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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:
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:
1975
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

Constituent 1
Chemical structure
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

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:
In all animals lethargy was observed 20 minutes post-treatment and ended within 48 hours.
Body weight:
no data
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.