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Toxicological information

Skin irritation / corrosion

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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:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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.