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EC number: 236-039-7 | CAS number: 13114-72-2
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03.02.-20.02.2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-methyl-1,1-diphenylurea
- EC Number:
- 236-039-7
- EC Name:
- 3-methyl-1,1-diphenylurea
- Cas Number:
- 13114-72-2
- Molecular formula:
- C14H14N2O
- IUPAC Name:
- 3-methyl-1,1-diphenylurea
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: 3-Methyl-1,1-diphenylurea- Physical state: white solid powder- Composition of test material, percentage of components: main component: 3-Methyl-1,1-diphenylurea CAS:13114-72-2 >98% (w/w) impurities: unlisted additives: unlisted-Molecular formula: C14H14N2O-Molecular weight: 226,27-Batch No.: 14015- Expiration date of the lot/batch: 11/2019- Stability under test conditions: stable- Storage condition of test material: in closed container, in dry room at room temperature (at laboratory conditions)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: breeding farm VELAZ s.r.o., Únětice, Czech Republic, RČH CZ 21760152- Fasting period before study: no- Housing:animal room with monitoring conditions – 1 animals of one sex in one plastic breeding cage- Diet: complete pelleted standard diet for experimental animals, ad libitum- Water: drinking water, ad libitum- Acclimation period: 7 days- Identification of animals: colour marks 1 - 5 on tail of animals, each cage was marked with the number of study, sex and dose of the test substance- Health condition: certificate of good health condition – from breeding farm; no signs of diseases were observed at clinical check-in, during the acclimatisation period and before the start of study.ENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 3°C, permanently monitored- Humidity (%): 30 – 70 %, permanently monitored- Photoperiod (hrs dark / hrs light): light period 12-hour light/12 hour dark TIME SCHEDULE OF OBSERVATION Body weight:before application (0th), 8th and 15th day of study Mortality:dailyClinical signs:dailyPathological examination:15th day of study
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE- Area of exposure: 6x6 cm on the back of animals- % coverage: 10% of body surface- Type of wrap if used: mull and held by plaster REMOVAL OF TEST SUBSTANCE- Washing: wiped off with water- Time after start of exposure: after 24 hoursTEST MATERIAL- The test substance in delivered form was applied on the depilated area of skin.
- Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 females/2000 mg/kg5 males/2000 mg/kg
- Control animals:
- no
- Details on study design:
- COURSE STUDYThe study was performed as limit test: two groups of animals – 5 males and 5 females at the dose of 2000 mg/kg. The pre-test was performed with 1 male and 1 female of those groups of the five animals. The pre-test was started one day before the start of limit testCLINICAL OBSERVATION-changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system-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.PATHOLOGICAL EXAMINATION-Nutritional state, body surface, body foramina, thoracic, abdominal and cranial cavity-sacrificed on the 15th day
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:
- no death of animals
- Clinical signs:
- No clinical signs of intoxication
- Body weight:
- In males and females, the weight increments were adequate to species and age of animals in the experiment (see table No.1 and No.2).
- Gross pathology:
- No macroscopic changes
Any other information on results incl. tables
Table No. 1: Individual body weight of animals – 2000 mg/kg – males
Animal No. | Before application (0th day) | 8th day | 15th day | Body weight gain (g) | |
day 0-8 | day 8-15 | ||||
1 (pre-test) | 231.80 | 279.90 | 313.8 | 48.10 | 33.90 |
2 | 237.30 | 269.90 | 304.8 | 32.60 | 34.90 |
3 | 254.80 | 293.20 | 338.6 | 38.40 | 45.40 |
4 | 244.90 | 275.60 | 312.5 | 30.70 | 36.90 |
5 | 248.70 | 284.50 | 313.9 | 35.80 | 29.40 |
Average | 243.5 | 280.62 | 316.72 | 37.12 | 36.1 |
Table No. 2: Individual body weight of animals – 2000 mg/kg – females
Animal No. | Before application (0th day) | 8th day | 15th day | Body weight gain (g) | |
day 0-8 | day 8-15 | ||||
1 (pre-test) | 211.50 | 225.50 | 254.2 | 14.00 | 28.70 |
2 | 207.20 | 219.70 | 228.8 | 12.5 | 9.10 |
3 | 207.80 | 210.60 | 228.2 | 2.80 | 17.60 |
4 | 216.90 | 222.10 | 238.6 | 5.20 | 16.50 |
5 | 208.60 | 214.60 | 240.0 | 6.00 | 25.40 |
Average | 210.4 | 218.5 | 237.96 | 8.1 | 19.46 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance toxicity was evaluated on the basis of mortality, body weight changes, and clinical signs of toxicity during the observation period and necropsy findings at the end of study. The test substance applied on skin at a dose of 2000 mg/kg of animal weight did not cause death of animals. No clinical signs of toxicity were observed during the whole study.No macroscopic changes were diagnosed during pathological examination of all animals. According to the results of study, the value of LD50 (dermal) of the test substance, Akardit, for rats of both sexes is higher than 2000 mg/kg of body weight.
- Executive summary:
The test substance,Akardit, was tested for acute dermal toxicity using Wistar rats.
Testing was performed according to Method B.3 - Acute toxicity(Dermal), Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
The study was performed as limit test: two groups of animals – 5 males and 5 females at the dose of 2000 mg/kg of body weight. The pre-test was performed with 1 male and 1 female from each group. After end exposure test substance of these pilot animals, the other animals of the group were dosed.
The test substance in delivered form was applied on the shaved skin of the test animals for 24 hours.
The test animals were observed 14 days after exposure to test substance, afterwards they were sacrificed, and the necropsy for macroscopic examination of the organs was performed.
The test substance applied at the dose of 2000 mg/kg of body weight did not cause death of animals. No clinical signs of toxicity were observed during the whole study. No macroscopic changes were diagnosed during pathological examination.
According to the results of study, the value of LD50(dermal) of the test substance,
Akardit, for rats of both sexes is higher than 2000 mg/kg of body weight.
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