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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2000
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
444-240-8
EC Name:
-
Cas Number:
302933-83-1
Molecular formula:
C55-n H95.5-2n N7 013 Na1.5 (n-0-6) molecular weight: 1097-l4n (n=0-6)
IUPAC Name:
Sodium surfactin
Test material form:
solid: particulate/powder

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
The test was conducted in absense (non-activated assay) and presence (activated assay) of the metablic activation system by the pre-incubation method.
Test concentrations with justification for top dose:
A dose-finding test was conducted at 7 doses (5000 to 5 µg/plate) which were set with an approximately treefold dilution step.
The main test was conducted at 9 doses (5000 to 19.5 µg/plate) in the non-activated assay and 7 doses (5000 to 78.1 µg/plate) in the activated assay, which were set with a twofold dilution step.
Vehicle / solvent:
Japanese pharmacopoeia water
Controls
Negative solvent / vehicle controls:
yes
Remarks:
water
Positive controls:
yes
Positive control substance:
sodium azide
furylfuramide
other: 9- aminoacridine hydrochloride hydrate; 2-aminoanthracene

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
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Key result
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity

Applicant's summary and conclusion

Conclusions:
The results indicate that sodium surfactin is not mutagenic in bacterial test strains under teh conditions of this test.
Executive summary:

The potential of sodium surfactin to induce point mutation in bacteria was evaluated in a reverse mutation test in Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP. The test was conducted in the absence (non-activated assay) and presence (activated assay)

The results indicate that sodium surfactin is not mutagenic in bacterial test strains under the conditions of this test.