 female rats (Wistar) were given a single oral dose of 2000 mg/kg body weight TDI-Urone in 1% Carboxymethylcellulose and were observed for 14 days.
Considering the reported data of this toxicity test it can be stated that the test item TDI-Urone has no acute toxic characteristics.
According to the results obtained the LD50 was determined to be > 2000 mg/kg bw.
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.
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