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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1982
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only Summary but Basic data given

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.18 (DNA Damage and Repair - Unscheduled DNA Synthesis - Mammalian Cells In Vitro)
Deviations:
yes
GLP compliance:
no
Type of assay:
DNA damage and repair assay, unscheduled DNA synthesis in mammalian cells in vitro

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium valproate
EC Number:
213-961-8
EC Name:
Sodium valproate
Cas Number:
1069-66-5
Molecular formula:
C8H16O2.Na
IUPAC Name:
sodium 2-propylpentanoate

Method

Species / strain
Species / strain / cell type:
hepatocytes: rat
Metabolic activation:
not applicable
Test concentrations with justification for top dose:
Formulation of sodium valproate and final concentrations: 0.1, 1, 10 and 100µg/ml
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
not specified
True negative controls:
no
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
Migrated to IUCLID6: 1µM

Results and discussion

Test results
Species / strain:
hepatocytes: rat
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not examined
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

In the conditions of the study, sodium valproate was found non mutagenic nor cytotoxic in a DNA repair test up to and including 100 µg/ml.