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Key value for chemical safety assessment

Genetic toxicity in vivo

Link to relevant study records
Reference
Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
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.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Schmid W., "The micronucleus test for citogenetic analyis" in "Chemical Mutagens:Principles and· methods for their detection" .A. Hollaender and F. J. Serres (eds) vol. 4, 31·53, Plenum press, New York. (1976).
GLP compliance:
no
Type of assay:
micronucleus assay
Species:
mouse
Strain:
CD-1
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Commercial laboratory animal supplier
- Age at study initiation: no data
- Weight at study initiation: 20-30g
- Assigned to test groups randomly: yes
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:
Route of administration:
intraperitoneal
Vehicle:
- Vehicle used: none;
Duration of treatment / exposure:
No data
Frequency of treatment:
Animals received carbitol (DEGEE) in two subsequent daily administrations
Remarks:
Doses / Concentrations:
2 ml/kg
Basis:
other: actual dose, intraperitoneal
No. of animals per sex per dose:
20
Control animals:
yes
Positive control(s):
benzo(a)pyrene;
- Justification for choice of positive control(s): no data
- Route of administration: intraperitoneal
- Doses / concentrations: 10 mg/kg dissolved in DMSO.
Tissues and cell types examined:
Bone marrow erythrocytes.
Details of tissue and slide preparation:
DETAILS OF SLIDE PREPARATION: Slides were stained with May-Grunwald Giemsa

Evaluation criteria:
The presence of micronuclei in polychromatic erythrocytes. In addition the polychromatic/ normochromatic erythrocytes ratio was also determined for evaluate a possible toxic effect.
Sex:
female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): none
Conclusions:
Interpretation of results (migrated information): negative
Carbitol, at the dose of 2 ml/Kg, does not induce micronuclei in mice bone marrow
Executive summary:

DEGDEE and DEGEE, which is in the above study tested in a micronucleus 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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vivo:

Justification for selection of genetic toxicity endpoint
This is an in vivo study and as such, is regarded as the most meaningful.

Justification for classification or non-classification

All in vivo studies return a negative result. Therefore this substance will not be classified as genotoxic.