N,N'-methanetetraylbis(1-methylethylamine)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Testing was performed as reported by Zeiger et al. (1992).

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-methanetetraylbis(1-methylethylamine)

EC Number:

211-743-7

EC Name:

N,N'-methanetetraylbis(1-methylethylamine)

Cas Number:

693-13-0

Molecular formula:

C7H14N2

IUPAC Name:

(propan-2-yl)({[(propan-2-yl)imino]methylidene})amine

Test material form:

liquid

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 97

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 98

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 100

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 1535

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver

Test concentrations with justification for top dose:

no data

Vehicle / solvent:

not specified

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

not specified

Details on test system and experimental conditions:

Testing was performed as reported by Zeiger et al. (1992). Diisopropylcarbodiimide was sent to the laboratory as a coded aliquot from Radian Corporation (Austin, TX). It was incubated with the Salmonella typhimurium tester strains TA97, TA98, TA100, and TA1535 either in buffer or S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver) for 20 minutes at 37° C. Top agar supplemented with L-histidine and d-biotin was added, and the contents of the tubes were mixed and poured onto the surfaces of minimal glucose agar plates. Histidine-independent mutant colonies arising on these plates were counted following incubation for 2 days at 37° C.
Each trial consisted of triplicate plates of concurrent positive and negative controls and five doses of diisopropylcarbodiimide. The high dose was limited by toxicity. Trials were generally repeated at the same or a higher S9 fraction.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

See it in Table E1 in full study report

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 2

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

See it in Table E1 full study report

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 3

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

See it in Table E1 in full study report

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 4

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

See it in Table E1 full study report

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Applicant's summary and conclusion

Conclusions:

Diisopropylcarbodiimide was not mutagenic in S. typhimurium strains TA97, TA98, TA100, or TA1535, with or without induced rat or hamster liver S9 activation enzymes (Table E1).

Executive summary:

Diisopropylcarbodiimide was not mutagenic in S. typhimurium strains TA97, TA98, TA100, or TA1535, with or without induced rat or hamster liver S9 activation enzymes (Table E1).