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EC number: 287-574-8 | CAS number: 85536-87-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from August 15, 1988 to August 18, 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt
- EC Number:
- 287-574-8
- EC Name:
- 7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt
- Cas Number:
- 85536-87-4
- Molecular formula:
- C20H19N3O11S3.xNa C20H(19-x)N3NaxO11S3
- IUPAC Name:
- 7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Orange 72/78
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: about 3-5 months
- Weight at study initiation: 3.3-3.7 Kg
- Housing: In fully air-conditioned rooms in separate cages arranged in a battery
- Diet: Altromin 2123 (Altromin GmbH, Lage/Lippe) ad libitum and hay (approx. 15 g daily)
- Water: water from automatic water dispenser ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Humidity: 50±20 %
- Photoperiod: 12 hours cycle dark/light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- The eyes were examined 1, 24, 48, 72 hours after application of the test substance.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- PREPARATION
About 24 hours before the start of the study the test eyes of all animal were examined under UV light for corneal lesion after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animal without ocular abnormalities were used for the study.
REMOVAL OF TEST SUBSTANCE
- Washing: yes with isotonic saline at 37°C
- Time after start of exposure: 24 hours
TOOL USED TO ASSESS SCORE: fluorescein; at 24 and 72 hours the eyes were also examined for corneal lesion under UV light after instillation of one drop of 0.01% fluorescein-sodium solution.
SCORING SYSTEM: according to OECD guideline 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 and #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- One hour up to 2 days after application the conjunctivae of the animals showed an evident hyperemia of the blood vessels to a diffuse, deeper crimson reddening and a slight to obvious swelling. Additionally a clear, red-orange colored discharge was observed in two animals one hour after application. 3 days after application the signs of irritation were reversible. One hour up to 2 days after application the conjunctivae of the animal showed an evident hyperemia of the blood vessels to a diffuse, deeper crimson reddening and a slight to obvious swelling. Additionally a clear, red-orange colored discharge was observed in two animals one hour after application. 3 days after application the signs of irritation were reversible.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Testing for primary eye irritation in the rabbit showed, that the substance is not irritating to eyes.
- Executive summary:
The test substance was examined for eye irritating effects in rabbit eyes according to OECD testing guideline 405.
About 24 hours before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01 % f1uorescein-sodium solution. Only animals without ocular abnormalities were used for
the study.
100 mg test substance was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.
24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C.
The eyes were examined 1, 24, 48 and 72 hours after application of the test substance.
At 24 and 72 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. Lesions in cornea. iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded.
One hour up to 2 days after application the conjunctivae of the animals showed an evident hyperaemie of the blood vessels to a diffuse, deeper crimson reddening and a slight to obvious swelling. Additionally a clear, red-orange coloured discharge was
observed in two animals one hour after application. Three days after application the signs of irritation were reversible.
Based on the individual scores after 24, 48 and 72 hours, the following mean values were calculated:
Opacity of cornea all animals 0.0; iris all animals 0.0; redness of conjunctiva all animals 0.4; chemosis of conjunctiva all animals 0.0
Hence, the substance is not irritating to the eye.
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