8,9,10-trinorborn-2-ene

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according 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:

8,9,10-trinorborn-2-ene

EC Number:

207-866-0

EC Name:

8,9,10-trinorborn-2-ene

Cas Number:

498-66-8

Molecular formula:

C7H10

IUPAC Name:

Bicyclo-[2.2.1]-hept-2-ene

Details on test material:

lot no 280694
purity 99.8% (a/a)
appearance: white solid
storage conditions: dark at approximately 5°C
stability under test conditions: stable for 4 hours

Method

Target gene:

his

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA98; TA 100; TA1535; TA1537

Additional strain / cell type characteristics:

other: all strains: rfa-cell wall deficiency; uvrB-deficient DNA excision-repair system. TA98 and TA 100 strains: presence of pKM101 plasmid (carying r-fctor) increased sensitivity to some mutagens

Metabolic activation:

with and without

Metabolic activation system:

S9-mix from livers of Arcolor 1254induced (500 mg/kg b.w.) male Sprague-Dawley rats

Test concentrations with justification for top dose:

0, 4, 20, 100, 500, 2500, 5000 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Remarks:

untreated

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

other: without S9: Sodium azide (TA 100, TA1535); 9-Aminoacridine (TA1537; 2-Nitrofluorene (TA98); with S9-mix: 2-Aminoanthracene

Details on test system and experimental conditions:

method of application: agar plate incorporation
duration: 48h,
temperature: 37°C,
other environmental conditions: in the dark

evaluation: visual thinning of the bacterial lawn and reduced rate of spontaneously occuring colonies determined through microscopical evalation

Evaluation criteria:

a) test produces at least 2-fold increase in the mean number of revertants per plate of at least one of the tester strains compared to the appropriate control
b) test induces a dose related increase in the mean number of revertants per plate of at least one of the tester strains compared to the appropirate control in at least 2 to 3 concentrations.

test results must be reproducible

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98; TA 100; TA1535; TA1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

observed at 2500 and 5000 µg/plate with TA100

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

table presenting the aerage revertant counts for all tests is giving in attachments

Applicant's summary and conclusion

Conclusions:

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

Norbornene was not mutagenic in Salmonella typhimurium (TA98; TA 100; TA1535; TA1537) with and without metabolic activiation (Ames test OECD 471)

Executive summary:

Norbornene was tested in a reverse gene mutation assay (Ames test) in bacteria (S. typhimuriumTA98; TA 100; TA1535; TA1537) in concentrations ranging from 0 to 5000 µg/plate in the presence and absense of mammalian metabolic activation (S9 mix induced from rat liver). The study was performed according to OECD 471 under GLP.

there was no evidence of induced mutant colonies over background. Cytotoxicity was obsevered with TA 100 at the highest concentrations of 2500 and 5000 µg/plate.