Registration Dossier
Registration Dossier
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EC number: 259-653-7 | CAS number: 55466-76-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22-Nov-1995 to 23-Nov-1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 405)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- 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
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.72 kg
- Housing: singly in a suspended metal cage
- 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 (%): 68-69
- Air changes (per hr): ~15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 22-Nov-1995 To: 23-Nov-1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
- Concentration (if solution): not applicable
VEHICLE
Not applicable - Duration of treatment / exposure:
- Test substance not washed from eyes, but presumably physiological mechanisms acted to remove it; eyes examined at 1 and 24 hours
- Observation period (in vivo):
- 24 hours
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure: not applicable
SCORING SYSTEM: Draize
- cornea (degree of opacity 0-4, area of opacity 1-4, total = 5 x product of scores (max 80))
- iris (0-2, total = 5 x score (max 10))
- conjunctivae (redness 0-3, chemosis 0-4, discharge 0-3, total = 2 x sum of 3 scores (max 20))
- maximum total score 110
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- ca. 17
- Max. score:
- 110
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- ca. 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- ca. 5
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- ca. 12
- Max. score:
- 20
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- ca. 63
- Max. score:
- 110
- Reversibility:
- other: animal humanely killed at 24 hours
- Remarks on result:
- other: severe irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- ca. 40
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- ca. 5
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- ca. 18
- Max. score:
- 20
- Irritant / corrosive response data:
- At 1 hour: cornea 0 (degree of opacity 0 with dulling of the normal lustre of the corneal surface and black-coloured staining, area of opacity 4), iris 5 (1 with black-coloured staining), conjunctivae 12 (redness 2 with black-coloured staining, chemosis 2, discharge 2 with residual test material around eye), total 17;
At 24 hours: cornea 40 (degree of opacity 2 with black-coloured staining, area of opacity 4), iris 5 (1 with black-coloured staining), conjunctivae 18 (redness 2 with black-coloured staining, chemosis 4, discharge 3 with residual test material around eye) - Other effects:
- Signs of pain and discomfort at 24 hours (therefore animal killed for humane reasons)
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In a guideline eye irritation study, according to GLP, ruthenium acetate (0.1 g) produced severe eye irritation following instillation into the eye of a single rabbit.
- Executive summary:
In an in vivo rabbit eye irritation study, conducted in accordance with OECD Test Guideline 405 and to GLP, ruthenium acetate (0.1 g) was instilled into one eye of a single New Zealand white rabbit. Observations of the cornea, iris and conjunctiva were made at 1 and 24 hr after application and the Draize scale was used to assess the degree of irritation.
The total eye irritation score was 17 (out of 110) at 1 hr and 63 (out of 110) at 24 hr. Due to signs of pain and discomfort the animal was killed immediately after the 24-hr time point and no further animals were tested. The 24-hr score indicated that the test substance was a severe eye irritant.
As the results were based on only one rabbit, it is not possible to give a definitive interpretation according to EU CLP criteria (EC 1272/2008). However, it is considered appropriate to classify the test material for serious eye damage (Category 1), as the severe effects observed are not expected to be reversible.
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