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EC number: 237-706-5 | CAS number: 13933-32-9
- 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
The acute oral LD50 value of tetraammineplatinum dichloride was reported to exceed 15.1 g/kg bw in rats (Jones, 1977a).
In rats, the acute dermal LD50 value (24-hour semi-occlusive application) for tetraammineplatinum hydrogen carbonate was >2000 mg/kg bw (Allen, 1977).
No relevant acute inhalation 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:
- Not stated
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only a 1-page study report, no data on guideline/GLP
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 5 rats/sex were given a single oral dose of tetrammine platinous chloride at 15.1 g/kg bw, and observed for mortality.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): tetrammine platinous chloride.
- Substance type: white powder
- Physical state: solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: Sponsor’s code no. CB 13 - Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: “young adult”
- Weight at study initiation: 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: - Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- 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
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 15.1 g/kg bw
- No. of animals per sex per dose:
- 5/sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: no data
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: no data - Preliminary study:
- 1/sex dosed at 0.001, 0.05, 0.5 or 15 g/kg bw. No deaths, no other findings reported.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 15 100 mg/kg bw
- Mortality:
- None
- Clinical signs:
- other: No data
- Gross pathology:
- No data
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to a brief report, the acute oral LD50 value for tetrammine platinous chloride in rats is >15.1 g/kg bw.
- Executive summary:
In a brief report of an acute oral toxicity test, in which 5 rats/sex were given a single oral dose of tetrammine platinous chloride at 15.1 g/kg bw, there were no deaths. The acute oral LD50 is therefore >15.1 g/kg bw. No other findings were reported (but the extent of examination and observation is unclear).
The study report notes that, according to the tabulation of toxicity classes incorporated in the American NFPA No. 704M labelling system, the acute oral LD50 of CB 13 is likely to fall within Class 0 – “relatively harmless”.
Based on the results of this study, tetraammineplatinum dichloride does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 15 100 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 to 23 January 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Conducted according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Sprague-Dawley CD (Crl : CD ® BR)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: males 209-236 g; females 206-227 g.
- Fasting period before study: none
- Housing: Housed individually during the 24-hr exposure period, then in groups of five by sex in suspended polypropylene cages on woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 41-55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: 10% of total body surface area
- Type of wrap if used: surgical gauze and self-adhesive bandage, secured with “Blenderm” latex- free, hypoallergenic, surgical tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with cotton wool moistened in distilled water
- Time after start of exposure: 24 hr
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: yes, powder moistened with distilled water
VEHICLE
- Amount(s) applied (volume or weight with unit): not stated - Duration of exposure:
- 24 hr
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed at 0.5, 1, 2 and 4 hrs after dosing, then daily for 14 days; weighed before treatment then weekly for 2 weeks.
- Necropsy of survivors performed: yes
- Other examinations performed: behavioural and clinical signs, body weight changes. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- No abnormalities
- Other findings:
- - Other observations: No dermal reactions, including erythema and oedema, were seen during the 14-day period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In rats, the acute dermal LD50 value (24-hour semi-occlusive application) for tetrammine platinum (II) hydrogen carbonate was >2000 mg/kg bw.
- Executive summary:
An acute dermal toxicity test was conducted in the Sprague-Dawley CD strain rat, in accordance with OECD Test Guideline 402 and to GLP. Ten rats (five males and five females) were given a single 24-hour, semi-occluded dermal application of tetraammineplatinum hydrogen carbonate to intact skin at a dose level of 2000 mg/kg bw. The animals were observed for 14 days after the day of treatment and were then killed for gross pathological examination.
There were no deaths, and no signs of systemic toxicity or skin irritation during the study. All rats showed the expected increase in body weight during the study except for one female which showed body weight loss during the first week only. No abnormalities were noted at necropsy.
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was >2000 mg/kg bw.
Based on the results of this study, tetraammineplatinum hydrogen carbonate does not require classification for acute dermal toxicity according to EU CLP criteria (EC 1272/2008).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
No relevant human acute toxicity data were identified.
In a brief report of an acute oral toxicity test, no deaths were reported following administration of a single oral dose of tetraammineplatinum dichloride at 15.1 g/kg bw, to a group of 5 rats/sex. The acute oral LD50 is therefore>15.1 g/kg bw. No other findings were reported (Jones, 1977a).
In an OECD Test Guideline 402 study, rats (5/sex) were given a single 24-hour, semi-occluded dermal application of tetraammineplatinum hydrogen carbonate to intact skin at a dose level of 2000 mg/kg bw. The animals were observed for 14 days after the day of treatment and were then killed for gross pathological examination. There were no deaths, and no signs of systemic toxicity or skin irritation during the study. All rats showed the expected increase in body weight during the study except for one female which showed body weight loss during the first week only. No abnormalities were noted at necropsy. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was >2000 mg/kg bw (Allen, 1997).
Tetraammineplatinum hydrogen carbonate is considered to fall within the scope of the read-across category "tetraammineplatinum(II) salts". See section 13 in IUCLID for full read-across justification report.
No acute inhalation toxicity data were identified, or are required at this tonnage (1-10 tpa).
Justification for selection of acute toxicity – oral endpoint
Brief study report, but the only acute oral study available;
sufficient to support the lack of classification for the compound.
Justification for selection of acute toxicity – dermal endpoint
OECD guideline study, and the only acute dermal study available.
Justification for classification or non-classification
Based on the results of the available acute oral rat study, tetraammineplatinum dichloride does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008).
Based on the results of the available and reliable acute dermal rat study with tetraammineplatinum hydrogen carbonate, tetraammineplatinum dichloride does not require classification for acute dermal toxicity 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.
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