Bis(2-ethoxyethyl) ether

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study run to a reliable method but not to GLP and no guideline followed and limited information. However it is a peer-reviewed publication.The restriction is also due to the use of the category read accross approach. study was performed not with DEGDEE but with DEGEE, a substance which like DEGDEE is part of the diethylene glycol monoalkyl and dialkyl ethers category. These substances have been demonstrated to be similar in structure, physical/chemical properties and toxicological profile.

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Zimmermann F. K., Kern R., and Rosmberger H., Mut. Res. 28, 381, (1975).

Principles of method if other than guideline:

Cells were grown in culture on a roller drum at 28°C, until they reached stationary phase. Cells were then washed twice with distilled water and resuspendcd in saline buffer pH 7.4, and combined with carbitol at the concentration of 1 and 10% for 4 hours. Ethylmethansulphonate was used as standard mutagen.
Washed cells suspensions were plated on an isoleucin free medium, on a medium without triptophan, and finally, on a complete medium.
All plates were incubated at 28°C. Plates could be scored for the number of survival and convertant colonies on the third day after treatment. Revertants and red/pink sectors were scored after 6 days.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-ethoxyethoxy)ethanol

EC Number:

203-919-7

EC Name:

2-(2-ethoxyethoxy)ethanol

Cas Number:

111-90-0

Molecular formula:

C6 H14 O3

IUPAC Name:

2-(2-ethoxyethoxy) ethanol

Test material form:

gas under pressure: refrigerated liquefied gas

Details on test material:

- Name of test material (as cited in study report): Carbitol
- Molecular formula (if other than submission substance): C6H14O3
- Molecular weight (if other than submission substance): 134.17
- Smiles notation (if other than submission substance): CCOCCOCCO
- Physical state: 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 100

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 102

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 1535

Species / strain 5

Species / strain / cell type:

S. typhimurium TA 1537

Species / strain 6

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S-9 fraction

Test concentrations with justification for top dose:

<=1%

Vehicle / solvent:

- Vehicle used: none

Controls

Untreated negative controls:

yes

Remarks:

2-amino-anthracene

Negative solvent / vehicle controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

sodium azide

mitomycin C

Details on test system and experimental conditions:

METHOD OF APPLICATION: on medium;

DURATION
- Expression time (cells in growth medium): until they reached stationary
- Fixation time (start of exposure up to fixation or harvest of cells): 4 hours

SELECTION AGENT (mutation assays): Ethylmethansulphonate

NUMBER OF REPLICATIONS: 1

NUMBER OF CELLS EVALUATED: no data

DETERMINATION OF CYTOTOXICITY
- Method: gene mutation

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 2

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 3

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

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:

positive

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 5

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 6

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
ambiguous with metabolic activation
ambiguous without metabolic activation

The results show that carbitol is a very weak mutagenic substance in S. typhimurium, TA1535, 1537, 1538, with and without metabolic activation. In the other strain tested carbitol is inactive. Further testing is required.

Executive summary:

DEGDEE and DEGEE, which is in the above study tested in an AMES test , are both part of the diethylene glycol monoalkyl and dialkyl ethers category described and evaluated in the document titled "Category Approach-Read across Bis(2 -ethoxyethyl)ether" (2013).

These substances have been demonstrated to be very similar in structure, physical/chemical properties and toxicological profile . Therefore, a read-across from DEGDEE to data obtained with DEGEE is scientifically justified.