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Toxicological information

Genetic toxicity: in vitro

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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:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

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.