Isopulegol

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Study period:

no data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Publication with limited documentation, limited set of parameters assessed

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Effect of essential oils on the concentration of serum lipids and apolipoproteins in rats.

Author:

Imaizumi K et al.

Year:

1985

Bibliographic source:

Agric. Biol. Chem.; 49 (9), 2795-6

Reference 2

Reference Type:

secondary source

Title:

Effect of essential oils on the concentration of serum lipids and apolipoproteins in rats.

Author:

Imaizumi K et al

Year:

1985

Bibliographic source:

Cited in: WHO (2001). Pulegone and related substances. WHO Food Additives Series 46: 221-243.

Reference 3

Reference Type:

secondary source

Title:

Effect of essential oils on the concentration of serum lipids and apolipoproteins in rats.

Author:

Imaizumi K et al

Year:

1985

Bibliographic source:

Cited in: Bhatia et al. 2008; Fragrance material review on isopulegol; Food. Chem. Toxicol. 46; 185-189; Cited in RIFM/FEMA database (Location 3215)

Materials and methods

Principles of method if other than guideline:

no data

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isopulegol

EC Number:

201-940-6

EC Name:

Isopulegol

Cas Number:

89-79-2

Molecular formula:

C10H18O

IUPAC Name:

isopulegol

Details on test material:

Isopulegol; no further data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 248 +/- 4.1 g
- Diet: ad libitum
- Water: ad libitum
no further data

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
no further data

Administration / exposure

Route of administration:

oral: feed

Vehicle:

not specified

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

14 days

Frequency of treatment:

continuously in the diet

Doses / concentrations

Remarks:

Doses / Concentrations:
0.5, 1% in the diet
Basis:
nominal in diet

No. of animals per sex per dose:

3-4 males per group

Control animals:

yes, plain diet

Details on study design:

Rats were fasted overnight prior to blood sampling from abdominal aorta.
No further data

Positive control:

Not applicable

Examinations

Observations and examinations performed and frequency:

Observations included body weight, liver weight and serum cholesterol, triacylglycerol and Apo A-1 levels.

Sacrifice and pathology:

No data

Other examinations:

No data

Statistics:

Student´s t test (no further data)

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Dose group 1%:

The relative weight of the liver and concentrations of cholesterol,  Apo A-1 and triglyceride were significantly increased.

Body weight gain was slightly (non-significant) decreased. Food intake was unaffected.

Body weight change (g/14 days): 56 +/-3 (vs. 68 +/-8 in controls)

Liver weight (g/100g bw): 3.7 +/-0.1 (vs 3.3 +/-0.1 in controls)

Cholesterol (mg/dl): 135 +/-5 (vs 91 +/-1 in controls)

Triacylglycerol (mg/dl): 135 +/-9 (vs 98 +/-7 in controls)

Apo A-1 (mg/dl): 86 +/-5 (vs 66 +/-4 in controls)

Dose group 0.5%:

No details given.

In the review of the WHO Food Additives Series, a NOEL of 250 mg/kg bw/d (referring to the 0.5% dose group) has been set for this study.