Star anise, Illicium verum, ext.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

09 October 2017

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute 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: 194-203g
- Fasting period before study: not mentioned
- Housing: 1-3 animals per cage, marked individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): The animals received tap water for human consumption. Supply of drinking water was unlimited.
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.60 ± 0.56 °C
- Humidity (%): 54.34 ± 2.71 %
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12-hour light /12-hour dark cycle

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

14 days

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 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:

All 3/3 females at the limit dose of 2000 mg/kg body weight survived.

Clinical signs:

other: No mortality was observed during the study. Animals lived through observation period without signs of intoxication. Neither change of health nor negative skin reactions were registered.

Gross pathology:

During necropsy, no macroscopic changes were noticed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on OECD Guideline 402 it can be concluded, that the test item Star anise, Illicium verum, ext. according to the Globally Harmonised System unclassified after single dermal application to Wistar rats.

Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test item Star anise, Illicium verum, ext. when applied as a single dermal dose to Wistar rats. The procedure according to OECD Guideline 402 Acute Dermal Toxicity was used.

A limit dose of 2000 mg/kg body weight was used as the starting dose. One female was dosed. Test item-related mortality was not observed during 48 hours. A total of three female rats were dosed with a limit dose of 2000 mg/kg body weight.

The test item Star anise, Illicium verum, ext. applied to 3 females at a limit dose of 2000 mg/kg body weight did not cause death. The body weights of all animals decreased during the first week after administration of the test item. No body weight losses were observed between the first and the second week after administration. No signs of toxicity were observed at the dosage of 2000 mg/kg body weight during the first 4 hours or 14-day observation period. No dermal changes were observed. During necropsy no macroscopic findings were noticed.

Based on OECD Guideline 402 it can be concluded, that the test item Star anise, Illicium verum, ext. according to the Globally Harmonised System unclassified after single dermal application to Wistar rats.