Registration Dossier
Registration Dossier
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EC number: 202-180-8 | CAS number: 92-70-6
Genetic toxicity: in vivo
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:
- 2 010
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
- 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
Constituent 1
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
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