Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Guideline study but only study abstract available

Data source

Reference
Reference Type:
grey literature
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Qualifier:
according to guideline
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Version / remarks:
(Chemical Substances Control Law of Japan)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3-hydroxy-2-naphthoic acid
EC Number:
202-180-8
EC Name:
3-hydroxy-2-naphthoic acid
Cas Number:
92-70-6
Molecular formula:
C11H8O3
IUPAC Name:
3-hydroxy-2-naphthoic acid
Details on test material:
- Name of test material (as cited in study report): 3-hydroxy-2-naphthoic acid
- Analytical purity: 99.2%
- Impurities (identity and concentrations): no data

Test animals

Species:
mouse
Strain:
other: mouse/BDF1
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Mouse/BDF1 (C57BL/6 × DBA/2)[SPF] was used.
No additional details

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
- Vehicle(s)/solvent(s) used: 0.5 % Methylcellulose solution
No additional data
Details on exposure:
PREPARATION OF DOSING SOLUTIONS:
no data
Duration of treatment / exposure:
2 consecutive days
Frequency of treatment:
daily
Post exposure period:
sampling was done 24 hours after the second dose
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 125, 250, 500 mg/kg
Basis:
actual ingested
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Positive control(s):
mitomycin C

Examinations

Tissues and cell types examined:
bone marrow cells
Details of tissue and slide preparation:
no data
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Remarks:
the test substance did not induce micronucleated erythrocytes in mouse bone marrow cells.
Toxicity:
yes
Remarks:
not specified; toxicity did not substantially differ between the sexes of mice.
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
RESULTS OF RANGE-FINDING STUDY
1 male animal died in the group treated with 700 mg/kg in the dose-finding study.

RESULTS OF DEFINITIVE STUDY
No data

Applicant's summary and conclusion