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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Test material

Constituent 1
Reference substance name:
C10-C16-(linear and branched)-alkyl esters of salicylic acid
IUPAC Name:
C10-C16-(linear and branched)-alkyl esters of salicylic acid
Test material form:
liquid

Method

Species / strain
Species / strain / cell type:
S. typhimurium, 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 resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 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
Key result
Species / strain:
S. typhimurium TA 100
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
Key result
Species / strain:
S. typhimurium TA 98
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
Key result
Species / strain:
S. typhimurium TA 97
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
Key result
Species / strain:
S. typhimurium TA 1535
Remarks:
Test not performed
Remarks on result:
other: no mutagenic potential

Applicant's summary and conclusion

Conclusions:
C10-C16-(linear and branched)-alkyl esters of salicylic 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 C10-C16-(linear and branched)-alkyl esters of salicylic acid concentration ranging fron 312 to 5000 ug/plate.

C10-C16-(linear and branched)-alkyl ester of salicylic acid is not mutagenic in this bacterial test system at the dose levels used.