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EC number: 237-489-7 | CAS number: 13815-17-3
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- 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 and EU guideline study. Unfortunately, a number of pages are missing from the study report, therefore it has not been possible to verify any deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Tetraamminepalladium (II) hydrogen carbonate
- IUPAC Name:
- Tetraamminepalladium (II) 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): Tetraamminepalladium hydrogen carbonate
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male
- 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: group means 26.0-27.7 g
- Assigned to test groups randomly: no data
- Fasting period before study: no data
- 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: From: To: no data
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- - Vehicle(s)/solvent(s) used: arachis oil
- Justification for choice of solvent/vehicle: no data
- Concentration of test material in vehicle: no data
- Amount of vehicle (if gavage or dermal): no data - Duration of treatment / exposure:
- Animals were given a single oral dose
- Frequency of treatment:
- Single dose
- Post exposure period:
- Animals were killed 24 and 48 hours following treatment
Doses / concentrations
- Remarks:
- Doses / Concentrations:
125, 250, 500 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- Groups of seven male mice per treatment group; Seven males recieved the vehicle (arachis oil) control; Five males recieved the positive (cyclophosphamide) control.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s): no data
- Route of administration: oral
- Doses / concentrations: 50 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow extracted and smear preparations made and stained. Polychromatic and normochromatic erythrocytes scored for the presence of micronuclei.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: maximum tolerated dose (MTD) was 500 mg/kg bw, in the dose-ranging finding study. Doses of 125 and 250 mg/kg bw were considered appropriate as the two lower dose levels.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): Animals were killed 24 or 48 hours later.
DETAILS OF SLIDE PREPARATION: bone marrow extracted and smear preparations made and stained.
METHOD OF ANALYSIS: Polychromatic and normochromatic erythrocytes were scored for the presence of micronuclei
OTHER: - Evaluation criteria:
- A statistically significant increase in the frequency of micronucleated PCEs compared to the concurrent vehicle control group was considered evidence of a positive effect.
- Statistics:
- PCE/NCE ratio
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Premature deaths were seen in the 24-hour 500 mg/kg bw (2) and 125 mg/kg bw (1) test material groups. Clinical signs were observed in animals dosed with the test material at and above 125 mg/kg bw in both the 24 and 48-hour groups, where applicable.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- There were no statistically significant increases in the frequency of micronucleated PCEs in any of the test material dose groups when compared to their concurrent vehicle control groups. There were no statistically significant decreases in the PCE/NCE ratio in the 24 or 48-hr test material groups when compared to their concurrent vehicle control groups. However, the presence of premature deaths and clinical observations indicated that systemic absorption had occurred.
There were premature deaths seen in the 24-hr 500 mg/kg bw (two animals) and 125 mg/kg bw (one animal) test material dose groups. Clinical signs were observed in animals dosed with the test material at and above 125 mg/kg bw in both the 24- and 48-hr groups, where applicable. Clinical signs included: hunched posture, ptosis, pilo-erection, lethargy, pallor of the extremities, splayed gait, tiptoe gait, decreased respiratory rate, laboured respiration, ataxia, noisy respiration, gasping respiration, increased lacrimation and increased salivation. It was considered that the loss of animals due to premature death did not effect the integrity of the study, with at least five analysable animals being available per group as recommended in the OECD guidelines.
The positive control group showed a marked increase in the incidence of micronucleated polychromatic erythocytes hence confirming the sensitivity of the system to the known mutagenic activity of cyclophosphamide under the conditions of the test.
Any other information on results incl. tables
Micronucleus study - summary of group mean data:
TREATMENT GROUP | Number of PCE with micronuclei per 2000 PCE | PCE/NCE ratio | ||
Group mean | SD | Group mean | SD | |
Vehicle control 48-hr sampling time |
1.4 | 1.7 | 1.47 |
0.55 |
Vehicle control 24-hr sampling time |
1.1 | 0.7 | 1.38 |
0.53 |
Positive control 24-hr sampling time |
25.0*** | 4.6 | 1.47 |
0.26 |
Tetraamminepalladium hydrogen carbonate 500 mg/kg bw 48-hr sampling time |
0.9 | 0.7 | 0.98 |
0.58 |
Tetraamminepalladium hydrogen carbonate(a) 500 mg/kg bw 24-hr sampling time |
1.8 |
1.9 |
1.67 |
1.16 |
Tetraamminepalladium hydrogen carbonate 500 mg/kg bw 24-hr sampling time |
1.7 |
1.5 |
1.13 |
0.16 |
Tetraamminepalladium hydrogen carbonate(b) 500 mg/kg bw 24-hr sampling time |
0.5 |
0.5 |
1.15 |
0.58 |
Key:
PCE = polychromatic erythrocytes
NCE = normochromatic erythrocytes
SD = standard deviation
*** = p<0.001
a = data from five animals
b = data from six animals
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
In an in vivo guideline study, tetraamminepalladium hydrogen carbonate failed to produce a significant increase in the frequency of micronuclei in polychromatic erythrocytes of mice following oral gavage at up to 500 mg/kg bw. - Executive summary:
An in vivo study was performed to assess the potential of tetraamminepalladium hydrogen carbonate to produce damage to chromosomes or aneuploidy when administered orally to mice. The study design complied with OECD Test Guideline 474 and EU Method B12.
Following a range-finding study, groups of seven male mice were given 125, 250 or 500 (the MTD) mg/kg bw of the test material and killed 24 or 48 hours later for analysis of micronuclei in polychromatic and normochromatic erythrocytes. Further groups of mice were given arachis oil or cyclophosphamide as vehicle and positive controls, respectively.
There was no evidence of a significant increase in the incidence of micronucleated polychromatic erythrocytes in animals dosed with the test material when compared to the concurrent vehicle control groups. No statistically significant decreases in the PCE/NCE ratio were observed in the 24- or 48-hr test material dose groups when compared to their concurrent control groups. However, the presence of premature deaths and clinical signs indicated that systemic absorption had occurred. The positive control material produced a marked increase in the frequency of micronucleated polychromatic erythrocytes, confirming the sensitivity of the test system.
In conclusion, tetraamminepalladium hydrogen carbonate failed to produce evidence of chromosome damage following oral gavage at up to 500 mg/kg bw, under the conditions of the test.
Tetraamminepalladium hydrogen carbonate is closely-related to tetraamminepalladium dichloride, 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 chloride 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 chloride and hydrogen carbonate counterions would not have an impact on the overall clastogenicity of the target or source substance, respectively. Therefore, it is considered that use of in vivo micronuclei induction data obtained on a test of tetraamminepalladium hydrogen carbonate to fill a gap in the standard information requirements for tetraamminepalladium dichloride is scientifically justified and suitably reliable.
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