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EC number: 270-241-6 | CAS number: 68413-68-3
- 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:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study. However, potential deviations could not be fully assessed as the study report appears to have some pages omitted. On closely-related surrogate.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Tetraammine palladium hydrogen carbonate
- IUPAC Name:
- Tetraammine palladium hydrogen carbonate
- Reference substance name:
- 134620-00-1
- Cas Number:
- 134620-00-1
- IUPAC Name:
- 134620-00-1
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Tetrammine palladium hydrogen carbonate
- Substance type: no data
- Physical state: no data
- Analytical purity: no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: animals were fasted, but no details on duration of fasting period
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%):no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: no data
DOSAGE PREPARATION (if unusual): no data - Doses:
- 0.5, 1 and 2 g/kg bw
- No. of animals per sex per dose:
- Five females/dose, a group of 5 males also treated at 2 g/kg bw
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed 30 minutes, 1, 2, 4 hours, and then daily and weighed at day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- Acute oral median lethal dose (LD50) and 95% confidence limits of the test material were calculated by the method of Thompson W.R.
Results and discussion
- Preliminary study:
- In the range finding study, one male and one female received 2 g/kg bw. The male was found dead two days after dosing, the female had no signs of systemic toxicity at day 5 after dosing. Hunched posture, lethargy and pilo-erection were seen in both animals, and ptosis and occasional body tremours were also noted in the male.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 933 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 664 - 1 310
- Mortality:
- In the main study, all 5 male and 5 female rats receiving 2 g/kg bw died by day 3, whilst 3 of 5 females died at 1 g/kg bw on days 4 to 6. No deaths were seen in the females receiving 0.5 g/kg bw.
- Clinical signs:
- other: Hunched posture, lethargy, decreased respiratory rate, laboured respiration and emaciation were commonly noted in all dose groups during the study. Pilo-erection and ptosis were noted in animals dosed with 1 g/kg bw and above. Ataxia was seen in females d
- Gross pathology:
- Haemorrhagic or abnormally red lungs, dark liver, dark or pale kidneys, gaseous distention of the stomach, dark, hardened or thickened gastric mucosa and haemorrhage of the small intestine were noted at necropsy of animals that died during the study. Sloughing of the non-glandular epithelium of the stomach with a raised limiting edge were noted in females receiving 0.5 and 1 g/kg bw killed at the end of the study period. Two female rats were found cannibalised, therefore necropsy was noted performed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- In an OECD guideline study, the acute oral LD50 of tetraamminepalladium hydrogen carbonate in the female rat was reported to be 933 mg/kg bw .
- Executive summary:
The acute oral toxicity of tetraamminepalladium hydrogen carbonate was assessed in rats, in a study conducted according to OECD Test Guideline 401.
In the range finding study, one male and one female rat received a single dose of 2000 mg /kg bw by oral gavage. The male was found dead two days after dosing whereas the female had no signs of systemic toxicity at day 5.
Therefore, in the main study, groups of 5 females were administered 500, 1000 or 2000 mg/kg bw of the test material and a group of 5 male rats received 2000 mg/kg bw. All 10 rats receiving 2000 mg/kg bw died by day 3 of the observation period, whilst 3 of 5 females receiving 1000 mg/kg bw died on days 4 to 6. No deaths were seen in the low dose females, following the 14-day observation period. The study authors conclude that the acute oral median lethal dose (LD50) of the test material in females rats is 933 mg/kg bw. “No significant difference in toxicity was noted between male and female animals”.
Based on the results of this study, tetraamminepalladium hydrogen carbonate should be classified for acute oral toxicity (category 4) according to EU CLP criteria (EU 1272/2008).
Tetraamminepalladium hydrogen carbonate is closely related to tetraamminepalladium dihydroxide, and is considered a suitable surrogate for read-across for this endpoint. The proposed read-across is appropriate because it is expected that the target and source substances undergo biotransformation to a common product. In solution, the hydrogen carbonate and hydroxide anions are expected to dissociate from the tetraamminepalladium cation; thus, this can be regarded as the common product and toxicologically-active species of both salts. The hydroxide and hydrogen carbonate counterions would not have an impact on the overall acute toxicity of the target or source substance, respectively. Therefore, it is considered that use of in vivo acute oral toxicity data obtained in a test on tetraamminepalladium hydrogen carbonate to fill a gap in the standard information requirements for tetraamminepalladium dihydroxide is scientifically justified and suitably reliable.
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