Registration Dossier
Registration Dossier
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EC number: 924-436-4 | CAS number: 68038-65-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 93 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 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- other: Direct Peptide Reactive Assay (DPRA)
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
Results and discussion
In vitro / in chemico
Results
- Key result
- Parameter:
- other: Direct Peptie Reactive Assay
- Value:
- 51.52
- Negative controls validity:
- not valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: The Skin sensitisation evaluation by "In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)" for Bacillus coagulans confirms it is classified as “Highly Reactivity" or predicts as “Positive".
- Conclusions:
- The Skin sensitisation evaluation by "In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)" for Bacillus coagulans confirms it is classified as "High Reactivity Sensitizer" or predicts as "Positive". The study is performed in compliance with guidelines OECD TG 442C.
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