Registration Dossier

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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only a publication was available for review, and did not include full details of results.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
substance was administered daily for 3 months
GLP compliance:
yes
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): 2-methyltetrahydrofuran; MeTHF CAS 96-47-9
- Substance type: Monoconstituent substance
- Physical state: no information
- Analytical purity: no information

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
3 months
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
up to 26 mg/kg/day
Basis:

No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
other: negative control
Positive control(s):
- Positive control substance: mitomycin C
- 5 male animals for low and high dose positive controls

Examinations

Tissues and cell types examined:
Bone marrow slides harvested at sacrifice the day after canal dose. 2000 polychromatic erythrocytes (PCE) scored for micronuclei (MN-PCE). Frequency of PCE and of mature normochromatic erythrocytes (NCE) recorded for 1000 erythrocytes per rat.
Details of tissue and slide preparation:
Stained with acridine orange

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Remarks:
on proportions of PCE among NCE
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Tetrahydro-2-methylfuran has been tested for induction of micronuclei. No induction of micronuclei was observed, and no effect on the proportion of polychromatic erythrocytes was noted was noted in male or female mice after three months treatment by oral gavage. It is concluded that the test substance is negative for the induction of micronuclei under the conditions of the test.