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EC number: 243-929-9 | CAS number: 20634-12-2
- 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:
- weight of evidence
- Study period:
- 23 June 1997 to 15 July 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Conducted according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according 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:
- yes
Test material
- Reference substance name:
- 123439-82-7
- Cas Number:
- 123439-82-7
- IUPAC Name:
- 123439-82-7
- Reference substance name:
- Tetraammine platinum hydrogencarbonate
- IUPAC Name:
- Tetraammine platinum hydrogencarbonate
- Details on test material:
- - Name of test material: tetramine platinum hydrogencarbonate
- Substance type: Technical product
- Physical state: Solid (powder)
- Analytical purity: > 99.9%
- Purity test date: 1997-02-19
- Lot/batch No.: 02/95
- Expiration date of the lot/batch: 1999-12-31
- Stability under test conditions: Stable throughout study according to sponsor
- Storage condition of test material: Stored dry at < 30oC in closed container
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: HsdCpb: WU
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, D-33176 Borchen
- Age at study initiation: males 7 weeks; females 9 weeks
- Weight at study initiation: males 156-166 g; females 151-173 g
- Fasting period before study: 16 hours
- Housing: 1 animal/Macrolon cage, type II; soft wood granulate bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-21.6
- Humidity (%): 41-73
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- Trade name TylopurR C 1000 P; 0.5% aqueous CMC: trade name Tylose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 215 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: test substance given as a suspension
- Lot/batch no. (if required): E 114 30100
DOSAGE PREPARATION: test substance suspended immediately before dosing using a homogenizer and magnetic stirrer - Doses:
- 2150 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Continuous observations for 4-6 hr after dosing, then once per day. Weighed at start of study and day 7 and 14 (or after death if this occurred earlier).
- Necropsy of survivors performed: yes - Statistics:
- Not applicable, LD50 higher than the dose administered
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 150 mg/kg bw
- Mortality:
- One male and one female died on days 5 and 6, respectively.
- Clinical signs:
- other: Surviving animals: Males (n=4): 2 had no symptoms, 2 showed slightly reduced movement, staggered gait and sunken sides (lasting 1-4 days). Females (n=4): 4 had diarrhoea, 2 had staggered gait, 2 had sunken sides, 1 had reduced movement. Deceased animals
- Gross pathology:
- No gross abnormalities detected.
- Other findings:
- No other findings reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 value of tetraammineplatinum hydrogen carbonate was determined to exceed 2150 mg/kg bw in male and female rats.
- Executive summary:
In an acute oral toxicity test, conducted in accordance with OECD Test Guideline 401 (withdrawn in 2002) and to GLP, HsdCpb: WU rats (5/sex) were gavaged with tetraammineplatinum hydrogen carbonate (as a suspension in aqueous carboxymethyl cellulose) at a limit dose of 2150 mg/kg bw and observed for 14 days.
Three males showed reduced movement, staggered gait and sunken sides starting 75 minutes after dosing and lasting until day 1 or 4 after dosing. One of these males additionally showed clonic convulsions, diarrhoea, piloerection, stilted gait, red crusted nose and emaciation, and subsequently died (on day 5 after dosing). The other two males showed no signs of toxicity during the observation period.
All females exhibited diarrhoea, and some showed staggered and/or stilted gait, reduced movement and sunken sides. These effects were evident from 90 minutes after dosing, and lasted for 6 days or, in one animal, until death (on day 6).
The acute oral LD50 value was therefore determined to exceed 2150 mg/kg bw in male and female rats.
Based on the results of this study, tetraammineplatinum hydrogen carbonate does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008).
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