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Toxicological information

Genetic toxicity: in vitro

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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:
1997

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified
Type of assay:
comet assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strainopen allclose all
Species / strain:
lymphocytes:
Details on mammalian cell lines (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 characteristics:
not specified
Metabolic activation:
not specified
Species / strain:
other: sperm
Details on mammalian cell lines (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 characteristics:
not specified
Metabolic activation:
not specified
Controls
Negative controls:
yes
Solvent 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
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
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.