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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
In vitro and in vivo genetic toxicology studies with diethylene glycol monohexyl ether.
Author:
Ballantyne, B. & Vergnes, J.S.
Year:
2001
Bibliographic source:
J. Appl. Toxicol. 21, 449-460

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
Deviations:
no
GLP compliance:
not specified
Type of assay:
other: chromosome aberration assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-hexyloxyethoxy)ethanol
EC Number:
203-988-3
EC Name:
2-(2-hexyloxyethoxy)ethanol
Cas Number:
112-59-4
Molecular formula:
C10H22O3
IUPAC Name:
2-[2-(hexyloxy)ethoxy]ethanol

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
According to Guideline.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Duration of treatment / exposure:
n.a.
Frequency of treatment:
single
Post exposure period:
12, 24, 48 h
Doses / concentrationsopen allclose all
Dose / conc.:
375 mg/kg bw/day (nominal)
Remarks:
(males)
Dose / conc.:
750 mg/kg bw/day (nominal)
Remarks:
(males)
Dose / conc.:
1 500 mg/kg bw/day (nominal)
Remarks:
(males)
Dose / conc.:
450 mg/kg bw/day (nominal)
Remarks:
(females)
Dose / conc.:
900 mg/kg bw/day (nominal)
Remarks:
(females)
Dose / conc.:
1 500 mg/kg bw/day (nominal)
Remarks:
(females)
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Positive control(s):
Cyclophosphamide (30 mg/kg bw)

Examinations

Tissues and cell types examined:
Femoral bone marrow smears
Details of tissue and slide preparation:
Sampling time: 12, 24, 48 h


Evaluation criteria:
According to Guideline.
Statistics:
Yes

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
RESULTS OF RANGE-FINDING STUDY
- Dose range: 410-1000 mg/kg bw

Applicant's summary and conclusion

Conclusions:
negative