Peppermint, ext.

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1965

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was not conducted according to an existing OECD guideline, and not under GLP, but acceptable basic information.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1965

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Male rats of the Wistar strain received 0.5, 1.0, and 2.0 ml/kg (451, 902, and 1804 mg/kg) of peppermint oil U.S.P., double distilled, intraperitoneally (ip). Twenty animals were used at each dosage, and the LD50 after 24 hr. was determined using the Reed-Muench method (Reed, L. J., and Muench, H., Am. J. Hyg., 27, 403, 1938). All animals in these studies were observed for a period of 30 days to include any possible latent effects.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Peppermint oil

IUPAC Name:

Peppermint oil

Details on test material:

- Name of test material (as cited in study report): Peppermint oil U.S.P. (double distilled)
- Composition of test material, percentage of components: ≥ 5% of esters, calculated as menthyl acetate, and ≥ 50% of total menthol, free and as esters.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

unchanged (no vehicle)

Doses:

0.5, 1.0, and 2.0 ml/kg (451, 902, and 1804 mg/kg)

No. of animals per sex per dose:

20

Control animals:

no

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 819 mg/kg bw

Remarks on result:

other: 24 hours

Any other information on results incl. tables

The animals receiving peppermint oil intraperitoneally exhibited brief stimulation, followed by depression beginning in approximately 15 minutes. Twitching, spastic convulsions, ataxia with hind limb paralysis, and abdominal contractions, very slowed respiration, and loss of righting reflex after 25 min. were all observed. Mortality after 24 hours: at 451 mg/kg: 5/20, at 902 mg/kg: 10/20 and at 1804 mg/kg: 19/20.

Applicant's summary and conclusion

Conclusions:

The LD50 of peppermint oil after IP injection was determined to be 819 ±126 mg/kg.

Executive summary:

Male rats of the Wistar strain received 0.5, 1.0, and 2.0 ml/kg (451, 902, and 1804 mg/kg) of peppermint oil U.S.P., double distilled, intraperitoneally (ip). Twenty animals were used at each dosage, and the LD50 after 24 hr. was determined using the Reed-Muench method (Reed, L. J., and Muench, H., Am. J. Hyg., 27, 403, 1938). All animals in these studies were observed for a period of 30 days to include any possible latent effects.

The animals receiving peppermint oil intraperitoneally exhibited brief stimulation, followed by depression beginning in approximately 15 minutes. Twitching, spastic convulsions, ataxia with hind limb paralysis, and abdominal contractions, very slowed respiration, and loss of righting reflex after 25 minutes were all observed. Mortality after 24 hours: at 451 mg/kg: 5/20, at 902 mg/kg: 10/20 and at 1804 mg/kg: 19/20. The ip LD50 after 24 hr was 819 ±126 mg/kg.