Registration Dossier
Registration Dossier
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EC number: 811-683-7 | CAS number: 1799707-26-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 April 2016 to 28 April 2016
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- yes
- Remarks:
- One of the negative control eyes was excluded from the analysis since a spot was present after the incubation which resulted in an IVIS >3. This result does not affect the study outcome.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,1'-(1-phenylethane-1,1-diyl)bis[4-(heptyloxy)benzene]
- EC Number:
- 811-683-7
- Cas Number:
- 1799707-26-8
- Molecular formula:
- C34H46O2
- IUPAC Name:
- 1,1'-(1-phenylethane-1,1-diyl)bis[4-(heptyloxy)benzene]
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Isolated bovine cornea
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 μl
- Duration of treatment / exposure:
- 10 ± 1 minutes at 32 ± 1°C
- Duration of post- treatment incubation (in vitro):
- 120 ± 10 minutes at 32 ± 1°C
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 2.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material did not induce ocular irritation under the conditions of this study.
- Executive summary:
In an in vitro eye corrosion/irritation study, isolated bovine cornea was exposed to undiluted substance for 10-minutes. The in vitro irritation score was 2.3% and so the substance is considered to be a non-irritant to the eye.
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