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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
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

Constituent 1
Chemical structure
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:
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 period.
Body weight:
Body weight loss was seen in 1 male (-3 g) and two females (-48 and -29 g) between days 0 and 7. Animals gained weight for the remainder of the study.
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.