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EC number: 238-203-3 | CAS number: 14286-02-3
- 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
Endpoint summary
Administrative data
Description of key information
In a guideline study, to GLP, the acute oral LD50 of diammineplatinum dinitrite was determined to be around 5000 mg/kg bw in rats (Berthold, 1989).
No relevant acute dermal or 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:
- 6 March 1989 to 11 April 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD and EU), and conducted according to GLP.
- 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
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Bor: WISW (SPFCpb)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder; Winklemann Versuchstierzucht GmbH & Co. KG., D-4799 Borchen
- Age at study initiation: Males 7-9 weeks, females 10 weeks
- Weight at study initiation: Males 130-204 g, females 144-162 g
- Fasting period before study: 16 hours
- Housing: Macrolon cages, type II (one animal/cage)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-23
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12 hrs natural light-dark-rhythm (6 pm to 6 am) / 12 hrs artificial lighting - Route of administration:
- oral: gavage
- Vehicle:
- other: 1% aqueous tylose suspension; Tylose(R)
- Details on oral exposure:
- Males were administered about 2.15 or 5.11 g/kg bw, at a concentration of 147 and 348 mg/ml, respectively. For the females, only one dose level of 5.11 g/kg bw was administered, at a concentration of 348 mg/ml.
- Doses:
- 2.15 or 5.11 g/kg bw
- No. of animals per sex per dose:
- Five/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: For behaviour and general toxicity, the animals were observed continuously for the first 4 to 6 hrs after administration, and then once daily. Mortality was checked twice daily, and the body weights recorded at the beginning, and then at 7 and 14 days after administration.
- Necropsy of survivors performed: yes - Statistics:
- The LD50 was determined by rational estimation for male rats. For female rats a limit test was conducted.
- Sex:
- male
- Dose descriptor:
- approximate LD50
- Effect level:
- 5 000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 5 110 mg/kg bw
- Mortality:
- Deaths occurred in two males at 5.11 g/kg bw on day seven after administration
- Clinical signs:
- other: Piloerection was seen between days 2 and 11 after treatment (or until death), in all 5 male and 5 female rats in the high dose groups only.
- Gross pathology:
- No abnormalities reported following a macroscopic examination, although a dark red discolouration of the intestine was seen in the two males that died at the top dose.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a GLP guideline study, the acute oral LD50 of dinitrodiammine-platinum(II) was determined to be about 5 g/kg bw in rats.
- Executive summary:
In an OECD Test Guideline 401 study, dinitrodiammine-platinum(II) was administered by stomach tube to groups of male rats at 2.15 and 5.11 g/kg bw and to 5 female rats at the higher dose only.
Two males died at the top dose seven days after administration. No other deaths were reported in the 14 day observation period. LD50 values were determined to be about 5 g/kg bw in males and above 5.11 g/kg bw in females. All dose groups exhibited reductions in body weight or growth after the first week of observation. Piloerection was seen in all rats in the high dose groups, but not in males given the lower dose. No abnormalities were seen following macroscopic examination, although a dark red discolouration of the intestine was seen in the two deceased males receiving the top dose.
Based on the results of this study, dinitrodiammine-platinum(II) 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:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No relevant human acute toxicity data were identified.
Diammineplatinum dinitrite was tested for its acute oral toxicity in rats, according to OECD Test Guideline 401. The test item was administered by gavage to groups of male rats at 2.15 and 5.11 g/kg bw and to 5 female rats at the higher dose only. Two males died at the top dose seven days after administration. No other deaths were reported in the 14 day observation period. LD50 values were determined to be about 5 g/kg bw in males and above 5.11 g/kg bw in females. All dose groups exhibited reductions in body weight or growth after the first week of observation. Piloerection was seen in all rats in the high dose groups, but not in males given the lower dose. No abnormalities were seen following macroscopic examination, although a dark red discolouration of the intestine was seen in the two deceased males receiving the top dose (Berthold, 1989).
No acute dermal or inhalation toxicity data were identified, or are required at this tonnage.
Justification for classification or non-classification
Based on the results of the available and reliable acute oral rat study, diammineplatinum dinitrite does not require classification for acute oral 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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