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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study; E. coli not tested

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Principles of method if other than guideline:
in accordance with Ames B.N. et al.: Proc. Nat. Acad. Sci. USA, 70, 2281-2285, (1973) as well as Ames B.N. et al.: Mut. Res. 31, 347-364, (1975)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
4-chlorobutyryl chloride
EC Number:
225-059-1
EC Name:
4-chlorobutyryl chloride
Cas Number:
4635-59-0
Molecular formula:
C4H6Cl2O
IUPAC Name:
4-chlorobutanoyl chloride
Details on test material:
Name of the test substance used in the study report: 4-Chlorbuttersäurechlorid
Purity: ca. 99%

Method

Target gene:
S. typhimurium
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S-9 fraction
Test concentrations with justification for top dose:
20 - 5000 ug/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
other: with S-9 mix (all strains): 2-Aminoanthracene (10 µg); without S-9 mix: N-Methyl-N'-nitro-N-nitroso-guanidine (5 µg) for strains TA 100, TA 1535 and TA 98, 4-Nitro-o-phenylenediamine (10 µg), 9-Aminoacridinium chloride monohydrate (100 µg) for TA 100
Details on test system and experimental conditions:
TEST SYSTEM
System: standard plate test.
Metabolic activation: with and without, using liver S-9 supernatant of male Aroclor 1254 induced Sprague-Dawley
rats.
Incubation: plates were incubated at 37 °C for 48 hours in the dark; the number of colonies was then counted.
Replicates: 4 plates per dose and control were used in 2 independent experiments.

Experiment 1 (standard plate test; with and without S-9 mix;
all strains): 20, 100, 500, 2500 and 5000 µg/plate;
Experiment 2 (standard plate test; with and without S-9 mix;
all strains): 250, 500, 750, and 1000 µg/plate.
Evaluation criteria:
test results considered positive, if
- doubling of revertant colonies compared to spontaneous mutation rate
- dose effect relationship
- reproducibility of results

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:
other: > 750 ug/plate
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: > 750 ug/plate
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Cytotoxicity:
A bacteriotoxic ffect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants in the titer was observed from about 750 µg onwards

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

Applicant's summary and conclusion