Sage, Salvia officinalis, ext.

Endpoint summary

Description of key information

In an acute oral toxicity study on rats, the Oral LD50 was found to be superior to 2000 mg/kg. (pre- GLP, Rel. K2)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

no guideline available

Principles of method if other than guideline:

Forty male albino rats Wistar strain, 10 per group, were fasted for a minimum of 16 hours prior to administration of the test material. The drug was administered as a concentrate.

GLP compliance:

no

Test type:

acute toxic class method

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-250 g
- Fasting period before study: 16 hours
- Diet: ad libitum
- Water : ad libitum

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The drug was administered as a concentrate

Doses:

1.29 g/kg bw
2.02 g/kg bw
3.20 g/kg bw
5.00 g/kg bw

No. of animals per sex per dose:

10 per group

Details on study design:

Observations for mortality were made at 1 and 6 hours after dosing and daily thereafter for fourteen days. Gross necropsies were performed on all survivors.

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

2 600 mg/kg bw

Based on:

test mat.

Mortality:

At the dose of 1.29 g/kg bw, one animal died
At the dose of 2.02 g/kg bw, four animals died
At the dose of 3.20 g/kg bw, seven animals died
At the dose of 5.00 g/kg bw, nine animals died

Clinical signs:

The rats experienced lethargy.

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 calculated from the data is 2 600 mg/kg bw with 95% confidence limites of 1 900 and 3300 mg/kg bw.

Executive summary:

Forty male albino rats Wistar strain, 10 per group, were fasted for a minimum of 16 hours prior to administration of the test material. The drug was administered as a concentrate. Observations for mortality were made at 1 and 6 hours after dosing and daily thereafter for fourteen days. Gross necropsies were performed on all survivors. The rats experienced lethargy. Deaths occured overnight following adnimistration of the drug. The LD50 calculated from the data is 2 600 mg/kg bw with 95% confidence limites of 1 900 and 3300 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 600 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

Forty male albino rats Wistar strain, 10 per group, were fasted for a minimum of 16 hours prior to administration of the test material. The drug was administered as a concentrate. Observations for mortality were made at 1 and 6 hours after dosing and daily thereafter for fourteen days. Gross necropsies were performed on all survivors. The rats experienced lethargy. Deaths occured overnight following adnimistration of the drug. The LD50 calculated from the data is 2 600 mg/kg bw with 95% confidence limites of 1 900 and 3300 mg/kg bw.

Justification for classification or non-classification

Self classification:

Acute toxicity via Oral route:

Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 2000 mg/kg bw