Registration Dossier
Registration Dossier
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EC number: 266-405-1 | CAS number: 66557-45-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
- EC Number:
- 258-110-1
- EC Name:
- N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
- Cas Number:
- 52697-38-8
- Molecular formula:
- C18H19BrN6O5
- IUPAC Name:
- N-{2-[(2-bromo-4,6-dinitrophenyl)diazenyl]-5-(diethylamino)phenyl}acetamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Disperse Violet 93:1
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- NZW Albino Rabbits
Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal
Food: mümmel Z
Supplier: sniff Spezialdiaten GmbH, Soest/Westfal
Water: Tap water
Food 100 to 120 g per animal per day; once per day in the morning
water ad libitum
Single housing
Weight: mean 2.2 kg
Acclimation: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 16-18°C
- Humidity: approx. 40 %
- Lighting time: 12 hours daily
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 µL (ca. 10 mg)
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- The eyes were examined 1, 24, 48, 72 hours and 8 days after application of the test substance.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no removal of test substance
- Time after start of exposure: NA
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: ophthalmoscope
fluorescein: at 24 hours the eyes were also examined for corneal lesion under UV light after instillation of one drop of fluorescein solution.
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:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Testing of Disperse Violet 93:1 for primary eye irritation in the rabbit showed, that the substance is not irritating to eyes.
- Executive summary:
100 µL of Disperse Violet 93:1was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.
The treated eyes were examined 1, 24, 48 and 72 hours and 8 days after application of the test substance.
At 24 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of a fluorescein-solution.
According to the study performed, Disperse Violet 93:1 is not irritating to eyes.
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