Registration Dossier
Registration Dossier
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EC number: 214-160-6 | CAS number: 1103-38-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no data to test item given (purity)
- GLP compliance:
- no
Test material
- Reference substance name:
- Barium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate]
- EC Number:
- 214-160-6
- EC Name:
- Barium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate]
- Cas Number:
- 1103-38-4
- Molecular formula:
- C20H14N2O4S.1/2Ba
- IUPAC Name:
- barium(2+) bis(2-[(1E)-2-(2-hydroxynaphthalen-1-yl)diazen-1-yl]naphthalene-1-sulfonate)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10-13 weeks
- Weight (kg) at study initiation: 2.22 male, 2.28 female
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 10h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- 100 mg of the test compound were instilled into the conjunctiual sac of the left eye. The eyelids uere then held closed for 1 second. The right eye serued as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.
- Observation period (in vivo):
- 1, 6, 24, 48 and 72 hours after application
- Number of animals or in vitro replicates:
- 3 per sex
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- see above
SCORING SYSTEM: The ocular reactions uere 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.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 6
- Max. score:
- 110
- Remarks on result:
- other: unwashed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 110
- Remarks on result:
- other: washed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 6h
- Score:
- 6.6
- Max. score:
- 110
- Remarks on result:
- other: unwashed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 6h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: washed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 110
- Remarks on result:
- other: unwashed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.6
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: unwashed
- Irritant / corrosive response data:
- A slight to mild conjunctiual reaction was seen in 5/6 eyes one hour after application the compound. After 5 hours the reaction subsided, washed eyes returning to normal slightly more quickly. All were normal by day 3.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
A slight to mild conjunctiual reaction was seen in 5/6 eyes one hour after application the compound. After 5 hours the reaction subsided, unwashed eyes returning to normal slightly more quickly. All uere normal by day 3.
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