Reaction mass of 2-isopropenyl-5-methylhex-4-en-1-ol and 2-isopropenyl-5-methylhex-4-enyl acetate and DL-borneol and caryophyllene and linalool and linalyl acetate and p-menth-1-en-4-ol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

october 2017 to january 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2-isopropenyl-5-methylhex-4-en-1-ol and 2-isopropenyl-5-methylhex-4-enyl acetate and DL-borneol and caryophyllene and linalool and linalyl acetate and p-menth-1-en-4-ol

EC Number:

946-901-0

Molecular formula:

not relevant

IUPAC Name:

Reaction mass of 2-isopropenyl-5-methylhex-4-en-1-ol and 2-isopropenyl-5-methylhex-4-enyl acetate and DL-borneol and caryophyllene and linalool and linalyl acetate and p-menth-1-en-4-ol

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

7,12-dimethylbenzanthracene

9,10-dimethylbenzanthracene

2-nitrofluorene

sodium azide

benzo(a)pyrene

mitomycin C

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

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

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

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

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

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

Test results 4

Key result

Species / strain:

S. typhimurium TA 100

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

Test results 5

Key result

Species / strain:

E. coli WP2

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:

Doses (5000, 1500, 500,150 and 50 µg/plate) prepared from solutions of the test item LAVANDIN OIL HEAVY FRACTION - LEMI code GPR 031017-2 - BATCH 170928-01 provided by BEAUVILLIERS FLAVORS, do not induce any mutagenic change in Salmonella typhimurium TA1535, TA1537, TA98, TA100 and in Escherichia coli WP2(uvrA¯) (pKM 101) without, or with metabolic activation, according to the OECD Guidelines n° 471. Nor hazard statement H340 is required, nor H341.