2-Buten-1-ol, 2-methyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-, (2E)-

Genetic toxicity: in vitro

Administrative data

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:

from 13th of August to 28th of November, 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Test conducted in GLP according to the version of the OECD guideline 471 applicable then. However under the currently version of the guideline it is also required to include Salmonella typhimurium TA102 and/or Escherichia coli WP2 or E.coli WP2 (pKM101)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

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

Test material information

Constituent 1

Reference substance name:

(E)-2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol

Cas Number:

106155-02-6

Molecular formula:

C13H22O

IUPAC Name:

(E)-2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

1st experiment: 8; 40; 200; 1000 and 5000 µg/plate
2nd experiment: 5, 10, 20, 50 and 100 µg/plate

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO and the untreated fresh cell suspensions served as negative control

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 4-nitro-o-phenylendiamine

Remarks:

As positive controls, sodium azide was used in the tester strains TA 100 and TA 1535, 9-aminoacridine in the tester strain TA 1537, and 4-nitro-o-phenylendiamine in the tester strains TA 98 and TA 1538 without microsomal drug-metabolizing enzymes (S9-mix)

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO and the untreated fresh cell suspensions served as negative control

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: The enzyme activity of the Aroclor 1254 induced S9 fractions was controlled by testing with 2-aminoanthracene in all strains.

Remarks:

The enzyme activity of the S9 fractions was controlled by testing with 2-aminoanthracene in all strains.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

see table 1, 2 & 3

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

see table 1, 2 & 3

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

The test item was tested in two independent test series at a concentration range of 5.0 - 5000 µg/plate (first and second test).
The test item was tested in the absence and presence of Aroclor 1254-induced S9-mix. In both test series (Tables 1 - 2) the plates were incubated for 48 hours at 37° C.
The findings show that the test item did not induce any reverse mutations in the absence of rat liver enzymes (without S9-mix), nor did occur any induced reverse mutations in the presence of Aroclor 1254-induced S9-mix (with S9-mix).

Toxic effects were noted, starting at a concentration of 40 µg/plate without S9-mix and above 200 µg/plate with S9-mix. Precipitations were not noted. The summarized results are presented in table 3.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

In the described mutagenicity test and under the experimental conditions reported, the test item did not induce point mutations by base-pair changes or frameshifts in the genome of the strains used.
Therefore the test item is not considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.

Executive summary:

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce point mutations by base-pair changes or frameshifts in the genome of the strains used.

Therefore, the test item is not considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.