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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 April – 24 August 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Diammineplatinum(II) nitrite
- EC Number:
- 238-203-3
- EC Name:
- Diammineplatinum(II) nitrite
- Cas Number:
- 14286-02-3
- Molecular formula:
- H6N4O4Pt
- IUPAC Name:
- diiminodinitroplatinumbis(ylium)
- Details on test material:
- - Name of test material (as cited in study report): Dinitrodiammine-platinum(II)
- Substance type: yellow powder
- Physical state: solid
- Analytical purity: no data
- Lot/batch No.: 6734
- Stability under test conditions: not indicated by the sponsor
- Storage condition of test material: kept refrigerated with a drying agent
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: White Russian (albino)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Origin/breeder: ASTA Pharma AG, D-4800 Bielefeld 14
- Age at study initiation: 8-11 months
- Weight at study initiation: 2.78-2.98 kg
- Housing: Stainless steel cages with grating floor, one animal/cage
- Diet (e.g. ad libitum): Approx. 120 g/day standard diet
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: One day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-23
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12 hrs natural light-dark-rhythm (6 pm to 6 am) / 12 hrs artificial lighting
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of each of the three rabbits was used as the control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of test material applied to the conjuctival sac of the left eye - Duration of treatment / exposure:
- Both lids were briefly closed by gentle finger pressure
- Observation period (in vivo):
- Inspection of the eyes occurred 1, 24, 48 and 72 hrs after application and then daily until day 21. An additional examination was performed on day 124.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not rinsed
SCORING SYSTEM: Signs of irritation on the cornea, iris and conjunctiva were assessed quantitatively and qualitatively using the Draize scale (see attachment 5 for details) assessed at 1, 24, 48, and 72 hrs following application of the test material into the eye. The irritation index is given by the sum of these scores, following a modified method according to Gilman et al. 1983:
Index ranges Gradation
0-10 non-irritant
11-25 slightly irritant
26-56 moderately irritant
57-110 severely irritant
TOOL USED TO ASSESS SCORE: Cliptrix pencil light
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- other: irritation index is the sum of the scores from the cornea, iris and conjuctiva
- Time point:
- other: 72 hrs
- Score:
- 39
- Reversibility:
- not fully reversible within: 3 months after application
- Other effects:
- There were no systemic toxic effects observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In a guideline study, to GLP, instillation of dinitrodiammine-platinum(II) into the conjuctival sac of the left eye of three rabbits caused moderate irritation according to the Draize scale. However, the test substance caused severe and sometimes irreversible effects, especially on the cornea, and therefore should be classified as Category 1 (irreversible effects on the eye) under EU CLP criteria.
- Executive summary:
In an OECD Test Guideline 405 study, conducted according to GLP, dinitrodiammine-platinum(II) was investigated for irritant effects on the rabbit eye and associated mucous membranes following instillation of 0.1 g into the conjuctival sac of the left eye of each of three animals.
No systemic toxic effects were detected, and the untreated control eyes showed no changes. Following application of the test material, slight partial or moderate circumcorneal hyperaemia was seen in the iris. Regarding the conjuctival sac, diffuse crimson discolouration, white foci, single haemorrhages and eye lid swelling were observed, of which some were considered severe effects. The cornea was particularly affected, with changes including diffuse opacity or opaque areas and diffuse capacity or easily discernable translucent areas, obscured iris and vessel ingrowth. The cornea lesions persisted in two rabbits when examined 3 months after application of the test material. After the 72 hr observation period, the primary index irritation index was 39, indicating a moderate eye irritant. However, as the test substance caused severe and sometimes irreversible effects (notably) on the cornea, the study authors conclude that dinitrodiammine-platinum(II) should be classified as a severe eye irritant in this test system.
According to EU CLP criteria (EC 1272/2008), dinitrodiammine-platinum(II) should be classified as Category 1 (irreversible effects on the eye).
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