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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.