Essential oil of Mentha Spicata L., Erospicata (Labiatae) obtained from aerial parts by steam distillation

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 Jul - 17 Aug 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 17 Dec 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Essential oil of Mentha Spicata L., Erospicata (Labiatae) obtained from aerial parts by steam distillation

EC Number:

811-616-1

Cas Number:

1563063-07-9

Molecular formula:

not applicable for UVCB substances

IUPAC Name:

Essential oil of Mentha Spicata L., Erospicata (Labiatae) obtained from aerial parts by steam distillation

Test animals

Species:

rat

Strain:

other: Crl:CD(SD), SPF

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8 weeks
- Weight at study initiation: 178.6 − 212.4 g
- Fasting period before study: overnight, approx. 16 h prior and 4 h after dosing
- Housing: 1 animal per cage in stainless wire mesh cages (260W x 350D x 210H mm)
- Diet: Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C (Envigo RMS. Ltd., USA), ad libitum
- Water: public tap water filtered and irradiated by ultraviolet light, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.6 − 23.6
- Humidity (%): 49.0 - 70.3
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Lot/batch no.: MKBV2080V (SIGMA-ALDRICH, Co., USA)

MAXIMUM DOSE VOLUME APPLIED: 2.24 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: Due to the low expected toxicity of the test substance 2000 mg/kg bw was selected as starting dose.

Doses:

2000 mg/kg bw (step 1 and 2)
300 mg/kg bw (step 3 and 4)

No. of animals per sex per dose:

6 (3 per step)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 30 min and 1, 2, 4 and 6 h after dosing and thereafter once daily for 14 days. Individual body weights were recorded prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured in step 1 at 2000 mg/kg bw. In step 2 at 2000 mg/kg bw, one animal was found dead on Day 2 and 3. No mortality was observed at 300 mg/kg bw.

Clinical signs:

In surviving animals at 2000 mg/kg bw abnormal gait was observed in one animal 6 h after dosing and chromaturia (brown color) and/or decrease of fecal volume were observed in one to four animals on Day 1 and 2. The changes disappeared on Day 3. In dead animals abnormal gait and/or decrease in locomotor activity were observed in one to two animals at 4 and 6 h after dosing and chromaturia (brown color), decrease of fecal volume, lacrimation, loss of locomotor activity, lying on side, decrease in locomotor activity and/or soiled perineal region were observed in one to two animals on Day 1 and/or Day 2. The clinical signs were considered to be test substance-related.
No clinical abnormalities were observed at 300 mg/kg bw.

Body weight:

In surviving animals at 2000 mg/kg bw a tendency for suppression of body weight gain was observed in three animals on Day 1 and a decrease in body weight was observed in one animal on Day 1 and Day 3. Normal body weight gains were observed in these animals on Day 3 and/or Day 7. In dead animals a decrease in body weight was observed on Day 1. The changes were considered to be test substance-related.
Normal body weight gains were observed in all animals at 300 mg/kg bw.

Gross pathology:

No abnormal morphological findings were observed in any animal at 300 and 2000 mg/kg bw, respectively.

Applicant's summary and conclusion

Interpretation of results:

other: Acute Tox. Cat. 4

Remarks:

according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study in rats a LD50 cut-off of 2000 mg/kg bw was determined.