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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Study period:
11/03/1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented report of a guideline study conducted to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

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:
Benzyldimethyl[2-[(1-oxoallyl)oxy]ethyl]ammonium chloride
EC Number:
256-283-8
EC Name:
Benzyldimethyl[2-[(1-oxoallyl)oxy]ethyl]ammonium chloride
Cas Number:
46830-22-2
Molecular formula:
C14H20NO2.Cl
IUPAC Name:
benzyldimethyl[2-(prop-2-enoyloxy)ethyl]azanium chloride
Details on test material:
- Name of test material (as cited in study report): ADAMQUAT BZ 80
- Physical state: liquid
- Analytical purity: 78.5%
- Impurities (identity and concentrations): Acrylic acid (0.54%), dimethylaminoethyacrylate (0.55%); EMHQ (0.0378%)
- Composition of test material, percentage of components: 100%
- Purity test date: 06/12/1991
- Lot/batch No.: op 611/613/615/616
- Expiration date of the lot/batch: 12/1992
- Stability under test conditions: stable
- Storage condition of test material: inthe dark at room temperature

Method

Target gene:
Histidine operon
Species / strain
Species / strain / cell type:
other: S. typhimurium TA1535, TA1537, TA1538, TA98 and TA100
Metabolic activation:
with and without
Metabolic activation system:
S9-mix (from livers of male Sprague-Dawley rats treated by Aroclor 1254)
Test concentrations with justification for top dose:
0, 125, 250, 500, 1000 and 2000 µg/plate
Vehicle / solvent:
distilled water
Controls
Untreated negative controls:
yes
Remarks:
vehicle
Negative solvent / vehicle controls:
yes
Remarks:
distilled water
True negative controls:
no
Positive controls:
yes
Remarks:
- without S9-mix: for TA1535 and TA100: sodium azide (1 µg/plate); for TA1537: 9-aminoacridine (50 µg/plate); for TA1538 and TA98: 2-nitrofluorene (0.5 µg/plate) - with S9-mix: for all strains: 2-aminoanthramin (2 µg/plate); for TA1535 and TA1537 (1 µg/
Positive control substance:
no
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)
- incubation temperature : 37°C

DURATION
- Preincubation period: 1h
- Exposure duration: 48 to 72 h
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):


NUMBER OF REPLICATIONS: 3


NUMBER OF CELLS EVALUATED:


DETERMINATION OF CYTOTOXICITY
Bacterial toxicity: determined by examination of background lawn growth on TA100
- Number of revertants / plate

OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:


OTHER:
Evaluation criteria:
Result is considered as positive when the following criteria are observed:
- dose-related increase in revertant colony count
- the number of revertant colonies per plate with the test substance is more than twice that of negative control.
- reproducibility of results
Statistics:
No data

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA1535, TA1537, TA1538, TA98 and TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 2500 µg/plate with S9 in TA 100
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: strain/cell type: TA 1538 and TA 100
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

CYTOTOXICITY: The test substance was toxic at the concentrations ≥ 2500 µg/plate for the TA 100 strain with and without S9 mix: the number of revertants decreased. At lower concentrations, no toxicity was observed.

GENOTOXICITY: No genotoxicity was observed in both experiments. The selected concentrations were 125, 250, 500, 1000 and 2000 µg/plate with and without the metabolic activation system S9 mix. The negative and solvent control results were equivalent to those usually obtained in our Laboratory. The number of revertants induced by the positive controls were higher than the controls, which demonstrated the sensitivity of the test and the effective activation of 2-anthramine by the S9 mix under the experimental conditions. The number of revertants obtained in the presence of ADAMQUAT BZ 80 with and without S9 mix for the 5 strains was equivalent to that of the negative and/or solvent controls.

Applicant's summary and conclusion

Conclusions:
ADAMQUAT BZ 80 did not show mutagenic activity in the Ames test.