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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:
1988-07-05 to 1988-07-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
This study was performed according to guideline OECD 471
Cross-reference
Reason / purpose for cross-reference:
other: Purity statement

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
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)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
GLP compliance:
yes
Type of assay:
bacterial gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3,5,5-trimethylhexanoic acid
EC Number:
221-975-0
EC Name:
3,5,5-trimethylhexanoic acid
Cas Number:
3302-10-1
Molecular formula:
C9H18O2
IUPAC Name:
3,5,5-trimethylhexanoic acid
Test material form:
liquid
Details on test material:
Name of test material (as cited in study report): Isononansäure, 3,5,5-trimethylhexanoic acid
Specific details on test material used for the study:
For details on test material see attached report in section 13

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 fraction of livers from Sprague-Dawley rats, induced with Aroclor 1254
Test concentrations with justification for top dose:
first experiment: 4, 20, 100, 500, 2500, 10000 µg/plate
second experiment: 4, 20, 100, 500, 2500, 5000 µg/plate

top dose selected on basis of highest concentration requested in guideline
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: without S9: sodium azide, 9-aminoacridine, 2-nitrofluorene; with S9: 2-aminoanthracene, benzo[a]pyrene
Details on test system and experimental conditions:
METHOD OF APPLICATION: 2 ml of molten top agar (plate incorporation) with 100 µl of overnight nutrient broth culture of bacteria tester strain and 100 µl of test compound solution with or without 500 µl of S9 mix are poured into a petri dish with a layer of minimal agar. His+ revertants were counted after 48-72 h incubation at 37 °C in the dark.
Evaluation criteria:
A reduced rate of spontaneously occuring colonies as well as visible thinning of the bacterial lawn (controlled microscopically) were used as indicator for toxicity.
Statistics:
Statistical analysis was not stated.

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 2500 µg/plate and above in most strains
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 2500 µg/plate and above
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 2500 µg/plate and above
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: strain/cell type: WP2 uvr A
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the test substance was not mutagenic with or without metabolic activation.
Executive summary:

The test substance was not mutagenic in an Ames-test with the Salmonella typh. strains TA98, TA100, TA1535, TA1537 and TA1538 and E.coli WP2uvrA in concentrations up to 10000 µg/plate, both with or without metabolic activation (Hoechst AG, 1988).

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