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:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted study by NTP done in compliance with GLP.

Data source

Reference
Reference Type:
other: NTP website
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
b-Picoline
IUPAC Name:
b-Picoline
Constituent 2
Chemical structure
Reference substance name:
3-methylpyridine
EC Number:
203-636-9
EC Name:
3-methylpyridine
Cas Number:
108-99-6
Molecular formula:
C6H7N
IUPAC Name:
3-methylpyridine

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female

Administration / exposure

Route of administration:
oral: drinking water
Duration of treatment / exposure:
13 week
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
78, 156, 312.5, 625 or 1,250 mg/l
Basis:
analytical conc.
No. of animals per sex per dose:
10
Control animals:
yes, concurrent no treatment

Examinations

Tissues and cell types examined:
Erythrocytes
Details of tissue and slide preparation:
CRITERIA FOR DOSE SELECTION: All doses.

TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): 0-24 hours

DETAILS OF SLIDE PREPARATION: 1,000 to 10,000 mature erythrocytes (normochromatic erythrocytes or NCEs) are scored per animal for presence
of micronuclei. Acridine orange.

METHOD OF ANALYSIS: Flow cytometry.

OTHER:
Statistics:
Trend test

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Following a 13-week drinking water study in mice at doses up to 1,250 mg/l , b-picoline was not genotoxic in an erythrocyte miconucleus test.