2-(2-ethoxyethoxy)ethanol

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:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A published study containing sufficient details to regard it as reliable for use in hazard assessment. Limited experimental detail provided.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

In vivo and in vitro toxicity of Carbitol

Author:

Berte F

Year:

1986

Bibliographic source:

Boll Chim Farm 125, 401-403

Reference 2

Reference Type:

publication

Title:

In vivo and in vitro toxicity of Carbitol

Author:

Berte F

Year:

1987

Bibliographic source:

Chem Abst 107 (3) 19235

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Deviations:

yes

Remarks:

one sex only; only 4 animals in control group; only 1000 PCE for each animal were scored.

GLP compliance:

not specified

Type of assay:

micronucleus 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:

C6H14O3

IUPAC Name:

2-(2-ethoxyethoxy)ethan-1-ol

Details on test material:

Test material was CARBITOL. Purity was not listed.

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male

Details on test animals or test system and environmental conditions:

20-30g
Sourced from Charles River

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

no data

Details on exposure:

i.p.

Duration of treatment / exposure:

2 days

Frequency of treatment:

daily

Post exposure period:

One group of animals treated with test material and BP was killed at 48 hours, and the other was killed at 72 hours. Negative controls were killed at 72 hours.

Doses / concentrations

Remarks:

Doses / Concentrations:
2ml/kg/day
Basis:
nominal conc.

No. of animals per sex per dose:

2 groups of 4 animals for test material and positive control
1 group of 4 animals for controls.

Control animals:

yes, concurrent no treatment

Positive control(s):

100 mg/kg benzoapyrene (BP) dissolved in DMSO

Examinations

Tissues and cell types examined:

Bone marrow .

Details of tissue and slide preparation:

Bone marrow smears were made according to the method of Schmitd et al (in 'Chemical Mutagens: Principles and methods for their detection', A. Hollaender and FJ Serres (eds) vol.4, 31-53, Plenum Press, New York, 1976), and stained with Giemsa.

Evaluation criteria:

One thousand polychromatic erythrocytes (PCE) from each animal were scored for micronuclei. The PCE/normochromatic erythrocyte ratio (NCE) was also scored to evaluate any toxic effect.

Statistics:

Not statistically analysed

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

not specified

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Test material had no effect on the number of NCE (1738 and 2010 in carbitol treated at 48 and 72 hrs, respectively vs. 1516 in control), ratio of PCE/NCE (2.30 and 1.99 in treated at 48 and 72 hrs, respectively vs. 2.64 in control), or on the number of micronuclei in PCE (1 at both time points, vs. 2 in negative control). The number of NCE was increased by treatment with BP at 72 hours (3692 vs. 1516 in control), and the number of micronuclei in PCE observed in animals treated with BP was increased at both time points (44 and 46, respectively vs. 2 in control). Therefore, the test was valid.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
The test substance carbitol did not induce micronuclei formation in bone marrow PCE in mice.

Executive summary:

Male mice were treated intraperitoneally with 2 -(2 -ethoxyethoxy)ethanol for two consecutive days at 2ml/kg/day. A positive control group was given 100mg/kg benzopyrene. Analysis of PCE in bone marrow of animals at 48 hours and 72 hours demonstrated that the substance did not induce micronuclei whereas the number of micronuclei observed in positive control animals was increased at both time points.