Reaction mass of 1,3-dichloropropene and 2-chloropropane and 2-chloropropene and 3-chloropropene

Genetic toxicity: in vitro

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:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study protocol generally followed the O.E.C.D. Testing Guideline. However, only Salmonella tester strain TA!00 was used and the GLP regulations were not followed.

Data source

Reference

Reference Type:

publication

Title:

Mutagenic potential of allyl and allylic compounds. Structure-activity relationship as determined by alkylating and direct in vitro mutagenic properties

Author:

E. Eder, et. al.

Year:

1980

Bibliographic source:

Biochem Pharmacol. 1980 Apr 1;29(7):993- 8, 1980.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Only Salmonella tester strain TA100 was used.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-chloropropene

EC Number:

203-457-6

EC Name:

3-chloropropene

Cas Number:

107-05-1

Molecular formula:

C3H5Cl

IUPAC Name:

3-chloroprop-1-ene

Details on test material:

As per the IUCLID5 Sections 1.1. - 1.4. for 3-chloropropene.

Method

Target gene:

Histidine operon

Species / strain

Species / strain / cell type:

S. typhimurium TA 100

Metabolic activation:

with and without

Metabolic activation system:

Induced Wistar rat liver S9 fraction with cofactors.

Test concentrations with justification for top dose:

Approximately 1532, 2870, 4783 and 5740 μg/plate.

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: epichlorohydrin

Details on test system and experimental conditions:

Salmonella strain TA100 was grown overnight at approximately 37 degrees C. The Preincubation method was used to control for volatility with an exposure period of 90 min with shaking in closed tubes with limited head space. The preincubation was conducted at 37 degrees C with and without rat liver S9 mix. Following preincubation treatment two mL of molten top agar was added to each tub and the contents mixed and poured over minimal glucose agar plates. The plates were inverted and incubated for 48 - 72 hr at 37 degrees C to allow revertant mutnat colonies to grow.

Evaluation criteria:

Generally a dose-responce relationship and two-fold increase in mean mutant frequency relative to the concurrent solvent background control value is considered to be a positive responce in tester strain TA100.

Statistics:

No data

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 100

Metabolic activation:

without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

There was a dose-related increase in mutant frequency that reached > two-fold at the high dose level of 5740 ug/plate without rat liver metabolic activation.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
positive without metabolic activation

3-Chloropropene induced a positive mutational responce in tester strain TA100 without rat liver metabolic activation S9 fraction. These data suggest that 3-chloropropene is a direct acting mutagen in this bacterial assay system.

Executive summary:

3 -Chloropropene, a structural analog of AC Light Ends was tested for mutagenic potential in an O.E.C.D. 471 "Bacterial Reverse Mutation Assay" by the preincubation method with and without rat liver derived S9 metabolic activation perperation. 3 -Chloropropene induced a positive mutational responce in tester strain TA100 without rat liver metabolic activation S9 fraction. These findings suggest that AC Light Ends would be mutagenic to Salmonella tester strain TA100 under similar experimental conditions.