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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
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

Constituent 1
Chemical structure
Reference substance name:
Propionyl chloride
EC Number:
201-170-0
EC Name:
Propionyl chloride
Cas Number:
79-03-8
Molecular formula:
C3H5ClO
IUPAC Name:
propanoyl chloride
Details on test material:
- Analytical purity: 99.3 %
- Name of test material (as cited in study report): propionsäurechlorid
- Lot/batch No.: 96 /561
- Physical state: colorless liquid
- Lot/batch No.: Vers. 127/V
- Storage condition of test material: at room temperature

Method

Target gene:
his
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-induced rat liver S-9 mix
Test concentrations with justification for top dose:
15.625 - 5000 µg/plate (standard plate test)
15.625 - 250 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 (2-AA), without metabolic activation: N-methyl-N' -nitro-N-nitrosoguanidine (MNNG), 4-nitro-o-phenyleridiamine(NOPD) and 9-aminoacridine (AAC) and N-ethyl-N'-nitro-N-nitrosoguanidine (ENNG)
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 hours
PIT: preincubation at 37°C for the 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:
The test chemical is considered positive when:
A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system.

A test substance is generally considered nonmutagenic when:
The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other.

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:
cytotoxicity
Remarks:
from 500 μg/plate onward in the standard plate test and at 125 μg - 250 μg/plate in the preincubation 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:
cytotoxicity
Remarks:
from 500 μg/plate onward in the standard plate test and at 125 μg - 250 μg/plate in the preincubation test
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
ADDITIONAL INFORMATION ON CYTOTOXICITY:
A bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants, reduction in the titer) was observed from about 500 μg/plate onward in the standard plate test or at about 125 μg - 250 μg/plate in the preincubation test.

SOLUBILITY:
No precipitation of the test substance was found.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion