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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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 the deleted OECD 401 guideline for testing acute oral toxicity. 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 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

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:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200 to 250 grams
- Fasting period before study: Fasted for a minimum of 16 hours prior to administration of the test material
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data available
Doses:
1600, 2050, 2560, 3200, and 4000 mg/kg
No. of animals per sex per dose:
10 rats (male)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality were made at 1 and 6 hours after dosing, and daily thereafter for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
No data

Results and discussion

Preliminary study:
Not relevant
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 2 650 mg/kg bw
95% CL:
>= 2 300 - <= 3 000
Mortality:
Observed mortality per dose was as follows: 1600 mg/kg: 1/10; 2050 mg/kg: 2/10; 2560 mg/kg: 4/10; 3200 mg/kg: 7/10; 4000 mg/kg: 10/10.
Clinical signs:
The rats experienced salvination, ataxia, hyperactiveness, loss of righting reflex, and depression.
Body weight:
No data on body weight changes.
Gross pathology:
No data
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 calculated from the data is 2650 mg/kg with 95% confidence limits of 2300 and 3000 mg/kg. The substance does not have to be classified according to the EU classification criteria outlined in 67/548/EEC and 1272/2008.
Executive summary:

In this acute oral toxicity test, performed similar to the deleted OECD 401 guideline, the undiluted compound was fed orally to 50 Wistar strain albino male rats in increasing doses at 5 levels (1600, 2050, 2560, 3200, and 4000 mg/kg). Observations for mortality were made at 1 and 6 hours after dosing and daily thereafter for 14 days. Gross necropsies were performed on all survivors.

The rats experienced salvination, ataxia, hyperactiveness, loss of righting reflex, and depression. The oral LD50 calculated from the data is 2650 mg/kg (95% confidence limits of 2300 and 3000 mg/kg). The substance does not have to be classified according to the EU classification criteria outlined in 67/548/EEC and 1272/2008.