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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study acoording to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
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:
other: solid

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium, other: TA 97a
Species / strain / cell type:
S. typhimurium TA 98
Species / strain / cell type:
S. typhimurium TA 100
Species / strain / cell type:
S. typhimurium TA 102
Species / strain / cell type:
S. typhimurium TA 1535
Metabolic activation:
with and without
Metabolic activation system:
post-mitochondrial (S9) fraction of induced rat liver
Test concentrations with justification for top dose:
TA 97a: 0.0016 - 0.16 mg/plate (-S9), 0.016 - 1.6 mg/plate (+S9)
TA 98: 0.05 - 5 mg/plaze (+/-S9)
TA 100: 0.016 - 1.6 mg/palte (+/-S9)
TA 102: 0.05 - 5 mg/plate (+/-S9)
TA 1535: 0.016 - 1.6 mg/plate (+/-S9)
Vehicle / solvent:
Bidistilled water
Controls
Untreated negative controls:
yes
Remarks:
aqua bidest
Negative solvent / vehicle controls:
no
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
cumene hydroperoxide
other: 4-nitro-o-phenylenediamine, nitrofurantoine, 2-aminoanthracene, danthron, ICR 191
Details on test system and experimental conditions:
NUMBER OF REPLICATIONS: 3

Evaluation criteria:
Induction rate of mean values from revertant colonies of test item and revertant colonies of corresponding control

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium, other: TA 97a
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Hostapon TPHC is not point mutagenic in the Ames test
Executive summary:

The point mutagenic effects of sodium methyl oleyl taurate were investigated in the reverse bacterial mutation assay (Ames tets) according to OECD TG 471 in two independent studies following the principles of GLP. Test systems used were Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 with and without the metabolic activation system S9 from induced rat liver. Positive and negative controls had been included. Duration of each study was 48 hours. The test item was dissolved in bidestilled water and applied once at concentrations between 0.0016 mg/plate up to 5.0 mg/plate (depending on cytotoxicity). Under the conditions of this test, no increase in revertant colonies in any of the tester strains were obderved. Based hereupon, it is concluded that the test item is not mutagenic in this bacterial test system.