Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1970s-1980s
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Method

Species / strain
Species / strain / cell type:
other: TA97, 98, 100, 102
Metabolic activation:
with
Metabolic activation system:
S9-mix from liver of Aroclor 1254 treated male rats
Test concentrations with justification for top dose:
0, 312, 625, 1250, 2500, 5000 ug/plate
Vehicle / solvent:
PBS (pH 7.4) with Sorbitan 80 OE monoleate and 20 OE monolaurate
Controlsopen allclose all
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
other: Daunomycin
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
methylmethanesulfonate
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
mitomycin C
Details on test system and experimental conditions:
48h exposure in 3 replicates

Results and discussion

Test results
Key result
Species / strain:
other: TA97, 98, 100, 102
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: no mutagenic potential

Applicant's summary and conclusion

Conclusions:
Esterification product of alcohols C12-13 linear and branched with lauric acid was not toxic for the 4 tester strains up to 5000 ug/plate.
No substantial increase in the number of revertant colonies was observed in any of the 4 tester strain after exposure to esterification product of alcohols C12-13 linear and branched with lauric acid concentration ranging fron 312 to 5000 ug/plate.

Esterification products of alcohols C12-13 linear and branched with lauric acid is not mutagenic in this bacterial test system at the dose levels used.