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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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 97
Species / strain / cell type:
S. typhimurium TA 100
Species / strain / cell type:
S. typhimurium TA 102
Species / strain / cell type:
S. typhimurium TA 1535
Species / strain / cell type:
S. typhimurium TA 1537
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 resultsopen allclose all
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
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
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
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
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
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.