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EC number: 604-667-4 | CAS number: 14898-67-0
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 July 2016-28 February 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 03 October 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Ruthenium (III) chloride hydrate
- IUPAC Name:
- Ruthenium (III) chloride hydrate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- Wistar rat as a rodent is one of the standard strains for repeat-dose toxicity studies.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633, Sulzfeld, Germany.
- Females (if applicable) nulliparous and non-pregnant: Yes.
- Age at study initiation: Approximately 8 weeks old at onset of treatment.
- Weight at study initiation: Males: 283-347 g. Females: 191-249 g. Weight did not exceed +/- 20% of mean weight at onset of treatment.
- Fasting period before study: Not specified.
- Housing: Type II polycarbonate/ wire grid bottomed cages. Animals were housed two or three per cage.
- Diet (e.g. ad libitum): ssniff® SM R/M-Z+H “Complete Diet for Rats and Mice- Breeding and Maintenance” (ssniff Spezialdiäten GmbH, D-59494 Soest Germany), with or without Ruthenium chloride (treated or control groups, respectively) provided ad libitum.
- Water (e.g. ad libitum): Tap water provided ad libitum.
- Acclimation period: 15 days.
DETAILS OF FOOD AND WATER QUALITY: Tap water as for human consumption, assessed once every three months, with monthly microbiological assessment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.3 - 27.4 °C
- Humidity (%): 33 - 78%
- Air changes (per hr): 15-20.
- Photoperiod (hrs dark / hrs light): 12 hours artificial light (6am - 6pm). 12 hours dark.
IN-LIFE DATES: From: 30 June 2016 (animal arrival) To: 25 August 2016 (last necropsy).
Administration / exposure
- Route of administration:
- oral: feed
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): A single diet mix batch was prepared before the study.
- Mixing appropriate amounts with (Type of food): About 6 minutes for pre-mixing and 4-8 minutes for diet mixing.
- Storage temperature of food: approximately 15-21 °C (storage areas); 22 +/- 3 °C (animal rooms). - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analysis of the diets for homogeneity and concentration of Ruthenium chloride were performed at the Test Site using a validated ICP/AES method to determine the Ruthenium content.
- Duration of treatment / exposure:
- 28 days.
- Frequency of treatment:
- Constant (dietary).
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Remarks:
- Control, received diet prepared in a similar manner to treatment groups, without inclusion of test material.
- Dose / conc.:
- 500 ppm
- Remarks:
- "Low dose" group. Approximately 40.6 mg/kg bw/day.
- Dose / conc.:
- 1 500 ppm
- Remarks:
- "Mid dose" group. Approximately 124 mg/kg bw/day.
- Dose / conc.:
- 5 000 ppm
- Remarks:
- "Mid high dose" group. Approximately 407 mg/kg bw/day.
- Dose / conc.:
- 15 000 ppm
- Remarks:
- "High dose" group. Approximately 1238 mg/kg bw/day.
- No. of animals per sex per dose:
- 5/sex/group (low and mid doses); 10/sex/group (control, mid high and high doses).
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: The concentrations of Ruthenium chloride in diet were selected based on the available data and information from a preliminary dose range finding study [CiToxLAB study code 15/266-100PE].
- Rationale for animal assignment (if not random): Randomisation based on body weights.
- Post-exposure recovery period in satellite groups: 5/sex/group, 28-day daily treatment with control, mid high or high dose. 14-day recovery period.
- Section schedule rationale (if not random): Not specified. - Positive control:
- None.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes.
- Time schedule: At least once a day, at approximately the same time. Animals were inspected for signs of morbidity and mortality twice daily (at the beginning and end of each day).
- Cage side observations: Not specified.
DETAILED CLINICAL OBSERVATIONS: Yes.
- The animals were monitored for any clinical signs, including pertinent behavioural changes, signs of toxicity including mortality, changes in skin, fur, eyes, mucous membranes, occurrence of secretions and excretions, and autonomic activity (e.g. lachrymation, piloerection, pupil size, unusual respiratory pattern), changes in gait, posture and response to handling as well as the presence of clonic or tonic movements, stereotypies (e.g. excessive grooming, repetitive circling), bizarre behaviour (e.g. selfmutilation, walking backwards), observation of tremors, convulsions, salivation,
diarrhoea, lethargy, sleep or coma.
BODY WEIGHT: Yes.
- Time schedule for examinations: 7 days prior to treatment start (Day -7), then daily until the first day of treatment (Day 0). Twice weekly thereafter, including before necropsy.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food//day: Yes (by measuring non-consumed diet on a regular basis throughout the study).
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes.
FOOD EFFICIENCY:
- Mean food utilisation (food conversion efficiency) was calculated: weekly body weight gain (g)/weekly food consumption (g).
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified.
OPHTHALMOSCOPIC EXAMINATION: No.
HAEMATOLOGY: Yes.
- Time schedule for collection of blood: Post-fasting and immediately prior to the scheduled necropsy (Day 28).
- Anaesthetic used for blood collection: Yes (pentobarbital).
- Animals fasted: Yes.
- How many animals: All animals.
- Parameters checked in table 1 were examined.
CLINICAL CHEMISTRY: Yes.
- Time schedule for collection of blood: Post-fasting and immediately prior to the scheduled necropsy (Day 28).
- Animals fasted: Yes.
- How many animals: All animals.
- Parameters checked in table 2 were examined.
URINALYSIS: No.
NEUROBEHAVIOURAL EXAMINATION: Yes.
- Time schedule for examinations: Day 21/22 of test.
- Dose groups that were examined: All animals.
- Battery of functions tested: sensory activity / grip strength.
IMMUNOLOGY: No. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (all tissues and organs).
HISTOPATHOLOGY: Yes (see table 3). Tissues and organs in Table 3 were retained from all animals. Full histopathology was performed for control and high dose animals, as well as any organs or tissues from other animals with macroscopic abnormalities. - Statistics:
- The mean and standard deviations values, for the frequency of treatment-related clinical observations and macroscopic findings were calculated.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Dark faeces was observed in the mid high (5000 ppm) and high dose (15,000 ppm) animals from Day 11 to Day 30. This was considered to be a non-adverse observation. No signs of toxicity were observed.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At completion of the feeding period (Day 27), the mean body weight gain of high dose (15,000 ppm) males was about 23% lower than controls. After a 14-day recovery period, these changes were completely recovered. No dose-related or statistically significant changes in body weight gain were observed in the other treated males, or any treated females. The mean body weight and body weight gain of females was more variable than for the males, but there was no clear evidence of a treatment-related effect.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- Statistically significantly lower (about 24%) food utilisation was observed in high dose (15,000 ppm) males dues to reduced body weight gain. No effects in other treated males or any treated females.
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not specified
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 5 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In an OECD 407-compliant 28-day repeated-dose oral toxicity study, rats were fed diets containing 0, 500, 1500, 5000 or 15,000 ppm ruthenium trichloride hydrate (providing up to approximately 1238 mg/kg bw/day). Males in the highest dose group had reduced body weight gain and reduced food conversion efficiency compared to controls. There were no other adverse effects in these animals, and no effects on clinical signs, pathology, organ weights or histopathology in any treated animals. Consequently, the NOAEL is 5000 ppm (providing approximately 407 mg/kg bw/day).
- Executive summary:
In an OECD 407 repeated-dose oral toxicity study, conducted according to GLP, groups of Wistar rats were fed diets containing ruthenium trichloride hydrate for 28 days. Diets were formulated to provide 0, 500, 1500, 5000 or 15,000 ppm of the test material (equivalent to approximately 0, 40.6, 124, 407 or 1238 mg/kg bw/day). Male rats recieving the highest dietary concentration (15,000 ppm, approximately 1238 mg/kg bw/day) showed reduced body weight gain compared to controls. These animals also demonstrated a statistically significant reduction in food conversion efficiency. No other significant differences in body weight or body weight gain were reported, although high dose females showed lower body weight gain for the first week only.
There were no adverse effects on food consumption, clinical signs of toxicity, behaviour (functional neurological assessment), haematology, clinical biochemistry, gross pathology, organ weights or histopathology.
The no-observed-adverse-effect level (NOAEL) of ruthenium trichloride hydrate in rats following dietary exposure was 5000 ppm (approximately 407 mg/kg bw/day), on the basis of reduced body weight gain in treated males.
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