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EC number: 238-269-3 | CAS number: 14323-43-4
- 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:
- 16 March 2012 - 10 August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, to GLP. Occasional deviations from protocol were not considered to impact the integrity or outcome of the study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- occasional humidity variations outwith protocol limits and daily-post dose observations made less frequently than protocol required were not considered to impact the integrity or outcome of the study
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Diamminedichloropalladium
- EC Number:
- 238-269-3
- EC Name:
- Diamminedichloropalladium
- Cas Number:
- 14323-43-4
- Molecular formula:
- Cl2H6N2Pd
- IUPAC Name:
- Diamminedichloropalladium
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Diamminedichloropalladium
- Substance type: Technical product
- Physical state: Dark yellow/orange powder
- Analytical purity: Not specified
- Impurities (identity and concentrations): Not specified
- Composition of test material, percentage of components: 50.33% palladium content; <10% Ir, Sb and Si; 6% Rh; <5% Pt, Mn and Sn; 3% Cu; <2% Ru, Au, Ag, Al, Co, Fe, Mg, Pb and Zn; <1% Ca, Cr and Ni
- Purity test date: Not specified (composition tested on 14 December 2011)
- Lot/batch No.: 11011
- Expiration date of the lot/batch: 31 October 2012
- Formulation stability under test conditions: At least 9 days at ambient temperature in the dark; actually used within 2 hours of preparation
- Storage condition of test material: Ambient temperature, in the dark
- Other: Supplier - Heraeus Precious Metals GmbH & Co., Heraeusstr. 12-14, 63450 Hanau, Germany
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley Crl:CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Margate, UK
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 222.9-250.0 g
- Fasting period before study: overnight
- Housing: In groups of 3 (except when reduced by mortality) in appropriately sized solid-bottomed polycarbonate cages with stainless steel mesh tops, suspended on movable racks
- Bedding: wood shavings
- Diet: ad libitum PMI Nutrition International Certified Rodent Diet No. 5CR4 (14% protein)
- Water: ad libitum from the public supply
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): daily average temperatures approx 20-21
- Humidity (%): range of daily average relative humidity approx. 43-49%; on several occasions humidity was intermittently below 40%, the actual minimum humidity was approx. 22% but, on that day, the daily mean humidity was approx. 43%
- Air changes (per hr): Minimum of 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
IN-LIFE DATES: From: 27 March 2012 To: 10 April 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: high viscosity hydroxypropyl methylcellulose in Milli-Q water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage): 0.5% (w/v)
- Justification for choice of vehicle: Not given
- Lot/batch no. (if required): DT200527
- Purity: Not given
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual): A weighed amount of hydroxypropyl methylcellulose (HPMC) was blended with a measured volume of Milli-Q water. The blender was rinsed with more Milli-Q water and the vehicle was then made up to a final volume in a volumetric flask. The required amount of test item was weighed into a mortar bowl and approx. 70% of the vehicle gradually added and the mixture homogenized then transferred to a suitable container that held the remaining 30% of vehicle. Formulations were magnetically stirred until an orange-coloured formulation was obtained. Analysis of prepared formulations with regard to stability, concentration and homogeneity was not conducted however, examination of the formulation records indicated that all preparations had been prepared correctly.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose was selected following review of the documentation of the test item supplied by the Sponsor - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females/low dose, 3 females/high dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals observed daily for clinical effects (although signs seen in all Group 1 animals were not recorded on days 5 and 6 and only recorded for 2 of the animals on day 13), twice daily for viability, and body weights recorded before dosing on day 1 and on days 8 and 15 for the low dosed animals and daily until day 9 and on days 13 and 15 for the survivors of th ehigh-dose group .
- Necropsy of survivors performed: yes (all animals were necropsied)
- Necropsy parameters: examination of cranial, thoracic and abdominal organs and tissues
- Other examinations performed: clinical signs, body weight, other: mortality/moribundity - Statistics:
- No formal statistical analysis was conducted.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: CL not applicable
- Mortality:
- There were no deaths amongst animals treated at a dose of 300 mg/kg bw. However 2 of the 3 animals were euthanised on days 9 and 13 with 2000 mg/kg bw.
- Clinical signs:
- other: All animals treated with 300 mg/kg bw displayed subdued behaviour for a short period after dosing. Full recovery was seen within 3 hours. At 2000 mg/kg bw, all animals displayed subdued behaviour, laboured breathing, piloerection and partial closure of
- Gross pathology:
- There were no macroscopic abnormalities at 300 mg/kg bw.
At 2000 mg/kg bw, lesions to the stomachs of all 3 animals were noted and included thickening of the non-glandular stomach and abnormal (black) stomach contents in one animal, distention of the stomach and filing with brown liquid in another, and distention of the stomach, dark pink discolouration of the glandular serosa, black discolouration of the glandular mucosa, thickening of the glandular stomach and thinness of the non-glandular stomach in the third animal. Other macroscopic abnormalities included pale discolouration of the lobes of the lungs in one animal and abnormal (green) contents of the oesophagus and dark red dicolouration of the pancreas in another.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an OECD Test Guideline 423 study, to GLP, the acute oral LD50 of diamminedichloropalladium was determined to be between 300 and 2000 mg/kg bw
- Executive summary:
In an acute oral toxicity test, conducted according to OECD Test Guideline 423 and to GLP, groups of 6 and 3 female rats were given a single oral intubation of 300 and 2000 mg/kg bw, respectively, and observed for 14 days.
No deaths were reported in any of the 6 animals at the lower dose and there were no effects on body weight gain and no macroscopic abnormalities. At 2000 mg/kg bw, unscheduled deaths were reported in 2 (euthanasia on days 9 and 13, respectively) of the 3 animals, with all animals showing overt signs of toxicity and (likely local) effects in the non-glandular stomach.
The acute oral median lethal dose (LD50) of diamminedichloropalladium was determined to be between 300 and 2000 mg/kg bw. Based on the results of this study, diamminedichloropalladium should be classified for acute oral toxicity (category 4) according to EU CLP criteria (EC 1272/2008).
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