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Genetic toxicity in vitro

Description of key information
Ames according to OECD471: negative (BASF 1998)
Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
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
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
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'.
Conclusions:
Interpretation of results (migrated information):
negative
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

The substance 5-Chloropontanoyl chloride was tested for its mutagenic potential based on the ability to induce back mutations in selected loci of several bacterial strains in the Ames test and in the Escherichia coli - reverse mutation assay .

Strains : TA 1535, TA 100, TA 1537, TA 98 and E . coli WP2 uvrA

Dose range: 20 .0 ug - 5,000 ug/plate (SPT), 62 .5 ug - 1,000 ug/plate (PIT)

Test conditions : Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (Aroclor induced rat

liver S-9 mix)

Solubility: No precipitation of the test substance was found

Toxicity : A bacteriotoxic effect was observed from about 1,500 - 2,500 ug/plate onward (SPT) or at doses of 500 ug/plate (PIT) .

Mutagenicity: An increase in the number of his' or trp` revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system .

Conclusion:

According to the results of the present study, the test substance 5-Chloropentanoyl chloride is not mutagenic in the Ames test and in the Escherichia coli - reverse mutation assay under the experimental conditions chosen here .


Justification for selection of genetic toxicity endpoint
The test substance did not induce point mutations in the Ames assay

Justification for classification or non-classification

Based on the information available for 5-chloropentanoyl chloride, classification for genetic toxicity is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and EU Directive 67/548 (DSD).

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