Registration Dossier
Registration Dossier
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EC number: 219-470-5 | CAS number: 2440-22-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP, little details on test item
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no housing details provided, body weights not determined before and after study, simultaneous testing in multiple animals
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP requirements.
Test material
- Reference substance name:
- 2-(2H-benzotriazol-2-yl)-p-cresol
- EC Number:
- 219-470-5
- EC Name:
- 2-(2H-benzotriazol-2-yl)-p-cresol
- Cas Number:
- 2440-22-4
- Molecular formula:
- C13H11N3O
- IUPAC Name:
- 2-(2H-1,2,3-benzotriazol-2-yl)-4-methylphenol
- Details on test material:
- - Name of test material (as cited in study report): TK 10047
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Not reported.
- Age at study initiation: Not reported.
- Weight at study initiation: Not reported.
- Housing: Not reported.
- Diet (e.g. ad libitum): Not reported.
- Water (e.g. ad libitum): Not reported.
- Acclimation period: Not reported.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported.
- Humidity (%): Not reported.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): Not reported.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg. - Duration of treatment / exposure:
- Single exposure.
- Observation period (in vivo):
- 7 days.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported.
- Time after start of exposure: Not reported.
SCORING SYSTEM: The method described by J. H. Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics" (p 51) was used.
TOOL USED TO ASSESS SCORE: Not reported.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- -Cornea, iris, and conjunctivae
- Basis:
- mean
- Time point:
- other: 1 day
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: None
- Irritation parameter:
- overall irritation score
- Remarks:
- -Cornea, iris, and conjunctivae
- Basis:
- mean
- Time point:
- other: 2 days
- Score:
- 1
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: None
- Irritation parameter:
- overall irritation score
- Remarks:
- -Cornea, iris, and conjunctivae
- Basis:
- mean
- Time point:
- other: 3 days
- Score:
- < 1
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: None
- Irritation parameter:
- overall irritation score
- Remarks:
- -Cornea, iris, and conjunctivae
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- < 1
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: None
- Irritation parameter:
- overall irritation score
- Remarks:
- -Cornea, iris, and conjunctivae
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: None
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 0-72h
- Score:
- 1
- Max. score:
- 20
- Remarks on result:
- other: no conjunctivae findings in 4 of 6 animals, no separate values for chemosis, redness or discharge given
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: all time points (1,2,3,4 and 7 days)
- Score:
- 0
- Max. score:
- 80
- Remarks on result:
- other: no cornea findings observed in any animal at any time point. This includes chemosis.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: all time points (1,2,3,4 and 7 days)
- Score:
- 0
- Max. score:
- 10
- Remarks on result:
- other: no iris findings observed in any animal at any time point.
- Irritant / corrosive response data:
- Temporary mild conjunctival reactions were observed in two animals only. In the remaining four animals, there was no observed response to treatment.
- Other effects:
- None reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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