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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7.11.1995 - 7.1.1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
O-benzyl-L-valine toluene-p-sulphonate
EC Number:
240-702-6
EC Name:
O-benzyl-L-valine toluene-p-sulphonate
Cas Number:
16652-76-9
Molecular formula:
C12H17NO2.C7H8O3S
IUPAC Name:
O-benzyl-L-valine toluene-p-sulphonate

Method

Target gene:
his and trp operons
Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 and E. coli WP2uvrA
Additional strain / cell type characteristics:
other:
Metabolic activation:
with and without
Metabolic activation system:
rat-liver post mitochondrial supernatant (S9 fraction)
Test concentrations with justification for top dose:
312.5, 625, 1250, 2500 and 5000 μg/plate (with and without metabolic activation for all strains)
Additionally, TA 100 and WP2uvrA were tested in a range finding study with concentrations of 20.58, 61.73, 185.19, 555.56, 1666.67 and 5000 μg/plate with and without metabolic activation.
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: +S9: 2-Aminoanthracene (TA1537, TA98, TA100, TA102, WP2uvrA), Cyclophosphamide (TA1535); -S9: Sodium Azide (TA1535, TA100), 4-Nitroquinoline (WP2uvrA), Mitomycin-C (TA102), 2-Nitrofluorene (TA98), 9-Aminoacridine (TA1537)

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 and E. coli WP2uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
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'.

Any other information on results incl. tables

In all experiments, performed with and without metabolic activation, none of the test substance concentrations led to an increase in the incidence of either histidine- or tryptophanprototrophic mutants by comparison with the negative control.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative