Registration Dossier
Registration Dossier
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EC number: 227-877-4 | CAS number: 6022-22-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions (only 1 animal, no washing).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (only one male animal used; no washing conducted)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disodium 4,4'-diamino-9,9',10,10'-tetrahydro-9,9',10,10'-tetraoxo[1,1'-bianthracene]-3,3'-disulphonate
- EC Number:
- 227-877-4
- EC Name:
- Disodium 4,4'-diamino-9,9',10,10'-tetrahydro-9,9',10,10'-tetraoxo[1,1'-bianthracene]-3,3'-disulphonate
- Cas Number:
- 6022-22-6
- Molecular formula:
- C28H16N2O10S2.2Na
- IUPAC Name:
- disodium 4,4'-diamino-9,9',10,10'-tetraoxo-9,9',10,10'-tetrahydro-1,1'-bianthracene-3,3'-disulfonate
- Details on test material:
- - Physical state: solid
- Analytical purity: 82.9 %
- Lot/batch No.: EN 901700.99
- Stability under test conditions: unknown (excluded from Statement of Compliance)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Fuellinsdorf, Switzerland
- Age at study initiation: 14 weeks
- Weight at study initiation: 2.6 kg
- Housing: individually
- Diet: Pelleted standard Kliba 341, Batch 47/89 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, Kaiseraugst, Switzerland) ad libitum
- Water: Community tap water from Itingen, ad libitum.
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+3°C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 (music at light period)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- see observation period (no washing conducted)
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 1 male animal
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed
SCORING SYSTEM: according to OECD
TOOL USED TO ASSESS SCORE: Eye examinations were made with a slit-lamp 30 SL/M (C. Zeiss AG, Zuerich / Switzerland) and a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel / Switzerland).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects observed
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritant / corrosive response data:
- The test substance showed a primary irritation score of 0.00 when applied to the conjunctival sac of the rabbit eye. No corrosion was observed at any of the measuring intervals. Sclera: generally vessels visible one hour after treatment.
- Other effects:
- A red staining of the conjunctivae and eyelashes of the treated eye by pigment or coloring of the test article was observed during the entire observation period.
No acute clinical symptoms were observed in the animal during the test period, and no mortality occurred. The body weight gain of the rabbit was within physiological limits.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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