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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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

Constituent 1
Chemical structure
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.