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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
ADMINISTRATION: vapor inhalation under dynamic head-nose only exposure conditions post observation period: approx. 4 weeks nominal concentrations: 13; 21; 54; 83; 108; 187; 399; 1077 mg/m³ analytical concentrations: 3.1; 7.2; 31.7; 55.6; 63.6; 109.8; 270.3; 861.9 mg/m³ EXAMINATIONS: mortality; clinical signs; body weight; rectal temperature,reflex, necropsy
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
n-butyl isocyanate, purity: 99.5 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose/head only
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
3, 7, 32, 56, 64, 110, 270, 862 mg/m³ (analytical)
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
ca. 59 mg/m³ air
Exp. duration:
4 h
Mortality:
Number of deaths at each dose (time of death), male rats: 3 mg/m³: 0/5; 7 mg/m³: 0/5; 32 mg/m³: 0/5; 56 mg/m³: 0/5; 64 mg/m³: 4/5 (10d-14d); 110 mg/m³: 5/5 (2d-9d); 270 mg/m³: 5/5 (1d-2d); 862 mg/m³: 5/5 (<4h) Number of deaths at each dose (time of death), female rats: 3 mg/m³: 0/5; 7 mg/m³: 0/5; 32 mg/m³: 0/5; 56 mg/m³: 3/5 (9d-19d); 64 mg/m³: 3/5 (11d-15d); 110 mg/m³: 5/5 (8d-16d); 270 mg/m³: 5/5 (1d-8d); 862 mg/m³: 5/5 (4h/1d)
Clinical signs:
other: Number of animals with clinical signs, male rats: 3 mg/m³: 0/5; >= 7 mg/m³: 5/5 showed during the exposure and up to 28d after the exposure decreased motility, piloerection, exsudate of nostris, cyanosis; rhinitis like vocalization, labored breathing, br
Body weight:
BODY WEIGHT: >= 32 mg/m³: body weight retardation
Gross pathology:
NECROPSY: rats died during the post observation period: distended lungs, pale liver, spleen, and kidneys, gastrointestinal tract was filled with a yellow mucous or bloody mucous mass, reddening of the intestinal mucosa, sporadic ulcus like foci in intestinal mucosa, lobular pattern of the liver, pulmonary edema, and hydrothorax; liver like changes in the lung; blood-incrusted and reddened noses with serous discharge  rats sacrificed at the end of the post observation period: no lung lesions in the control and 3 mg/m³ dose group animals; the animals of the other dose groups showed significant gross findings in the lung
Other findings:
REFLEX EXAMINATION: no substance induced effects
RECTAL TEMPERATURE: concentration dependent decrease
VALUE: NOEL = 3 mg/m³ the LC50-value is true for both sexes

Any other information on results incl. tables

the LC50-value is true for both sexes

 


Applicant's summary and conclusion

Interpretation of results:
highly toxic
Remarks:
Migrated information
Executive summary:

ADMINISTRATION:
vapor inhalation under dynamic head-nose only exposure conditions
post observation period: approx. 4 weeks
nominal concentrations: 13; 21; 54; 83; 108; 187; 399; 1077 mg/m³
analytical concentrations: 3.1; 7.2; 31.7; 55.6; 63.6; 109.8; 270.3; 861.9 mg/m³
EXAMINATIONS:
mortality; clinical signs; body weight; rectal temperature,reflex, necropsy

LC50 = 59 mg/m³ (rat, male/female)