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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
Adopted 26 May 1983; current version adopted 21 Jul 1997, corrected 26 Jun 2020 (CAS RN parag.24).
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
Version / remarks:
Adopted 26 May 1983; deleted TG, included in the OECD471 (adopted 21 Jul 1997, corrected 26 Jun 2020 (CAS RN parag.24)).
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Valeryl chloride
EC Number:
211-330-1
EC Name:
Valeryl chloride
Cas Number:
638-29-9
Molecular formula:
C5H9ClO
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
Remarks:
Details on cell type: E. coli WP2 uvrA
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'.

Any other information on results incl. tables

see attached document

Applicant's summary and conclusion