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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
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From March 13, 1991 to April 23, 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Refer to the section 13 for details on the category justification.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)
EC Number:
271-653-9
EC Name:
Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)
Cas Number:
68603-38-3
Molecular formula:
The alkyl chain length of the amide ranges between 16 and 18 carbon atoms
IUPAC Name:
Amides, C16-18 (even numbered) and C18-unsatd., N, N-bis(hydroxyethyl)
Test material form:
not specified

Method

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:
Luminal-induced rat liver microsomes
Test concentrations with justification for top dose:
5,000 µg/plate
Vehicle / solvent:
Dimethylsulfoxide (DMSO)
Controls
Positive controls:
yes
Positive control substance:
2-nitrofluorene

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium, other: TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
valid

Any other information on results incl. tables

For detailed results table kindly refer to the attached background materials section of the IUCLID.

Applicant's summary and conclusion

Conclusions:
Under the study conditions, the test substance was considered to be non-mutagenic.
Executive summary:

A study was conducted to evaluate the in vitro genetic toxicity of the test substance, C16-18 and C18-unsatd. DEA (95.9% active) using EU Method B.13/14, in compliance with GLP. In a test bacterial strains salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100 with and without metabolic activation with rat liver S9 mix were tested with the test concentration 5,000 µg/plate. Under the study conditions, the test substance was considered to be non-mutagenic (Schoberl, 1991).