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Registration Dossier
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EC number: 243-325-5 | CAS number: 19800-42-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 05, 1982 to October 08, 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Not conducted under GLP
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)
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]phenol
- EC Number:
- 243-325-5
- EC Name:
- 4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]phenol
- Cas Number:
- 19800-42-1
- Molecular formula:
- C19H15N5O4
- IUPAC Name:
- 4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]phenol
- Test material form:
- solid: particulate/powder
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
- Weight at study initiation: 2.3 - 2.6 kg
- Housing: single
- Diet: EKRA Z 6000 ad libitum
- Water: tap water ad libitum
- Acclimation period: not applicable
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 05 to 08 October 1982
Test system
- Vehicle:
- physiological saline
- Remarks:
- 0.07 mL to form a paste
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg in the conjunctival sac of the left eye
- Duration of treatment / exposure:
- 24 h (following this period, the eyes were flushed with warm physiological saline)
- Observation period (in vivo):
- 1, 7, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- 24 h before the application of the test substance, the eyes were instilled with a fluorescein solution (0.01%) and the eyes were examined by means of UV-light for corneal damages.
In addition corneal damage was investigated after 24 and 72 hours by fluorescein staining.
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:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- 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:
- Two animals at 1 and 7h post - application exhibited conjunctival redness and swelling.
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 irritating to rabbit eye.
- Executive summary:
A study was conducted to determine the eye irritation potential of the test substance according to OECD Guideline 405. Three New-Zealand white rabbits received 100 mg of substance moistened with 0.07 ml saline solution in the conjunctival sac of the left eye. The right eye remained untreated and served as negative control. After 24 h of exposure, the treated eye was gently rinsed with 37°C saline solution and evaluated for effects on iris, cornea and conjunctiva after 1, 7, 24, 48 and 72 h. (Jung, 1982). There were no changes in the iris or cornea of any of the rabbits throughout the study. Conjunctival redness and chemosis (Grade 1 or 2) occurred in two animals 1 and 7 hours after treatment; the symptoms had resolved at the 24 h time point. No other effects were recorded. Under the study conditions, the test substance was therefore considered to be not irritating to rabbit eyes (Jung, 1982).
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