1-bromo-3-chloropropane

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

Study period:

1993

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-bromo-3-chloropropane

EC Number:

203-697-1

EC Name:

1-bromo-3-chloropropane

Cas Number:

109-70-6

Molecular formula:

C3H6BrCl

IUPAC Name:

1-bromo-3-chloropropane

Details on test material:

Lot 9207093 (colourless liquid ; 99,6% purity)
The test substance was stored at room temperature, except for a period of several days when it was stored at 4°C.

Method

Target gene:

- Histidine dependance
- rfa mutation (snesivity to crystal violet solution)
- uvrB mutation (sensivity to UV radiation)
- pKM101 plasmid (resistance to ampicillin)

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix

Test concentrations with justification for top dose:

Preliminary test : 1, 5, 10, 50, 100, 500, 1000, 2500, 5000 µg/plate
Mutagenicity test : 250, 500, 1000, 2500, 5000 µg/plate

Vehicle / solvent:

Solvant used : DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

other: Sodium azide, 2-nitrofluorene, 9-aminoacridine, 2-aminoanthracene

Evaluation criteria:

Number of revertant colonies compared to solvant control.

Results and discussion

Test results

Test results 1

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

not determined

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

At test concentration of 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Species / strain:

other: S. typhimurium TA 1535 and TA 100

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 3

Species / strain:

other: S. typhimurium TA 1537, TA 1538 and TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

* First mutagenicity test :
A cytotoxic effect (as indicated by a thinning of the bacterial background lawn) was noted on all plates at the highest test substance concentration of 5000 µg/plate. 1-bromo-3-chloropropane induced concentration dependant significant increases in the revertant numbers of strains TA100 and TA 1535. In strain TA100, these increses reached 4,39-fold the numbers of revertants on solvent control plates in the absence of S9 mix and 3,48-fold in the presence of S9 mix. In strain TA 1535 these increases reached 4,53-fold the numbers of revertants on solvent control plates in the absence of S9 mix and 9,38-fold in the presence of S9 mix. 1-bromo-3-chloropropane did not induce any significant increases in the revertant numbers of strain TA 1538 except on one plate in the presence of S9 mix. No concentration dependent effect was observed and this increase was assumed not to be test substance-related. 1-bromo-3-chloropropane did not induce any concentration dependant significant increases in the revertant numbers of the tester strain TA98 and TA1537 at any of the test substance concentration studied.

* Second mutagenicity test :
A cytotoxic effect (as indicated by a thinning of the bacterial background lawn) was noted on all plates at the highest test substance concentration of 5000 µg/plate. 1-bromo-3-chloropropane induced concentration dependant significant increases in the revertant numbers of strains TA100 and TA 1535. In strain TA100, these increses reached 3,06-fold the numbers of revertants on solvent control plates in the absence of S9 mix and 3,14-fold in the presence of S9 mix. In strain TA 1535 these increases reached 3,68-fold the numbers of revertants on solvent control plates in the absence of S9 mix and 7,18-fold in the presence of S9 mix. 1-bromo-3-chloropropane did not induce any concentration dependant significant increases in the revertant numbers of the tester strain TA98 and TA1537 an TA1538 at any of the test substance concentration studied.

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

1-bromo-3-chloropropane was considered to be mutagenic under the conditions of this assay.
Since the criteria contained in the chapters 3.5.2.3.8 & 3.5.2.3.9 of the annex 1 of the regulation 1272/2008 are fulfilled, 1-bromo-3-chloropropane does require labelling concerning mutagenic toxicity in accordance with the CLP regulation.