3-diethylaminophenol

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The substance 3-diethylaminophenol was found to be not mutagenic in nature.

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:

weight of evidence

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

PREINCUBATION : In the standard protocol (preincubation) for conducting the Ames assay, a test tube containing a suspension of one strain of Salmonella typhimurium (or E. coli) plus S9 mix or plain buffer without S9, is incubated for 20 minutes at 37º C with the test chemical. Control cultures, with all the same ingredients except the test chemical, are also incubated. In addition, positive control cultures are prepared; these contain the particular bacterial tester strain under investigation, the various culture ingredients, and a known potent mutagen*. After 20 minutes, agar is added to the cultures and the contents of the tubes are thoroughly mixed and poured onto the surface of Petri dishes containing standard bacterial culture medium. The plates are incubated, and bacterial colonies that do not require an excess of supplemental histidine appear and grow. These colonies are comprised of bacteria that have undergone reverse mutation to restore function of the histidine-manufacturing gene. The number of colonies is usually counted after 2 days.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

S. typhimurium TA 1535

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

S. typhimurium TA 97

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

S. typhimurium TA 98

Additional strain / cell type characteristics:

not specified

Metabolic activation:

without

Metabolic activation system:

none

Test concentrations with justification for top dose:

10-666 UG/PLATE

Vehicle / solvent:

DMSO

Details on test system and experimental conditions:

Test System : AMES SALMONELLA TYPHIMURIUM

Species / strain:

S. typhimurium TA 100

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Species / strain:

S. typhimurium TA 97

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Species / strain:

S. typhimurium TA 98

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Conclusions:

Interpretation of results (migrated information):
negative without metabolic activation

In an Ames test , 3-diethylaminophenol, in dimethyl sulfoxide from doses 10-666 UG/PLATE was not mutagenic in Salmonella typhimurium strains TA100,TA1535,TA97 and TA98 without metabolic activation.

Executive summary:

In an Ames test , 3-diethylaminophenol, in dimethyl sulfoxide from doses 10-666 UG/PLATE was not mutagenic in Salmonella typhimurium strains TA100,TA1535,TA97 and TA98 without metabolic activation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Genetic Toxicity in vitro :

Based on studies of target substance CAS NO 91-68-9 reviewed for genetic toxicity from reliable sources having Klimisch rating 2 considering weight of evidence approach.

 

The summary of the results are presented below

 

Sr. No	End point	Effect	Species	Remarks
1	In vitro Genetic toxicity	negative without S9 metabolic activation	S. typhimurium TA 100	Predicted data of target chemical
2	In vitro Genetic toxicity	negative without S9 metabolic activation	S. typhimurium TA 1535	Predicted data of target chemical
3	chromosome aberration	negative without S9metabolic activation	Chinese hamster Lung (CHL)	Predicted data of target chemical
4	In vitro Genetic toxicity	negative without metabolic activation	S. typhimurium TA 100, TA 1535,TA97,TA98	Data is from publication for Target chemical

 

Based on the results summarized in above table for the target chemical CAS NO 91-68-9, it can be concluded that the substance is non-genotoxic.Thus according to CLP criteria it can be concluded that the substance 3-diethylaminophenol is not a genotoxic substance.

Justification for selection of genetic toxicity endpoint

In an Ames test , 3-diethylaminophenol, in dimethyl sulfoxide from doses 10-666 UG/PLATE was not mutagenic in Salmonella typhimurium strains TA100,TA1535,TA97 and TA98 without metabolic activation.

Justification for classification or non-classification

Substance will not be classified in Genetic toxicity category as per the C & L criteria set by EU.