Essential oil of Spearmint obtained from the aerial part of Mentha spicata and/or Mentha cardiaca (Lamiaceae) obtained by distillation

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Study performed equivalent or similar to OECD 401, and not according to GLP guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Federal Hazardous Substance Act (FHSA)

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Essential oil of Spearmint obtained from the aerial part of Mentha spicata and/or Mentha cardiaca (Lamiaceae) obtained by distillation

EC Number:

946-253-9

Molecular formula:

Not applicable

IUPAC Name:

Essential oil of Spearmint obtained from the aerial part of Mentha spicata and/or Mentha cardiaca (Lamiaceae) obtained by distillation

Details on test material:

- Name of test material (as cited in study report): Spearmint Oil N.F.
- Physical state: Liquid
- Purity: No data
- Lot/batch No.: Confidential information

Specific details on test material used for the study:

CAS 8008-79-5

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: Approx. 200 g
- Fasting period: 16 - 18 hours
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

No data available

Doses:

5000 mg/kg

No. of animals per sex per dose:

10 rats (male)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily (and frequently on day of test)
- Necropsy of survivors performed: no
- Other examinations performed: symptomatology

Statistics:

not relevant

Results and discussion

Preliminary study:

Not relevant

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

5 / 10

Clinical signs:

other: Piloerection in 7/10 rats, lethargy at 24 hours in 5/10 rats

Gross pathology:

not performed

Other findings:

Necropsy was not performed

Any other information on results incl. tables

Not relevant

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Based on CLP criteria

Conclusions:

The oral LD50 value of Spearmint Oil in rats was established as approximately 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).

Executive summary:

A single 5000 mg/kg bw dose of Spearmint Oil was administered by oral gavage to 10 male Wistar albino rats. The animals were observed for 14 days while food and water were available ad libitum. Mortality was observed in 5/10 rats and the following symptoms were observed: Piloerection in 7/10 rats, lethargy at 24 hours in 5/10 rats. The oral LD50 value of Spearmint Oil in rats was established as approximately 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).