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EC number: - | CAS number: -
- 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
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- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Specific investigations
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Endpoint summary
Administrative data
Description of key information
In an acute oral toxicity study (OECD TG 423) with N-(4-((4-(3-phenylureido)phenyl)sulfonyl)phenyl)-benzenesulfonamide, no mortality was observed. The LD50 can be considered to be >2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020-05-14 to 2020-09-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Name: N-(4-((4-(3-phenylureido)phenyl)sulfonyl)phenyl)benzenesulfonamide
- Lot/batch no.: 2019001
- Purity: 98.78%
- Appearance/physical state: white crystalline powder
- Expiry Date: 2020-10-28
- Storage: at room temperature, protected from light
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- The test item was suspended with aqua ad injectionem. The decision on the vehicle was made based on the solubility test. The formulation was used within 1 hours after adding the vehicle to the test item and was kept under magnetic stirring during the daily administration. - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 – 9 weeks
- Weight at study initiation: Step 1: 128 – 140 g; Step 2: 156 – 164 g
- Fasting period before study: Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted). Following the period of fasting the animals were weighed and the test item was administered. Food was provided again approximately 4 hours post dosing.
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding.
- Historical data:
- Diet: ad libitum, Altromin 1324 maintenance diet for rats and mice
- Water: ad libitum, tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least five days under laboratory conditions
- Microbiological status: The animals were derived from a controlled full-barrier maintained breeding system (SPF).
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES:
- Step 1: From: 19 May 2020 To: 02 June 2020
- Step 2: From: 26 May 2020 To: 09 June 2020 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 1.3-1.6 mL (corresponding to 10 mL/kg body weight)
- Justification for choice of vehicle: The decision on the vehicle was made based on the solubility test and its non-toxic characteristics
- Lot/batch no. (if required): Deltamedica, lot no. 901110, expiry date: 12/2021
- Purity: ad injectionem
MAXIMUM DOSE VOLUME APPLIED: 1.6 mL
CLASS METHOD
- Rationale for the selection of the starting dose: The starting dose was selected to be 2000 mg/kg body weight. No compound-related mortality was recorded for any animal of step 1 or 2. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 females per step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes. All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. At the end of the observation period the animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally at a dosage of 400 mg/kg bw.
- Clinical signs including body weight: Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Statistics:
- Results were interpreted according to OECD Guideline 423, Annex 2 and GHS.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test item showed no mortality.
- Clinical signs:
- other: The most relevant clinical findings in the animals were reduced spontaneous activity and apathy starting shortly after test item administration. All animals recovered within 4 hours post-dose.
- Body weight:
- other body weight observations
- Remarks:
- no effects on body weight throughout the 14-day observation period.
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study conducted according to OECD TG 423 (acute toxic class method), the test item did not induce mortality at the limit dose of 2000 mg/kg bw. The LD50 is therefore considered to be >2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study (OECD TG 423, acute toxic class method), groups of 3 fasted female Crl:WI (Han) rats (8-9 weeks of age), were given a single dose of 2000 mg/kg bw N-(4-((4-(3-phenylureido)phenyl)sulfonyl)phenyl)-benzenesulfonamide (purity 98.78%) in water via oral gavage. Animals were then observed for 14 days.
There was no mortality observed. Transient slight, unspecific signs of toxicity including reduced spontaneous activity and apathy were observed shortly after test item administration. All animals recovered within 4 hours post-dose.
Based on the results, the oral LD50 is considered to be greater than 2000 mg/kg bw and no clssification for acute oral toxicity is warranted according to CLP Regulation 1272/2008.
Reference
Table 1: Absolute Body Weights in g and Body Weight Change in %
Step | Animal No. / Sex | Starting Dose (mg/kg bw) | BW (g) | Body Weight Change in Comparison to Day 1 (%) | ||
Day 1 | Day 8 | Day 15 | Day 15 | |||
1 | 1 / Female | 2000 | 128 | 160 | 165 | +29 |
1 / Female | 140 | 175 | 185 | +32 | ||
1 / Female | 136 | 166 | 186 | +37 | ||
2 | 2 / Female | 2000 | 156 | 177 | 185 | +19 |
2 / Female | 162 | 189 | 195 | +20 | ||
2 / Female | 164 | 191 | 202 | +23 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- GLP study
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In an acute oral toxicity study (OECD TG 423, acute toxic class method), groups of 3 fasted female Crl:WI (Han) rats (8-9 weeks of age), were given a single dose of 2000 mg/kg bw N-(4-((4-(3-phenylureido)phenyl)sulfonyl)phenyl)-benzenesulfonamide (purity 98.78%) in water via oral gavage. Animals were then observed for 14 days.
There was no mortality observed. Transient slight, unspecific signs of toxicity including reduced spontaneous activity and apathy were observed shortly after test item administration. All animals recovered within 4 hours post-dose.
Based on the results, the oral LD50 is considered to be greater than 2000 mg/kg bw and no clssification for acute oral toxicity is warranted according to CLP Regulation 1272/2008.
Justification for classification or non-classification
Based on the available results, classification for acute oral toxicity according to CLP Regulation 1272/2008 is not warranted.
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