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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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Jun 2012 to 17 Jul 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 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- 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:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
-Females nulliparous and non-pregnant: yes
-Age/weight at dosing: Young adult rats, 9-10 weeks old / 217-229 g
-Housing: Individual caging
-Diet: complete diet for rats ad libitum
-Water: Tap water from municipal supply, provided in 500 mL bottles ad libitum
-Acclimatisation period: At least 5 days
ENVIRONMENTAL CONDITIONS:
-Temperature: 21.9 - 25°C
-Humidity: 38 – 70 %
-Air changes: 15-20 air exchanges/hour
-Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES: from 26 June 2012 to 17 July 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1%
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 10 mL/kg bw - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed individually after dosing at 30 minutes, then 1, 2, 3, 4, and 6 hours after dosing and once each day for 14 days thereafter
- Necropsy of survivors performed: All animals were euthanised at the end of the observation period by exsanguination under pentobarbital anaesthesia. After examination of the external appearance the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. All gross pathological changes were recorded for each animal on the post mortem record sheets. The body weight of animals found dead were recorded at necropsy.
- Clinical signs including body weight: Individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern were assessed.
Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
The body weights were recorded on Days -1, 0 (beginning of the experiment), 7 and 14 - Statistics:
- Mean and Standard deviation was calculated for body weight and body weight gain. The LD50 was calculated using the AOT425StatPgm program.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths occurred during the study
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- There were no treatment related effects on body weight or body weight gain
- Gross pathology:
- No treatment related macroscopic observations were recorded
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item was greater than 5000 mg/kg bw (limit dose) in female CRL:(WI) rats.
- Executive summary:
In an OECD TG 425 acute oral toxicity study,performed under GLP, fasted female CRL:(WI) rats, 9-10 weeks old were given a single oral (gavage) dose of the test item, at dose levels of 5000 mg/kg. Single animals were dosed sequentially at no less than approximately 48 hour intervals. Animals were observed individually for up to 14 days thereafter and necropsies were performed on all surviving animals at the end of the study. No deaths occurred during the study.
Treatment with the test substance at the dose level of 5000 mg/kg bw caused vocalisation in one animal who was symptom free from 48 hours after treatment. The other two animals showed no clinical signs. There were no treatment related body weight changes. Body weights were within the range commonly recorded for this strain and age. No treatment related macroscopic observations were recorded in any animals dosed at 5000 mg/kg bw.
Under the conditions of this study, the acute oral median lethal dose (LD50) of the test item was found to be above 5000 mg/kg bw in male CRL:(WI) rats.
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