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EC number: 424-620-1 | CAS number: 13909-63-2 TUPH
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: data from ELINCS notification dossier approved by MSCA
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 92/69/EEC, B.7
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 1-phenyl-3-(p-toluenesulfonyl)urea
- EC Number:
- 424-620-1
- EC Name:
- 1-phenyl-3-(p-toluenesulfonyl)urea
- Cas Number:
- 13909-63-2
- Molecular formula:
- C14H14N2O3S
- IUPAC Name:
- 3-(4-methylbenzenesulfonyl)-1-phenylurea
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- Method of administration: gavage
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 6 animals at 0 mg/kg bw/day
Male: 6 animals at 3 mg/kg bw/day
Male: 6 animals at 30 mg/kg bw/day
Male: 6 animals at 300 mg/kg bw/day
Female: 6 animals at 0 mg/kg bw/day
Female: 6 animals at 3 mg/kg bw/day
Female: 6 animals at 30 mg/kg bw/day
Female: 6 animals at 300 mg/kg bw/day
Results and discussion
Results of examinations
- Body weight and weight changes:
- effects observed, treatment-related
- Details on results:
- 1) Clinical observations:
Mortality Data:
There were no death during the treatment and recovery periods.
Clinical observations:
Males and females dosed at 300 mg/kg/day showed treatment related effecxts including salivation, cyanosis, coloured urine, and coat staining.
Bodyweight:
A reduction in anticipated bodyweight gain was observed in males and females at 300 mg/kg/day.
Food consumption:
Decreased food consumption was noted in males and females dosed at 300 mg/kg/day.
2) Laboratory findings:
Haematology:
A reduction in mean corpuscular volume and increases in platelet count, reticulocyte count and leukjocyte count were detected in male rats
dosed at 300 mg/kg/day. Increased reticulocyte count was recognised in male and females from the 300 mg/kg/day recovery group,
and reducced haematocrit levels were noted in the males of this recovery group.
Blood chemistry:
Increases in GPT activity, gamma-GPT activity, bilirubin, urea nitrogen, total choloesterol, total protein and calcium, as well as a reduction on
A/G ratio were seen in male and female animals from the 300 mg/kg/day dose group. Increased alkaline phosphatase activity and declined
albumin level were also noted in males and females from the same dose group. n addition, serum colouration was recognised in this dose
group. Males from the 300 mg/kg/day recovery group showed increased bilirubin and urea nitrogen levels.
Urinanalysis:
Acidic urine was seen in males from the 300 mg/kg/day dose group. In urinary sediment, increases in disk or column-shaped yellow crystals
were detected in males and females from the 300 mg/kg/day dose group, In addition, increases in epithelial cells were noted in males from the
same dose group. These changes were not seen in the 300 mg/kg/day dose recovery group.
3) Effect in organs:
Necropsy:
Discolouration, scatteered haemorrhagic dots,brownish coloured areas, induration roughnes of surface and enlargement of the liver,
enlargement and dark reddish colour change of the spleen, atrophy of thymus, thickening of stomach mucosa, edema of glandular stomach
and haemorrhaic dots on the glndular stomach were noted in the 300 mg/kg/day dose at necropsy. In the 300 mg/kg/day dose recovery
group discolouration and roughness of the hepatic surface, and enlargement and dark reddish discolouration of the spleen were noted.
Oragn weights:
Absolute kidney weight decreases were noted in males from the 300 mg/kg/day dose group. Absolute liver weight increased in females dosed
at this level. Decreases in absolute kidney weight but increases in relative spleen weight were seen in males from the 300 mg/kg/day dose
recovery group. Increases in relative liver weights were seen in males and females from the 300 mg/kg/day dose group.
Histopathology:
Histopathological changes considered to be treatment-related noted in the 300 mg/kg/day dose group included multifocal necrosis of the liver,
bile duct hyperplasia, hyperplasia of the collecting duct, inflammatory cell infiltration in papillary interstitium, regenerative change of distal tubular
epithelium, and vacuolation of proximal tubular epithelium of the kidneys, increase of hemetopoietic cells in the spleen, and focal mucosal necrosis and edema of submucosal layer of the glandular stomach. Animals from the 300 mg/kg/day recovery group showed a tendency to recover from
hepatic abnormalities, and recovery in renal abnormalities after the 14-day treatment-free period. An increase in siderophores was seen in the
spleen. However, it is a cured picture seen after erythroclasis and shows a tendency toward healing of cythemolytic reactions themselves.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as Xn - harmful
- Executive summary:
Serious effects on the health of the animal, as defined in Annex VI of Council Directive 67/548/EEC, were observed at the 300 mg/kg/day dose level, so it is considered necessary to classify the substance as "harmful".
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