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EC number: 222-164-4 | CAS number: 3375-31-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 January 1989 to 24 January 1989
- 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:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive patch rather than the semi-occlusive one recommended in the guidelines
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive patch rather than the semi-occlusive one recommended in the guidelines
- GLP compliance:
- yes
Test material
- Reference substance name:
- Palladium(II) acetate
- EC Number:
- 222-164-4
- EC Name:
- Palladium(II) acetate
- Cas Number:
- 3375-31-3
- Molecular formula:
- C2H4O2.1/2Pd
- IUPAC Name:
- palladium(II) acetate
- Details on test material:
- - Name of test material (as cited in study report): palladium(II)-acetate trimer
- Substance type: brown powder
- Physical state: solid
- Analytical purity: 47.15% palladium
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Purity test date: no data
- Lot/batch No.: 6597
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable “according to information from the sponsor”
- Storage condition of test material: room temperature
- Other:
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White Russian (albino)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ASTA Pharma AG
D-4800 Bielefeld 14
- Age at study initiation: 10 months
- Weight at study initiation: male 2.75 kg; females 2.37 and 2.70 kg
- Housing: stainless steel cages with grating floor
- Diet (e.g. ad libitum): conventional; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-22.5
- Humidity (%): 40-60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g applied as a paste
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.25 ml to make a paste
- Purity: demineralized - Duration of treatment / exposure:
- 4 hr
- Observation period:
- 1, 24, 48 and 72 hr, then once daily until day 14 post treatment
- Number of animals:
- 3, (1 male, 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm2
- % coverage:
- Type of wrap if used: site covered with a linen patch, kept in place with a synthetic film glue and a bandage wrapped several times around the trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test material gently washed off as far as possible
- Time after start of exposure: 4 hr
SCORING SYSTEM: Assessed for primary irritation at 1, 24, 48 and 72 hrs after removal of the patch using the Draize system of scoring. Scores for erythema/eshcar and oedema at these time points were totalled for all animals and divided by 12 to give the primary irritation index. The test material was classified as follows:
Primary irritation index Classification
0 non-irritant
> 0-2 mild irritant
> 2-5 moderate irritant
> 5-8 severe irritant
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: Mean of 1, 24, 48 and 72 hr time points
- Score:
- 1.3
- Max. score:
- 8
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: Mean of 1, 24, 48 and 72 hr time points
- Score:
- 0.75
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Mean of 1, 24, 48 and 72 hr time points
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- A slight irritant effect (edema, erythema/eschar formation) was observed in the rabbits, 1 day after exposure, which was fully reversible within 7 days (edema) or 8 days (erythema/eschar). In two of the rabbits skin scales were formed but immediately peeled off. No signs of corrosion were observed.
- Other effects:
- No systemic effects were evident
Any other information on results incl. tables
Table 1: Individual irritation scores at each observation time
| Skin reaction | Time after termination of exposure | Draize score | ||
| 1969 | 1994 | 2000 | ||
| Erythema/eschar formation | 1 hr | 0 | 0 | 0 |
| 24 hr | 1 | 1 | 2 | |
| 48 hr | 1 | 1 | 1 | |
| 72 hr | 0 | 1 | 1 | |
| 4 d | 0 | 1 | 1 | |
| 7 d | 0 | 1 | 1 | |
| 14 d | 0 | 0 | 0 | |
| Edema | 1 hr | 0 | 0 | 0 |
| 24 hr | 0 | 1 | 1 | |
| 48 hr | 0 | 1 | 1 | |
| 72 hr | 0 | 1 | 1 | |
| 4 d | 0 | 1 | 1 | |
| 7 d | 0 | 0 | 0 | |
| 14 d | 0 | 0 | 0 | |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guideline study, to GLP, slight irritation was observed following a single 4-hr occluded application of palladium(II)-acetate trimer to the intact skin of three rabbits. The test item would not be classified for skin irritation under EU CLP.
- Executive summary:
The irritant potential of palladium(II)-acetate trimer was assessed in a guideline study, to GLP. The test item (0.5 g as a paste), applied to the intact skin of three White Russian albino rabbits (4-hr occluded), caused slight irritation within 24 hr of removal of the patch.
Edema was observed in two animals which was fully reversible within 7 days after exposure. Erythema/eschar formation which occurred in all three rabbits was fully reversible within 8 days after exposure. The primary irritation index was calculated to be 1.3. The test substance was not corrosive and no systemic effects were observed.
Mean erythema/eschar and edema scores were below 2.3 for all three animals. Accordingly, palladium(II)-acetate trimer does not require classification for skin irritation according to EU CLP criteria (EC 1272/2008).
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