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EC number: 242-854-9 | CAS number: 19168-23-1
- 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:
- 15 September 1989 – 11 October 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to a company standard protocol designed to comply with the recommendations of OECD Guideline No. 401 and EEC Directive 84/449/EEC.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 19168-23-1
- Details on test material:
- - Name of test material (as cited in study report): Ammonium hexachloropalladate (IV)
- Substance type: red coloured powder
- Physical state: solid
- Lot/batch No.: 042011
- Stability under test conditions: not determined
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bantin & Kingman Ltd, Grimston, Aldborough, Hull UK
- Age at study initiation: approx. 5-8 weeks
- Weight at study initiation: males 120-146 g, females 120-136 g
- Fasting period before study: over night
- Housing: groups of up to 5/sex in solid-floor polypropylene cages with sawdust bedding
- Diet: ad libitum Rat and Mouse Expanded Diet No. 1 supplied by Special Diet Services Limited, Witham, Essex, UK
- Water: ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- Humidity (%): 54-64
- Air changes (per hr): approx. 15/hr
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% methyl cellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50, 100, 300 and 500 mg/ml in range-finding study; 100.0, 144.2, 208.0 and 300.0 mg/ml in main study
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: no data
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
DOSAGE PREPARATION (if unusual): Test material freshly prepared, as required. - Doses:
- 500, 1000, 3000 and 5000 mg/kg bw in the range finding study; 1000, 1442, 2080 and 3000 mg/kg bw in the main study
- No. of animals per sex per dose:
- 1/sex/dose in the range-finding study; 5/sex/dose in the main study
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 5 days for range-finding study; 14 days for main study
- Frequency of observations and weighing: in the main study: observed 1 and 4 hrs after dosing and once daily thereafter for 14 days; bodyweights recorded on the day of treatment (day 0) and on days 7 and 14, or at death
- Necropsy of survivors performed: in main study: yes
- Other examinations performed: in main study: clinical signs, body weight - Statistics:
- Acute oral median lethal dose (LD50) and 95% confidence limits were calculated using the method of Thompson, 1947.
Results and discussion
- Preliminary study:
- In the preliminary range-finding study, all animals survived a dose of up to 1000 mg/kg bw, while both died at 3000 mg/kg bw and above, indicating that the oral LD50 lies between 1000 and 3000 mg/kg bw.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 226 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 044 - 1 438
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 147 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 809 - 1 627
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 292 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 116 - 1 496
- Mortality:
- All deaths were noted 1-9 days after treatment. All of the animals at the top two dose levels and 4 male and 4 female rats at 1442 mg/kg bw died. Only one male and no female deaths were recorded at the lowest dose level.
- Clinical signs:
- other: Animals at all dose levels showed hunched posture, piloerection, pallor of the extremities, emaciation and red/brown staining around the snout. A decrease in respiration rate was noted in one female given 1000 mg/kg bw, 11 days after treatment. Incidents
- Gross pathology:
- No abnormalities were found amongst the low dosed animals. Thickening and sloughing of the glandular gastric epithelium and sloughing of the non-glandular gastric epithelium were seen in the animals which survived exposure to 1442 mg/kg bw. Amongst the animals which died during the study following exposure to 1442 mg/kg bw or above, abnormally red lungs, dark liver, pale kidneys, severe or very severe haemorrhage, ulceration, thickening and sloughing of the glandular gastric epithelium, haemorrhage and sloughing of the non-glandular gastric epithelium and haemorrhage of the small and large intestines were noted. The non-glandular gastric epithelium was also distended or greatly distended with fluid.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a GLP study, similar to OECD guidelines, an acute oral LD50 of 1226 mg/kg bw was reported in rats gavaged with ammonium hexachloropalladate (IV), and observed for up to 14 days.
- Executive summary:
In a standard acute oral toxicity study (to GLP), groups of five male and five female rats were administered 1000, 1442, 2080 or 3000 mg/kg bw of ammonium hexachloropalladate (IV) by stomach tube and observed for 14 days.
All animals in the top two dose levels and 4 males and 4 females given 1442 mg/kg bw died. Only one male in the lowest dose group died. Clinical signs of toxicity appeared immediately following administration in all dose groups and lasted for up to 8 days. Reductions in body weight gain or loss of body weight were noted amongst the survivors and gross pathological examination revealed effects on the lungs, liver, kidneys, glandular gastric epithelium, non-glandular gastric epithelium and the small and large intestines of animals treated with 1442 mg/kg bw or above. Using the prescribed statistical method, the acute oral median lethal dose (LD50) and 95% confidence limits were found to be 1226 (1044-1438) mg/kg bw for all animals combined, 1147 (809-1627) mg/kg bw for males and 1292 (1116-1496) mg/kg bw for females.
Based on the results of this study, ammonium hexachloropalladate (IV) should be classifed for acute oral toxicity (Cat. 4) according to EU CLP criteria (EU 1272/2008).
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