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Registration Dossier
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EC number: 303-161-8 | CAS number: 94158-87-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April/May 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
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)
- GLP compliance:
- not specified
- Remarks:
- but parallel running acute oral study was conducted under GLP
Test material
- Reference substance name:
- 4-[[2-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1,3-dioxobutyl]amino]-5-methoxy-2-methylbenzenesulphonic acid, sodium salt
- EC Number:
- 303-161-8
- EC Name:
- 4-[[2-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1,3-dioxobutyl]amino]-5-methoxy-2-methylbenzenesulphonic acid, sodium salt
- Cas Number:
- 94158-87-9
- Molecular formula:
- C22H(27-x)N3NaxO14S3 x<=2 C22H27N3O14S3.xNa
- IUPAC Name:
- 4-[[2-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1,3-dioxobutyl]amino]-5-methoxy-2-methylbenzenesulphonic acid, sodium salt
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Yellow 160
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, Kastengrung, konventionelle Zucht
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.5 - 3.0 kg
- Housing: single
- Diet (e.g. ad libitum): Altromin 2013 Zuchtdiät - Kaninchen (Altromin GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): deionized (ad libitum)
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From April 12 to April 15,1983
Test system
- Vehicle:
- physiological saline
- Remarks:
- pasted with 0.04 mL
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, 72 hours
0, 24, 72 h under UV light after fluorescein instillation - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): ca 37°C warm physiological saline
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein, UV light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- 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
- Irritant / corrosive response data:
- The florescein test was negatve on all occasions. Slight effects on conjunctiva (and iris) were only observed 1 hour after test item application.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was determined to be not irritant to rabbit eye.
- Executive summary:
A study was conducted to determine the in vivo eye irritation potential of the test substance according OECD Guideline 405 and EU Method B.5. Three rabbits (New-Zealand White) were exposed to the test substance for 24 h. The observation period covered the following 72 h. Conjunctival redness and swelling, as well as cornea opacity and iris irritation were assessed in the rabbits. The mean score at 24, 48, and 72 h after test substance application for all parameters were 0. Under the study conditions, the test substance was determined to be not irritating to rabbit eye.
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