Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 September 1989 - 18 December 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:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Tetrakis(triphenylphosphine)palladium(0)

- Physical state: yellow crystals

- Composition of test material, percentage of components: 9% Pd

- Lot/batch No.: Order 23819

- Stability under test conditions: Not indicated by sponsor
- Storage condition of test material: Kept in closed container (under nitrogen) at room temperature

Test animals

Species:
rabbit
Strain:
other: White Russian (albino)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ASTA Pharma AG, D-4800 Bielefeld 14
- Age at study initiation: 11 months
- Weight at study initiation: 2.68 - 2.75 kg
- Housing: Stainless steel cages with grating floor
- Diet (e.g. ad libitum): approx 120 g/day standard diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: I day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 45 - 65
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To:

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped free of hair 1 day before treatment
Vehicle:
water
Remarks:
Test substance moistened
Controls:
other: control site opposite was treated in the same way but without test substance
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.43 ml water
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after the end of treatment
Number of animals:
3
Details on study design:
Application sites on the dorsal skin were clipped free of hair 1 day prior to treatment; after application of the test substance, the test site was completely occluded; a control site opposite was treated in the same way but without test substance; at the end of the exposure, the skin was gently washed; observations of the treated skin were made 1, 24, 48 and 72 hours after the end of treatment; animals were observed for signs of systemic toxicity for 3 days post-application; irritation index calculated from the sum of the arithmetic means for erythma and oedema for the 4 time points; a descriptive grade was allocated according to the score

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Remarks on result:
other: Reversibility not applicable
Irritant / corrosive response data:
No erythema and no oedema were seen on the skin of any rabbit at any timepoint; treated skin was discoloured yellow due to the colour of the test substance
Other effects:
Systemic toxic effects did not occur after dermal application of the test substance. The general condition of the test animals was not affected.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a guideline GLP study, no irritation was observed following a single 4-hr occluded application of tetrakis(triphenylphosphine) palladium to the intact skin of three rabbits.
Executive summary:

The skin irritant potential of tetrakis(triphenylphosphine) palladium was assessed in a study conducted according to OECD Test Guideline 404 and to GLP.

 

No irritation was observed when 0.5 g of the test substance, moistened with water, was applied as a 4 hour occluded patch to the intact skin of three female White Russian (albino) rabbits, and observed at 1, 24, 48 and 72 hours following removal of the patch. The primary dermal irritation index was 0.

 

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