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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
(Only two of the recommended strains were tested)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Pin-2(3)-ene
EC Number:
201-291-9
EC Name:
Pin-2(3)-ene
Cas Number:
80-56-8
Molecular formula:
C10H16
IUPAC Name:
2,6,6-trimethylbicyclo[3.1.1]hept-2-ene

Method

Target gene:
Histidine-requiring gene in Salmonella typhimurium
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
other: uvrB and rfa mutated
Species / strain / cell type:
S. typhimurium TA 98
Additional strain / cell type characteristics:
other: uvrB and rfa mutated
Species / strain / cell type:
S. typhimurium, other: UTH 8414
Species / strain / cell type:
S. typhimurium, other: UTH 8413
Metabolic activation:
with and without
Metabolic activation system:
liver homogenate (S9) from Aroclor-induced male Sprague-Dawley rats (100 µL/plate)
Test concentrations with justification for top dose:
Five concentrations, from 10 µg/plate to 500 µg/plate.
Toxicity and/or solubility determined the upper limit of the dose tested.
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
(With and without metabolic activation)
Positive controls:
yes
Positive control substance:
sodium azide
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene
Positive controls:
yes
Positive control substance:
other: Cisplatin
Details on test system and experimental conditions:
DURATION
- Exposure duration: The plates were incubated at 37 ºC for 48 h, at which time the number of colonies per plate was determined.

SELECTION AGENT (mutation assays): the lack of amino-acid in the medium. Only the mutants can grow due to their capability to synthesize the essential amino acid.

NUMBER OF REPLICATIONS: 2

Results and discussion

Test resultsopen allclose all
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:
not examined
Untreated negative controls validity:
valid
Positive controls validity:
valid
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:
not examined
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
other: UTH 8414
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not examined
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
other: UTH 8413
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not examined
Untreated negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Alpha pinene was not mutagenic in all strains tested with and without metabolic activation.

Applicant's summary and conclusion

Conclusions:
Alpha pinene was not mutagenic in all strains tested with and without metabolic activation.
Executive summary:

Alpha pinene was tested for mutagenecity (doses: 10 -500µg/plate). The mutagenicity assay employed was that described by Maron and Ames using Salmonella typhimurium strains TAl00 and TA98, which are DNA-repair deficient, and two additional strains, UTH 8414 and UTH 8413, developed by Matney, which have full DNA repair capacity. The mutagenicity assays were carried out both with and without metabolic activation (S9). Alpha pinene was not mutagenic in all strains tested with and without metabolic activation.