Isovaleryl chloride

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Valeryl chloride

EC Number:

211-330-1

EC Name:

Valeryl chloride

Cas Number:

638-29-9

IUPAC Name:

pentanoyl chloride

Details on test material:

- Substance number: 96/184
- Batch number: Vers. 130/U
- Analytical purity: 99.4%
- Appearance: liquid, colourless, clear

Method

Target gene:

his

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-induced rat liver S-9 mix

Test concentrations with justification for top dose:

20 - 5000 µg/plate (standard plate tes, first test)
20 - 1500 µg/plate (standard plate tes, second test)
20 - 1500 µg/plate (preincubation test)

Vehicle / solvent:

- Vehicle used: DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: with metabolic activation: 2-aminoanthracene, without metabolic activation: N-methyl-N' -nitro-N-nitrosoguanidine, 4-nitro-o-phenyleridiamine, 9-aminoacridine chloride monohydrate and N-ethyl-N'-nitro-N-nitrosoguanidine

Details on test system and experimental conditions:

METHOD OF APPLICATION: standard plate test (SPT) and preincubation test (PIT)
SPT: incubation at 37°C for 48 - 72 hours in the dark
PIT: preincubation at 37°C for a duration of 20 minutes; incubation at 37°C for 48 - 72 hours in the dark

NUMBER OF REPLICATIONS: three plates per dose/control

Evaluation criteria:

In general, a substance to be characterised as positive in the bacterial tests has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control);
- dose-response relationship;
- reproducibility of the results.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

from 1,500 μg/plate in the standard plate test and from 500 µg/plate in the preincubation assay

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

No precipitation of the test substance was found.
A bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants) was observed at doses from 1,500 μg/plate in the standard plate test and at doses from 500 µg/plate in the preincubation assay.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.