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Toxicological information

Eye irritation

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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:
1989
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

Constituent 1
Chemical structure
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)

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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