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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, no irritation potential was observed when 0.5 g dinitrodiammine-platinum(II) was applied (under occlusion for 4 hr) to the clipped, intact skin of three rabbits (Zechel, 1989a).
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). As such, the study authors conclude that dinitrodiammine-platinum(II) should be classified as a severe eye irritant in this test system (Zechel, 1989b).
No relevant respiratory tract irritation data were identified.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 to 7 April 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: White Russian (albino)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder: ASTA Pharma AG, D-4800 Bielefeld 14
- Age at study initiation: Male 10 months, females 11 and 12 months
- Weight at study initiation: Male 2.75 kg, females 2.58 and 3.02 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): 21.5-23.5
- Humidity (%): 45-60
- Photoperiod (hrs dark / hrs light): 12 hrs natural light-dark-rhythm (6 pm to 6 am)/ 12 hrs artificial lighting - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped free of hair one day before treatment
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Concentration (if solution): about 3 g/ml (moistened with 0.17 mL demineralised water) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Inspection of the skin occurred 1, 24, 48 and 72 hrs after removal of the patches
- Number of animals:
- Three (one male and two females)
- Details on study design:
- TEST SITE
- Area of exposure: The site of application was covered with a linen cloth (approx. 6.25 cm2) which adhered to a synthetic film glue
- Type of wrap if used: A bandage (Acrylastic No. 2408, width 8 cm) wrapped several times around the trunk provided complete occlusion
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After removal of the patch, remaining test material “was gently washed off as far as possible”
- Time after start of exposure: about 4 hours
SCORING SYSTEM: The treated skin area was qualitatively and quantitatively assessed using the Draize method at 1, 24, 48, and 72 hrs following removal of the patches. The irritation index is given by the sum of the mean values for erythema (and eschar) formation, and edema, following a modified method according to Gilman et al. 1983:
Index ranges Gradation
0-0.5 non-irritant
0.6-3 slightly irritant
3.1-5 moderately irritant
5.1-8 severely irritant
In addition, attention was paid to the occurrence of further reactions on the skin (including corrosive effects) and to clinical symptoms (systemic toxic effects). - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, and 72 hrs
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, and 72 hrs
- Score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24, 48, and 72 hrs
- Score:
- 0
- Irritant / corrosive response data:
- No erythema or edema (Draize score of 0) was seen on the skin of the animals within the 3 day observation period.
- Other effects:
- Systemic toxic effects did not occur and the general condition of the rabbits was not affected by treatment.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guideline study, to GLP, no irritation potential was observed when 0.5 g dinitrodiammine-platinum(II) was applied (under occlusion for 4 hr) to the clipped, intact skin of three rabbits.
- Executive summary:
In an OECD Test Guideline 404 study, conducted according to GLP, dinitrodiammine-platinum(II) (0.5 g, moistened with 0.17 mL water) was applied (occluded) to the clipped intact skin of 3 White Russian rabbits. After 4 hours, the dressings were removed and the treated skin sites were washed and subsequently observed for erythema and oedema at 1, 24, 48 and 72 hours.
No skin reactions were recorded at any time point in any animal during the 72 -hr observation period. The primary dermal irritation index was therefore 0, and dinitrodiammine-platinum(II) was classified as a non-irritant to rabbit skin under the conditions of the test. Systemic toxic effects were not detected and the general condition of the rabbits was unaffected by treatment.
No skin classification, according to EU CLP criteria (EC 1272/2008), is required on the basis of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- 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 - 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 - 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.
- 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).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No relevant irritation/corrosion human data were identified.
In an OECD Test Guideline 404 study, conducted according to GLP, dinitrodiammine-platinum(II) (0.5 g, moistened with 0.17 mL water) was applied (occluded) to the clipped intact skin of 3 White Russian rabbits. After 4 hours, the dressings were removed and the treated skin sites were washed and subsequently observed for erythema and oedema at 1, 24, 48 and 72 hours. No skin reactions were recorded at any time point in any animal during the 72-hr observation period. The primary dermal irritation index was therefore 0, and dinitrodiammine-platinum(II) was classified as a non-irritant to rabbit skin under the conditions of the test. Systemic toxic effects were not detected and the general condition of the rabbits was unaffected by treatment (Zechel, 1989a).
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 (Zechel, 1989b).
No respiratory tract data were identified.
Justification for classification or non-classification
Based on the results of the available reliable skin and eye irritation studies (in rabbits), diammineplatinum dinitrite need not be classified for skin irritation, but should be classified for ‘irreversible effects on the eye’ (category 1), according to EU CLP criteria (EC 1272/2008).
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