Bis(2-ethoxyethyl) ether

Genetic toxicity: in vivo

Administrative data

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.

Data source

Reference

Reference Type:

review article or handbook

Title:

In vivo and in vitro toxicity of carbitol

Author:

F. Berté et al

Year:

1986

Bibliographic source:

Bolletino Chimico Farmaceutico

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Carbitol

IUPAC Name:

Carbitol

Constituent 2

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

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

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male

Details on test animals or test system 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:

Administration / exposure

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

Doses / concentrations

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.

Examinations

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.

Results and discussion

Test results

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

Applicant's summary and conclusion

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.