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EC number: 480-890-9 | CAS number: 906532-68-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 480-890-9
- EC Name:
- -
- Cas Number:
- 906532-68-1
- Molecular formula:
- C23H24N6O17S5 · xNa
- IUPAC Name:
- sodium 3,5-diamino-2-[(E)-2-{2-sulfo-4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]-4-[(E)-2-{4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]benzoate
- Details on test material:
- Nature of substance: powder
Constituent 1
Test animals / tissue source
- Species:
- other: Albino rabbit, New Zealand White
Test system
- Amount / concentration applied:
- .1 ML
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- 7 days after dosing
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- 7 days after dosing
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- 7 days after dosing
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks:
- 7 days after dosing
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- 7 days after dosing
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- 7 days after dosing
- Remarks on result:
- other: mean of all observation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 7 days
- Other effects:
- Yellow/orange staining of (peri) ocular tissues by the test
substance was observed throughout the study period.
Yellow/orange staining of the fur on the head and paws, caused by the test substance, was noted during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Executive summary:
Summary from report of the eye irritation
Single samples of approximately 73.2 mg of Everzol Orange ED-G Crude (a volume of approximately 0.1 mL) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 days after instillation.
Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 7 days in all animals.
No radial irritation or corneal opacity was observed and treatment of the eye with 2 % fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage.
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