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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
(number of animals not given)

Data source

Reference
Reference Type:
publication
Title:
Cytogenetic Studies on Sodium o-Phenylphenate
Author:
Yoshida S, Nawai S, Hiraga K
Year:
1979
Bibliographic source:
Ann. Rep. Tokyo Metr. Res. Lab. 30-2

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
Deviations:
not specified
GLP compliance:
no
Type of assay:
other: mammalian bone marrow chromosome aberration test

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2-biphenylate
EC Number:
205-055-6
EC Name:
Sodium 2-biphenylate
Cas Number:
132-27-4
Molecular formula:
C12H9NaO
IUPAC Name:
sodium 2-biphenylate

Test animals

Species:
mouse
Strain:
ICL-ICR
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 weeks
- Diet: Basal diet (CE-2. CLEA Japan Inc.), ad libitum
- Water: Tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 ± 1
- Humidity (%): 55 ± 5
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 15/9

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
- Vehicle(s)/solvent(s) used: Distilled water
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: The test item was dissolved in distilled water and orally administered with stomach tube at a volume of 10 mL/kg bw.
Duration of treatment / exposure:
6, 24 and 48 h, respectively
Frequency of treatment:
Single treatment
Doses / concentrationsopen allclose all
Dose / conc.:
300 mg/kg bw/day (nominal)
Dose / conc.:
600 mg/kg bw/day (nominal)
Dose / conc.:
1 200 mg/kg bw/day (nominal)
Control animals:
yes

Examinations

Tissues and cell types examined:
Bone marrow cells
Details of tissue and slide preparation:
DETAILS OF SLIDE PREPARATION: Chromosome stainings were routinally made.

Results and discussion

Test results
Key result
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable

Any other information on results incl. tables

Table 1: Frequency of Chromosome Aberrations in Mice

        Gap Break
Duration of Treatment (h) Dose Level (mg/kg bw) Number of analysed cells Total aberrations C1 a) C2 b) C1 C2
6 1200 200 1 1 0 0 0
600 200 0 0 0 0 0
300 200 1 1 0 0 0
0 200 0 1 0 0 0
24 1200 200 2 2 0 0 0
600 200 0 0 0 0 0
300 200 1 0 0 0 0
48 1200 200 2 2 0 0 0
600 200 0 0 0 0 0
300 200 0 0 0 0 0
0 200 0 0 0 0 0

a) Chromatid Type

b) Chromosome Type

Applicant's summary and conclusion

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