Disodium tetrachloropalladate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data (report date is March 1978)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Early study, pre-GLP, but scientifically acceptable

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Standard acute method, to assess the acute oral toxicity of the test

GLP compliance:

no

Remarks:

(prior to GLP)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 002

Cas Number:

13820-53-6

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): sodium chloropalladite
- Substance type: brown powder
- Physical state: solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data; (supplied in screw-capped glass jar)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Olac (1976) Ltd
Shaws Farm
Blackthorn
Bicester
Oxon
UK
- Age at study initiation: no data
- Weight at study initiation: males mean 215 g; females mean 180 g
- Fasting period before study: overnight
- Housing: polypropylene cages
- Diet (e.g. ad libitum): conventional; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): “thermostatically controlled”
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): “controlled”

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: no data
- Lot/batch no. (if required):
- Purity: water for injection

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

500 mg/kg bw (main study)
25, 50, 200, 500 and 2000 mg/kg bw (range-finding study)

No. of animals per sex per dose:

5/sex (main study)
1/sex/dose (range-finding study)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at 4 hr, then daily. Weighed prior to dosing.
- Necropsy of survivors performed: no
- Other examinations performed: none

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 500 - < 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: CL not determined

Mortality:

At 2000 mg/kg bw both animals died; the female within 24 h and the male after 6 days. All animals dosed at 500 mg/kg bw survived the observation period.

Clinical signs:

other: No overt signs of toxicity were observed in animals treated at 500 mg/kg bw. Symptoms occurring before death in the two animals dosed at 2000 mg/kg bw are not reported.

Gross pathology:

There is no indication that gross pathology was examined

Other findings:

- Other observations: none

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

An acute oral LD50 value of between 500 and 2000 mg/kg bw was determined for disodium tetrachloropalladate in male and female rats.

Executive summary:

In an early pre-GLP study, disodium tetrachloropalladate was assessed for acute oral toxicity after single gavage administration in rats. The test substance, available as a brown powder, was given as an aqueous solution at doses of 25-2000 mg/kg bw to one rat of each sex in a range-finding study. A dose of 500 mg/kg bw was administered to groups of five male and female rats in the main study. Body weights were not recorded, except prior to dosing.

 

Both animals died after exposure to 2000 mg/kg bw, the female within 24 hr and the male after 6 days. No clinical signs were reported for either the deceased animals or the rats dosed at 25-500 mg/kg bw which survived the observation period.

 

In the main study in which animals were exposed to 500 mg/kg bw, all survived the 14-day observation period. There were no overt signs of toxicity at this dose level. Necropsies were not performed.

 

An acute oral LD50 value of between 500 and 2000 mg/kg bw was determined for disodium tetrachloropalladate in male and female rats. Based on the results of this acute oral rat study, disodium tetrachloropalladate should be classified for acute oral toxicity (category 4) according to EU CLP criteria (EC 1272/2008).