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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

Referenceopen allclose all

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 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 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

Constituent 1
Chemical structure
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.

Applicant's summary and conclusion

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