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EC number: 678-448-7 | CAS number: 3084-53-5
- 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:
- From 06 to 23 July 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- trimethylsulfanium bromide
- EC Number:
- 678-448-7
- Cas Number:
- 3084-53-5
- Molecular formula:
- C3H9BrS
- IUPAC Name:
- trimethylsulfanium bromide
Constituent 1
- Specific details on test material used for the study:
- Batch No.: 20SP9-1
Purity: 98.6%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable)
- Source: SPF(Beijing) Biotechnology Co., Ltd.
- Females (if applicable) nulliparous and non-pregnant: yes
- Rationale for use of males (if applicable)
- Age at study initiation: 49-56 days on arrival, 57-67 days at the commencement of each animal’s dosing
- Weight at study initiation: 202~215 g at arrival, 182~246 g at the commencement of each animal’s dosing
- Fasting period before study: Food was removed overnight prior to dosing and returned approximately three to four hours after dosing.
- Housing: Animals were housed in Room D125 of the facility’s barrier system. Animals were raised in suspended, stainless steel cages (L32.0cm ×W28.0cm×H20.0cm) on cage racks (L167.0cm×W70.0cm×H171.0cm). There were 10 cages per layer, and 4 layers per rack. Animals were housed individually during the test.
- Historical data:
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days prior to the test
- Microbiological status when known
- Method of randomisation in assigning animals to test and control groups
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.0-25.3oC (target value 22±25oC)
- Humidity (%): 53%-73% (target value 40%-70%)
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Details on oral exposure:
- Dosing: The prepared formulations were administrated to animals’ stomachs using standard gavage tubes attached to disposal syringes.
Dosing Frequency: Each animal was dosed once.
Dosing Volume: The dosing volume was calculated according to the fasted body weight weighed before dosing.
Dosing Time: In the morning - Doses:
- The first step dosing was 300 mg/kg b.w. and 3 animals died, so 50 mg/kg b.w. was selected as the second step dosing and no animals died. Thus, 50 mg/kg b.w. was selected as the third step dosing and no animals died, the study procedure completed.
- No. of animals per sex per dose:
- 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Inspections were made twice daily, in the morning and afternoon, during normal working days (except that it was made once at necropsy days), and once daily at weekends and public holidays.
Clinical observations were performed at least once during the first 30 minutes, and at about 1, 2 and 4 hours after applications, and then once each day for 14 days.
General observations were made once daily for the animals have not been administrated with the test item.
Careful observations and records of animal fur changes, eyes and mucosa, respiratory, circulatory, autonomic and central nervous system, particularly limb activity and behavior changes were made. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhea, lethargy, sleep and coma.
Individual weights of animals were determined within 24 hours after arrival, at grouping, on Day -1, Day 0 (day of dosing), Day 7 and Day 14. At the end of the test surviving animals were weighed.
- Necropsy of survivors performed:
Animals surviving to the end of the study were anesthetized by CO2 and bled by abdominal aorta to death. Gross necropsies were performed on all animals under test. The necropsy included carefully eye examinations of the abdominal, thoracic organs and their contents of all animals.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dose Level-The first dosing (300 mg/kg b.w.): All animals died during the test and the mortality was 3/3.
Dose Level-The second dosing (50 mg/kg b.w.): There were no deaths or moribund status of any of the animals during the test and the mortality was 0/3.
Dose Level-The third dosing (50 mg/kg b.w.): There were no deaths or moribund status of any of the animals during the test and the mortality was 0/3. - Clinical signs:
- other: All animals showed abnormal symptoms of low spontaneous movement at 1 hour after administration and died at 2 hours after administration.
- Body weight:
- other body weight observations
- Remarks:
- All survived animals showed expected gains in body weights during the test.
- Gross pathology:
- No abnormalities were found in all animals at necropsies.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The acute LD50 was estimated to be between 50 to 300 mg/kg b.w.. and Cut-off value of LD50 was estimated to be 200 mg/kg b.w.
- Executive summary:
The study was performed to assess the acute oral toxicity with Trimethylsulfonium bromide in Sprague Dawley rats. The method was designed to meet the OECD Guideline for Testing of Chemicals: Acute Oral Toxicity-Acute Toxic Class Method (TG 423, adopted 2001).
Based on the results, the acute oral LD50 in rats for Trimethylsulfonium bromide was estimated to be between 50 and 300mg/kg b.w., and the cut-off value of LD50 was estimated to be 200 mg/kg b.w.. According to the GHS’s classification criteria for acute oral toxicity, the test item was classified as “Category 3”.
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