Registration Dossier
Registration Dossier
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EC number: 921-112-4 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Sample sent to to Vanta Bioscience Limited, K2B, 11th Cross Street, SIPCOT Industrial Complex, Gummidipundi- 601 201, Tamil Nadu, India for analysis.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 56 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 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(3β-hydroxyolean-12-en-28-oyl)-L-lysyl-L-threonyl-L-threonyl-L-lysyl-L-Serine
- EC Number:
- 921-112-4
- Molecular formula:
- C53H91N7O11
- IUPAC Name:
- N-(3β-hydroxyolean-12-en-28-oyl)-L-lysyl-L-threonyl-L-threonyl-L-lysyl-L-Serine
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Metabolic activation:
- with and without
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-Aminoanthraene
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA98,TA100,TA1535,TA1537,TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Bacterial Reverse Mutation Test in Salmonella typhimurium Tester strains for N-(3β-hydroxyolean-12-en-28-oyl)-L-lysyl-L-threonyl-L-threonylL-lysyl-L-Serine confirms it is non-mutagenic. The study is performed in compliance with OECD guidelines No.471.
Any other information on results incl. tables
.
Applicant's summary and conclusion
- Conclusions:
- Bacterial Reverse Mutation Test in Salmonella typhimurium Tester strains for N-(3β-hydroxyolean-12-en-28-oyl)-L-lysyl-L-threonyl-L-threonyl-L-lysyl-L-Serine confirms it is non-mutagenic. The study is performed in compliance with OECD guidelines No.471.
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