Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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: General results were provided but experimental details and details on results were not provided. However, the based on the clear dose-response relationship, the results could be evaluated.

Data source

Reference
Reference Type:
publication
Title:
The mutagenicity of Dialkylaminoalkyl chlorides in a battery of short-term assays
Author:
Thompson CZ, Rinzel SM, Probst GS, McMahon RE
Year:
1981
Bibliographic source:
Environmental Mutagenesis 3:33-43 (1981)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diethylaminoethyl chloride
- Analytical purity: not provided. Since the test substance was obtained from a reliable supplier it is assumed that the purity was sufficiently high to use the results.
- Other: The test item was obtained from Aldrich Chemical Company, Inc. Milwaukee, Wisconsin, USA as hydrochloride salt.

Method

Target gene:
tryptophan auxotrophy
Species / strainopen allclose all
Species / strain / cell type:
E. coli WP2 uvr A
Species / strain / cell type:
S. typhimurium TA 1535
Species / strain / cell type:
S. typhimurium TA 100
Metabolic activation:
without
Test concentrations with justification for top dose:
WP2uvrA: ca. 1.75 - 225 µM
TA 1535: ca. 3.5 - 1800 µM
TA 100: ca. 3.5 - 1800 µM
Note: the molecular mass of DEC is 172.1 g/mol. Hence the concentrations ranged from about 0.3 µg/mL to about 310 µg/mL for WP2uvrA.
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: sterile destilled water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
not specified
Details on test system and experimental conditions:
According to Ames et al. (1975) modified as follows: Ten milliliter base layers o minimal agar were prepared and used on the same day of preparation. Ten serial twofold dilutions were made of each compound in sterile culture tubes to which were added 3 mL top agar and 0.1 mL of an overnight culture of the selected tester strain.
Evaluation criteria:
Not provided. In the publication, figures with error bars are presented in figure 4. Based on this information and the shape of hte dose-response relationship, the onset of mutagenicity was estimated.
Statistics:
not performed, but error bars were provided in the figure 4

Results and discussion

Test resultsopen allclose all
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
without
Genotoxicity:
positive
Remarks:
starting at the lowest concentration, i.e., about 1.75 µM
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
without
Genotoxicity:
positive
Remarks:
starting at 7 µM
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Species / strain:
S. typhimurium TA 100
Metabolic activation:
without
Genotoxicity:
positive
Remarks:
starting at about 112.5 µM
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive

should be considered as potentially mutagenicic
Executive summary:

In the publication of Thompson et al. (1981), the AMES test was performed with DEC using E.coli strain WP2uvrA and S. typhimurium strains TA 1535 and TA 100. Cytotoxic concentrations were not reported. The results were not reported in detail but in one graph. Statistics was not performed. However, due to the clear dose response the information was sufficient to consider DEC as potentially mutagenicic in the AMES test.