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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21-Jul-04 to 04-Aug-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

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: no data
- Physical state: dark green/black crystalline 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.: 60947
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature in the dark
- Other:
- Receipt data: 18-Jun-2004

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: 8-12 weeks
- Weight at study initiation: >=200 g, "the weight variation did not exceed +- 20% of the mean weight for each sex"
- Fasting period before study: no data
- Housing: 5/cage; solid floor polypropylene cages with woodflakes, "the animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study"
- Diet (e.g. ad libitum): Certified Rat and Mouse Diet (Code 5LF2), ad libitum
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: >=5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 20-70
- Air changes (per hr): >=15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 14-Jul-04 To: 22-Jul-04

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

TEST SITE
- Area of exposure: not specified in cm2, but as 10% of total body surface area
- % coverage: 10
- Type of wrap if used: surgical gauze covered with self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with cotton wool moistened with arachis oil
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): moistened with vehicle
- Constant volume or concentration used: yes
- For solids, paste formed: no data, but described as being moistened with vehicle, rather than dissolved in it

VEHICLE
- Amount(s) applied (volume or weight with unit): sufficient to moisten the required weight of test material
- Concentration (if solution): no data, but used to moisten test material, rather than to dissolve it
- Lot/batch no. (if required): no data
- Purity: no data, but described as "arachis oil BP"

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- observervations - 0.5, 1, 2 and 4 hours after dosing, then once daily for 14 days
- body weight - days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal reactions

Statistics:

not done

Results and discussion

Preliminary study:

not applicable

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 examined
- Histopathology: not examined
- Potential target organs: not examined
- Other observations:
- dermal reactions - grey-coloured staining at all treatment sites on day 1

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, conducted to GLP, the acute dermal LD50 of ruthenium acetate in rats was found to exceed 2000 mg/kg bw .

Executive summary:

In an acute dermal toxicity test, conducted according to OECD Test Guideline 402 and to GLP, groups of 5 male and 5 female rats were dermally exposed to ruthenium acetate (moistened with arachis oil) for 24 hr (application to the shaved skin under semi-occlusion). Animals were observed at 0.5, 1, 2 and 4 hr after the start of exposure and then once daily over a 2-week period. There was no control group.

 

There were no deaths, clinical signs, gross pathological effects or indications of skin irritation in any of the animals. The acute dermal LD50 of ruthenium acetate is greater than 2000 mg/kg bw in rats.

 

Based on the results of this study, ruthenium acetate should not be classified for acute dermal toxicity according to EU CLP criteria (EU 1272/2008).