Registration Dossier
Registration Dossier
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EC number: 201-506-6 | CAS number: 83-86-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 2020
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Aqua; Water
- Reference substance name:
- Fytic acid
- EC Number:
- 201-506-6
- EC Name:
- Fytic acid
- Cas Number:
- 83-86-3
- Molecular formula:
- C6H18O24P6
- IUPAC Name:
- fytic acid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Biosil PA diluted at 20%
Test animals / tissue source
- Species:
- human
Test system
- Vehicle:
- water
- Controls:
- yes
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- Run 3 : 4 hours
- Value:
- ca. 6
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- Run 2 : 1 hour
- Value:
- ca. 7
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- Run 1 : 20 minutes
- Value:
- ca. 27
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
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