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Toxicological information

Genetic toxicity: in vitro

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
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

Method

Species / strain
Species / strain:
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:
Test substance was dissolved in Aqua destillata
Controls
Positive controls:
yes
Positive control substance:
sodium azide
methylmethanesulfonate
other: 4-nitro-0-phenylene-diamine, 2-aminoanthracene

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes

Applicant's summary and conclusion

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.