Registration Dossier

Diss Factsheets

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:
2017
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

Constituent 1
Chemical structure
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-(5-tert-Butyl-2-hydroxyphenyl)benzotriazole
Test material form:
solid: particulate/powder

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