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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In vitro: Ames: negative (OECD 471, BASF 1998)

Link to relevant study records
Reference
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:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP study report.
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to guideline
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Remarks:
testing lab.
Type of assay:
bacterial reverse mutation assay
Target gene:
S. typhimurium and E. coli
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:
rat liver S-9 fraction
Test concentrations with justification for top dose:
20 - 5000 ug/plate (standard plate test); 4 - 2500 µg/plate (preincubation test)
Vehicle / solvent:
water
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: with metabolic activation: 2-aminoanthracene; without metabolic activation: N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylendiamine, 9-aminoacridine and N-ethyl-N'-nitro-N-nitrosoguanidine
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: A bacteriotoxic effect was observed under all test conditions.
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:
other: A bacteriotoxic effect was observed under all test conditions.
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S-9 mix or after the addition of a metabolizing system.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Bacterial gene mutation (BASF, 1998)


 


The test substance (2-aminoethyldiethylamine) was tested for mutagenicity with the strains TA 98, TA 100, TA 1535 and TA 1537 Salmonella typhimurium and Escherichia coli WP2 uvrA (Ames Test). The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. A dose range up to 5.000 µg/plate was used. The test substance did not show in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated a dose dependent increase in the number of revertants in any of the bacterial strains. The positive controls showed the expected results.


Based on these results it can be stated that the test substance is not mutagenic in these bacterial test systems.


 

Justification for classification or non-classification

Based on the results of the in vitro genetic toxicity study (Ames test), it is concluded that 2-aminoethyldiethylamine does not have to be classified according to CLP (EC) No 1272/2008.