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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Weight of evidence: In an acute oral toxicity study of the test item on Swiss and NMRI mice, the LD50 was found to be greater than 10000 mg/kg bw. Other reviews report the substance to be non-toxic, with an LD50 in rats greater than 3000 mg/kg bw, and an absence of substance-related effects. Based on the available information, the LD50 value of 3000 mg/kg bw is taken as a worst case.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

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
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
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.
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Doses:
Tested up to 3000 mg/kg.
Control animals:
not specified
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.
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.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1968.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
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
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
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).
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.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
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). Under test conditions, the substance was found to be non toxic to mice, with an LD50 ≥ 10000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Weight of evidence: The acute oral toxicity of the test item on homogeneous groups of Swiss and NMRI mice was determined by Desnoyers (1968) using the method of Miller and Tainter (1944); the LD50 was found to be greater than 10000 mg/kg bw. Reviews by Hitzenberger (1997) and Meyer (1994) report the substance to be non-toxic, with an oral LD50 in rats greater than 3000 mg/kg bw, and the absence of toxic effects. Based on the available information, the LD50 value of 3000 mg/kg bw is taken as a worst case.

Justification for classification or non-classification

Based on the available data (LD50 > 3000 mg/kg bw), the substance is not classified for Acute toxicity, according to CLP Regulation (EC) 1272/2008.