Registration Dossier
Registration Dossier
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EC number: 457-310-8 | CAS number: 127733-97-5 PLATINUM(2+), TETRAAMMINE-, (SP-4-1)-, DIACETATE (9CI)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 September - 15 October 2004
- 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:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, JMAFF (2000) including the most recent partial revisions
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Platinum (2+) tetraammine (SP-4-1) diacetate
- IUPAC Name:
- Platinum (2+) tetraammine (SP-4-1) diacetate
- Reference substance name:
- 127733-97-5
- Cas Number:
- 127733-97-5
- IUPAC Name:
- 127733-97-5
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Platinum (2+) tetraammine (SP-4-1) diacetate
- Substance type: No data
- Physical state: white crystalline powder
- Analytical purity: 95.2%
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: Pt (48.75%), Cl (0.029%)
- Isomers composition: Not applicable
- Purity test date: No data
- Lot/batch No.: GB 379
- Expiration date of the lot/batch: 28 June 2005
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: room temperature in the dark
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 7-9 weeks
- Weight at study initiation: 1.43-1.67 kg
- Housing: individual cages with perforated floors
- Diet (e.g. ad libitum): 100g/day (standard laboratory rabbit diet)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: at least 5 days before treatment initiation
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.2-22.3 deg C
- Humidity (%): 33-70% humidity
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hr light/12 hr dark
IN-LIFE DATES: From: 21 September 2004 To: 15 October 2004
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- not specified
- Remarks:
- 0.3 mL used to moisten the test material
- Controls:
- other: adjacent areas of the untreated skin of each animal served as controls
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): Not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 mL
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): No data
- Purity: No data - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Animals observed at 1, 24, 48 and 72 hr after removal of the test material
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm squared
- % coverage: No data
- Type of wrap if used: Micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin cleared of residual test material using water
- Time after start of exposure: 4 hours
SCORING SYSTEM: The irritation was assessed according to the Draize classification system based on the extent of formation of erythema, eschar and oedema in each test subject.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: Reversibility not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Reversibility not applicable
- Irritant / corrosive response data:
- No irritant or corrosive effect was observed on the skin after 4 hour exposure to the test material
- Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred
Any other information on results incl. tables
| Animal | Mean 24 -72 hours | |
| Erythema | Oedema | |
| 220 | 0 | 0 |
| 262 | 0 | 0 |
| 264 | 0 | 0 |
| Mean | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guideline study, to GLP, platinum (2+) tetraammine (SP-4 -1) diacetate was not irritating to the clipped skin of three New Zealand white rabbits following a 4 hr semi-occlusive application.
- Executive summary:
In an OECD Test Guideline 404 study, to GLP, 0.5 g of platinum (2+) tetraammine (SP-4 -1) diacetate was applied to the clipped skin of 3 male New Zealand white rabbits. After 4 hours, the semi-occlusive dressings were removed and the skin sites assessed for signs of irritation (oedema and erythema/eschar) at 1, 24, 48 and 72 hours.
No erythema/eschar or oedema was seen at any of the observation points. The test material produced a primary irritation index of 0 and was classified as non-irritant to rabbit skin according to the Draize classification system. No corrosive effects were noted and there was no evidence of systemic toxicity. The test material did not meet the criteria for classification as irritant or corrosive according to EU CLP regulations.
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