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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Octanoyl chloride
EC Number:
203-891-6
EC Name:
Octanoyl chloride
Cas Number:
111-64-8
Molecular formula:
C8H15ClO
IUPAC Name:
octanoyl chloride
Details on test material:
- Name of test material (as cited in study report): n-Octansaeurechlorid
- Physical state: Colorless liquid
- Analytical purity: 97% (by GC)
- Lot/batch No.: Vers. 62/V
- Storage condition of test material: Room temperature

Method

Target gene:
his- (S. typhimurium)
trp- (E. coli)
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 1254 induced rat liver S-9 mix
Test concentrations with justification for top dose:
4.0 µg - 1000 µg/plate (SPT)
0.8 µg - 500 µg/plate (PIT)
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: see table
Details on test system and experimental conditions:
Experiment 1: Standard plate test (SPT)
Test tubes containing 2 ml soft agar kept in a water bath at 45°C, and remaining components added in the following order:
0 .1 ml test solution or vehicle
0 .1 ml bacterial suspension
0 .5 ml S-9 mix (in tests with metabolic activation) or 0 .5 ml phosphate buffer (in tests without metabolic activation).
After mixing, the samples are poured onto Vogel-Bonner agar plates.

Experiment 2: Preincubation test (PIT)
0.1 ml test solution or vehicle, 0.1 ml bacterial suspension and 0 .5 ml S-9 mix are incubated at 37°C for the duration of 20 minutes. Subsequently, 2 ml of soft agar is added
and, after mixing, the samples are poured onto the Vogel-Bonner agar plates.

Experiment1&2
In each experiment 3 test plates per dose or per control used; after incubation at 37°C for
48 hours in the dark, the bacterial colonies ( his+ revertants) are counted.
Positive control:
with metabolic activation: 2.5 μg/plate 2-aminoanthracene for each S. typhimurium strain; 60 μg/plate 2-aminoanthracene for the E. coli strain
without metabolic activation: 5 μg/plate N-methyl-N'-nitro-N-nitrosoguanidine for TA 100 and TA 1535, 10 μg/plate 4-nitro-o-phenylendiamine
for TA 98, 100 μg/plate 9-aminoacridine chloride monohydrate for TA 1537 and 10 µg/plate N-Ethyl-N-nitro-N-nitrosoguanidine for E. coli WP2 uvrA, all substances were dissolved in DMSO.
The titer was determined and in regularly measurements the strain characteristics were
checked. Sterility control was performed.
Evaluation criteria:
Positive results
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the result

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:
A bacteriotoxic effect was observed at doses >= 500 µg/plate
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:
A bacteriotoxic effect was observed at doses >= 500 µg/plate
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'.

Any other information on results incl. tables

Standard plate test (4 - 1000 µg/plate)
Strain Metabolic activation system mean revertants in Controls maximum revertant factor dose dependency Assessment
TA 98 no 32 0.9 no negative
  yes 42 1.1 no negative
TA 100 no 125 1.1 no negative
  yes 127 1.3 no negative
TA 1535 no 21 1.0 no negative
  yes 20 1.0 no negative
TA 1537 no 9 1.2 no negative
  yes 9 1.2 no negative
WP2 uvr A no 33 1.3 no negative
  yes 37 1.1 no negative
Preincubation test (0.8 - 500 µg/plate)
Strain Metabolic activation system mean revertants in Controls maximum revertant factor dose dependency Assessment
TA 98 no 29 1.0 no negative
  yes 45 0.9 no negative
TA 100 no 139 1.0 no negative
  yes 136 1.3 no negative
TA 1535 no 23 0.8 no negative
  yes 24 0.8 no negative
TA 1537 no 11 1.1 no negative
  yes 12 0.9 no negative
WP2 uvr A no 32 1.0 no negative
  yes 36 0.9 no negative

Applicant's summary and conclusion