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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:
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

Constituent 1
Chemical structure
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 / 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:
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 resultsopen allclose all
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
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
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.