Diosmin

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

secondary literature

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1997

Reference 2

Reference Type:

review article or handbook

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Toxicological studies were conducted in mice and rats with respect to the acute symptoms, after single oral administration up to the maximum dose of 3000 mg/kg.

GLP compliance:

not specified

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:

diosmin

Constituent 2

Reference substance name:

Hesperidin

EC Number:

208-288-1

EC Name:

Hesperidin

Cas Number:

520-26-3

IUPAC Name:

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

Test material form:

not specified

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Purity: 90% diosmin + 10% flavonoids expressed as hesperidin.

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Doses:

Tested up to 3000 mg/kg.

Control animals:

not specified

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No deaths were registered up to 15 days after administration.

Clinical signs:

other: No effects observed.

Gross pathology:

No substance-related changes were detectable at autopsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

EU criteria.

Conclusions:

The LD50 of the test item is greater than 3000 mg/kg bw in rats.

Executive summary:

An acute oral toxicity study was performed with the test item at doses up to 3000 mg/kg bw on rats. The animals were observed for clinical signs and mortality for up to 15 days. Under test conditions, an LD50 value could not be determined due to the absence of toxic effects. Thus, the LD50 in rats is greater than 3000 mg/kg bw.