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Toxicological information

Genetic toxicity: in vitro

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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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No guideline study, not according to GLP. Conducted according accepted scientific standards. Well conducted and reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
no positive controls
GLP compliance:
no
Remarks:
not required at time of performance
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hostapur SAS 30
- Structural formula attached as image file (if other than submission substance): see Fig.
- Physical state: liquid
- Analytical purity: 30%
- Composition of test material, percentage of components: 30% Hostapur SAS 93, water
- Isomers composition: n.a.
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stability and homogeneity guaranteed by sponsor
- Storage condition of test material: no data
- Other:

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9-mix from Aroclor 1254 pretreated rats
Test concentrations with justification for top dose:
0,001 - 5 microL/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: appropriate vehicle for this type of test
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation


DURATION
- Preincubation period: 48 hours

Evaluation criteria:
numbers of reverted bacterial colonies

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and 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:
not examined
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no
- Effects of osmolality: no
- Evaporation from medium: no
- Water solubility: no
- Precipitation: no
- Other confounding effects: no

Applicant's summary and conclusion

Conclusions:
Sec-alkane sulfonate-sodium salts SAS (30%) tested in 4 bacterial strains of Salmonella typhimurium exhibited no mutagenic effects neither with nor without metabolic activation (S9-mix from Aroclor 1254 pretreated rats)
Executive summary:

Sec-alkane sulfonate-sodium salts SAS (30%) was tested for potential point mutagenic effects in bacteria according to the methodology described by Ames. The study was not conducted according to GLP and OECD test guideline as these were not available at time of performance. However, it followed the scientific standards at this time and is regarded to be valid with restrictions. Sec-alkane sulfonate-sodium salts SAS (30%) was investigated in the Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537. The tests were performed in the presence and in the absence of a metabolizing system derived from rat liver homogenate (S9 -mix). A dose range of 0.001 to 5 microliter per plate was used. Based on the results obtained, sec-alkane sulfonate-sodium salts SAS (30%) is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation.