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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:
comparable to guideline study with acceptable restrictions
Remarks:
Limited documentation. No information on analytical purity of test substance given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Limited documentation. No information on analytical purity of test substance given.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
(1R)-1-isopropyl-4-methyl-cyclohex-3-en-1-ol
Cas Number:
20126-76-5
Molecular formula:
C10H18O
IUPAC Name:
(1R)-1-isopropyl-4-methyl-cyclohex-3-en-1-ol

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
600, 1220, 2470 and 5000 mg/kg bw
No. of animals per sex per dose:
10 animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Remarks:
calculated
Effect level:
1 300 mg/kg bw
Based on:
test mat.
95% CL:
840 - 2 100
Mortality:
600 mg/kg bw: 1/10 animals died
1220 mg/kg bw: 4/10 animals died
2470 mg/kg bw: 9/10 animals died
5000 mg/kg bw: 10/10 animals died
Mortality occurred in all animals within 24 h.
Clinical signs:
other: 600 mg/kg bw: ataxia, lethargy, tremors, chromorhinorrhea, chromodacryorrhea 1220 mg/kg bw: lethargy, ptosis, piloerection, chromorhinorrhea 2470 mg/kg bw: salivation, chromorhinorrhea, ataxia 5000 mg/kg bw: coma and death
Gross pathology:
600 mg/kg bw: dark lungs (1/10), dark liver (1/10), dark kidneys (1/10) and areas of redness in intestines (1/10)
1220 mg/kg bw: dark lungs (4/10), dark liver (4/10), dark kidneys (2/10) and areas of redness in intestines (4/10) and motteled kidneys (3/10)
2470 mg/kg bw: dark lungs (9/10), dark liver (8/10), dark kidneys (2/10), areas of redness in intestines (6/10), dried blood around eyes (3/10), yellow exudate from nose and mouse (3/10), yellow portions of intestines (3/10), red portions of stomach (3/10), bloody urine in bladder (2/10), red exudate from mouth (2/10) and mottled kidneys(1/10)
5000 mg/kg bw: dark lungs (9/10), dark liver (7/10), dark kidneys (3/10) and areas of redness in intestines (6/10)

Applicant's summary and conclusion

Interpretation of results:
other: Acute Tox. 4 according to Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicity study a LD50 value of 1300 mg/kg bw was derived in rats.