Ginger, ext.

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

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Ginger, ext.

EC Number:

283-634-2

EC Name:

Ginger, ext.

Cas Number:

84696-15-1

Molecular formula:

N/A

IUPAC Name:

Essential oil extract of Zingiber officinalis (Zingiberaceae) root GINGER ESSENTIAL OIL Ginger Oil Ginger Oleoresin Ginger, ext Ginger, ext. Ginger, Extrakt HE Zingiber officinalis INCI name: Zingiber Officinale (Ginger) Root Extract OILS, GINGER Reaction mass of camphene and pin-2(3)-ene and 7-methyl-3-methyleneocta-1,6-diene and pin-2(10)-ene and cineole and [S-(R*,S*)]-5-(1,5-dimethylhexen-4-yl)-2-methyl-1,3-cyclohexa-1,3-diene and (R)-p-mentha-1,8-diene Zingiber officinalis, Zingiberaceae.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

olive oil

Doses:

The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight.

No. of animals per sex per dose:

The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. Available information indicated that the test item is likely to be non-toxic with regard to acute toxicity. A limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore, in a second step, another 3 females were treated at the same dose.

Control animals:

yes

Remarks:

Animals were observed individually immediately after administration of the test item and 0.5, 1, 2, and 4 hours later. Each animal was inspected daily for the next 14 days.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

0

Clinical signs:

other: No signs of toxicity were observed during the first 4 hours in females or the 14-day observation period thereafter.

Other findings:

During necropsy, no macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 of the test item Ginger, 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 Ginger, ext. is classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.