Peppermint, ext.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study can be compared to OECD guideline 402, 1987. The study was not performed under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

yes

Remarks:

Observatiion period: 7 days

Principles of method if other than guideline:

Npt applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

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): 71-65 (peppermint oil)
- Physical state: Liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.0 to 2.2 kg
- Housing: no data

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped and abraded abdominal skin
- Type of wrap if used: The animals were wrapped with binders of rubber dam, gauze and adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

5000 mg/kg

No. of animals per sex per dose:

10 animals/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Daily for signs of dermal irritation; weights once at pre-treatment and at post-treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal irritation (erythema and edema signs)

Statistics:

Not relevant

Results and discussion

Preliminary study:

Not relevant

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No animals died during the course of the study.

Clinical signs:

other: There was no evidence of toxicity from percutaneous absorption of the test material. All animals were essentially normal by the termination of the study. Slight to moderate erythema and edema was observed in all animals.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In this acute dermal toxicity in rabbits no mortality occurred after administrating a single dose of 5000 mg/kg. The acute dermal LD50 for the test material as indicated by the data in this study is >5000 mg/kg when applied to the abraded skin of albino rabbits. Based on these results and according to EU criteria the test substance does not need to be classified as acute toxic (dermal) according to the classification criteria outlined in 67/548/EEC and 1272/2008.

Executive summary:

An acute dermal toxicity study was conducted similar to OECD guideline 402. A single 24-hour application of the test material (5000 mg/kg) was made to the clipped abraded abdominal skin of 10 rabbits (New Zealand White). Following exposure, daily observations were made for mortality, toxic effects, and dermal irritation (erythema and edema signs) for a period of 7 days. Individual body weights were recorded once at pre-treatment and at post-treatment. A gross necropsy was performed on all animals at the termination of the study.

No animals died during the course of the study. There was no evidence of toxicity from percutaneous absorption of the test material. All animals were essentially normal by the termination of the study. The individual animal weight changes were normal. Slight to moderate skin irritation was observed in all animals. No abnormalities were noted at necropsy.

The acute dermal LD50 for the test material as indicated by the data in this study is >5000 mg/kg when applied to the abraded skin of albino rabbits. Based on these results and according to EU criteria the test substance does not need to be classified as acute toxic (dermal) according to the classification criteria outlined in 67/548/EEC and 1272/2008.