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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Full study report available with very detailed infromation, although no GLP study. Major deficiency is the non-disclosure of the composition and identity of hte 'carrier oil'.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
See original document
Only without metabolic activation
GLP compliance:
no
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
not specified

Method

Species / strain
Species / strain / cell type:
hepatocytes: Rat Liver RL4 cells
Metabolic activation:
without
Test concentrations with justification for top dose:
62.5 - 125 - 250 µg/ml
Vehicle / solvent:
Unspecified 'Carrier oil'

Results and discussion

Test results
Key result
Species / strain:
mammalian cell line, other: Rat,Liver RL4
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid

Any other information on results incl. tables

See original document

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Calcium Naphthenate is non-mutagenic in the Rat Liver chromosomal damage test system.
Executive summary:

Calcium Naphthenate is non-mutagenic in the Rat Liver chromosomal damage test system at 62.5-250 µg/ml without metabolic activation.