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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
69 Days
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

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
Reference substance name:
Bacillus Ferment Filtrate Extract
EC Number:
924-436-4
Cas Number:
68038-65-3
Molecular formula:
Not Available
IUPAC Name:
Bacillus Ferment Filtrate Extract
Test material form:
liquid

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium TA 98
Remarks:
S. typhimurium TA 100 S. typhimurium TA 1535 S. typhimurium TA 1537 & S. typhimurium TA 102.
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
True negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Non mutagenic

Applicant's summary and conclusion

Conclusions:
Bacterial Reverse Mutation Test in Salmonella typhimurium Tester strains for Bacillus coagulans confirms it is non-mutagenic . The study is performed in compliance with OECD guidelines No.471.