Schinus terebinthifolius, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From May 2 to 17, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study conducted in compliance with OECD Guideline No. 401 without any deviation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

31 July 1992

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Essential oil of Schinus Terebinthifolius (Anacardiaceae) obtained from red berries by steam distillation

EC Number:

946-006-5

Cas Number:

1175539-64-6

Molecular formula:

not available (UVCB)

IUPAC Name:

Essential oil of Schinus Terebinthifolius (Anacardiaceae) obtained from red berries by steam distillation

Test material form:

liquid

Details on test material:

- Storage conditions: Room temperature in the dark
- Appearance: clear colorless liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage IFFRA CREDO (69210 L'Arbresle, France)
- Age at study initiation: 5-7 weeks
- Weight at study initiation: M: 190.5-209.4 g / F: 175.8-198.4 g
- Fasting period before study: Animals were fasted before dosing and then for 3-4 h after dosing.
- Housing: Animals were housed in groups of 5 in polypropylene cages.
- Diet: Pelleted diet, ad libitum.
- Water: tap water, ad libitum.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 30-70 %
- Air changes: 10 changes/h
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From: May 02, 2001 To: May 17, 2001

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

PEG 300

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.37 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighting: On test days -1, 1 (prior to administration), 4, 8 and 15
- Frequency of observations:
Mortality / viability/ clinical observations: during the first 30 minutes and at approximately 1, 2, 3,4, 5 and 6 hours after administration on test day 1 (with the clinical signs) and at least only daily thereafter.
- Necropsy of survivors performed: Yes; All animals were killed at the end of the observation period by intraperitoneal injection of Pentaboarbital sodique

Statistics:

None

Results and discussion

Preliminary study:

See below

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: None

Gross pathology:

No macroscopic findings were recorded at necropsy

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (combined) > 2000 mg/kg bw. Under the test conditions, the substance is not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline No. 401 and in compliance with GLP, male and female Sprague-Dawley rats were administered a single oral dose of 2000 mg test material/kg bw by gavage. Animals were observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.

All animals survived until the end of the study period. No clinical signs nor effects on body weight were reported during the course of this study. No macroscopic findings were recorded at necropsy.

LD50 (combined) > 2000 mg/kg bw

Under the test conditions, the substance is not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.