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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-and OECD testing guideline compliant study with well characterised test material

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
Principles of method if other than guideline:
Method: other: OECD Test Guidelines 471 and 472 "Genetic Toxicology (Salmonella typhimurium and Escherichia coli)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Mitsuboshi Chemical Co., Ltd.: purity >99%

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium (TA100, TA1535, TA98, TA1537); Escherichia coli (WP2uvrA)
Metabolic activation:
with and without
Metabolic activation system:
S9 from male rat liver, induced with phenobarbital and 5,6-benzoflavone
Test concentrations with justification for top dose:
-S9mix and +S9mix: 0, 313, 625, 1250, 2500, 5000 ug/plate
Vehicle / solvent:
S9 from male rat liver, induced with phenobarbital and 5,6-benzoflavone
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: See details in test conditions below
Details on test system and experimental conditions:
number of replicate: 2
plates per test: 3
application: pre-incubation

positive control groups and the solvent:
without S9 mix; 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide (TA98, TA100, WP2; DMSO), sodium azide (TA1535; pure water), 9-aminoacridine
(TA1537; DMSO)
with S9 mix; 2-aminoanthracene (all five strains; DMSO)

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium (TA100, 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:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Salmonella typhimurium            Escherichia coli
     TA100, TA1535, TA98, TA1537           WP2 uvrA
              +      ?      -             +      ?      -
-S9 mix:    [   ]  [   ]  [ * ]         [   ]  [   ]  [ * ]
+S9 mix:    [   ]  [   ]  [ * ]         [   ]  [   ]  [ * ]

In each experiment, the positive control chemicals induced
the expected responses, indicating that the assay was
working satisfactorily.

Applicant's summary and conclusion

Conclusions:
This substance was not mutagenic to Salmonella typhimurium
and Escherichia coli.