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EC number: 682-131-9 | CAS number: 1190427-50-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-06-30 to 2016-09-26
- 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:
- adopted 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- [1,3-bis(2,4,6-trimethylphenyl)-4,5-dimethylimidazol-2-ylidene](2-thienylmethylidene)(tricyclohexylphosphine)ruthenium(II)dichloride
- Cas Number:
- 1190427-50-9
- Molecular formula:
- C46H65Cl2N2PRuS
- IUPAC Name:
- [1,3-bis(2,4,6-trimethylphenyl)-4,5-dimethylimidazol-2-ylidene](2-thienylmethylidene)(tricyclohexylphosphine)ruthenium(II)dichloride
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- WISTAR rats Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: animals no. 1 – 3: 11 - 12 weeks old; animals no. 4 – 6: 8 - 9 weeks old
- Weight at study initiation: animals no. 1 – 3: 171 – 187 g; animals no. 4 – 6: 152 – 161 g
- Fasting period before study: 16 to 19 hours
- Housing: group housing in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): ad libitum, Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): ad libitum, tap water, sulphur acidified to a pH value of approximately 2.8
- Acclimation period: Step 1, animals no. 1 - 3: 07 June - 05 July 2016; Step 2, animals no. 4 - 6: 05 - 12 July 2016
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 10 ml/kg.
- Justification for choice of vehicle: preparation with corn oil yielded a well applicable suspension, corn oil has non-toxic characteristics, test substance is insoluble in water
- Lot/batch no. (if required): Sigma-Aldrich, lot no. MKBV2080V
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight.
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: toxicity was not expected - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 per step, 2 steps performed
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animal were examined once daily, on the day of dosing, examination was carried out several times (at least once during the first 30 minutes and special attention was given during the first 4 hours post-dose), animals were weighed on day 1 (prior to the administration), day 8 and day15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- not observed
- Clinical signs:
- other: no specific findings during the whole observation period
- Gross pathology:
- no specific gross pathological changes were recorded for any animal
Any other information on results incl. tables
Please see attached file for results.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- - A single oral application of the test item to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality
- The median lethal dose of the test item after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): 5000 mg/kg bw
- According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for toxicity and is not classified.
- According to GHS (Globally Harmonized Classification System), the test item has no obligatory labelling requirement for toxicity and is not classified. - Executive summary:
A valid test for acute oral toxicity according to OECD Guideline and under GLP was carried out with the test substance and did not identify any signs of toxicity.
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