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EC number: 485-320-2 | 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
- 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 Feb - 17 Feb 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): N-[[4-[(cyclopropylamino)carbonyl]phenyl]sulfonyl]-2-methoxybenzamide
- Analytical purity: 97.4%
- Lot/batch No.: 08466/0013
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, Borchen, Germany
- Age at study initiation: approx. 9 -13 weeks
- Body Weight at study initiation: 245 - 281 g for males and 205 - 223 g for females
- Fasting period before study: ad libitum
- Housing: Caged individually in polycarbonate cages on low dust wood granulate bedding.
- Diet (e.g. ad libitum): standard diet for rats and mice "Provimi Kliba 3883.0.15 Maus/Ratte Haltung, Kaiseraugst Switzerland", ad libitum
- Water (e.g. ad libitum): ad libitum tap water from polycarbonate bottles, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 5
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 2005-02-03 to 2005-02-17
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: approx. 10% (6.0 cm x 5.0 cm = 30.0 cm²)
- Type of wrap if used: Test material was placed on a wet gauze-layer of a ,,Cutiplast® steril" coated with air-tight ,,Leukoflex®"; gauze strip which was placed on the rat's back and secured in place using ,,Peha®-Haft" cohesive stretch tape (8 cm x 23 cm) and additionally covered with a "Lomir biomedical Inc rat jacket" and connnected with a safety pin to the stretch tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsed with tepid water using soap and gently patting the area dry
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw; 21.8 - 25 mg/cm² for males and 18.2 - 19.8 mg/cm² for females
- Constant volume or concentration used: yes
- For solids, paste formed: no, test substance was applied via a wet gauze layer. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Clinical signs and mortality rates were determined several times on the day of application and subsequently at least once daily for an observation period of at least 14 days.
- Mortality and in the event of symptoms occurring, nature, duration and intensity were recorded individually.
- Body weight and bodyweight gain were checked weekly until the end of the study.
Terminal procedures: Animals which died or were killed in moribund state were weighed (except on day of application) and dissected as soon as possible, and examined macroscopically. The surviving animals were sacrificed by carbon dioxide asphyxiation at the end of the study, dissected and
examined macroscopically. - Statistics:
- Means and standard deviations were calculated for bodyweights
The LD50 value was calculated with the aid of a software program according to Spearman, Karber (D. J. Finney; Statistical method in biological assay, 2nd Edition, Griffin, London, 524-530; 1971). The algorithm was taken from L. Sachs (Angewandte Statistik, 6th Edition 1984, pp. 178 ff.).
Where calculation of the LD50 using the software program was not possible or meaningful, an assessment was made based on the applied dose
and dose-response curve, respectively.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study
- Clinical signs:
- Clinical signs of toxicity were not observed during the 14-day observation period
- Body weight:
- There were no toxicological effects on body weight or body weight development in males and females.
- Gross pathology:
- The necropsies performed at the end of the study revealed no specific findings
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
-
CLP: Not classified
DSD: not classified
CLP: not classified
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