Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
- only 4 animals used, no data on purity of test substance, no data on necropsy findings
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:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 3.1-3.2 kg; females: 3.1-3.3 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
Backs of male and female rabbits were shaved and the skin was abraded by scrubbing briskly with a nail brush. Compound was applied undiluted to the skin at a dose level of 2000 mg/kg. The test area was loosely covered with plastic to prevent evaporation of compound and the rabbits were held in stocks for 24 hours. After 24 hours, wrappings were removed and test areas wined with a clean, dry cloth. Animals were observed 14 days for symptoms and mortality. The survivors were sacrificed at the end of this period. A gross necropsywas performed with a general inspection of the digestive tract, liver, kidneys, heart, lungs and spleen.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the 14-day-observation period.
Clinical signs:
No clinical signs were observed.
Body weight:
no data
Gross pathology:
At the time of sacrifice, a gross necropsy revealed a darkened ring inside the kidneys. Other internal organs appeared normal.
Other findings:
none

Applicant's summary and conclusion

Executive summary:

The acute dermal toxicity of octadecyl isocyanate was low with an LD50 value > 2000 mg/kg bw for male and female rats (method similar to OECD TG 402). Single occlusive administration of 2000 mg/kg bw for 24 hours was tolerated without mortalities. No clinical signs were observed.