Registration Dossier
Registration Dossier
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EC number: 221-574-0 | CAS number: 3147-76-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 march 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(2H-benzotriazol-2-yl)-4-tert-butylphenol
- EC Number:
- 221-574-0
- EC Name:
- 2-(2H-benzotriazol-2-yl)-4-tert-butylphenol
- Cas Number:
- 3147-76-0
- Molecular formula:
- C16H17N3O
- IUPAC Name:
- 2-(2H-1,2,3-benzotriazol-2-yl)-4-tert-butylphenol
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: local abattoir
- Number of animals: 3 tissues per study group
- Characteristics of donor animals: age 12 to 60 months old
- Storage, temperature and transport conditions of ocular tissue: transported to the test facility over ice packs on the same day of slaughter
- Time interval prior to initiating testing: The corneas were prepared immediately on arrival.
- indication of any existing defects or lesions in ocular tissue samples: only corneas free of damage were used.
- Indication of any antibiotics used: penicillin at 100 IU/mL and streptomycin at 100 µg/mL
Test system
- Vehicle:
- physiological saline
- Amount / concentration applied:
- 0.75 mL of 20% w/v solution in sodium chloride 0.9% w/v
- Duration of treatment / exposure:
- 240 minutes
- Number of animals or in vitro replicates:
- 3 corneas per test group
- Details on study design:
- TEST ITEM
- Batch: 02002IX3
- Purity: 99.9%
- Physical state/Appearance: white powder
- Expiry Date: 25 August 2017
- Storage Conditions: room temperature in the dark
NEGATIVE CONTROL USED
- Sodium chloride 0.9% w/v
Lot: 3012488
Purity: 0.9%
Expiry Date: 01 Nov018
Storage Conditions: room temperature
POSITIVE CONTROL USED
- Imidazole
- 20% w/v solution in sodium chloride 0.9% w/v.
- Batch: 163571
- Purity: ≥99%
- Expiry Date:01 May 2019
- Storage Conditions:room temperature in the dark
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 3
- POST-EXPOSURE INCUBATION: yes. 90 minutes
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: calibrated opacitometer
- Corneal permeability: Optical density at 492 nm (OD492) was measured using the Camspec Model M108 Spectrophotometer.
- Others: The corneas were retained after testing for possible conduct of histopathology
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
In Vitro Irritancy Score = mean opacity value + (15 x mean permeability OD492 value)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 1.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- mean
- Value:
- 0.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Permeability (OD)
- Run / experiment:
- mean
- Value:
- 0.012
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No category. Not requiring classification to UN GHS or EU CLP
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