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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
17.5.2017-21.7.2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
Version 21.7.1997.
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Sulfonic acids, C13-17-sec-alkane, compds. with triethanolamine
EC Number:
288-492-5
EC Name:
Sulfonic acids, C13-17-sec-alkane, compds. with triethanolamine
Cas Number:
85736-79-4
Molecular formula:
Sulfonic acid, C13-17-sec-alkane: C13H28O3S (MW 264,42) - C17H36O3S (MW 320,53) and 2,2',2''-nitrilotriethan: C6H15NO3 (MW 149,19) , typical medium molecular weight of mixture 454 g/mol.
IUPAC Name:
Sulfonic acids, C13-17-sec-alkane, compds. with triethanolamine
Test material form:
liquid: viscous
Specific details on test material used for the study:
Fain, Batch 401-404

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Additional strain / cell type characteristics:
other:
Remarks:
See full report for details
Metabolic activation:
with and without
Metabolic activation system:
2-AA;2-aminoanthracene
Test concentrations with justification for top dose:
0.00316, 0.0100, 0.0316, 0.100, 0.316, 1.0, 2.5, and 5.0 microliters/plate. The 5.0 microliters par plate is the recommended maximum volume for soluble, non-toxic test compound.
Vehicle / solvent:
Distilled water
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
Distilled water
Negative solvent / vehicle controls:
yes
Remarks:
Distilled water
Positive controls:
yes
Remarks:
3 without metabolic activation
Positive control substance:
sodium azide
methylmethanesulfonate
other: 4-NOPD; 4-nitro-o-phenylene-diamine
Remarks:
concentration 10 micrograms/plate for sodium azide and 4-NOPD
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-AA; 2aminoathracene

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
See full report for more information about strains etc.

Applicant's summary and conclusion

Conclusions:
Fain was considered to be non-mutagenic in this bacterial reverse mutation assay
Executive summary:

Fain is considered to be non-mutagenic