Sage, Salvia officinalis, ext.

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Sage, Salvia officinalis, ext.

EC Number:

282-025-9

EC Name:

Sage, Salvia officinalis, ext.

Cas Number:

84082-79-1

IUPAC Name:

Sage, Salvia officinalis, ext.

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levels

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.

Applicant's summary and conclusion

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.