Registration Dossier
Registration Dossier
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EC number: 210-719-3 | CAS number: 622-08-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 2018
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-benzyloxyethanol
- EC Number:
- 210-719-3
- EC Name:
- 2-benzyloxyethanol
- Cas Number:
- 622-08-2
- Molecular formula:
- C9H12O2
- IUPAC Name:
- 2-(benzyloxy)ethanol
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- human
Test system
- Controls:
- yes, concurrent no treatment
- yes, concurrent negative control
Results and discussion
In vitro
Results
- Irritation parameter:
- other: TISSUE VIABILITY
- Value:
- ca. 4.04
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test method and test conditions employed the tissues treated with test item benzyl glycol showed a relative percent viability < 60 % hence, it is concluded that the test item was Irritant. According to the test method , the test substance is considered as requiring further testing for resolving between UN GHS categories 1 and 2.
- Executive summary:
The test substance Benzyl Glycok CAS 622 -08 -2 Assay > 99% was subjected to occular irritation assay, conducted according to OECD 492:2018. The test was carried out using Reconstructed human cornea-like Epithelium (RhCE), in duplicate. The exposure of the insert to the test substance was carried out for 30 minutes at 37 +/- 1°C, 5 +/- 1% CO2. After treatment the inserts were rinsed with D-PBS and incubated for 12 minutes at room temperature. Then the inserts were post incubated with assay medium for addtional 120 minutes at 37 +/- 1°C, 5 +/- 1% CO2. Finally, insertes were incubated with MTT solution in order to evaluate cell viability which is a direct measure of the irritant potential of the test substance. Under these conditions, the test substance is identified as requiring further testing for resolving between UN GHs Cat 1 and 2)
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