Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
only two strains were used for the experiments
Deviations:
yes
Principles of method if other than guideline:
only two strains were used for the experiments
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methoxy-N,N,β-trimethyl-10H-phenothiazine-10-propylamine
EC Number:
212-706-8
EC Name:
2-methoxy-N,N,β-trimethyl-10H-phenothiazine-10-propylamine
Cas Number:
851-68-3
Molecular formula:
C19H24N2OS
IUPAC Name:
2-methoxy-N,N,β-trimethyl-10H-phenothiazine-10-propylamine
Test material form:
solid: crystalline
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: LEV-1332
- Purity test date: 12 2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in a well-closed vial up to 25°C


Method

Target gene:
GC
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 98
Species / strain / cell type:
S. typhimurium TA 100
Metabolic activation:
with and without
Metabolic activation system:
post-mitochondrial fraction (S9)
Test concentrations with justification for top dose:
1.6, 5, 16, 50, 160, 500
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
other: 4-Nitro-1,2-phenylenediamine, 2-aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)


DURATION
- Preincubation period: 11-14 hours
- Exposure duration: 48 hours


NUMBER OF REPLICATIONS: 2

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
The reported data of this mutagenicity assay show that under the experimental conditions applied, the test item did not induce gene mutations in the genome of the strains of Salmonella typhimurium TA98 and TA100.

In conclusion, the test item Racem Tisercin base no mutagenic activity on the applied bacterium tester strains under the test conditions used in this study.