tetraammine palladium (II) hydrogen carbonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

OECD guideline study to GLP. Limited reporting (e.g. test purity and exposure area)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Tetraammine palladium (II) hydrogen carbonate

IUPAC Name:

Tetraammine palladium (II) hydrogen carbonate

Constituent 2

Reference substance name:

134620-00-1

Cas Number:

134620-00-1

IUPAC Name:

134620-00-1

Details on test material:

- Name of test material (as cited in study report): Tetrammine palladium hydrogen carbonate
- Substance type: no data
- Physical state: no data
- Analytical purity: no data
- Lot/batch No.: 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: David Percival Ltd., Moston, Sanbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.6 and 2.71 kg (females) and 2.69 kg (male)
- Fasting period before study: no data
- Housing: individually housed in suspened metal cages
- Diet (e.g. ad libitum): ab libitum
- Water (e.g. ad libitum): ab libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19
- Humidity (%): 49-56
- Air changes (per hr): about 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: intact

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (moistened with 0.5 ml of distilled water)

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 (2 females and 1 male)

Details on study design:

TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: cotton gauze patch (2.5 x 2.5 cm)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing. Residual test material removed by gentle swabbing with cotton wool soaked in 74% industrial methylated spirits.

SCORING SYSTEM: Individual scores for erythema/eschar and oedema were made for the three rabbits according to the Draize classification scheme at the 1, 24, 48 and 72-hr readings. The mean of the scores at the 24 and 72-hr observations were summed, and divided by 6 to give the primary irritation index.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 1, 24, 48 and 72-hour observations

Score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

female 1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

female 2

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

male

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

female 1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

female 2

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

male

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Irritant / corrosive response data:

No irritation or corrosive effects seen during the study.

Other effects:

Yellow-staining was noted at all treated sites at 1, 24, 48 and 72-hr observations.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an OECD guideline study, to GLP, no irritation was observed when 0.5 g of tetraamminepalladium(II) hydrogen carbonate, moistened in water, was applied (semi-occluded for 4 hr) to the intact shaved skin of three New Zealand white rabbits.

Executive summary:

In an OECD Test Guideline 404 study, to GLP, 0.5 g of tetraamminepalladium(II) hydrogen carbonate, moistened with 0.5 mL of distilled water, was applied (semi-occluded) to the 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.

 

Yellow-staining was noted at all treated skin sites at 1, 24, 48 and 72 hrs. No irritation (erythema/eschar formation or erythema) or corrosion of the skin was seen at any time point during the study period. The primary irritation index was therefore 0, and tetraamminepalladium(II) hydrogen carbonate was classified as non-irritating.

 

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