Star anise, Illicium verum, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2019

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

Adopted: 17th December 2001

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Guidance Document on Acute Oral Toxicity Testing, OECD Series on Testing and Assessment No 24, 2001

Version / remarks:

No 24, 2001

Deviations:

not specified

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(E)-anethole

EC Number:

224-052-0

EC Name:

(E)-anethole

Cas Number:

4180-23-8

Molecular formula:

C10H12O

IUPAC Name:

1-methoxy-4-prop-1-en-1-ylbenzene

Constituent 2

Reference substance name:

4-allylanisole

EC Number:

205-427-8

EC Name:

4-allylanisole

Cas Number:

140-67-0

Molecular formula:

C10H12O

IUPAC Name:

1-allyl-4-methoxybenzene

1

Reference substance name:

Caryophyllene

EC Number:

201-746-1

EC Name:

Caryophyllene

Cas Number:

87-44-5

Molecular formula:

C15H24

IUPAC Name:

4,11,11-trimethyl-8-methylenebicyclo[7.2.0]undec-4-ene

Constituent 3

Reference substance name:

2,6-dimethyl-6-(4-methyl-3-pentenyl)bicyclo[3.1.1]hept-2-ene

EC Number:

241-702-9

EC Name:

2,6-dimethyl-6-(4-methyl-3-pentenyl)bicyclo[3.1.1]hept-2-ene

Cas Number:

17699-05-7

Molecular formula:

C15H24

IUPAC Name:

2,6-dimethyl-6-(4-methylpent-3-en-1-yl)bicyclo[3.1.1]hept-2-ene

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dobrá Voda, Slovak Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 173-186g for females
- Fasting period before study: overnight before treatment
- Housing: 3 animals per cage in a room.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): The animals received tap water for human consumption. Supply of drinking was unlimited.
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.58 ± 0.56 °C
- Humidity (%): 54.31 ± 2.71 %
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12-hour light /12-hour dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

Animals were treated orally, with a single dose by means of a stomach tube.( Oral administration simulates a potential route of human exposure, and oral dosing is recommended by regulatory agencies.)

Doses:

2000 mg/kg body weight

Control animals:

no

Details on study design:

Clinical signs of toxicity, physical condition, and rate of death was monitored throughout the 14-day observation period.

All test animals were subjected to gross necropsy and the results were recorded for each animal whenever they died, survivors at the end of the observation period.

Individual weights of animals were measured immediately prior to test item administration and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 - <= 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: The 95% CL is not available

Remarks:

The 95% CL is not available

Mortality:

5/6 animals survived the limit dose of 2000 mg/kg body weight.

Clinical signs:

other: Test item-related mortality was observed within 24 hours. Animal No 6 died one day after administration of the test item probably during the night hours, because cadaver was in a state of autolysis. In animals No 1, 2, 3, 5 piloerection and lethargy were

Gross pathology:

During necropsy, no macroscopic findings were observed. Animal No 6 could not be necropsied because of autolysed cadaver.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 of the test item Star anise, Illicium verum, ext. is greater than 2000 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 it can be concluded that the test item Star anise, Illicium verum, ext is according to Globally Harmonized System classified in Category 5 with a LD50 cut off value 2500 mg/kg body, after single oral administration to Wistar rats.

Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test itemStar anise, Illicium verum, ext.when administered as a single oral dose to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class(ATC)method was used.

A limit dose of 2000 mg/kg body weight was used as a starting dose.The test itemadministeredto 6 females at a limit dose caused death of one animal. Piloerection and lethargy were observed during the observation period. A slight decrease of body weights in two animals was noticed during the first post-treatment week. No body weight losses were observed between the first and second week after administration.During necropsy, no macroscopic findings were observed.

The LD₅₀of the test itemStar anise, Illicium verum, ext.is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Based onAnnex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423itcan be concluded that thetest itemStar anise, Illicium verum, ext.is according toGlobally Harmonized Systemclassified in Category 5 with a LD₅₀cutoff value 2500 mg/kg body weight,after single oral administration to Wistar rats.