Registration Dossier

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

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
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:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
no
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): diethylene glycol monohexyl ether
- Ethoxylation degree: 2EO
- Physical state: No data
- Analytical purity: 96.8%
- Lot/batch No.: No data

Test animals

Species:
mouse
Strain:
Swiss Webster
Sex:
male/female
Details on test animals and environmental conditions:
According to Guideline.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
corn oil
Duration of treatment / exposure:
n.a.
Frequency of treatment:
single
Post exposure period:
30, 48, 72 h
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 200, 400, 640 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Positive control(s):
Triethylenemelamine (0.3 mg/kg)

Examinations

Tissues and cell types examined:
Tail blood smears
Details of tissue and slide preparation:
Sampling time: 30, 48, 72 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:
Interpretation of results (migrated information): negative