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EC number: 485-320-2 | CAS number: 221667-31-8
- 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:
- 22 Feb - 15 Mar 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17 Dec 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 485-320-2
- EC Name:
- -
- Cas Number:
- 221667-31-8
- Molecular formula:
- C18H18N205S
- IUPAC Name:
- N-[4-(cyclopropylcarbamoyl)benzenesulfonyl]-2-methoxybenzamide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar HsdCpb:Wu
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan/Winkelmann, Borden, Germany.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Approx. 10 -14 weeks.
- Body weight at study initiation: 161 g - 177 g (167 ± 6.4 g)
- Fasting period before dosing: Approx. 16 - 24 h before administration of the test compound, and approx. 2 - 4 h after administration.
- Diet: Standard diet "Provimi Kliba 3883.0.15 Maus/Ratte Haltung. Nutritive composition and the contaminant content checked and analyzed routinely, ad libitum.
- Water: Tap water was of drinking water quality, ad libitum.
- Acclimitazation period: At least 5 days.
- Housing: Group caged conventionally in polycarbonate cages on low dust wood granulate bedding.
ENVIRONMENTAL CONDITIONS
Temperature: 22 ± 2 °C
Air humidity: 55 ± 5%
Ventilation: Approx. 10 air changes per hour.
Light/ Dark cycle: 12/12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: tap water with the aid of 2% Cremophor EL
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: In accordance with procedure described in the flow charts of Annex 2, OECD guideline 423, three animals are used for each step. The dose level to be used as the starting dose is selected from one of four fixed levels, 5, 50, 300 and 2000 mg/kg body weight, for this study 2000 mg/kg bw. The starting dose level should be that which is most likely to produce mortality in some of the dosed animals. Absence or presence of compound-related mortality of the animals dosed at one step will determine the next step, i.e.:
• no further testing is needed,
• dosing of three additional animals, with the same dose,
• dosing of three additional animals at the next higher or the next lower dose level. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 (3 + 3) female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality rates were determined several times on the day of administration and subsequently at least once daily. Weight gain of the animals was checked weekly.
- Necropsy of survivors performed: Yes, gross examination of organs and tissues at necropsy.
- Clinical signs including body weight: Yes, nature, duration and intensity of clinical signs and body weight measurements.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 cut-off according to OECD 423
- Mortality:
- There were no deaths during the study period
- Clinical signs:
- other: No clinical signs of toxicity were observed during the 14-day observation period
- Gross pathology:
- Necropsies performed at the end of the study revealed no specific or treatment-related findings
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- The study was performed in accordance to OECD TG 423 under GLP conditions and is considered reliable. The LD50 was determined to be ≥ 5000 mg/kg bw (LD50 cut-off of value).
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