Isobutyl (S)-2-chloropropionate

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:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Principles of method if other than guideline:

BASF Test

The study was carried out according to
- Ames BN et al (1973). Carcinogens are mutagens: A simple test system combining liver homogenates for activation and bacteria for detection. Proc Nat Acad Sci USA 70: 2281-2285.
- Ames BN et al (1975). Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test. Mut Res 31: 347-364.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Isobutyl (S)-2-chloropropionate

EC Number:

280-349-5

EC Name:

Isobutyl (S)-2-chloropropionate

Cas Number:

83261-15-8

Molecular formula:

C7H13ClO2

IUPAC Name:

isobutyl (S)-2-chloropropanoate

Details on test material:

- Name of test material (as cited in study report): L-chloropropionic acid isobutyl ester
No further data.

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

rat liver S-9

Test concentrations with justification for top dose:

20, 100, 500, 2500, 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: no data

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene, N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylenediamine, 9-aminoacridine chloride monohydrate

Remarks:

positive control substances depending on the tester strain and activation conditions

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

Evaluation criteria:

In general, a substance to be characterized as positive in the Ames test has to fulfil the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.

Statistics:

no data

Results and discussion

Test results

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:

cytotoxicity

Remarks:

>= 2500 µg, without activation only

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'. Remarks: Salmonella typhimurium TA98, TA100, TA1535, TA1537

Any other information on results incl. tables

No mutagenicity (increase in the number of revertants) was noted.

A weakly bacteriotoxic effect (reduced his- background growth, decrease in the number of his+ revertants) was observed in some cases only without metabolic activation from about >= 2500 µg onward.

The test substance was completely soluble in DMSO up to the highest dose of 5000 µg/plate.

Applicant's summary and conclusion

Executive summary:

Report Summary

The substance L-chloropropionic acid isobutyl ester was tested for mutagenicity in the Ames test (standard plate test).

Strains: TA 1535, TA 100, TA 1537, TA 98

Dose range: 20 µg - 5000 µg/plate

Test conditions: Standard plate test with and without metabolic activation (S-9 mix).

Solubility: Complete solubility of the test substance in DMSO.

Toxicity: In some cases a weakly bacteriotoxic effect (reduced his- background growth, decrease in the number of his+ revertants) was observed from about >= 2500 µg onward in the experiments without S-9 mix only .

Mutagenicity:

An increase in the number of his+ revertants could not be observed either without S-9 mix or after addition of a metabolizing system.

Assessment:

According to the results of the present study, the test substance L-chloropropionic acid isobutyl ester is thus not mutagenic in the Ames test under the experimental conditions chosen here.