Terpenes and terpenoids, turpentine-oil, α-pinene fraction, oligomers

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: NTP study, fully valid for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Materials and methods

Test guideline

Qualifier:

equivalent or similar 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:

Alpha-pinene

IUPAC Name:

Alpha-pinene

Constituent 2

Reference substance name:

Pin-2(3)-ene

EC Number:

201-291-9

EC Name:

Pin-2(3)-ene

Cas Number:

80-56-8

IUPAC Name:

2,6,6-trimethylbicyclo[3.1.1]hept-2-ene

Method

Species / strain

Species / strain / cell type:

other: TA 100, TA98, eColi PK101

Controls

Untreated negative controls:

yes

Remarks:

Dimethyl Sulfoxide

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

sodium azide

methylmethanesulfonate

Evaluation criteria:

Offical NTP Protocol
The bacterial colonies that do not require an excess of supplemental histidine appear and grow. These colonies are comprised of bacteria that have undergone reverse mutation to restore function of the histidine-manufacturing gene.
The test chemical is considered to be nonmutagenic in the Ames test when no increase in mutant colonies are observed.

Results and discussion

Test results

Species / strain:

other: TA100, TA98, eColi pKM101

Metabolic activation:

with and without

Genotoxicity:

negative

Any other information on results incl. tables

Strain: TA100
S9 Activation	S9 Species	Concentration
No Activation	N/A	N/A
10% RLI	Rat	10%
Strain: TA98
S9 Activation	S9 Species	Concentration
No Activation	N/A	N/A
10% RLI	Rat	10%
Strain: eColi pKM101
S9 Activation	S9 Species	Concentration
No Activation	N/A	N/A
10% RLI	Rat	10%

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The Ames test conducted on Alpha-pinene under NTP program showed no mutagenic effects.

Executive summary:

The mutagenic profile of Alpha-pinene was investigated using the Ames test, which was conducted under the NTP screening study.

The Ames test was performed using a Salmonella typhimurium and E. coli strains with S9 mix or plain buffer without S9. Specific control per each strain were also included. The number of colonies was counted after 2 days and the results showed no mutagenic effects.