Hexachloroplatinic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Early guideline study (US Department of Transportation), prior to GLP, scientifically acceptable

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: US Code of Federal Regulation, Title 49, Part 173, Appendix A, 27th September, 1976, Department of Transportation

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexachloroplatinic acid

EC Number:

241-010-7

EC Name:

Hexachloroplatinic acid

Cas Number:

16941-12-1

Molecular formula:

Cl6Pt.2H

IUPAC Name:

platinum(4+) dihydrogen hexachloride

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Chloroplatinic acid
- Substance type: No data
- Physical state: crystalline material
- Analytical purity: not stated
- Impurities (identity and concentrations): not stated
- Lot/batch No.: not stated
- Stability under test conditions: not stated
- Storage condition of test material: not stated. Material supplied in screw capped glass bottle

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Healthy female rabbits from "recognised breeders"
- Age at study initiation: 16 - 18 weeks
- Weight at study initiation: mean 2.5 kg
- Housing: caged in environmentally controlled room
- Diet (e.g. ad libitum): commercial rabbit diet (Rank Hovis MacDougal)
- Water (e.g. ad libitum): filtered, ad libitum
- Acclimation period: not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not stated
- Humidity (%): not stated
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): natural lighting

IN-LIFE DATES: From: To:

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

test material applied as supplied (crystalline material)

Controls:

no

Amount / concentration applied:

0.5 g/test site

Duration of treatment / exposure:

4 hours

Observation period:

Assessed for necrosis and ulceration, immediately after the end of treatment (4 hours) and at 48 hours and 7 days after the start of treatment.

Number of animals:

6

Details on study design:

Area of the back of each rabbit (at least 10% of body surface) was shaved 24 hours prior to treatment. One test site over the mid-line on each rabbit. 0.5 g test material applied to each test site on a gauze pad 2.5 x 2.5 cm. Pads secured with occlusive tape and dressings and left in place for 4 hours.

Assessed for necrosis and ulceration, immediately after the end of treatment (4 hours) and at 48 hours and 7 days after the start of treatment.

No control sites or animals were incorporated into the test

Criteria for classification as corrosive included destruction or irreversible alteration of the tissue, where tissue destruction involved ulceration or necrosis at any reading, not merely sloughing of the epidermis, erthyema, oedema or fissuring.

Results and discussion

In vivo

Results

Irritation parameter:

other: assessment for corrosivity

Basis:

other: assessment of necrosis and ulceration in 6 rabbits

Time point:

other: 4 hours, 48 hours, 7 days

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

Irritation was observed at the 4-hr time point in four animals. After 48 hr this had developed into necrosis in five animals, which was still evident at the end of the observation period. One animal was unaffected by treatment at every time point.

Irritant / corrosive response data:

One animal was unaffected by treatment at every timepoint.
Results from the remaining 5:
At 4 hours, 4/5 animals had skin irritation and 1/5 was unaffected.
At 48 hours, 5/5 animals had at least 1 area of necrotic tissue.
At 7 days, necrosis was maintained in 5/5 animals.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: other: US Federal Register Corrosivity Test (1976)

Conclusions:

In an early US guideline study, irreversible necrosis was observed following a single 4-hr occluded application of chloroplatinic acid to the skin of six rabbits.

Executive summary:

In an early US guideline study, the skin irritant potential of chloroplatinic acid was assessed in six female New Zealand White rabbits. The test material (0.5 g, crystalline solid) was applied to shaved intact skin for 4 hr under occlusion. The sites were assessed for evidence of necrosis or ulceration immediately upon removal of the patch, with further assessments made at 48 hours and 7 days after application of the test material.

 

Irritation was observed at the 4-hr time point in four animals. After 48 hr this had developed into necrosis in five animals, which was still evident at the end of the observation period. One animal was unaffected by treatment at every time point.

 

Based on the results of this study, the test material should be classified as corrosive to skin (at least category 1C) under EU CLP criteria (EC 1272/2008).