Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
In a GLP study, similar to OECD guidelines, an acute oral LD50 of 1226 mg/kw bw was reported in rats gavaged with diammonium hexachloropalladate, and observed for up to 14 days (Dreher, 1989).
No acute inhalation or dermal toxicity
data were identified.
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:
- 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.
- 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
- 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 - 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.
- 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.
- 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.
- 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).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 226 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.
In a standard acute oral toxicity study (to GLP), groups of five male and five female rats were administered diammonium hexachloropalladate at 1000, 1442, 2080 or 3000 mg/kg bw by stomach tube and observed for 14 days. All animals in the top two dose levels died, as did 4 rats/sex given 1442 mg/kg bw. 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 growth or 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 (Dreher, 1989).
No acute inhalation toxicity data were identified. However, the compound 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. However, skin contact during production and/or use is expected to be negligible.
Justification for selection of
acute toxicity – oral endpoint
GLP study, similar 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, diammonium 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.