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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Liquidambar Styraciflua, oil
EC Number:
946-732-2
IUPAC Name:
Liquidambar Styraciflua, oil

Method

Target gene:
Salmonella enterica serovar Typhimurium
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535.
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
0.003, 0.01, 0.03, 0.1, 0.3 and 1.0 mg.plate-1 for the strains TA1535
0.01, 0.03, 0.1, 0.3, 1.0 and 3.0 mg.plate-1 for the other strains.
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
cumene hydroperoxide
other: 2-Aminoanthracene
Evaluation criteria:
The test substance is considered mutagenic if the following criteria are attained:
1) Dose related response (p<0.05) in the number of induced revertants and the tested concentrations;
2) Considering that are necessary 5 analyzable doses in the definitive test, the calculations for the mutagenicity reason (MR) for all concentrations tested should be within a specific range for each strains. The strains TA97a, TA98, TA100 and TA102 this value should be less than 2 and the strain TA1535 less than 3, for the substance is not characterized as a mutagenic.
Statistics:
The data were statiscally analysed by the Salmonella Program Assay (MYERS et al., 1991).

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535
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

Applicant's summary and conclusion

Conclusions:
Under the test conditions and the obtained results, the test substance did not induce mutagenic activity in the strains of Salmonella Typhimurium used in this assay.