Registration Dossier
Registration Dossier
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EC number: 231-198-9 | CAS number: 7446-14-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
- Type of assay:
- comet assay
Test material
- Reference substance name:
- Lead sulphate
- EC Number:
- 231-198-9
- EC Name:
- Lead sulphate
- Cas Number:
- 7446-14-2
- Molecular formula:
- H2O4S.Pb
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- lymphocytes:
- Details on mammalian cell type (if applicable):
- - Type and identity of media: PBS
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no
- Periodically checked for karyotype stability: no
- Periodically "cleansed" against high spontaneous background: no - Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- other: sperm
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI 1640
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no
- Periodically checked for karyotype stability: no
- Periodically "cleansed" against high spontaneous background: no - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- not specified
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
Results and discussion
Test resultsopen allclose all
- Species / strain:
- lymphocytes:
- Metabolic activation:
- not specified
- Species / strain:
- other: sperm
- Metabolic activation:
- not specified
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Lead sulphate showed positive effects despite difficulties with its solubility, and inconsistencies in dose response may also have been related to its solubility.
It should be pointed out that the induction of DNA breaks is not evidence of reproductive, mutagenic, or carcinogenic activity.
Single strand breaks are among the most innocuous alterations and are readily and apparently accuratly rejoined by repair process.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
ambiguous
In the conditions of the studies, Lead sulphate showed effects on DNA. However mutagenic or carcinogenic effects cannot be assessed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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