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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: Comparable to guideline study with acceptable restrictions (only summary of clinical signs, only male rats, necropsy findings are not reported, purity of test substance not specified)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Principles of method if other than guideline:
ADMINISTRATION: Volume administered or concentration: 1 ml/100g bw post observation period: 14d
EXAMINATIONS: mortality and clinical signs
CALCULATION OF LD50: Probit analysis (Fink, H. et al., Methods of Information in Medicine 5, 19, 1966)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
n-butyl isocyanate, purity: technical grade

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Doses:
100, 200, 300, 400, 500, 1000 mg/kg bw
No. of animals per sex per dose:
10 (only males)
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
360 mg/kg bw
Mortality:
Number of deaths at each dose (time of death): 100 mg/kg: 0/10; 200 mg/kg: 1/10 (2d); 300 mg/kg: 2/10 (2d); 
400 mg/kg: 7/10 (2d); 500 mg/kg: 8/10 (2-3d); 1000 mg/kg: 10/10 (2h- 2d)
Clinical signs:
Number of animals with clinical signs: 100 mg/kg: 0/10; >=200 mg/kg: 10/10 10-30 minutes after application 
the rats showed dose related behavior disturbances (apathy; stiff gait) connected with sedation and labored 
breathing
Body weight:
the animals of the high dose groups lost weight and were cyanotic
Gross pathology:
necropsy findings are not reported

Any other information on results incl. tables

no further data

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information
Executive summary:

single oral application per gavage of 100, 200, 300, 400, 500 or 1000 mg/kg bw on 10 male rats per dose.

post observation period: 14 d

result: LD50 = 360 mg/kg bw