Registration Dossier
Registration Dossier
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EC number: 215-246-6 | CAS number: 1314-87-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: In spite of a lack of some information, the study is comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Genetic toxicology of lead compounds
- Author:
- J. T. Zelikoff, J. H. Li, A. Hartwig, X. W. Wang, M. Costa and T. G. Rossman
- Year:
- 1 988
- Bibliographic source:
- Carcinogenesis vol.9 n°10 pp. 1727-1732, 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 479 (Genetic Toxicology: In Vitro Sister Chromatid Exchange Assay in Mammalian Cells)
- Deviations:
- yes
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Lead sulphide
- EC Number:
- 215-246-6
- EC Name:
- Lead sulphide
- Cas Number:
- 1314-87-0
- Molecular formula:
- PbS
- Reference substance name:
- Lead sulfide
- IUPAC Name:
- Lead sulfide
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Ham's F12 media supplemented with 10% heat-inactivated Fetal Bovine Serum
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- not specified
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine
- Remarks:
- 0.5µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in F12 medium
DURATION
- Preincubation period: 24H
- Exposure duration: 24H
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent): 2
- Fixation time (start of exposure up to fixation or harvest of cells): 10Days
NUMBER OF CELLS EVALUATED: 500 - Evaluation criteria:
- clonal survival
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: strain/cell type: HPRT
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
Under the conditions of the study lead sulphide was found mutagenic at the HPRT locus, in V79 cells, at concentrations that do not induce SCE.
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