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Diss Factsheets
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EC number: 233-265-8 | CAS number: 10102-05-3
- 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:
- 17 December 2002 to 23 January 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD, EU, EPA), to GLP, on the dihydrate, with minor deviations (dose level and humidity) that are not considered to affect the validity of the study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- starting dose 200mg/kg bw (not 300 mg/kg bw) and humidity up to 6% below the minimum level recommended.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- starting dose 200mg/kg bw (not 300 mg/kg bw) and humidity up to 6% below the minimum level recommended.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 10102-05-3
- Reference substance name:
- Palladium(II) nitrate dihydrate
- Cas Number:
- 32916-07-7
- Molecular formula:
- 2NO3.Pd.2H2O
- IUPAC Name:
- Palladium(II) nitrate dihydrate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): palladium(II)nitrate dihydrate
- Substance type: orange-brown powder
- Physical state: solid
- Analytical purity: 40.1% (+/- 0.1%) palladium
- Impurities (identity and concentrations): no data [but see gentox study, with same batch no]
- Purity test date: no data [see gentox study, with same batch no]
- Lot/batch No.: 2403/02-02
- Expiration date of the lot/batch: 21 October 2003
- Stability under test conditions: no data
- Storage condition of test material: room temperature in dark
- Other: [Please note that the dihydrate has a different CAS RN (32916-07-7) to the anhydrous form (10102-05-3)]
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Wistar strain Crl(Wl) BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland
Sulzfeld
Germany
- Age at study initiation: about 8 weeks
- Weight at study initiation: females 168-173 g (200 mg/kg bw)
males 241-252 g (200 mg/kg bw)
females 208-238 g (2000 mg/kg bw)
- Fasting period before study: overnight
- Housing: Macrolon cages on sawdust
- Diet (e.g. ad libitum): conventional diet; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3
- Humidity (%): 30-70
- Air changes (per hr): about 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 or 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- Purity: tissue culture grade
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data - Doses:
- male and female: 200 mg/kg bw
female: 2000 mg/kg bw - No. of animals per sex per dose:
- 3 of each sex at 200 mg/kg bw
3 females at 2000 mg/kg bw - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed twice daily. Weighed at start of study and day 7 and 14.
- Necropsy of survivors performed: yes - Statistics:
- no data
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - < 2 000 mg/kg bw
- Remarks on result:
- other: CL not determined
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 200 mg/kg bw
- Remarks on result:
- other: CL not determined
- Mortality:
- All three females dosed at 2000 mg/kg died or were sacrificed due to distress, one on day 1, and two on day 2 after dosing.
- Clinical signs:
- other: 200 mg/kg bw: females had a hunched posture (lasting 2-3 days); uncoordinated movements (lasting 2 days); piloerection (from 4 hr to 1 day); salivation (lasting 2 hr); one animal had noisy breathing (lasting 4 hr). males exhibited a hunched posture (last
- Gross pathology:
- No gross abnormalities were detected at 200 mg/kg bw. At 2000 mg/kg bw, the stomachs of two animals contained blood and perforations were seen in the glandular musocae. In all three animals the glandular mucosae showed either dark red or black discolouration. The caecal contents in two animals were dark red. Dark red foci were apparent in the thymus of one animal.
- Other findings:
- No other findings were reported
- Potential target organs: gastrointestinal tract
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- An acute oral LD50 value of >200 mg/kg bw and < 2000 mg/kg bw was determined in male and female rats.
- Executive summary:
Palladium(II)nitrate dihydrate was studied for acute toxicity after single oral administration in rats. The test substance, available as an orange-brown powder, was given as an aqueous solution at a dose of 200 mg/kg bw to groups of three male and three female rats. A further group of three females received a dose of 2000 mg/kg bw.
At the higher dose one animal died within 24 hr and the remaining two animals were sacrificed due to distress on day 2 after dosing. Lethargy and hunched posture was evident within 2 hr of treatment. The two females surviving until day 2 showed abdominal swelling, chromodacryorrhoea around the snout and forelegs, yellow discolouration of the urine, yellow staining of the genital region, piloerection and slow breathing. At necropsy, all three females exhibited dark red or black discolouration of the glandular mucosa. In two animals the stomach contained blood, the glandular mucosa was perforated and the caecal contents were dark red. Dark red foci were apparent in the thymus of one animal.
A hunched posture and uncoordinated movements, lasting 2-3 days, and piloerection, lasting from 4 hr to 1 day, were evident in females treated with 200 mg/kg bw. One female also had noisy breathing, lasting 4 hr. In males dosed at 200 mg/kg bw the only clinical sign was hunched posture lasting for 1 day. All animals survived the 14 day observation period and at necropsy no abnormalities were evident in the rats dosed at 200 mg/kg bw.
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