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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 days
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method

Test material

Constituent 1
Test material form:
solid: crystalline
Details on test material:
Batch number 37160906202

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
None supplied

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
The material was prepared as 10% and 40% w/v suspensions in corn oil and administered by oral intubation at a range of sage volumes of 1.0 to 40mL/kg bodyweight. Rats were treated with vehicle alone (40mL/kg) served as controls
Doses:
0, 0.1, 1.0, 4.0, 4.0, 16.0 g/kg
No. of animals per sex per dose:
2 male and 2 female per dose
Control animals:
yes
Details on study design:
Observation period 14 days. Weighed weekly.
Statistics:
No deaths.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 other: b/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Lethargy, diarrhoea and increased lacrimation amonst rats at 4.0g/kg and above.
Ptosis, for up to one hour after dosing amonst rates at 4.0 and 16g/kg
fur loss in two males at 4.0g/kg and one at 16g/kg
diuresis in two females and pallor if the extremities at 4g/kg
Pilo-erection was observed in all control rats accompanied by diuresis in one female.
Gross pathology:
Pallor of the liver was observed in one male at 4.0g/kg (40w/v) and one female at 16g/kg at terminal autopsy. Other macroscopic findings were normal.

Applicant's summary and conclusion