Registration Dossier
Registration Dossier
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EC number: 235-558-6 | CAS number: 12286-66-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read across substance, no inormation about test substance, in life dates not given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: see below
- Principles of method if other than guideline:
- "Hazardous Substances Regulations" under the U.S.A. Federal- Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with
slight modification - GLP compliance:
- not specified
Test material
- Reference substance name:
- 5280-70-6
- Cas Number:
- 5280-70-6
- IUPAC Name:
- 5280-70-6
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Californian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hylyne Commercial Rabbits Ltd.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.21 kg male, 2.11 kg female
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): sterile water ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 +/- 1
- Humidity (%): 50-70
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 10h, 8-18.00 o`clock
IN-LIFE DATES: From: To:
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
- Concentration (if solution): / - Duration of treatment / exposure:
- unwashed 72h, washed after 30 sec
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 3 per sex
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 200 ml warm water
- Time after start of exposure: 30sec
SCORING SYSTEM: scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 3
- Remarks on result:
- other: washed and unwashed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 3
- Remarks on result:
- other: unwashed eye
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: washed and unwashed eyes
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness, chemosis and discharge
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: washed and unwashed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: washed and unwashed eyes
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: unwashed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: washed and unwashed
- Irritant / corrosive response data:
- Con.junctiva
Reactions were slight in 3/3 unwashed and 3/3
washed eyes at 1 hour. Improvement was apparent at 24- hours and 1/3
washed eyes was normal. At 48 hours 1/3 unwashed and 1 /3 washed
eyes were normal. All eyes were normal at 72 hours.
Cornea
Slight opacity and damage to the surface
epithelium was seen in all eyes at 1 hour. At 24 hours 3/3
washed and 2/3 unwashed eyes were normal. All eyes were normal
at 48 hours.
There was very little difference between the reactions in unwashed
and washed eyes.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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