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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
Study period:
21.01.2001-26.02.2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to guideline
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Details on test material:
Purity: 98.8%

Method

Target gene:
his-operon
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
Phenobarbital and 5,6-benzoflavone induced rat liver S9
Test concentrations with justification for top dose:
-S9: 0, 156.3, 312.5, 625, 1250, 2500, 5000 µg/plate (five strains)
+S9: 0, 156.3, 312.5, 625, 1250, 2500, 5000 µ/g/plate (five strains)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Choice based on information from sponsor
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: -S9 mix: 2-(2-furyl)-3-(5-nitro-2-furyl) acrylamide (TAlOO, TA98, WP2uvrA), sodium azide (TA1535) and 9-aminoacridine(TA1537) +S9 mix: 2-arninoanthracene (five strains).
Details on test system and experimental conditions:
Test Design:
Procedure
(1) Plate incorporation test with and without S9 using five strains
(2) Pre-incubation test with and without S9 using five strains
Number of replicates: 2
Plates/dose: 3
Rationale for test conditions:
A confirmation test was carried out in pre-incubation method as negative mutagenic effect (-) was noted in plate incorporation test.
Evaluation criteria:
The test substance was judged positive ( +) when the number of revertant colonies in the test substance treated plates increased dose dependently and became two-fold or more compared to that of the negative control and this effect was reasonably reproducible or significant reproducible increase was noted at one or more concentrations at least in one strain with or without metabolic activation system and negative (-) when any of the above criteria were not fulfilled.
Statistics:
No statistical method was followed.

Results and discussion

Test results
Key result
Species / strain:
bacteria, other: Salmonella typhimurium TAlOO, TA1535, TA98, TA1537 Escherichia coli Wp2uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
ATBC has been tested according OECD TG 471 and 472 in compliance with GLP. Under conditions of the test, no mutagenic effect was observed for ATBC tested up to cytotoxic concentration in any of the test strains (S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2) without and with metabolic activation. ATBC is non-mutagenic in test strains used.