Ruthenium trichloride hydrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 April - 14 May 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study conducted according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(guideline deleted 17-Dec-2002)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

(obsolete)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Rutheniumchloride hydrate

IUPAC Name:

Rutheniumchloride hydrate

Constituent 2

Reference substance name:

Ruthenium trichloride hydrate

EC Number:

604-667-4

Cas Number:

14898-67-0

Molecular formula:

RuCl3.xH2O

IUPAC Name:

Ruthenium trichloride hydrate

Details on test material:

- Name of test material (as cited in study report): Ruthenium(III) chloride hydrate

- Substance type: Brown crystals

- Physical state: Solid

- Analytical purity: Metal used for the production of test substance was 99.9% pure

- Impurities (identity and concentrations): No data

- Composition of test material, percentage of components: No data

- Isomers composition: No data

- Purity test date: No data

- Lot/batch No.: 8089/3-07/92

- Expiration date of the lot/batch: Jul-1997

- Stability under test conditions: Stable

- Storage condition of test material: Dry in a closed container in a refrigerator

- Other:
- Solubility: soluble in water
- pH: 1

Test animals

Species:

rat

Strain:

other: Bor: WISW (SPFCpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co. KG., D-33176 Borchen

- Age at study initiation: Males 8 weeks, females 9 weeks

- Weight at study initiation: Males 172-224 g, females 155-186 g

- Fasting period before study: ~16 hours

- Housing: Macrolon cages type II, soft wood granulate HW 300/500W animal bedding, 1/cage

- Diet (e.g. ad libitum): Standard diet, Ssnif(R) special diet for rats, ad libitum

- Water (e.g. ad libitum): Drinking water quality, automatic drinking water system with drinking nipples, ad libitum

- Acclimation period: >=5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 - 22.5

- Humidity (%): 39 - 68

- Air changes (per hr): No data

- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 28-Apr-1993 To: 14-May-1993

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100, 215 and 464 mg/ml

- Amount of vehicle (if gavage): 2.15 ml/kg bw

- Justification for choice of vehicle: No data, but standard vehicle

- Lot/batch no. (if required): No data

- Purity: No data, but deionized water

MAXIMUM DOSE VOLUME APPLIED: 2.15 ml/kg bw

DOSAGE PREPARATION (if unusual): Aqueous solutions were prepared by shaking immediately before dosing

CLASS METHOD (if applicable): Not applicable

Doses:

215, 464 and 1000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:
- Behaviour, general condition and clinical signs: continuously for 4-6 hours after dosing, then once daily
- Mortality: twice daily on working days, otherwise once daily
- Body weight: at start of study and on day 7 and 14 or after death

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs - yes, body weight - yes, organ weights - no, histopathology - no, other - no

Statistics:

Probit analysis for LD50 and 95% confidence limits

Results and discussion

Preliminary study:

None

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

723 mg/kg bw

95% CL:

>= 379 - <= 1 131

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

525 mg/kg bw

95% CL:

>= 272 - <= 1 095

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

595 mg/kg bw

95% CL:

>= 444 - <= 808

Mortality:

Males: 215 and 464 mg/kg bw , 0/5 deaths in each group; 1000 mg/kg bw, 5/5 deaths (1 at 24 hours, 2 at 2 days and 2 at 3 days);
Females: 215 mg/kg bw, 0/5 deaths; 464 mg/kg bw, 2/5 deaths (1 at 3 days and 1 at 9 days); 1000 mg/kg bw, 5/5 deaths (1 at 24 hours, 2 at 2 days, 1 at 3 days and 1 at 4 days)

Clinical signs:

other: 215 mg/kg bw: in all animals, sunken sides, slight hypokinesia; in 2/10 rats stilted/restrained gait; recovery by 24 hours in 9/10 and after 8 days in 1/10; 464 mg/kg bw: in most animals sunken sides, slight hypokinesia, stilted gait, piloerection; in ind

Gross pathology:

464 mg/kg bw: surviving animals - thickened stomach wall, red brown foci/masses in the mucosa
464 and 1000 mg/kg bw; deceased animals - liquid in abdominal and thoracic cavities, black contents in dilated stomachs, hardened intestinal tissue, reddened viscera, discoloured stomach mucosa with focal haemorrhages

Other findings:

- Organ weights: Not done

- Histopathology: Not done

- Potential target organs: Not done

- Other observations: Not done

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

In a guideline study, to GLP, the acute oral LD50 value for ruthenium (III) chloride hydrate was determined to be 595 mg/kg bw in rats.

Executive summary:

The acute toxicity of ruthenium (III) chloride hydrate was investigated in rats, in an OECD Test Guideline 401 study, conducted according to GLP. Animals (5/sex/group) were administered the test substance (in water) by oral gavage at doses of 215, 464 or 1000 mg/kg bw, and observed for up to 14 days.

There were no deaths in the low dose group, while two females died in the mid-dose group and all animals died at the highest tested dose. Clinical signs of toxicity were seen in all treated animals. Gross pathology indicated effects in the stomach mucosa at the higher two doses. The acute oral LD50 was determined (using probit analysis) to be 723 mg/kg bw in male rats (95% CI 379-1131 mg/kg bw), 525 mg/kg bw in females (95% CI 272-1095 mg/kg bw) and 595 mg/kg bw for both sexes combined (95% CI 444-808 mg/kg bw).