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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames test: The structural analogue substance 9-octadecenoic acid was not mutagenic in a bacterial reverse mutation assay.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
For justification of read-across see section 13.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Additional information from genetic toxicity in vitro:

No adequate animal data are available and no epidemiological studies investigating the genotoxicity of the test substance were identified. However, data from a structural analogue (read across substance) are available.  

Bacterial reverse mutation assay

The read across substance 9-octadecenoic acid (CAS 112-80-1) was tested in a bacterial reverse mutation assay using 4 Salmonella typhimurium strains: strain TA98, TA100, TA1535 and TA1537. The substance was tested in the following concentrations: 0.1, 0.3, 1, 3.3, 10, 33, 100, 333 µg/plate. Besides that, the vehicle (DMSO) and a positive control were included in the test for each strain. The read across substance was tested without and with metabolic activation (induced male Sprague Dawley rat liver S9 and induced male Syrian hamster liver S9). The test results gave no indication for a mutagenic property of the tested substance in the bacterial reverse mutation assay.  

A publication is also available in which a bacterial reverse mutation assay using 6 bacterial strains (Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538 and Escherichia coli WP2 uvrA) and 9-octadecenoic acid (CAS 112-80-1) with and without rat liver S9 mix (induced with polychlorated biphenyls) is described. DMSO served as a vehicle. 9-octadecenoic acid was tested at the concentraions 0.01, 0.05, 0.1, 0.5, 1, 5, 10, 50 and 100 µg/plate in strains TA 1537 and TA 1538 and at 1, 5, 10, 50, 100, 500, 1000, 5000 µg/plate in all other strains. As positive controls, benzo(a)pyrene, 2-nitrofluorene, 9-aminoacridine, N-ethyl-N-nitro-N-nitrosoguanidine, 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide, 4-nitroquinoline-1-oxide and 2-aminoanthracene were used. The revertant colonies were counted using an automated colony counter. As a result the tested substance was not mutagenic in this assay, neither with nor without metabolic activation. Growth inhibition as an indication for cytotoxicity was observed in strains TA 1537 and TA 1538 in the test concentrations 10, 50 and 100 µg/plate without metabolic activation.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for genetic toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for genetic toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC 605/2014.