Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Comparable to guideline study. Original study report not available.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Method of Ames (1975)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
5-vinylnorborn-2-ene
EC Number:
221-259-8
EC Name:
5-vinylnorborn-2-ene
Cas Number:
3048-64-4
Molecular formula:
C9H12
IUPAC Name:
5-ethenylbicyclo[2.2.1]hept-2-ene
Test material form:
liquid
Details on test material:
- Test substance: 5-vinyl-2-norbornene (CAS 3048-64-4)
- Purity: 98.44%
- Source: Union Carbide Corporation, South Charleston, West Virginia
- LOT 59FGC27

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9 liver homogenate, prepared from Aroclor l254-induced, Sprague-Dawley male rats, was purchased from Microbiological Associates, Bethesda, MD. For tests with metabolic activation, 0.5 ml of S9 mix containing 50 microL of S9 was added per plate.
Test concentrations with justification for top dose:
0.001, 0.003, 0.01, 0.03, 0.1 mg/plate
Controls
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Remarks:
Without metabolic activation: 4-NPD for TA98 and TA1538, NaN3 for TA100 and TA1535, 9-AA for TA1537. With metabolic activation 2-AA for all strains.
Positive control substance:
other: 4-nitro-o-phenylenediamine, sodium azide, 2-aminoanthracene, and 9-aminoacridine (depending on strain)
Details on test system and experimental conditions:
VNB was tested in triplicate at each of 5 doses using the preincubation method.  Either 0.5 mL sodium phophate buffer or S9/bacteria mix was added to the tubes containing  2 mL top agar, 100 uL bacterial strain and 100 uL of ENB, control substance, or solvent.  The contents of the tubes were poured on agar plates which were allowed to harden.  Plates were then incubated for 48-72 hours at 37C in a darkened incubator. Revertant colonies were counted by automatic colony counter. 
Evaluation criteria:
The test substance was considered positive if it produced at least a reproducible two-fold increase in the number of revertant colonies compared to the negative control, and there is evidence for a dose-related increase in the number of revertant colonies.

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
Remarks:
Only assessed in TA100 strain. Non toxic up to doses of 0.3mg/plate without metabolic activation and up to 0.1mg/plate with metabolic activation.
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No indication of mutagenicity was observed at any of the tested doses, either by evidence of a dose-response relationship or a doubling of the number of colonies over the solvent control.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
The test substance was not mutagenic with or without metabolic activation in this test system.
Executive summary:

In an Ames test using 5 strains of bacteria, vinyl norbornene did not produce a mutagenic response in the Salmonella/microsome mutagenicity assay when tested with or without metabolic activation.