Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
content: 99.5 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose/head only
Vehicle:
air
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
0, 91.7, 97.4, 150.7, 255.5, 452.3 mg/m³
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LC50
Effect level:
0.338 mg/L air
Exp. duration:
4 h
Sex:
male
Dose descriptor:
LC50
Effect level:
> 0.452 mg/L air
Exp. duration:
4 h
Mortality:
male:
control 0/0/10
91.7 mg/m³ 0/0/5
97.4 mg/m³ 0/5/5
150.7 mg/m³ 0/5/5
255.5 mg/m³ 0/5/5
452.3 mg/m³ 1/5/5

female:
control 0/0/10
91.7 mg/m³ 0/0/5
97.4 mg/m³ 0/5/5
150.7 mg/m³ 1/5/5
255.5 mg/m³ 2/5/5
452.3 mg/m³ 3/5/5
Clinical signs:
up to and including 91.7 mg/kg no symptoms, >= 97.4 mg/m³ laboured breathing, bloddy and serious effluent of nose, reduced motility, ruffled coat, cyanosis, tachypnoe
Body weight:
loss of body weight
Gross pathology:
up to and including 97.4 mg/m³ no significant pulmonary change.
Animals which died during post observation period: inflated lung, liver, spleen and kidneys were pale, bloody content of gastro-intestinal tract, reddened intestine mucosa, hydrothorax and edema of the lung.
Other findings:
A pronounced irritational potential of the substance to the respiratory system was found.

Any other information on results incl. tables

no further data

Applicant's summary and conclusion

Interpretation of results:
Category 2 based on GHS criteria
Conclusions:
LC50 (female) = 0.338 mg/L
LC50 (male) > 0.452 mg/L
Executive summary:

Rats were exposed nose/head to 0, 91.7, 97.4, 150.7, 255.5, 452.3 mg/m³ 3,4 -dichlorophenyl isocyanate during 4 h.

Animals treated with 91.7 mg/m³ showed no clinical symptoms and no significant pathological pulmonary change. Therefore 91 mg/m³ is considered as the NOAEL. A pronounced irritational potential of the substance to the respiratory system was found.

Conclusion

LC50 (female) = 0.338 mg/L

LC50 (male) > 0.452 mg/L