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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been conducted in compliance with GLP and according to the OECD guideline 471.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
potassium (2S)-2-{[(2Z)-4-ethoxy-4-oxobut-2-en-2-yl]amino}propanoate
EC Number:
609-057-1
Cas Number:
35052-92-7
Molecular formula:
C9H14KNO4
IUPAC Name:
potassium (2S)-2-{[(2Z)-4-ethoxy-4-oxobut-2-en-2-yl]amino}propanoate

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Details on mammalian cell type (if applicable):
TA 98: hisD3052, rfa, uvrB
TA 100: hisG46, rfa, uvrB
TA 102: hisG428 (pAQ1), rfa
TA 1535: hisG46, rfa, uvrB
TA 1537: hisC3076, rfa, uvrB
Metabolic activation:
with and without
Metabolic activation system:
S9 mix (rat)
Test concentrations with justification for top dose:
25-5000 µg/plate
Vehicle / solvent:
Water for the test item.
Controls
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
mitomycin C
Evaluation criteria:
For a test item to be considered positive, it must (in two independent experiments) cause at least a doubling in the mean revertants per plate of at least one tester strain. This increase must be accompanied by a dose response towards increasing concentrations of the test item. A test item that does not meet these criteria was called non-mutagenic in bacteria. Single increases in revertants frequencies, which are not dose-related and not reproducible in two independent experiments were considered non-relevant.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
up to 5000 µg/plate
Vehicle controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

Ala-Dane-salt did not induce a mutagenic effect in S. typhimurium. lt is therefore not considered to be a bacterial mutagen.