2,2'-iminodi(ethylamine)

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

Study period:

Not applicable

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to test guidelines and in accordance with GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-iminodi(ethylamine)

EC Number:

203-865-4

EC Name:

2,2'-iminodi(ethylamine)

Cas Number:

111-40-0

Molecular formula:

C4H13N3

IUPAC Name:

bis(2-aminoethyl)amine

Details on test material:

- Name of test material (as cited in study report): Diaethylentriamin, Substance-No. 96/675
- Physical state: Colorless liquid
- Analytical purity: 98 .5% (GC)
- Lot/batch No.: B 940 (CZA/A - G 404)
- Storage condition of test material: refrigerator
- Other: Date of manufacture: November 7, 1996

Method

Target gene:

histidine-operon

Species / strain

Species / strain / cell type:

other: TA 1535, TA 100, TA 1537, TA 98 and E .coli WP2 uvrA

Details on mammalian cell type (if applicable):

- Properly maintained: yes

Metabolic activation:

with and without

Metabolic activation system:

rat liver S9 fraction (Aroclor 1254-induced)

Test concentrations with justification for top dose:

Experiment 1: 0; 20 ; 100 ; 500 ; 2500 and 5000 μg/plate (vehicle water)
Experiment 2: 0; 1,000 ; 2000 ; 3000 ; 4000 and 5000 μg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: with S9: 2-aminoanthracene; without S9: N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylendiamine, 9-aminoacridine, N-ethyl-N'-nitro-N-nitrosoguanidine

Details on test system and experimental conditions:

No data

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 non-mutagenic 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

Key result

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: no toxicity observed, but mean number of revertants is slightly reduced at the highest dose selected, indicating beginning toxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

Not applicable

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Standart plate test:  Dose (µg/plate)  TA1535     TA100     TA1537     TA98        E. coli WP2 uvrA    -S9  +S9  -S9  +S9  -S9  +S9 -S9  +S9 -S9  +S9   0 19±1 19±3  108±8 120±17 10±1 10±4 30±3 43±5 32±3 41±2 20  17±3 17±2 101±4 125±10 9±2 11±2 32±3 38±3 34±4 41±2  100 17±2 20±2 105±5 125±22 9±1 11±1 27±5 41±5 33±3 41±3  500 15±2 21±2 121±2 148±7 8±2 12±2 25±1 39±3 36±3 50±2  2500 16±2 17±3 141±7 191±7 9±1 11±1 25±5 35±5 73±8 66±2  5000 13±2 19±2 109±16 155±26 7±3 10±1 14±2 17±3 60±3 87±3  2-AA - 194±12 - 1192±183 - 870±93 -  880±53 -  209±12  MNNG 997±56 - 1346±108 - - - - - - -  AAC - - - - 546±106 - -  -  - -  NPD  - - - - - - 940±9  -  -  -  ENNG - - - - - - - - 927±31 - Mean ± SD Standart plate-test (replication):  Dose (µg/plate)  TA100       E. coli WP2 uvrA           -S9  +S9  -S9  +S9 0 107±11 115±4 28±3 39±3 20 102±11 123±28 52±9 40±5  100 114±15 146±8 113±12 68±3  500 120±9 152±22 123±5 75±5  2500 103±11 127±27 104±5 61±12  5000 71±10 84±12 75±8 37±6  2AA  - 1058±20 - - MNNG 1145±53 - - -  AAC -  - - -  NPD - - - - ENNG - - 873±42 - Mean ± SD 2-AA: 2-aminoanthracene; MNNG; N-methyl-N-nitro-N-nitrosoguanidine ENNG; N-ethyl-N-nitro-N-nitrosoguanidine NPD: 4-nitro-o-phenylendiamine AAC: 9-aminoacridine chloride monohydrate According to the results of the present study, the test substance leads to an increase in the number of revertant colonies using E. coli WP2 uvrA both without S-9 mix and after adding a metabolizing system in two experiments carried out independently of each other. Thus, under the experimental conditions chosen here, it is concluded that diethylentriamine is a mutagenic agent in the bacterial reverse mutation test in vitro.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
positive

Diethylentriamine is a mutagenic agent in the bacterial reverse mutation test in vitro.

Executive summary:

The mutagenicity potential of DETA was evaluated in the Ames test. According to the present study, the test substance leads to an increase in the number of revertant colonies using E. coli WP2 uvrA both without S-9 mix and after adding a metabolizing system in two experiments carried out independently of each other. Thus, under the experimental conditions chosen here, it is concluded that diethylentriamine is a mutagenic agent in the bacterial reverse mutation test in vitro.