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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:
18 November 1981 – 21 November 1981
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:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
See below
Principles of method if other than guideline:
The fur of the rabbits was clipped 4-16 hrs prior to commencement of the study but the guidelines suggest that this should be done “approximately 24 hours before the test”. The test material was applied under an occlusive patch, whereas the guidelines state that “a suitable semi-occlusive dressing” should be used.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): potassium tetrachloroplatinate (II)
- Molecular formula (if other than submission substance): K2PtCl4
- Substance type: orange-brown powder
- Physical state: solid
- Lot/batch No.: 031440A

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire
- Weight at study initiation: 2.10-2.45 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum rabbit diet supplied by John Waring (Feeds) Limited, Shardlow, Derbyshire
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Air changes (per hr): a minimum of 20/hr
- Photoperiod (hrs dark / hrs light): lighting cycle of 12 hrs on and 12 hrs off with no daylight

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): enough to moisten the test substance
- Purity: sterile distilled water

Duration of treatment / exposure:
4 hrs
Observation period:
1, 24, 48 and 72 hrs after removal of the patch
Number of animals:
Three, sex not specified
Details on study design:
TEST SITE
- Area of exposure: not specified
- Type of wrap if used: a composite patch consisting of 6.25 cm2 of absorbent lint BPC backed by 16.0 cm2 of absorbent lint BPC with a final backing of 9.0 cm2 of polythene. The patch was then secured in position with two lengths of Sleek adhesive strapping supplied by Smith & Nephew Ltd, in the form of a cross and the trunk of each animal was wrapped in an elasticated corset (Seaton’s Tubigrip).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, gentle swabbing with cotton wool soaked in lukewarm water
- Time after start of exposure: 4 hrs

SCORING SYSTEM: The test sites were examined for evidence of primary irritation approximately 1 hr following removal of the patch and 24, 48 and 72 hrs later and scored according to the method of Draize (1959). The scores for erythema (and eschar) formation and oedema formation at the 1, 24, 48 and 72 hr observation times were totalled for the three rabbits (24 values) and divided by 12 to give the primary cutaneous irritation index. This was then used to classify the skin irritation properties of the test material according to the scheme by Draize (1959):

Primary Irritation Index Classification
0 Non-irritant
>0 – 2 Mild irritant
>2 – 5 Moderate irritant
>5 – 8 Severe irritant

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hrs after removal of the patch
Score:
0
Max. score:
8
Reversibility:
other: Not applicable
Irritant / corrosive response data:
There was no evidence of any cutaneous irritant effects in any of the treated rabbits throughout the observation period.
Other effects:
No systemic effects noted.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a guideline study, potassium tetrachloroplatinate (II) (0.5 g) was not irritating following a 4-hr occluded application to the shaved intact skin of three rabbits.
Executive summary:

In a study conducted to OECD Test Guideline 404, potassium tetrachloroplatinate (II) (0.5 g) was applied (occluded) to the shaved intact skin of three rabbits. After 4 hrs, the dressings were removed, any residual material immediately removed from the skin sites by gentle swabbing and, 1 hr later, the formation of erythema (and eschar) and oedema assessed. Readings were also made 24, 48 and 72 hr after patch removal, and the sum of these values combined and divided by 12 to give a primary cutaneous irritation score of 0.0. No systemic toxic effects were reported.

 

Under EU CLP criteria (EC 1272/2008), potassium tetrachloroplatinate (II) would not be classified as a skin irritant under the conditions of this test.