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EC number: 276-380-9 | CAS number: 72140-65-9
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- yes
- Remarks:
- No observation for clinical signs was performed on Day 7 of Group 1 (animals Nos.1-3) of the study. Evaluation: Sufficient data was available for evaluation of the study.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- (2-cyano-1-methylethyl)dodecylethylsulphonium tetrafluoroborate(1-)
- EC Number:
- 276-380-9
- EC Name:
- (2-cyano-1-methylethyl)dodecylethylsulphonium tetrafluoroborate(1-)
- Cas Number:
- 72140-65-9
- Molecular formula:
- C18H36NS.BF4
- IUPAC Name:
- (2-cyano-1-methylethyl)dodecylethylsulphonium tetrafluoroborate(1-)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch No. 605803
- Expiration date of the lot/batch: 23 October 2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: approximately 9-11 weeks old
- Weight at study initiation: 174 g
- Fasting period before study: None
- Housing: Group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet (e.g. ad libitum): Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period:Acclimatization period was at least 5 days before start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C
- Humidity (%): 40 to 70%
- Air changes (per hr): at least 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
IN-LIFE DATES: From: 28 April 2016 To: 07 June 2016
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Dosed at 300 mg/kg and 2000 mg/kg at dose volumes of 4 mL/kg bw
- Amount of vehicle (if gavage): 4 mL/kg bw
- Justification for choice of vehicle: The vehicle was selected based on trial preparations performed at Charles River Den Bosch and on test item data supplied by the Sponsor.
MAXIMUM DOSE VOLUME APPLIED: 4 mL/kg bw
DOSAGE PREPARATION (if unusual): The preparations (w/w) were kept at room temperature and were dosed within 4 hours after adding the vehicle to the test item. Homogeneity was assessed by visual inspection of the solutions and the formulations were stirred during dosing, which ensures homogeneity sufficient for these kinds of studies. Adjustment was made for specific gravity of the vehicle. No correction was made for purity of the test item.
The concentration of the test item in vehicle was varied to allow constant dosage volume in terms of mL/kg body weight.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on a previous study. - Doses:
- 300 mg/kg bw
2000 mg/kg bw - No. of animals per sex per dose:
- 3/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality twice daily. Body weights were recorded on days 1, 8, and 15 or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At 2000 mg/kg, on Day 2 one animal was sacrificed for humane reasons after showing severe clinical signs (e.g. lethargy, tremors and pale- and lean appearance). On Day 4, one animal was found dead. At 300 mg/kg, no mortality occurred.
- Clinical signs:
- other: At 2000 mg/kg, lethargy, tremor, muscle twitching, abnormal posture, ventro-lateral recumbency, hunched posture, uncoordinated movements, loss of righting reflex, increased activity, abnormal gait, hypotonia, deep respiration, piloerection, shaking head,
- Gross pathology:
- At 2000 mg/kg, abnormalities of the spleen (reduced in size) and/or gastro-intestinal tract (GI-tract; distended with gas) were noted for the two animals that died during the study at macroscopic post mortem examination. Additionally, emaciation was noted for the animal sacrificed for humane reasons. At 300 mg/kg, an abnormality of the gastro-intestinal tract (GI-tract; distended with gas) was noted for one animal.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the results of the study, the rat oral LD50 of the test article is between 300 -2000 mg/kg bw.
- Executive summary:
The acute oral lethality of the test article was determined in rats. Female Wistar rats received 300 mg/kg (6 females) or 2000 mg/kg (3 females) test article dissolved in DMSO via oral gavage. Observations for mortality (recorded twice daily), body weights (day 1, 8, 15 or at death), clinical signs (once daily), and macroscopic examination (at necropsy). At 2000 mg/kg all animals exhibited clinical signs of toxicity including lethargy (3/3), spasms (3/3), abnormal and/or hunched posture (3/3), abnormal gait (3/3), uncoordinated movements (2/3), ventro-lateral recumbency (1/3), loss of righting reflex (1/3), increased activity (1/3), hypotonia (1/3), deep breathing (1/3), piloerection (3/3), shaking head (1/3), paleness (1/3), salivation (1/3), dehydration (2/3), and ptosis (3/3). On Day 2 one animal in the 2000 mg/kg group was euthanized for humane reasons after exhibiting symptoms including lethargy, tremors, and pale and lean appearance. Another animal was found dead on Day 4 in this dose group. These two animals had reduced spleen sizes, and gastrointestinal distension upon post mortem examination. At the 300 mg/kg animals exhibited piloerection and hunched posture (6/6), lethargy (3/6), ptosis (3/6), rales (1/6), and slow breathing (1/6) between Days 1 and 8. No mortality was seen at this dose level, however, and only one animal had gastrointestinal distention due to gas noted on necropsy. Based on the results of the study, the rat oral LD50 of the test article is between 300 -2000 mg/kg bw.
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