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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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