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Description of key information

Acute toxicity: oral. Weight of evidence. Based on the read across approach from two analogue substances, the LD50 of the test item is not acutely toxic, with an LD50 greater than 4934 mg/kg bw in mice (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:
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
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:
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.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See 'Attached justification'.
Reason / purpose for cross-reference:
read-across source
Limit test:
no
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 4 934 mg/kg bw
Based on:
test mat.
Remarks on result:
other: read-across from analogue substance.
Interpretation of results:
GHS criteria not met
Remarks:
EU criteria
Conclusions:
Based on the read-across approach, the target substance is deemed to be non toxic, with an LD50 ≥ 4934 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. Based on the read-across approach, the target substance is deemed to be non toxic, with an LD50 ≥ 4934 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 934 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

Acute toxicity: oral. Weight of evidence.

In an acute oral toxicity study for the analogue substance diosmin on Swiss and NMRI mice (no TG, no GLP), where groups of mice were exposed to either 500, 1000 or 10000 mg/kg bw of test item, the substance was found to be non-toxic to mice, with an LD50 ≥ 10000 mg/kg bw. Based on the read-across approach, the target substance is deemed to have an LD50 ≥ 4934 mg/kg bw.

In an acute oral toxicity of the analogue substance naringin in rats, a limit test was performed, according to the ‘‘Technical Guideline for Acute Toxicity Test of chemical drugs’’(SFDA, 2004, China), similar to OECD 420 (GLP study). The test item was orally administered to 6 male and 6 female Sprague-Dawley rats, at a single bolus dose of 16 g/kg bw, by gavage. The test item was found to be non toxic by oral route, with an LD50 > 16g/kg in rats. Based on the read-across approach, the target substance is deemed to have an LD50 > 8275 mg/kg bw in rats.

Based on the available information for the read-across approach, the test item is deemed to be not acutely toxic, with an LD50 ≥ 4934 mg/kg bw.

Justification for classification or non-classification

Based on the available data (oral LD50 ≥ 4934 mg/kg bw in mice), the substance is not classified for Acute toxicity, according to CLP Regulation (EC) 1272/2008.