Registration Dossier
Registration Dossier
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EC number: 260-375-3 | CAS number: 56773-42-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented and scientifically acceptable
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
- Principles of method if other than guideline:
- In vitro assay was to evaluate the ability of PFOS (perfluorooctansulfonate) to induce chromosomal aberrations in human whole blood lymphocytes with and without metabolic activation.
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Potassium heptadecafluorooctane-1-sulphonate
- EC Number:
- 220-527-1
- EC Name:
- Potassium heptadecafluorooctane-1-sulphonate
- Cas Number:
- 2795-39-3
- IUPAC Name:
- potassium 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctane-1-sulfonate
- Details on test material:
- FC-95 (PFOS), Lot #: 217 (perfluoroctansulfonate)
Constituent 1
Method
- Target gene:
- no data
Species / strain
- Species / strain / cell type:
- lymphocytes: Human Whole Blood Lymphocytes
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- 12.5,24.9,49.7, 99.3, 149, 199, 249, 299, 349, 449, and 599 µg/mL without metabolic activation and
12.5,24.9, 49.7,99.3, 149, 199,249,299,349, and 449 µg/mL with metabolic activation
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: mitomycin C (MMC), cyclophosphamide (CP)
Results and discussion
Test results
- Species / strain:
- lymphocytes: Human Whole Blood Lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Due to toxicity constraints, the highest concentration tested in the assay was 599 µg/ml without metabolic activation and 449 µg/ml with metabolie activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: other: Human Whole Blood Lymphocytes
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No significant increase in cells with chromosomal aberrations, polyploidy, or endoreduplieation was
observed in the cultures analyzed.
PFOS was considered negative for inducing chromosomal aberrations in human whole blood
lymphocytes with and without metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
The objective of this in vitro assay was to evaluate the ability of PFOS to induce chromosomal
aberrations in human whole blood lymphocytes with and without metabolic activation.
Due to toxicity constraints, the highest concentration tested in the assay was 599 µg/ml without
metabolic activation and 449µg/ml with metabolic activation. The test article was dissolved in
dimethylsulfoxide (DMSO) for the assay. The stock solution and its dilutions were dosed using a
dosing volume of 1 % (10.0 µl/ml) and the vehicle control cultures were treated with 10.0
µl/ml of DMSO.
In the chromosomal aberrations assay, the treatment period was for 3.0 hours with and without
metabolic activation, and cultures were harvested 22.0 hours from the initiation of treatment.
Replicate cultures of human whole blood lymphocytes were incubated with 12.5, 24.9,49.7,
99.3, 149, 199, 249, 299, 349, 449, and 599 µg/ml without metabolic activation and 12.5, 24.9,
49.7,99.3, 149, 199, 249, 299, 349, and 449 µg/ml with metabolic activation. Cultures treated
with concentrations of 199, 249, 299, and 349 µg/ml without metabolic activation and 99.3, 149,
199, and 299 µg/ml with metabolic activation were analyzed for chromosomal aberrations. No
significant increase in cells with chromosomal aberrations, polyploidy, or endoreduplication was
observed in the cultures analyzed.
PFOS was considered negative for inducing chromosomal aberrations in human whole blood
lymphocytes with and without metabolic activation.
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