Disodium tetrachloropalladate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 days; no data on actual dates

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Conducted according to US CFR (1973) guidelines, pre-GLP, but 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 Federal register Vol. 38, No. 187, section 1500:41 (1973)

Deviations:

no

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 002

Cas Number:

13820-53-6

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): sodium chloropalladite
- Substance type: brown powder
- Physical state: solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Purity test date: no data
- Lot/batch No.: 041118/A
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: supplied in closed glass jar; no further details

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: “recognised breeder”
- Age at study initiation: 14-16 weeks
- Weight at study initiation: mean 2.2 kg
- Housing: no data
- Diet (e.g. ad libitum): conventional; ad libitum
- Water (e.g. ad libitum): filtered water; ad libitum
- Acclimation period: no details

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): natural lighting
report states “environmentally controlled room”

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: shaved and (on one side) abraded

Vehicle:

unchanged (no vehicle)

Controls:

other: no concurrent control site

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg (no data if applied as the powder or made into a paste)

Duration of treatment / exposure:

24 hr

Observation period:

24 and 72 hr

Number of animals:

6 females

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm2 each of shaved dorsal skin and shaved and abraded dorsal skin
- % coverage: about 5% each intact and abraded
- Type of wrap if used: gauze pad, secured by adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no removal of test substance
- Time after start of exposure:

SCORING SYSTEM: assessed for primary irritation index at 24 and 72 hr using the Draize method of scoring. Scores for erythema/eschar formation and edema for both intact and abraded skin at both time points were totalled and divided by 24 to give 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 24 and 72 hr time points

Score:

0

Max. score:

8

Reversibility:

other: not relevant

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: Mean of 24 and 72 hr time points

Score:

0

Max. score:

8

Reversibility:

other: not relevant

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: Mean of 24 and 72 hr time points

Score:

0

Max. score:

8

Reversibility:

other: not relevant

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No irritant effects were observed; no indication that corrosivity was assessed

Other effects:

No indication that systemic effects were assessed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No irritation was observed following a 24-hr semi-occluded application of disodium tetrachloropalladate (500 mg) to the intact or abraded skin of six rabbits.

Executive summary:

In an early pre-GLP study, conducted according to US CFR guidelines, the irritant potential of disodium tetrachloropalladate, available as a brown powder, was assessed on the shaved intact and abraded skin of six New Zealand white rabbits.

 

In a 24 hr semi-occluded patch test, 500 mg of the test substance did not cause any irritation to either intact or abraded skin when assessed immediately on removal of the patch and 48 hr later. Residual test material was not washed off the skin during this period. As such, no classification for skin irritancy is required according to EU CLP criteria (EC 1272/2008).