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EC number: 617-298-9 | CAS number: 82097-50-5
- 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:
- 28 June 2012 to 12 July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-(2-chloroethoxy)-N-[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)carbamoyl]benzene-1-sulfonamide
- EC Number:
- 617-298-9
- Cas Number:
- 82097-50-5
- Molecular formula:
- C14H16ClN5O5S
- IUPAC Name:
- 2-(2-chloroethoxy)-N-[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)carbamoyl]benzene-1-sulfonamide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- CRL:(WI)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult rats
- Weight at study initiation: Between 236 g and 273 g
- Housing: Individual caging
- Diet: Autoclavable complete diet for rats and mice – breeding and maintenance. Ad libitum
- Water: Tap water. Ad libitum
- Acclimatisation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21.2 – 27.5°C
- Humidity: 44 – 70 %
- Air changes: 15-20 air exchanges per hour
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES: from 28 June to 12 July 2012
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- tap water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back
- Pre-treatment: Approximately 24 hours before treatment an area on the back of the rat was shaven
- % coverage: Approximately 10 % area of the total body surface
- Type of wrap if used: Sterile gauze pads, a patch with adhesive hypoallergenic plaster and semi occlusive plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period, residual test item was removed, using body temperature water
- Time after start of exposure: 24 hours
VEHICLE
- Amount applied : 1 mL - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A clinical examination was performed on the day of treatment, at 1 and 5 hours after the application of the test item, and once each day for 14 days thereafter. The body weight of all animals was recorded on Day 0 (beginning of the experiment) and on Days 7 and 14.
- Necropsy of survivors performed: All animals were subjected to gross macroscopic examination. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed
- Clinical signs including body weight: Observations included the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, and somatomotor activity and behaviour pattern. Particular attention was directed to the observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma - Statistics:
- Means and their standard deviations were calculated for body weight and body weight gain
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality occurred after the 24-hour dermal exposure to the test item in CRL:(WI) Wistar rats
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- There were no effects on body weight and body weight gain during the observation period
- Gross pathology:
- There was no evidence of any test item related observations at a dose level of 2000 mg/kg bw at necropsy. Pelvic dilatation of the right kidney was incidentally seen in 1/10 animal
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of the test item after single dermal administration was found to be greater than 2000 mg/kg bw in male and female CRL:(WI) Wistar rats
- Executive summary:
In an OECD TG 402 acute toxicity study performed under GLP, single administration of the test item at a dose of 2000 mg/kg body weight was applied dermally to 5 male and 5 female CRL:(WI) rats, followed by a 14-day observation period. The test item was applied as supplied. The application period was 24 hours. Clinical observations were assessed in all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. All animals were euthanized and subjected to a gross macroscopic examination at the end of the 14-day observation period (Day 14).
On test day 0, the test item was applied at a single dose of 2000 mg/kg body weight applied uniformly over the skin and remained on the skin throughout a 24- hour exposure period.
No mortality occurred during the study. No adverse clinical signs were observed after treatment with the test item or during the 14 day observation period and no treatment related skin irritation was observed in any animal throughout the study. Pelvic dilatation of the right kidney was incidentally seen in 1/10 animal.
The median lethal dose of the test item after a single dermal administration was found to be greater than 2000 mg/kg bw in male and female CRL:(WI) Wistar rats.
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