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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Pre-GLP, pre-guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Principles of method if other than guideline:
no data
GLP compliance:
no
Remarks:
pre-GLP study
Test type:
standard acute method
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 Sample: RIFM 71-47 (5-11-71 and 6-2-71)
Clear liquid in 4 ounce bottles

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Sprague-Dawley rats
- Weight at study initiation: 115-141 g
- Fasting period before study: yes, overnight predose
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
ca. 285, 570, 1140, 2275, 4550 mg/kg bw (0.313, 0.625, 1.25, 2.5, 5 ml/kg bw based on a density of 0.909 g/ml)
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 0.5, 1, 2, 4, 24h and daily during 14 days
- Frequency of weighing: initial and at day 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 936 mg/kg bw
Remarks on result:
other: Original value: LD50 = 1.030 +/- 0.10 ml/kg; density: 0.909 g/ml
Mortality:
10/10, 10/10, 6/10, 1/10 and 0/10 rats given 5, 2.5, 1.25, 0.625 and 0.313 ml/kg bw died, respectively.
Clinical signs:
5 ml/kg bw: unconsciousness prior to death which occurred within 2 hours (all animals), salivation, respiratory congestion and ataxia, lacrimation

2.5 ml/kg bw: unconsciousness prior to death which occurred within 24 hours (all animals), salivation, respiratory congestion and ataxia, lacrimation

1.25 ml/kg bw: unconsciousness prior to death, salivation, respiratory congestion and ataxia

0.625 ml/kg bw: unconsciousness up to 4 h post dose, salivation, respiratory congestion and ataxia

0.313 ml/kg bw: salivation, respiratory congestion and ataxia

Number of affected animals not given.
Gross pathology:
Pathology of deaths indicated dose related hyperemia of lungs and stomach.
Lung consolidation in 1 male of the 1.25 ml/kg dose group.
No gross pathological changes were noted in surviving animals necropsied at day 14.

Applicant's summary and conclusion