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EC number: 240-722-5 | CAS number: 16673-34-0
- 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:
- 2011
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-[2-[4-(aminosulphonyl)phenyl]ethyl]-5-chloro-2-methoxybenzamide
- EC Number:
- 240-722-5
- EC Name:
- N-[2-[4-(aminosulphonyl)phenyl]ethyl]-5-chloro-2-methoxybenzamide
- Cas Number:
- 16673-34-0
- Molecular formula:
- C16H17ClN2O4S
- IUPAC Name:
- 5-chloro-2-methoxy-N-[2-(4-sulfamoylphenyl)ethyl]benzamide
- Details on test material:
- Batch No.: 2010/8102 F
Chemical Name: 4-[2-(5-chloro-2-methoxybenzamido)-ethyl] benzenesulfonamide
Colour: Almost white or pale yellow
Physical State: Powder
Purity: 99.5%
Expiry Date: October 2014
Storage Conditions: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species/strain: healthy rats, WISTAR rats Crl: WI(Han) (full barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: male and female The female animals were non-pregnant and nulliparous.
Number of animals: 5 male and 5 female
Age at the beginning of the study: males: 8 - 9 weeks old females: 8 - 9 weeks old
Body weight on the day of administration: males: 236 – 249 g; females: 224 – 232 g.
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare [9] the animals were bred for experimental purposes.
Housing and Feeding Conditions:
- Full barrier in an air-conditioned room
- Temperature: 22 3 °C
- Relative humidity: 55 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1307)
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 08/11/10)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days, for details see Schedule)
The animals were marked for individual identification by tail painting.
Approximately 25 hours before the test, the fur was removed from the dorsal area of the trunk by using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used.
No less than 10% of the body surface was cleared for the application. Prior to the application a detailed clinical observation was made of all animals.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- cotton seed oil
- Details on dermal exposure:
- Application
The test item was applied at a single dose, uniformly over an area which was approximately 10% of the total body surface. - Duration of exposure:
- The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
All animals were observed for 14 days after dosing. - Doses:
- The test item was applied at a single dose of 2000 mg/kg body weight to each animal.
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: No treatment-related effects were observed.
Any other information on results incl. tables
Signs of toxicity related to dose level used, time of onset and duration: No treatment-related effects were observed.
Effect on organs (related to dose level): No treatment-related effects were observed.
Signs of irritation: No erythema or oedema was observed. Desquamation was observed in 1 of 5 male animals on a single day (day 3 post administration).
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Single dermal application of the test item Benzenesulfonamide to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity and nor of irritation.
The dermal LD50 was determined to be > 2000 mg Benzenesulfonamide / kg body weight.
In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC [6] and according to Annex I of Regulation (EC) 1272/2008 [7] the test item Benzenesulfonamide has no obligatory labelling requirement for percutaneous toxicity.
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