Diamminedichloropalladium

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01-15 August 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study, to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

other: Acute dermal toxicity study: limit test

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diamminedichloropalladium

EC Number:

238-269-3

EC Name:

Diamminedichloropalladium

Cas Number:

14323-43-4

Molecular formula:

Cl2H6N2Pd

IUPAC Name:

Diamminedichloropalladium

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Diamminedichloropalladium
- Substance type: Technical product
- Physical state: Solid (yellow powder)
- Analytical purity: >99.5% (Palladium content 50.33%)
- Impurities (identity and concentrations): A certificate of analysis, detailing levels of metals (some present in trace amounts), constitutes Appendix 4 of the study report
- Composition of test material, percentage of components: A certificate of analysis, detailing levels of metals (some present in trace amounts), constitutes Appendix 4 of the study report
- Purity test date: 14 December 2011
- Lot/batch No.: 11011
- Expiration date of the lot/batch: 31 October 2012
- Stability under test conditions: No data
- Storage condition of test material: Controlled Room Temperature (15-25°C, below 70 RH%)

Test animals

Species:

rat

Strain:

other: CRL:(WI) rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Hygienic level at arrival: SPF
- Age at study initiation: Not reported
- Weight at study initiation: Between 222 g and 247 g
- Fasting period before study: None
- Housing: "Standard housing conditions": Individual caging; Type II. polypropylene/polycarbonate cage; Laboratory bedding:
Lignocel(R) Hygienic Animal Bedding produced by J. Rettenmaier & Söhne GmbH&Co.KG
- Diet (e.g. ad libitum): Animals received ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest, Germany ad libitum,
- Water (e.g. ad libitum): tap water from the municipal supply, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Remarks:

But "Sufficient water to damp the material was used to ensure good contact with the skin."

Details on dermal exposure:

TEST SITE
- Area of exposure: the back
- % coverage: approximately 10 % area of the total body surface
- Type of wrap if used: sterile gauze, held in place with a patch of adhesive hypoallergenic plaster, wrapped with semi occlusive plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water at body temperature
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Paste formed: presumably yes - "Sufficient water to damp the material was used to ensure good contact with the skin."

Duration of exposure:

24 hours (occlusive contact)

Doses:

2000 mg/kg bw only

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: on the day of treatment at 1 and 5 hours after application of the test item, and once each day thereafter. Observations included the skin and fur, eyes and mucous membranes, the respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Frequency of weighing: The body weights were recorded on Day 0 (before test item administration) and on Days 7 and 14.
- Necropsy of survivors performed: yes. Macroscopic examination was performed on all animals. All surviving animals were anaesthetised with Euthasol®40% and exsanguinated. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All macroscopic changes were recorded.

Statistics:

None reported.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: CL not applicable

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: CL not applicable

Mortality:

None

Clinical signs:

other: No adverse clinical signs were observed after the treatment with the test item or during the 14-day observation period.

Gross pathology:

There were no macroscopic abnormalities in any animals

Other findings:

No signs of dermal irritation were observed following patch removal or during the 14 day observation period.

Any other information on results incl. tables

There were no control animals; the benchmark by which there was considered to be no effect on body weights is not clear from the study report.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an OECD Test Guideline 402 study, to GLP, there were no deaths over a 2-week observation period following application of neat diamminedichloropalladium for 24 hours under occlusion at a limit dose of 2000 mg/kg bw to the skin of groups of 5 male and 5 female rats.

Executive summary:

In an acute toxicity test by the dermal route, conducted according to OECD Test Guideline 402 and to GLP, groups of 5 male and 5 female rats were dermally exposed to neat diamminedichloropalladium for 24 hours (under occlusion).

There were no deaths, clinical signs, gross pathological effects or indications of skin irritation in any of the animals over a 2 -week post-dose observation period. The acute dermal median lethal dose (LD50) of diamminedichloropalladium is greater than 2000 mg/kg bw in rats.

Based on the results of this study, diamminedichloropalladium does not need classification for acute dermal toxicity according to EU CLP criteria (EC 1272/2008).