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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
Using the weight of evidence approach, there is adequate data to prove that 3-oxoglutaric acid is unlikely to exhibit genetic toxicity to bacteria as well as negative chromosomal abberation effect.
Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
other: modelling database
Principles of method if other than guideline:
Ames mutagenicity. Multicase model.
Note: The four sub models were made using only positive Ames test results to discriminate between direct mutagens (–S9) / and mutagens requiring metabolic activation (+S9) frame-shifts, basepairs and potency (>10 x background). They may serendipitously give some Ames
POS/NEG information.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
bacteria, other: Salmonella
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Species / strain:
bacteria, other: Salmonella
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: strain/cell type:
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative

Genetic toxicity in vitro in Salmonella sp. for 3-oxoglutaric acid was estimated to give negative result in Ames test according to the Danish EPA database which is an authoritative database
Executive summary:

Genetic toxicity in vitro in Salmonella sp. for 3-oxoglutaric acid was estimated to give negative result in Ames test according to the Danish EPA database which is an authoritative database

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Using the weight of evidence approach, there is adequate data to prove that 3-oxoglutaric acid is unlikely to exhibit genetic toxicity to bacteria as well as negative chromosomal abberation effect.


Justification for selection of genetic toxicity endpoint
Adequate studies are available to use weight of evidence approach which indicate that 3-oxoglutaric acid is unlikely to exhibit genetic toxicity to bacteria as well as negative chromosomal abberation effect.

Justification for classification or non-classification

Since there is adequate data to prove that 3-oxoglutaric acid is unlikely to exhibit genetic toxicity to bacteria as well as negative chromosomal abberation effect; the chemical is not classified as a gene toxicant.