Registration Dossier
Registration Dossier
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EC number: 924-436-4 | CAS number: 68038-65-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 Days
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 491 (Short Time Exposure In Vitro 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
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bacillus Ferment Filtrate Extract
- EC Number:
- 924-436-4
- Cas Number:
- 68038-65-3
- Molecular formula:
- Not Available
- IUPAC Name:
- Bacillus Ferment Filtrate Extract
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- other: Medium Control
- Amount / concentration applied:
- 0.05% and 5.0%
- Number of animals or in vitro replicates:
- 3-replicates wells
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Relative cell viability
- Value:
- >= 23.22 - <= 80.95
- Vehicle controls validity:
- valid
- Negative controls validity:
- not valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No prediction an made
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- No prediction can be made for Bacillus Coagulans.
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