2-(2-butoxyethoxy)ethanol

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Published study wjhich contains sufficient scientific information to be able to judge it as reliable for hazard assessment purposes.

Data source

Reference

Reference Type:

publication

Title:

Toxicology of diethylene glycol monobutyl ether 3. Genotoxicity evaluation in an in vitro gene mutation assay and an in vivo cytogenic test

Author:

Gollapudi, B.B., et al. (1993).

Year:

1993

Bibliographic source:

J. Am. Coll. Toxicol. 12(2), 155-59

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)

Deviations:

no

Remarks:

significant deviations noted.

GLP compliance:

not specified

Remarks:

reported as a GLP compliant study

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-butoxyethoxy)ethanol

EC Number:

203-961-6

EC Name:

2-(2-butoxyethoxy)ethanol

Cas Number:

112-34-5

Molecular formula:

C8H18O3

IUPAC Name:

2-(2-butoxyethoxy)ethanol

Details on test material:

- Name of test material (as cited in study report): diethylene glycol monobutyl ether (DGBE)
- Analytical purity: 99.51%
- Impurities (identity and concentrations): peroxides 43ppm
- Lot/batch No.: QP-870323-35-S1 ex Dow Chemicals, Midland, MI

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8 weeks

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

- water

Details on exposure:

- gavage dose 10ml/kg of substance in vehicle.

Duration of treatment / exposure:

single dose

Frequency of treatment:

not applicable

Post exposure period:

Animals sacrificed at 24, 48 and 72 hours after treatment. Positive control group only for 24hr sacrifice.

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 330, 1100 or 3300 mg/kg bw
Basis:
actual ingested

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Positive control(s):

- cyclophosphamide;
- Route of administration: gavage
- Doses / concentrations: 120mg/kg/bw

Examinations

Tissues and cell types examined:

Polychromatic erythrocytes for micronucleation

Details of tissue and slide preparation:

CRITERIA FOR DOSE SELECTION: Top dose was set at 80% of LD50 (4230mg/kg)

TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): See post exposure period field. Sampling times sufficient to allow for absorption and/or metabolism delays.

DETAILS OF SLIDE PREPARATION: Bone marrow smears allowed to air dry, fixed in methanol and stained with 5% giemsa

METHOD OF ANALYSIS: 1000 polychromatic erythrocytes (PCE) were examined per animal to determine incidence of micronucleated PCE and expressed as ration to normochromatic erythrocytes.

Evaluation criteria:

no further data

Statistics:

Three way ANOVA (sex, time, dose) on log transformed data. Pairwise comparisons of dose groups versus negative control done if required by t-test using Bonferroni correction for multiple comparisons. Significance set at p<0.01.

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

not examined

Vehicle controls validity:

valid

Negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): No
- Ratio of PCE/NCE (for Micronucleus assay): 24hrs males: 69-76 (54 in positive control) but not significantly different. females 82-85 (71 in positive control) but not significantly different. 48hrs both sexes: 83-92.
- Appropriateness of dose levels and route:
- Statistical evaluation: No significant increase in the incidence of MN-PCE at any dose level tested and at any time point. Positive control induced significant increase as expected.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
The substance does not induce cytogenicity manifest as micronuclei in the bone marrow of mice when evaluated up to the maximum tolerated dose.

Executive summary:

In an in vivo mouse micronucleus test that used 3 post treatment sampling times, 2 -(2 -butoxyethoxy)ethanol did not increase the incidence of micronucleated polychromatic erythrocytes in either sex when tested up to a single maximum tolerated dose of 3300mg/kg/bw.