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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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol
EC Number:
405-040-6
EC Name:
A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol
Cas Number:
63500-71-0
Molecular formula:
C10 H20 O2
IUPAC Name:
Reaction mass of (rel-2R,4R)-tetrahydro-4-methyl-2-(2-methylpropyl)-2H-pyran-4-ol and (rel-2R,4S)-tetrahydro-4-methyl-2-(2-methylpropyl)-2H-pyran-4-ol
Details on test material:
- Lot/batch No.: S1943401
-Analytical purity: >99%
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bodyweight (2.12 ml/kg Bodyweight)
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no deaths
Clinical signs:
pilo-erection, increased salivation, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy, decreased respiratory rate, ptosis and pallor of the extremeties
recovery of all rats was complete by day 3
Body weight:
all rats achieved anticipated bodyweight gains throughout the study with the exception of one male on day 8, this animal achieved an anticipated gain on day 15
Gross pathology:
no abnormalities were recorded

Applicant's summary and conclusion

Conclusions:
The acute lethal oral dose was found to be greater than 2000 mg/kg bodyweight.