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EC number: 259-653-7 | CAS number: 55466-76-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20-Nov-1995 to 25-Dec-1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 406)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study conducted in 1996
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Ltd, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 380-431 g
- Housing: singly or in pairs in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Guinea pig FD1 diet, ad libitum
- Water (e.g. ad libitum): mains tap water, ad libitum
- Acclimation period: >=5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 47-60
- Air changes (per hr): ~15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 20-Nov-1995 To: 25-Dec-1995
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 0.05% w/v in water, 0.05% w/v in Freund's Complete Adjuvant:water (1:1)
Topical induction: 50% w/v in water
Topical challenge: 25% and 10% in water
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 0.05% w/v in water, 0.05% w/v in Freund's Complete Adjuvant:water (1:1)
Topical induction: 50% w/v in water
Topical challenge: 25% and 10% in water
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
For intradermal induction:
- Test material concentrations: 0.01, 0.05, 0.1, 0.5, 1 and 5%
- Vehicle: water
- No. animals/concentration: 1
- Injection volume: 0.1 ml
- Timepoints for assessment: 24, 48 and 72 hours and 8 days after injection
- Evaluation parameters: erythema using Draize scale, systemic toxicity
- Interpretation criteria: highest concentration that caused mild/moderate skin irritation and well tolerated systemically selected for main study
- Results: selected concentration 0.05%
For topical induction:
- Preparation of animals: intradermal injection with Freund's Complete Adjuvant (FCA) 18 days previously
- Test material concentrations: 5, 10, 25 and 50%
- Vehicle: water
- No. animals: 2, each treated with 4 concentrations
- Conditions of exposure: occlusive, 48 hours
- Timepoints for assessment: 1, 24 and 48 hours after end of exposure
- Evaluation parameters: erythema and oedema
- Interpretation criteria: highest concentration that caused mild/moderate skin irritation selected for main study
- Results: selected concentration 50%
For topical challenge:
- Preparation of animals: as for control animals in main study up to day 14
- Test material concentrations: 5, 10, 25 and 50%
- Vehicle: water
- No. animals: 2, each treated with 4 concentrations
- Timepoints for assessment: 1, 24 and 48 hours after end of exposure
- Interpretation criteria: highest non-irritant concentration selected for main study
- Results: selected concentrations 25 and 10%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2, 1 intradermal, 1 topical
- Exposure period: 48 hours (topical)
- Test groups: 1 group of 10 animals
- Control group: 1 group of 5 animals
- Site: shoulder, hair clipped from an area ~4 cm x ~6 cm
- Frequency of applications: weekly (intradermal on study day 0, topical on study day 7)
- Duration: not applicable (details of exposure as above)
- Concentrations:
- Intradermal injection at 3 sites: a) FCA: water (1:1), b) 0.05% test material in water, c) 0.05% test material in FCA: water (1:1)
- Topical application across same sites: 50% test material in water (v/v) applied on filter paper ~4 cm x ~ 2 cm
- Similarly for control animals with the omission of the test material
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Study day 21
- Exposure period: 24 hours
- Test groups: 1 group of 10 animals, each tested with 25% and 10%
- Control group: 1 group of 5 animals, each tested with 25% and 10%
- Site: flank (right 25%, left 10%)
- Concentrations: 25% and 10% in water (applied on filter paper ~2 cm x ~2 cm)
- Evaluation (hr after challenge): 24 and 48 hours
OTHER:
- Body weight: recorded on day 0 and 24 of the main study - Challenge controls:
- 5
- Positive control substance(s):
- yes
- Remarks:
- historical data, various substances
Results and discussion
- Positive control results:
- In 5 studies performed at the testing laboratory between March 1994 and August 1995, the incidence of skin sensitisation with the positive control material ranged from 39 to 100%; the positive control materials used were 2-mercaptobenzothiazole, ethyl 4-aminobenzoate, 2,4-dinitrochlorobenzene and neomycin sulphate
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Body weight gains were comparable in the test and control groups over the 24-day period of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guideline in vivo guinea pig maximisation test (GPMT), to GLP, ruthenium acetate exhibited mild sensitising potential, but did not meet the EU criteria for classification as a skin sensitiser.
- Executive summary:
The skin sensitisation potential of ruthenium acetate was evaluated in a guinea pig maximisation test (GPMT), conducted according to OECD guideline 406, and to GLP. Following sighting tests to establish appropriate induction and challenge doses, a group of 15 guinea pigs (10 test and 5 control) was used for the main study. Intradermal induction with the test material at 0.05% in water (with and without Freund's Complete Adjuvant) was followed 1 week later by a 48-hour topical induction with the test material at 50% in water; controls received vehicle only. Challenge doses of 10 and 25% (in water) were applied (for 24-hr) to all test and control animals on day 21, and the skin was evaluated 24 and 48 hr later.
A single animal showed a reaction to the 25% challenge concentration at both time points; there were no reactions at the 10% challenge, or in controls at either time point. The test substance gave a 10% sensitisation response at the challenge concentration of 25%, making it a mild sensitiser.
Since a 30% sensitisation response is required for classification under EU CLP criteria (EC 1272/2008), the test substance is not classified as a skin sensitiser.
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