Registration Dossier
Registration Dossier
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EC number: 700-150-3 | CAS number: 156572-81-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial forward mutation assay
Test material
- Reference substance name:
- Fatty acids, coco, 2-sulfoethyl esters, sodium salts
- EC Number:
- 263-052-5
- EC Name:
- Fatty acids, coco, 2-sulfoethyl esters, sodium salts
- Cas Number:
- 61789-32-0
- Molecular formula:
- C10H20O5S.Na-C20H40O5S.Na
- IUPAC Name:
- Fatty acids, coco, 2-sulfoethyl esters, sodium salts
- Details on test material:
- - Name of test material: sodium cocoyl isethionate (LB7819-1)
- Physical state: white waxy flakes
- Analytical purity: 72.45%
- Lot/batch No.: 1247
- Storage condition of test material: Stored at room temperature.
Test substance characterised and test solution concentrations verified by sponsor.
Aqueous SCI suspensions/solutions of 1.0, 14.0 and 36.0% were found to be stable over eight day period.
Constituent 1
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:
- Post mitochondrial supernatant (S9) prepared from livers of male Sprague Dawley rats induced with single ip injection of Arochlor 1254 at 500mg/kg.
- Test concentrations with justification for top dose:
- 1.0, 3.3, 10, 33, 100 µg (+s9 mix)
10, 33, 100, 333, 1000 µg (-S9 mix) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Migrated to IUCLID6: 2- aminoanthracene, sodium azide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Preincubation period: 20±2 minutes
- Exposure duration: 48 hours
Plates that were not counted immediately following the incubation period were stored at 4±2¿C until colony counting could be conducted.
SELECTION AGENT (mutation assays): Number of revertants
NUMBER OF REPLICATIONS: Each treatment was plated in triplicate.
Three independent experiments were conducted
NUMBER OF CELLS EVALUATED: 1.9 x 108 cells seeded per plate
Results and discussion
Test results
- Key result
- 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:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
In experiment B1, no positive responses were observed in any of the tester strains in the presence or absence of metabolic activation. As toxicity was only marginal at the highest dose without metabolic activation, the top dose was adjusted to 333 µg/plate for the subsequent confirmatory assays
In experiment B2, no positive responses were observed with tester strains TA98, TA1535 and TA1538. Tester strains TA100 and TA1537 were not reported due to unacceptable titre values and were retested in experiment B3.
In experiment B3, no positive reactions were observed in TA100 and TA1537 in the presence or absence of metabolic activation. A 2 fold non-dose responsive increase was observed with tester strain TA1537 in the absence of metabolic activation, however, it was considered that increases of this magnitude (less than 3 fold) with this strain and non-dose-responsive increases are not evaluated as positive.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: Negative
The results of the assay, indicate that under the conditions of the study, the test article LB-7819-1 did not cause a positive response with any of the tester strains in the presence or absence of metabolic activation
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