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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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Laurinsäure (98 - 100%)
IUPAC Name:
Laurinsäure (98 - 100%)
Details on test material:
no data

Method

Target gene:
TA1537: his C 3076; rfa; uvrB- frame shift mutations
TA 98: his D 3052; rfa; uvrB- (pKM101) frame shift mutations
TA 1538: his D 3052; rfa; uvrB- frame shift mutations
TA1535: his G 46; rfa; uvrB- base-pair substitutions
TA 100: his G 46; rfa; uvrB (pKM101) base-pair substitutions
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1538
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix
Test concentrations with justification for top dose:
4, 20, 100, 500 and 2500 µg substance /plate
Vehicle / solvent:
Solvent used: DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
no
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylenediamine, sodium azide for test without S-9 mix; 2-aminoanthracene for test with S-9 mix
Details on test system and experimental conditions:
METHOD OF APPLICATION: the test was conducted on agar plates
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 100, TA 1535, TA 1537, TA 1538, TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not examined
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article did not induce gene mutations by base pair changes or frame shifts in the genome of the strains used with and without S9 mix.
Therefore, Edenor C 12 98/100 % is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
Executive summary:

This study was performed to investigate the potential of Edenor C 12 98/100 % to induce gene mutations according to the plate incorporation test using the Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100.

The assay was performed with and without metabolic activation.

The test article was tested at the following concentrations:

4, 20, 100, 500 and 2500 µg/plate

No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Edenor C12 98/100% at any dose level, neither in the presence nor absence of metabolic activation (S9 mix).

Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.

Therefore, Edenor C 12 98/100 % is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.