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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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Salmonella/mammalian-microsme test, performed twice in presence and absence of rat liver homogenate metabolic activation system. Tested at various concentrations.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: vapour

Method

Target gene:
Histidine operon
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
other: defective lipopolysaccharide coat, deleted vitamin biotin synthesis gene, deleted UV damage repair gene
Metabolic activation:
with and without
Metabolic activation system:
rat liver homogenate
Test concentrations with justification for top dose:
2, 1.6, 1.2, 0.8, 0.4, 0.1
ml of liquid vaporised in 9 l desicator (the highest concentration is approximately the vapour pressure at 37°C)

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
""None of the eight taggant samples tested appeared to be mutagenic in any of these assays"
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

Material dos not cause genetic toxocity.
Executive summary:

Testing concluded the material had no ability to induce mutations under test conditions.