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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09-Nov-1995 to 12-Nov-1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 404)

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(occlusive)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(occlusive)

GLP compliance:

yes (incl. QA statement)

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: not stated

- Impurities (identity and concentrations): not stated

- Composition of test material, percentage of components: not stated

- Isomers composition: not stated

- Purity test date: not stated

- Lot/batch No.: 60350

- Expiration date of the lot/batch: not stated

- Stability under test conditions: not stated

- Storage condition of test material: room temperature

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

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK

- Age at study initiation: 12-16 weeks

- Weight at study initiation: 2.38-2.48 kg

- Housing: individually in suspended metal cages

- Diet (e.g. ad libitum): Stanrab SQC rabbit diet, ad libitum

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

- Acclimation period: >=5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-18

- Humidity (%): 56-65

- Air changes (per hr): ~15

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

IN-LIFE DATES: From: 09-Nov-1995 To: 12-Nov-1995

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

- Concentration (if solution): not applicable, crystalline solid moistened with water

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml

- Concentration (if solution): not applicable, solid test material moistened with water

- Lot/batch no. (if required): not applicable

- Purity: not stated, distilled water

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm2

- % coverage: not stated

- Type of wrap if used: cotton gauze patch (2.5 cm x 2.5 cm) secured with Blenderm (2.5 cm x 4.0 cm) (note: this is an occlusive tape), trunk wrapped in an elasticated Tubigrip corset

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, gentle swabbing with cotton wool soaked in distilled water, followed by 74% Industrial Methylated Spirits

- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize (erythema and eschar 0-4, oedema 0-4; primary irritation index calculated as total of scores for both endpoints, for both timepoints, for all 3 rabbits (12 values) divided by 6; classification according to Draize scheme)

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24- and 72-hour timepoints combined

Score:

0

Max. score:

8

Reversibility:

other: not applicable

Irritant / corrosive response data:

No skin reactions (erythema or oedema) were seen at any timepoint (1, 24, 48 and 72 hours after removal of patches) in any of the 3 test animals; scores of 0.0 were recorded on each occasion giving a primary irritation index of 0.0

Other effects:

Faint green/black staining at all treatments sites

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a guideline study, to GLP, no irritation potential was observed when ruthenium acetate was applied (under occlusion for 4 hr) to the clipped, intact skin of three rabbits.

Executive summary:

In an OECD Test Guideline 404 study, conducted according to GLP, ruthenium acetate (0.5 g, moistened with 0.5 mL water) was applied (occluded) to the clipped intact skin of 3 New Zealand White rabbits. After 4 hours, the dressings were removed and the treated skin sites were washed and subsequently observed for erythema and oedema 1, 24, 48 and 72 hours.

 

No skin reactions were recorded at any time point in any animal during the 72-hr observation period. The primary dermal irritation index was therefore 0, and ruthenium acetate was classified as a non-irritant to rabbit skin under the conditions of the test.

 

No skin classification, according to EU CLP criteria (EC 1272/2008), is required on the basis of this study.