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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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dicyclopentadiene resin grade
- Physical state: clear light yellow liquid
- Analytical purity: 75%
- Lot/batch No.: TNZ001
- Expiration date of the lot/batch: 1 April 2000
- Storage condition of test material: room temperature in dark

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 from Arochlor 1254 induced rat liver
Test concentrations with justification for top dose:
Dose range 1-666 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: ethanol
Controls
Negative solvent / vehicle controls:
yes
Remarks:
ethanol
Positive controls:
yes
Positive control substance:
other: sodium azide, 9-aminoacridine, daunomycine, methylmethanesulfonate, 4-nitroquinoline N-oxide, 2 aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 30 minutes
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS: 2

DETERMINATION OF CYTOTOXICITY
- Method: observation of reduction of bacterial background lawn, reduction in revertant colonies
Evaluation criteria:
Negative (ie non-mutagenic) if:
a) total number of revertants in tester strain at any concentration is not > 2 x solvent control value for TA100 and 3 x solvent control value for TA1535, TA1537, TA98 and WP2uvrA +/- activation
b) Negative response should be repeatable in at least one independently repeated expt.
Positive (ie mutagenic) if:
a) it produces at least a 3-fold (TA1535, TA1537, TA98 and WP2uvrA) or 2-fold (TA100) dose-related increase in the number of revertants with respect to the number induced ny solvent control in TA100 +/- activation. However any mean plate count < 20 is considered to be not significant
b) Positive response should be repeatable in at least one independently repeated expt.

Results and discussion

Test resultsopen allclose all
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
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

Dicyclopentadiene resin grade is not mutagenic in the Salmonella typhimurium reverse mutation assay or in the Excherichia coli reverse mutation assay.
Executive summary:

Dicyclopentadiene resin grade did not induce a dose-related or a two-fold, increase in the number of revertant (His+) colonies in any of the four tester strains (TA1535, TA1537, TA98 and TA100) nor in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment.

Dicyclopentadiene resin grade is not mutagenic in the Salmonella typhimurium reverse mutation assay or in the Excherichia coli reverse mutation assay.