Registration Dossier
Registration Dossier
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EC number: 201-940-6 | CAS number: 89-79-2
Acute Toxicity: oral
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:
- 1 971
- 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
- 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
Constituent 1
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:
- other: 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, re
- 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
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