Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: Guideline study (OECD 471)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

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

Constituent 1
Chemical structure
Reference substance name:
2-ethoxyethylamine
EC Number:
203-801-5
EC Name:
2-ethoxyethylamine
Cas Number:
110-76-9
Molecular formula:
C4H11NO
IUPAC Name:
2-ethoxyethylamine
Details on test material:
- Name of test material (as cited in study report): 2-Ethoxyethylamin
- Analytical purity: 99.7%

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9-mix from rat livers (treated with 500 mg Aroclor 1254)
Test concentrations with justification for top dose:
20, 100, 500, 2500, 5000 ug/Platte
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
Controls
Untreated negative controls:
yes
Remarks:
sterility control
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: with S-9 mix: 2-aminoanthracene; without S-9 mix: N-methyl-N-nitro-N-nitrosoguanidine for the strains TA 100 and TA 1535, 4-nitro-o-phenylendiamine for the strain TA 98, 9-aminoacridine chloride monohydrate for the strain TA 1537.
Details on test system and experimental conditions:
METHOD OF APPLICATION: standard plate test

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3


METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3

Evaluation criteria:
doubling of the spontaneous mutation rate, dose-response relationship, reproducibility of the results

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:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: Salmonella typhimurium TA98, TA100, TA1535, TA1537

Any other information on results incl. tables

Standart plate test:

 Dose (µg/plate)  TA1535     TA100     TA1537     TA98   
   +S9  -S9  +S9  -S9  +S9  -S9 +S9  -S9
 0  16±6  17±3 133±5  142±6  12±2 15±3  35±4  38±5 
20   22±1 16±2  148±15  141±12  10±2  12±3  38±4  43±7 
 100  22±10 22±9  144±6  140±19  10±1  15±3  30±9  36±2 
 500  22±1 16±5 144±6  130±18  9±4  10±3  33±7  36±4 
 2500  26±6 22±4  144±15  135±9  11±2  11±2  23±8  38±6 
 5000  18±8 20±4  148±12  133±4 10±2  9±7  26±4  25±2
 2-AA  -  185±73  -  1393±29 -   106±8 -   680± 34
 MNNG  1220±69  -  1185±49  -  - -  -  - 
 AAC  -  - -   -  683±137  - -  - 
 NPD -  -   -  - -   -  890±200 - 

Preincubation-test:

 Dose (µg/plate)  TA1535     TA100     TA1537     TA98   
   +S9  -S9  +S9  -S9  +S9  -S9 +S9  -S9
 0  20±5 17±5  122±7  120±19  12±4  12±2  36±3  48±2 
20   16±2 16±1  136±23  112±11  12±2  13±1  32±7  49±1 
 100  15±2  21±4 139±10  112±11  12±2  10±5  32±4  49±5 
 500  22±4 17±5  128±13  126±5  13±5  11±4  23±4 49±15 
 2500 12±4  14±4  79±12  131±9  6±0  4±5  8±5  22±9 
 5000  - 130±5 - 94±14  -  9±5  8±5  22±9 
 2AA  -  169±24  -  965±68  -  111±18  -  598±37
 MNNG  660±51  -  754±55  -  -  -  -  -
 AAC  -  -  -  -  1028±86  -  -  -
 NPD  -  -  -  -  -  -  1180±82  -

2-AA: 2-aminoanthracene;

MNNG; N-methyl-N-nitro-N-nitrosoguanidine

NPD: 4-nitro-o-phenylendiamine

AAC: 9-aminoacridine chloride monohydrate

Under the conditions testet the substance was not mutagenic in the bacterial AMES-Test. The positive control gave the expected values.

Applicant's summary and conclusion