Reaction mass of stigmast-5-en-3-β-ol and stigmasta-5,22-dien-3-β-ol and (24R)-ergost-5-en-3β-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2023

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (24R)-ergost-5-en-3β-ol and stigmast-5-en-3-β-ol and stigmasta-5,22-dien-3-β-ol

EC Number:

904-790-6

Molecular formula:

C28H48O; C29H50O; C29H48O

IUPAC Name:

Reaction mass of (24R)-ergost-5-en-3β-ol and stigmast-5-en-3-β-ol and stigmasta-5,22-dien-3-β-ol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Age 6 to 7 weeks old
Weight range at arrival 158-166 grams
Acclimatisation period At least 5 days
Veterinary health check During acclimatisation period
Animals per cage up to 4 during the study; up to 5 during acclimatisation
Housing Polisulphone solid bottomed cages measuring 59.5×38×20 cm with nesting material provided into suitable bedding bags
Cage control Daily inspected and changed as necessary (at least 2 times/week)
Water drinking water supplied to each cage via a water bottle
Water supply ad libitum
Diet supply ad libitum throughout the study except for the dosing procedure
Room lighting Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
Air changes Approximately 15 to 20 air changes per hour
Temperature range 22 °C ± 2 °C
Relative humidity range 55 % ± 15 %

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

Concentrations: 30 and 200 mg/mL.

No. of animals per sex per dose:

4 females

Details on study design:

An initial sighting study was performed on a single female animal which was dosed at
300 mg/kg. No mortality occurred and the animal was observed for a period of 14 days. Then,
another sighting study was performed on a single female which was dosed at 2000 mg/kg.
No death occurred. A main study was then performed on a group of 4 females, dosed at
2000 mg/kg and observed for a period of 14 days.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was observed in the main study.

Gross pathology:

No abnormalities were observed at the necropsy examination performed on termination of
the observation period in the sighting study animals and in all animals of the main study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute toxicity of Mixture of phytosterols was investigated following a single oral admin-
istration (10 mL/kg in corn oil) to the Sprague Dawley rat followed by a 14-day observation
period.
Mortality did not occur and no clinical signs were observed in the animals following dosing
at 2000 mg/kg.
These results indicate that the test item, Mixture of phytosterols, has no toxic effect on
the rat following oral administration of a single dose at 2000 mg/kg. The lack of mortality
demonstrates the LD50 to be greater than 2000 mg/kg body weight.