Registration Dossier
Registration Dossier
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EC number: 907-349-6 | CAS number: -
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 acceptable with restrictions, limited documentation, non GLP.
Data source
Reference
- Reference Type:
- other: short report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- - purity of test substance not specified, no recording of body weights
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Octadecyl isocyanate
- EC Number:
- 204-019-7
- EC Name:
- Octadecyl isocyanate
- Cas Number:
- 112-96-9
- Molecular formula:
- C19H37NO
- IUPAC Name:
- 1-isocyanatooctadecane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: males: 210-230 g; females: 190-225 g
- Fasting period before study: 20-24 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 20000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- At the time of death or sacrifice, a gross necropsy was conducted with a general inspection of the digestive tract, liver, lungs, kidneys, heart and spleen. - Statistics:
- no data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 20 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the 14-day-observation period.
- Clinical signs:
- other: In all animals lethargy was observed 20 minutes post-treatment and ended within 48 hours.
- Gross pathology:
- Internal organs appeared normal by gross examination. One observation was made about external appearance at sacrifice. The posterior ventral surface of all rats dosed in this test was hairless.
- Other findings:
- none
Applicant's summary and conclusion
- Executive summary:
The acute oral toxicity of octadecyl isocyanate was low with an LD50 value > 20000 mg/kg bw for male and female rats (method similar to OECD TG 401). Single administration of 20000 mg/kg bw was tolerated without mortality. In all animals lethargy was observed 20 minutes post-treatment and ended within 48 hours.
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