Registration Dossier
Registration Dossier
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EC number: 274-861-8 | CAS number: 70775-75-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test substance was negative in the Salmonella/microsome mutagenicty test according tom OECD 471 with the strains TA 98, 100, 102, 1535 and 1537 with and without metabolic activation.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Test material Octenidine dihydrochloride
Lot/Batch number Lot No.: 1067998
Specification Octenisept (0.1 % octenidine dihydrochloride)
Description Liquid - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Remarks:
- and TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix, S9 liver microsomal fraction form male Wistar rats induced with Phenobarbital (80 mg/kg bw) and β-Naphtoflavone (100 mg/kg bw)
- Test concentrations with justification for top dose:
- 0.00316, 0.01, 0.0316, 0.1, 2.5 μl/plate, in addition: 5 μl/plate TA 89 and TA 100
- Vehicle / solvent:
- Test substance was dissolved in Aqua destillata
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-0-phenylene-diamine, 2-aminoanthracene
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Octenidine is considered to be non-mutagenic in this bacterial reverse mutation assay.
- Executive summary:
Octenidine was tested in the Salmonella/microsome mutagenicty test according tom OECD 471 with the strains TA 98, 100, 102, 1535 and 1537 with and without metabolic activation. It induced no biologically relevant increases in the revertant colony numbers of any of the five test strains at any dose levels with or without metabolic activation. Octenidine is considered to be non-mutagenic in this bacterial reverse mutation assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No classification justified.
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