Tetraamminepalladium(2+) diacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 to 21 November 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study, on closely-related surrogate.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Remarks:

individual experimental studies were not inspected for GLP compliance. Inspections of skin irritation studies were reported to be carried out 19-20 February 1981

Test material

Test material information

Constituent 1

Reference substance name:

Tetraamminepalladium dichloride

IUPAC Name:

Tetraamminepalladium dichloride

Constituent 2

Reference substance name:

Tetraamminepalladium(2+) dichloride

EC Number:

237-489-7

EC Name:

Tetraamminepalladium(2+) dichloride

Cas Number:

13815-17-3

Molecular formula:

H8Cl2N4Pd

IUPAC Name:

Tetraamminepalladium(2+) dichloride

Details on test material:

- Name of test material (as cited in study report): tetraamminepalladous chloride
- Substance type: light yellow crystalline powder
- Physical state: solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: 041232
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Nottingham University
School of Agriculture
Sutton Bonington
Leicestershire
UK
- Age at study initiation: no data
- Weight at study initiation: 2.34-3.19 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): conventional, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): no data
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: no concurrent control site

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg moistened with water to make a paste


VEHICLE
no data

Duration of treatment / exposure:

4 hr

Observation period:

72 hr with an additional 7 day observation period if irritation was still apparent at 72 hr

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data
- Type of wrap if used: absorbent lint covered with polythene, secured by adhesive tape. The trunk of each rabbit was wrapped in an elasticated bandage (Tubigrip)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in warm water
- Time after start of exposure: 4 hr

SCORING SYSTEM: assessed at 1, 24, 48 and 72 hr. Scored using the method of Draize (1959) for erythema/eschar formation and edema at all time points and the total scores were divided by 12 to hive the primary irritation index.
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

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: Mean of 1, 24, 48 and 72 hr time points

Score:

0

Max. score:

8

Reversibility:

other: no irritation observed

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: Mean of 1, 24, 48 and 72 hr time points

Score:

0

Max. score:

8

Reversibility:

other: no irritation observed

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: Mean of 1, 24, 48 and 72 hr time points

Score:

0

Max. score:

8

Reversibility:

other: no irritation observed

Irritant / corrosive response data:

None seen at any time point

Other effects:

No indication of whether systemic effects were assessed

Any other information on results incl. tables

Very slight yellowing staining of the test site which did not interfere with the assessment of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a guideline study, no irritation potential was observed when tetraammine palladous chloride was applied (under occlusion for 4 hr) to the intact shaved skin of three rabbits.

Executive summary:

In an OECD Test Guideline 404 study, tetraammine palladous chloride (0.5 g, moistened) was applied (occluded) to the clipped but intact skin of three New Zealand white rabbits. After 4 hours, the dressings were removed and the skin sites assessed for signs of irritation (oedema and erythema/eschar) and corrosion at 1, 24, 48 and 72 hours.

No irritation (erythema/eschar formation or erythema) or corrosion of the skin was seen at any time point during the 72 hr study period. The primary irrational index was therefore 0, and tetraammine palladous chloride is classified as non-irritating.

No skin classification, according to EU CLP criteria (EC 1272/2008), is required on the basis of this study.