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EC number: 700-910-4 | CAS number: 1354201-99-2
- 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:
- 30 June - 16 August 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Also in accordance with GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- O,O-bis(2-methylpropyl) sulfanidylphosphonothioate; trimethylazanium
- EC Number:
- 700-910-4
- Cas Number:
- 1354201-99-2
- Molecular formula:
- C11H28NO2PS2
- IUPAC Name:
- O,O-bis(2-methylpropyl) sulfanidylphosphonothioate; trimethylazanium
- Test material form:
- solid
- Remarks:
- pale yellow glassy solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): S-10713
- Physical state: solid
- Colour: brown
- Storage condition of test material: at room temperature in the dark
- Lot/batch No.: S20227-179
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 161-175 g
- Fasting period before study: yes
- Housing: groups of up to four in solid-floor polypropylene cages furnished with woodflakes
- Diet: free access to 2014C Teklad Global Rodent diet (Harlan Laboratories UK Ltd., Oxon, UK)
- Water: free access to mains drinking water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 30 June - 16 August 2011
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml (at 2000 mg/kg bw) and 30 mg/ml (at 300 mg/kg bw)
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
DOSAGE PREPARATION: the substance was prepared as a suspension in distilled water within 2 hours of administration
- Rationale for the selection of the starting dose: based on available information of toxicity of the test substance - Doses:
- 2000 and 300 mg/kg bw (stepwise procedure)
- No. of animals per sex per dose:
- 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations: 0.5, 1, 2 and 4 hours after dosing and daily thereafter
Morbidity and mortality: twice daily
Body weight: day of dosing and on day 7 and 14
- Necropsy of all animals performed: yes - Statistics:
- Not applicable
Results and discussion
- Preliminary study:
- One female per dose was treated. No mortality or evident toxicity was observed.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two animals were found dead four hours after dosing at 2000 mg/kg bw. No deaths occurred at 300 mg/kg bw.
- Clinical signs:
- other: At 2000 mg/kg bw hunched posture, lethargy, ataxia, pilo-erection, ptosis, tiptoe gait, prostration and increased respiratory rate of noisy respiration were observed. Surviving animals appeared normal throughout the study or one day after dosing. At 300 m
- Gross pathology:
- 2000 mg/kg bw: patchy pallor of the liver was noted at necropsy of animals that died during the study; no abnormalities in surviving animals
300 m/kg bw: no abnormalities observed
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of the test substance in female Wistar rats was found to be between 300 and 2000 mg/kg bw. According to EC Regulation 1272/2008 the substance requires classification in category 4.
- Executive summary:
An acute oral toxicity study in rats was performed according to OECD 420 and EC 440/2008, B1bis, following GLP principles. Clinical observations at 2000 mg/kg bw included hunched posture, lethargy, ataxia, pilo-erection, ptosis, tiptoe gait, prostration and increased respiratory rate of noisy respiration. Patchy pallor of the liver was noted in the animals that died. The LD50 of the test substance in female Wistar rats was found to be between 300 and 2000 mg/kg bw.
According to EC Regulation 1272/2008 the substance requires classification in category 4.
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