Palladium (II) di(4-oxopent-2-en-2-oate)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 February to 6 March 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Palladium (II) di(4-oxopent-2-en-2-oate)

EC Number:

237-859-8

EC Name:

Palladium (II) di(4-oxopent-2-en-2-oate)

Cas Number:

14024-61-4

Molecular formula:

C10H14O4Pd

IUPAC Name:

Palladium (II) di(4-oxopent-2-en-2-oate)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material: Palladium (II) di(4-oxopent-2-en-2-oate)
- Substance type: No data
- Physical state: Yellow solid
- Analytical purity: 100%
- Impurities (identity and concentrations): Platinum at 40 ppm, iridium, antimony and silicon at <10 ppm, rhodium at 6 ppm, manganese and tin at <5 ppm, ruthenium, gold, silver, aluminium, cobalt, copper, iron, magnesium, lead and zinc at <2 ppm, calcium, chromium and nickel at <1 ppm
- Composition of test material, percentage of components: Palladium concentration: 34.98%
- Isomers composition: No data
- Purity test date: 29 May 2013
- Lot/batch No.: 21613
- Expiration date of the lot/batch: June 2014
- Stability under test conditions: No data
- Storage condition of test material: Controlled room temperature (15-25°C, below 70% relative humidity), under inert gas

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories S.r.l., S.Pietro al Natisone (UD), Zona Industriale Azzida, 57, 33040, Italy
- Age at study initiation: "Young adult rats"
- Weight at study initiation: 200-254 g
- Fasting period before study: No data
- Housing: Individually in polypropylene/polycarbonate cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4-22.7
- Humidity (%): 31-45%
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 12 February 2014 To: 4-6 March 2014

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: No data
- % coverage: About 10%
- Type of wrap if used: Sterile gauze pad covered in a patch with an adhesive hypoallergenic plaster. The entire trunk of the animal was wrapped in a semi-occlusive plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With water (at body temperature) at the end of the exposure period
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: No data
- For solids, paste formed: Dampened with water

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations at 1 and 5 hours after treatment, then once daily. Body weight recorded just before treatment (day 0) and on study days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, skin irritation, body weight

Statistics:

Not performed

Results and discussion

Preliminary study:

Not performed

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortalities seen

Mortality:

No deaths were seen.

Clinical signs:

other: At 2000 mg/kg bw, the test item caused slightly decreased activity and a hunched back in four animals (2 females and 2 males) and piloerection in one male. All animals were symptom free from 10 days after the treatment until the end of the observation per

Gross pathology:

No adverse findings observed.

Other findings:

- Other observations: Yellowish staining was observed on the treated skin in all animals after treatment.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a limit test conducted according to OECD Test Guideline 402, and to GLP, the acute dermal LD50 in rats of palladium di(4-oxopent-2-en-2-oate) following 24-hr skin contact was more than 2000 mg/kg bw .

Executive summary:

In a limit test performed in accordance with OECD Test Guideline 402 and to GLP, young Wistar rats (5/sex) were given a 24-hour semi-occlusive application of palladium di(4-oxopen-2-en-2-oate) at 2000 mg/kg bw (dampened with water to ensure good contact with the skin). Animals were observed for 14 days after treatment for deaths, as well as changes in body weight and clinical signs of toxicity. At necropsy, any gross abnormalities were reported.

 

No deaths were seen over the 14-day observation period; the acute dermal LD50 was determined to be more than 2000 mg/kg bw. Based on the results of this study, classification for acute dermal toxicity under the EU CLP regulation would not be required for the test compound.