Hexakis[μ-(acetato-O:O')]-μ3-oxo-triangulo-triruthenium acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06-Nov-1995 to 06-Dec-1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 401)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(deleted 17-Dec-2002)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(now obsolete)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hexakis[μ-(acetato-O:O')]-μ3-oxo-triangulo-triruthenium acetate

EC Number:

259-653-7

EC Name:

Hexakis[μ-(acetato-O:O')]-μ3-oxo-triangulo-triruthenium acetate

Cas Number:

55466-76-7

Molecular formula:

C12H18O13Ru3.C2H3O2

IUPAC Name:

hexamethyl-2λ³-oxa-4λ³-oxa-6λ³-oxa-8λ³-oxa-10λ³-oxa-12λ³-oxa-13λ³-oxa-15λ³-oxa-16λ³-oxa-18λ³-oxa-19λ³-oxa-21λ³,22λ¹-dioxa-1,5,9-triruthenahexacyclo[7.3.3.3¹,⁵.3⁵,⁹.1¹,⁵.0⁹,²²]docosa-3,7,11,14,17,20-hexaene-1,1,1,5,5,5,9,9,9-nonakis(ylium)-2,6,10,13,16,19-hexaide-22,22-diuide acetate

Details on test material:

- Name of test material (as cited in study report): Ruthenium acetate

- Substance type: Black crystalline solid

- Physical state: Solid

- Analytical purity: No data

- 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.: 60350

- Expiration date of the lot/batch: No data

- Stability under test conditions: No data

- Storage condition of test material: Room temperature

- Other:
- Date received: 23-Oct-1995

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent

- Age at study initiation: 5-8 weeks

- Weight at study initiation: Males 150-167 g, females 138-160 g

- Fasting period before study: Yes, overnight

- Housing: Solid-floor polypropylene cages with wood flakes

- Diet (e.g. ad libitum): Rat and mouse expanded diet no. 1, ad libitum

- Water (e.g. ad libitum): Mains drinking water, ad libitum

- Acclimation period: >=5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22

- Humidity (%): 46-59

- Air changes (per hr): ~15

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

IN-LIFE DATES: From: 06-Nov-1995 To: 06-Dec-1995

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml

- Amount of vehicle (if gavage): 10 ml/kg bw

- Justification for choice of vehicle: none stated, but well-known vehicle


- Purity: not stated, but distilled water

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

Single dose: 2000 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:
- Observation for deaths or overt signs of toxicity: 0.5, 1, 2 and 4 hours after dosing, then once daily for 14 days
- Body weights: days 0, 7 and 14 of the study

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs (overt signs of toxicity and behavioural and clinical observations) and body weight

Statistics:

An estimate of the acute oral medial lethal dose (LD50) was made using mortality data from the study

Results and discussion

Preliminary study:

1 male and 1 female were dosed at 2000 mg/kg bw and observed for 5 days. As no toxicity was observed, a dose of 2000 mg/kg bw was selected for the main study.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths

Clinical signs:

other: No signs of systemic toxicity

Gross pathology:

No abnormalities

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:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a guideline study, to GLP, the acute oral LD50 of ruthenium acetate in rats was >2000 mg/kg bw .

Executive summary:

Ruthenium acetate was tested for its acute oral toxicity in rats, according to OECD Test Guideline 401. Following a range-finding study in which no toxicity was observed at 2000 mg/kg bw, the main study was performed at this dose level (limit test). Sprague-Dawley rats (5/sex) were administered the test substance by gavage in water at 2000 mg/kg bw and subsequently observed for 14 days.

 

There were no deaths, no overt signs of toxicity, no effect on body weight and no abnormalities were seen at necropsy. The acute oral LD50 of ruthenium acetate in rats was >2000 mg/kg bw under the conditions of the test.

 

Based on the results of this study, the test item should not be classified for acute oral toxicity according to EU CLP criteria (EC 1272/2008).