Registration Dossier

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
Year:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 3',5-diallyl[biphenyl]-2,4'-diol and 5,5'-diallyl[biphenyl]-2,2'-diol
Cas Number:
947686-05-7
Molecular formula:
C18H18O2
IUPAC Name:
Reaction mass of 3',5-diallyl[biphenyl]-2,4'-diol and 5,5'-diallyl[biphenyl]-2,2'-diol
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
confirm to the best of knowldge#

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 2 000 - <= 5 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Executive summary:

The LD50 of the test item “Magnolia Officinalis Bark Extract” is greater than 2000 mg/kg and lower than 5000 mg/kg body weight after single oral administration to Wistar rats.


Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 (USA) it can be concluded that the test item “Magnolia Officinalis Bark Extract” is according to GHS criteria classified in Category 5 with a LD50 cut off value equal to 2500 mg/kg body weight, after single oral administration to Wistar rats. It can be stated that Magnolia Officinalis Bark Extract shows low acute toxicity regarding oral toxicity test.