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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-standard method, published study

Data source

Reference
Reference Type:
publication
Title:
Evaluation of a genotoxicity test measuring DNA-strand breaks in mouse lymphoma cells by alkaline unwinding and hydroxyapatite elution
Author:
Garberg, M., Akerblom, E.L. & Bolcsfoldi, G.
Year:
1988
Bibliographic source:
Mutation Research 203(3): 155-76

Materials and methods

Principles of method if other than guideline:
Rapid genotoxicity test measuring proportion of single- to double-stranded DNA breaks by alkaline unwinding and hydroxyapatite elution in mouse lymphoma cells
GLP compliance:
not specified
Remarks:
: published study
Type of assay:
other: Alkaline unwinding / elution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: analytical grade

Method

Target gene:
Not relevant
Species / strain
Species / strain / cell type:
mouse lymphoma L5178Y cells
Details on mammalian cell type (if applicable):
No information available
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Male Sprague-Dawley rat liver S9 fraction
Test concentrations with justification for top dose:
20.2- 43.0 g/l (339 - 718 mmolar)
Vehicle / solvent:
Water
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: various
Details on test system and experimental conditions:
Cells were incubated with tritiated thymidine prior to a 3-hour exposure in the absence or presence of metabolic activation. DNA strand breaks were detected by alkaline unwinding an elution.
Evaluation criteria:
Increased strand breaks in the absence of toxicity.
Statistics:
No information available

Results and discussion

Test results
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
without
Genotoxicity:
positive
Remarks:
at very high concentrations
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Positive results were obtained at very high concentrations (628 and 718 mmolar) with relative fractions of ssDNA of 9.2% and 17.3%, respectively. Lower urea concentrations (359 - 339 mmolar) did not yield responses classed as positive.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive without metabolic activation at very high concentrations

Positive results were obtained at very high concentrations (628 and 718 mmolar). Lower urea concentrations (359 - 339 mmolar) did not yield responses classed as positive.
Executive summary:

Positive results were obtained at very high concentrations (628 and 718 mmolar). Lower urea concentrations (359 - 339 mmolar) did not yield responses classed as positive.