Sodium 2-biphenylate

Genetic toxicity: in vivo

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

Test material information

Constituent 1

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-phenylphenolate

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 / concentrations

Doses / concentrations 1

Dose / conc.:

300 mg/kg bw/day (nominal)

Doses / concentrations 2

Dose / conc.:

600 mg/kg bw/day (nominal)

Doses / concentrations 3

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