Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay
Target gene:
histidine
Species / strain / cell type:
bacteria, other: S. typhimurium TA 97a
Species / strain / cell type:
S. typhimurium TA 100
Species / strain / cell type:
S. typhimurium TA 98
Species / strain / cell type:
E. coli WP2 uvr A
Species / strain / cell type:
S. typhimurium TA 1535
Metabolic activation:
with and without
Metabolic activation system:
S9-mix fraction
Test concentrations with justification for top dose:
50, 100, 500, 1000 and 5000µg/plate of 50 mg/ml squalane solution prepared in acetone
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
acetone
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium, other: TA1535, TA98, TA100, TA97a
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

There is no significant difference between the number of spontaneaous reversions, the number of reversions obtained in the positive controls (with or without metabolic activation), and the mean of corresponding experimental historic values obtained in the laboratory.

There is no evidence of any increase of number of revertant colonies in the presence of the test substance (5000, 1000, 500, 100 and 50 µg) with or without metabolic activation for bacterial strains in Salmonella typhimurium TA1535, TA97a, TA98, TA100 and Escherichia coli WP2(uvrA).

Conclusions:
Interpretation of results (migrated information):
negative

The test substance does not indice reverse mutation on four salmonella typhimurium strains and one Escherichia coli strain according to the OECD guideline n°471 .
Executive summary:

Assessment of mutagenic activity of squalane was conduced on "Salmonella typhimurium his-" and "Escherichia coli WP2(uvrA)" strains according to the OECD guideline n°471.

There is no significant difference between the number of spontaneaous reversions, the number of reversions obtained in the positive controls (with or without metabolica cativation), and the mean of corresponding experimental historic values obtained in the laboratory.

There is no evidence of any increase of number of revertant colonies in the presence of the test substance (5000, 1000, 500, 100 and 50 µg) with or without metabolic activation for bacterial strains in Salmonella typhimurium TA1535, TA97a, TA98, TA100 and Escherichia coli WP2(uvrA).

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

Additional information

Additional information from genetic toxicity in vitro:

There is no significant difference between the number of spontaneaous reversions, the number of reversions obtained in the positive controls (with or without metabolica cativation), and the mean of corresponding experimental historic values obtained in the laboratory. There is no evidence of any increase of number of revertant colonies in the presence of the test substance (5000, 1000, 500, 100 and 50 µg) with or without metabolic activation.

Justification for selection of genetic toxicity endpoint

Recent study according OECD guideline and reliable without restriction

Justification for classification or non-classification

Regarding all experimental studies (gene mutation assays on bacteria or mammalian cells, and DNA damage assay on mammalian cells), the test item squalane is considered to be non-mutagenic.