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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:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

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

Constituent 1
Chemical structure
Reference substance name:
5-chlorovaleryl chloride
EC Number:
216-403-1
EC Name:
5-chlorovaleryl chloride
Cas Number:
1575-61-7
Molecular formula:
C5H8Cl2O
IUPAC Name:
5-chlorovaleryl chloride
Details on test material:
- Name of test material (as cited in study report): hloropentanoyl chloride
- Physical state: liquid, colorless
- Analytical purity: 98.5%
- Lot/batch No.: 40/3/Faß 12
- Storage condition of test material: room temperature

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Test concentrations with justification for top dose:
20 .0 ug - 5,000 ug/plate (SPT)
62 .5 ug - 1,000 ug/plate (PIT)
Vehicle / solvent:
Vehicle: DMSO
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene for all strains
Remarks:
with S9 mix
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: N-methyl-N'-nitro-N-nitroso-guanidine (MNNG) for TA100 and TA1535, 4-nitro-o-phenylendiamine for TA98, 9-aminoacridine for TA1537 and N-ethyl-N'-nitro-N-nitrosoguanidin (ENNG) for E.coli
Remarks:
without S9 mix
Details on test system and experimental conditions:
Preincubation test:
0 .1 ml test solution or vehicle, 0 .1 ml bacterial suspension and 0 .5 ml S-9 mix are incubated at 37°C for the duration of 20 minutes . Subsequently, 2 ml of soft agar is added and, after mixing, the samples are poured onto the agar plates within approx . 30 seconds. After incubation at 37°C for 48 - 72 hours in the dark, the bacterial colonies are counted .

Standard Plate test:
0 .1 ml of the overnight cultures is diluted to 10^-6 in each case . Test tubes containing 2 ml portions of soft agar containing maximal amino acid solution (5 mM tryptophan or 5 mM histidine + 0 .5 mM biotin) are kept a water bath at 45°C, and the remaining components are added in the following order :
0 .1 ml vehicle (without and with test substance)
0 .1 ml bacterial suspension (dilution : 10^-6 )
0 .5 ml S-9 mix

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:
other: A bacteriotoxic effect was observed from about 1,500 - 2,500 ug/plate onward (standard plate test) or at doses 2 500 μg/late (preincubations test)
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: A bacteriotoxic effect was observed from about 1,500 - 2,500 ug/plate onward (standard plate test) or at doses 2 500 μg/late (preincubations test)
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No test substance precipitation was found .
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):
negative