5,7-dihydroxy-2-(3-hydroxy-4-methoxyphenyl)-4-benzopyrone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1968.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1968

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The test item was orally administered to homogeneous groups of Swiss and NMRI male mice, and the LD50 was estimated using the method of Miller and Tainter (1944) (see 'attached background materials'): a log-probit graph paper was used for the estimation of the ED50 and its standard error.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diosmin

EC Number:

208-289-7

EC Name:

Diosmin

Cas Number:

520-27-4

Molecular formula:

C28H32O15

IUPAC Name:

5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4-oxo-4H-chromen-7-yl 6-O-(6-deoxy-alpha-L-mannopyranosyl)-beta-D-glucopyranoside

Test material form:

not specified

Test animals

Species:

mouse

Strain:

other: Swiss and NMRI.

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 19-22 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 5% gum tragacanth in water

Details on oral exposure:

Oral administration: single dose by gavage, administered to groups of male Swiss mice and groups of male NMRI mice.

Doses:

500, 1000 and 10000 mg/kg.

No. of animals per sex per dose:

No data.

Control animals:

not specified

Statistics:

Method of Miller and Tainter (1944).

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No effects.

Clinical signs:

other: No effects.

Gross pathology:

No effects.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

EU criteria

Conclusions:

Under test conditions, the substance was found to be non toxic to mice, with an LD50 ≥ 10000 mg/kg bw.

Executive summary:

The acute oral toxicity was studied for the test substance on Swiss and NMRI mice, using the method of Miller and Tainter (1944) (no TG, no GLP). Groups of mice were administered a single dose of test item by gavage, at concentrations of 500, 1000 or 10000 mg/kg bw of test item. A log-probit graph paper was used to estimate the LD50 from the results obtained. Under test conditions, the substance was found to be non toxic to mice, with an LD50 ≥ 10000 mg/kg bw.