Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Test material form:
solid: particulate/powder
Details on test material:
Light pink tinted powder

Method

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:
Liver S9 derived from phenobarbital and beta-naphthaflavone-induced male Sprague Dawley rats
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 100, 200, 500,100, 2500, 5000 µg/plate
Concentration range in the main test (without metabolic activation): 100, 200, 500,100, 2500, 5000 µg/plate
Vehicle / solvent:
Solvent: Dimethylsulphoxide (dried)
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
N-ethyl-N-nitro-N-nitrosoguanidine
benzo(a)pyrene
other: Acridine mutagen ICR191, 2-aminoantracene, Daunorubicin HCl

Results and discussion

Test results
Key result
Species / strain:
other: Salmonella typhimurium tester strains (TA1535, TA1537, TA98 and TA100) and the two Escherichia coli strains (WP2 (pKM101) and WP2 uvrA (pKM101))
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
Observations: none
Remarks on result:
no mutagenic potential (based on QSAR/QSPR prediction)

Applicant's summary and conclusion

Conclusions:
It is concluded that, under the conditions of this assay, UL125 gave a negative, i.e. nonmutagenic,
response in S.typhimurium strains TA1535, TA1537, TA98 and TA100 and E.coli
strains WP2 (pKM101) and WP2 uvrA (pKM101) in both the presence and absence of S9-mix.
Executive summary:

Study design

UL125 was evaluated in a bacterial mutagenicity assay (Gatehouse et al, 1990: based on Maron

and Ames (1983)) over a range of concentrations using four strains of Salmonella typhimurium

(TA1535, TA1537, TA98 and TA100) and two strains of Escherichia coli (WP2 (pKM101) and

WP2 uvrA (pKM101)) in the presence and absence of a rat liver - derived metabolic activation

system (S9-mix).

Results

In two separate experiments, the test substance did not induce any significant, reproducible

increases in the observed numbers of revertant colonies in any of the strains used, either in the

presence or absence of S9-mix.

The sensitivity of the test system, and the metabolic activity of the S9-mix, were clearly

demonstrated by the increases in the numbers of revertant colonies induced by positive control

substances.

Conclusion

It is concluded that, under the conditions of this assay, UL125 gave a negative, i.e. nonmutagenic,

response in S.typhimurium strains TA1535, TA1537, TA98 and TA100 and E.coli

strains WP2 (pKM101) and WP2 uvrA (pKM101) in both the presence and absence of S9-mix.

Categories Display