2,5-Furandione, reaction products with 2-ethyl-1-hexanamine and triethanolamine

Genetic toxicity: in vitro

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

(2E)-3-({3-carboxy-3-[(2-ethylhexyl)amino]propanoyl}(2-ethylhexyl)carbamoyl)prop-2-enoic acid; (2E)-3-[(2-ethylhexyl)carbamoyl]prop-2-enoic acid; (2E)-4-{2-[bis(2-hydroxyethyl)amino]ethoxy}-4-oxobut-2-enoic acid; 2-[(2-hydroxyethyl)amino]ethyl (2E)-3-[(2-ethylhexyl)carbamoyl]prop-2-enoate

EC Number:

939-488-3

Cas Number:

1471311-93-9

Molecular formula:

C18 H36 N2 O6

IUPAC Name:

(2E)-3-({3-carboxy-3-[(2-ethylhexyl)amino]propanoyl}(2-ethylhexyl)carbamoyl)prop-2-enoic acid; (2E)-3-[(2-ethylhexyl)carbamoyl]prop-2-enoic acid; (2E)-4-{2-[bis(2-hydroxyethyl)amino]ethoxy}-4-oxobut-2-enoic acid; 2-[(2-hydroxyethyl)amino]ethyl (2E)-3-[(2-ethylhexyl)carbamoyl]prop-2-enoate

Details on test material:

- Name of test material (as cited in study report): Korantin MAT
- Physical state: liquid
- Analytical purity: ca. 100 % (UVCB)

Method

Target gene:

HIS/TRP

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix

Test concentrations with justification for top dose:

20 ug - 5000 ug/plate (SPT; all tester strains)
4 ug - 5000 ug/plate (PIT; Salmonella strains)
4 ug - 1000 ug/plate (PIT; E. coli WP2 uvrA )

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: [water]
- Justification for choice of solvent/vehicle: water was chosen due to the good solubility of the test substance

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: with S-9 mix: 2-aminoanthracene (all strains); without S-9 mix: N-methyl-N'-nitro-N-nitrosoguanidine (TA 100, TA 1535), 4-nitro-o-phenylendiamine (TA 98), 9-aminoacridine (TA 1537), 4-nitroquinoline-N-oxide (E.coli WP2 uvrA)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

The test chemical is considered positive in this assay if the following criteria are met:
A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in this test if:
The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other.

Statistics:

not applicable

Results and discussion

Test results

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:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY:
No bacteriotoxic effect was observed in the standard plate test .
In the preincubation assay bacteriotoxicity (reduced background growth, decrease in the number of revertants and/or slight reduction in the titer) was observed depending on the strain and test conditions from about 500 - 2,500 ug/plate onward.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.