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EC number: 240-974-6 | CAS number: 16919-73-6
- 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
Endpoint summary
Administrative data
Description of key information
In a GLP study, conducted according to OECD guidelines, the acute oral LD50 of dipotassium hexachloropalladate in the rat has been calculated as 1448 mg/kg bw (Zechel, 1990).
No acute inhalation or dermal toxicity
data were identified (for dipotassium or diammonium hexachloropalladate).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The administration and the pre- and post- observation periods were between 27 June and 09 August 1989.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, conducted to OECD guidelines
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Remarks:
- No significant deviations
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Bor: WISW (SPFCpb)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co. KG., D-4799 Borchen
- Age at study initiation: 8 weeks (males); 9 weeks (females)
- Weight at study initiation: 152-210 g (males); 136-167 g (females)
- Fasting period before study: 16 hours
- Housing: 1 rat/cage in type II Macrolon cages
- Diet (e.g. ad libitum): ad libitum standard diet ssniff R “Special diet for rats”, supplied by ssniff Spezialfutter GmbH, D-4770 Soest
- Water (e.g. ad libitum): ad libitum from Stadtwerke Beilefeld (Municipal Works)
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-22.5
- Humidity (%): 40-70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12 (6 am- 6 pm: artificial lighting; 6 pm-6 am: “natural light-dark-rhythm”) - Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
VEHICLE
- Concentration in vehicle: 46.4, 68.1 or 100 mg/ml.
- Amount of vehicle (if gavage): 21.5 ml
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): Batch 5479, supplied by H. Lamotte, D-2800 Bremen
- Purity: no data- Doses:
- Rats were administered 1000, 1470 or 2150 mg/kg bw in 21.5 ml/kg bw.
- No. of animals per sex per dose:
- Five rats/sex/dose
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days (a single animal was observed for 21 days because of reduced body weight at 14 days)
- Frequency of observations and weighing: Observed for 4-6 hours after administration, then once daily; weighed at the beginning and at 7 and 14 days (or after death; a single animal was weighed at 21 days); deaths recorded twice daily, except on Saturdays, Sundays and national holidays when they were only counted once.
- Necropsy of survivors performed: yes
- Other examinations performed: external appearance, “body orifices”, thoracic and abdominal body cavities and their contents, histopathology of the lungs, clinical signs, body weight.- Statistics:
- Acute oral median lethal dose (LD50)
- Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 448 mg/kg bw
- 95% CL:
- > 1 234 - < 1 696
- Remarks on result:
- other: Probit analysis
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 358 mg/kg bw
- 95% CL:
- > 924 - < 1 882
- Remarks on result:
- other: Probit analysis
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 562 mg/kg bw
- 95% CL:
- > 1 123 - < 2 249
- Remarks on result:
- other: Probit analysis
- Mortality:
- Two males in the mid-dose group died 6 days after administration; all high-dose males died within 7 days. Four females in the mid-dose group died within five days of administration; all high-dose females died within 3 days.
- Clinical signs:
- Slightly reduced movement, diarrhoea, red nasal discharge and “sunken sides” were seen in some of the females given 1000 mg/kg bw. At 1470 and 2150 mg/kg bw, more obvious signs of neurotoxicity than reduced movement were reported (restrained gait, tremor, reduced muscle tone), along with other general signs of toxicity (including piloerection, strenuous respiration yellow nasal discharge and, in the high dose group only, red-discoloured urine). In males, slightly reduced movement was reported in two animals given 1000 mg/kg bw. Higher doses caused similar neurotoxic and general toxicity symptoms as those seen in females (but included loss of righting reflex, reduced body temperature and black discolouration of the faeces).
- Body weight:
- Reduced body weight gain was reported in three females given 1000 mg/kg bw, and in one female and two males given 1470 mg/kg bw.
- Gross pathology:
- Effects on the digestive organs (glandular stomach, forestomach, intestine and liver) consistent with a local irritant effect were reported in mid- and high-dose males and females. A slightly diminished spleen was noted in one mid-dose male, and one mid-dose female exhibited a foam-filled trachea. Abnormalities in the lungs (dark red, puffy, emphysematous appearance and dark red discolouration or spotting) were seen in high-dose male and female animals; dark red spotting in the lungs was also seen in mid-dose females.
- Other findings:
- - Histopathology: Lung congestion was reported in males given 2150 mg/kg bw and in females given 1470 and 2150 mg/kg bw.
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a GLP study, conducted according to OECD guidelines, the acute oral LD50 of dipotassium hexachloropalladate in the rat has been calculated as approximately 1400 mg/kg bw.
- Executive summary:
In a GLP study conducted according to OECD Test Guideline 401, five rats/sex/group were treated with 1000, 1470 or 2150 mg/kg bw dipotassium hexachloropalladate by stomach tube, and observed for 14 days (although one animal was observed for 21 days).
Two males and four females in the mid-dose group died within six days; all animals in the high-dose group died within seven days. Toxic effects included neurotoxicity, local irritant effects on the digestive organs and lung damage.
Based on the results of this study, dipotassium hexachloropalladate should be classified for acute oral toxicity (category 4) according to EU CLP criteria (EU 1272/2008).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 448 mg/kg bw
- Quality of whole database:
- Overall, good-quality database which meets REACH Standard Information Requirements.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No human data were identified for acute exposure (for dipotassium or diammonium hexachloropalladate).
In a GLP study conducted according to OECD Test Guideline 401, five rats/sex/group were treated with 1000, 1470 or 2150 mg/kg bw dipotassium hexachloropalladate by stomach tube, and observed for 14 days (although one animal was observed for 21 days). Two males and four females in the mid-dose group died within six days; all animals in the high-dose group died within seven days. Toxic effects included neurotoxicity, local irritant effects on the digestive organs and lung damage. The study authors calculate (using probit analysis) that the acute oral median lethal dose (LD50) is 1562 mg/kg bw in male rats (95% CI 1123-2249 mg/kg bw), 1358 mg/kg bw in female rats (95% CI 924-1182 mg/kg bw) and 1448 mg/kg bw for both sexes combined (95% CI 1234-1696 mg/kg bw) (Zechel, 1990).
Based on the results of this study, dipotassium hexachloropalladate should be classified for acute oral toxicity (category 4) according to EU CLP criteria (EC 1272/2008).
No acute inhalation toxicity data were identified (for dipotassium or diammonium hexachloropalladate). However, dipotassium hexachloropalladate is not expected to reach the lungs in appreciable quantities (based on respiratory tract deposition modelling data). Thus, inhalation will not be a significant route of exposure.
Similarly, no acute dermal toxicity data were identified (for dipotassium or diammonium hexachloropalladate). However, skin contact during production and/or use is expected to be negligible.
Justification for selection of
acute toxicity – oral endpoint
GLP study, conducted according to OECD guidelines, and the only
acute oral toxicity study available.
Justification for classification or non-classification
Based on the results of the available reliable acute oral rat study, dipotassium hexachloropalladate should be classified for acute oral toxicity (category 4) according to EU CLP criteria (EC 1272/2008).
No clear evidence of specific target organ toxicity was noted. As such, classification for STOT-SE is not considered appropriate.
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