Registration Dossier
Registration Dossier
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EC number: 949-588-9 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Enzymatic hydrolysis products of Sargassum hemiphyllum, Sargassum, Sargassaceae.
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)
- IUPAC Name:
- Enzymatic hydrolysis products of Sargassum hemiphyllum, Sargassum, Sargassaceae.
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
Test system
- Vehicle:
- not specified
- Duration of post- treatment incubation (in vitro):
- 4 hours
- Details on study design:
- After the initial incubation, the medium was changed and the baseline opacity for each cornea was recorded. None of the corneas showed tissue damage; therefore, all corneas were used. For each treatment group (negative control solution, test item and positive control), three replicates were used. After removal of the pre-incubation medium (cMEM without phenol red), 750 µL of negative control solution, test item suspension and positive control solution were applied to each replicate.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 8.85
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- other: need further study to confirm the classification
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