Registration Dossier
Registration Dossier
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EC number: 208-008-8 | CAS number: 505-32-8
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: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
- Principles of method if other than guideline:
- BASF-Test, no guideline available at that time.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- EC Number:
- 208-008-8
- EC Name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- Cas Number:
- 505-32-8
- Molecular formula:
- C20H40O
- IUPAC Name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- Details on test material:
- - Name of test material (as cited in study report): Isophytol G
- Physical state: fluid
- Analytical purity: ca. 90 %
- Impurities (identity and concentrations): not reported
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gassner, Sulzfeld
- Age at study initiation: no data
- Weight at study initiation: males 231 g, females 186 g
- Fasting period before study: no data
- Housing: 5/cage
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Traganth
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2, 20, 30 %
MAXIMUM DOSE VOLUME APPLIED: 21.3 ml/kg bw - Doses:
- 200, 1600, 3200, 6400 µl/kg bw (corresponding to 169, 1350, 2700, 5400 mg/kg bw, based on a density of 0.844 g/cm³)
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: weighing at begin of the study, observations daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- The approximate LD50 was calculated, the method of calculation was not reported.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 400 mg/kg bw
- Remarks on result:
- other: > 6400 mm^3/kg bw, converted using a relative density of 0.844
- Mortality:
- No mortality occurred
- Clinical signs:
- other: Apathy, tachypnea in the two highest dose groups; all dose groups without symptoms 3 days after dosing
- Gross pathology:
- No findings
Applicant's summary and conclusion
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