Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
GLP compliance:
yes
Test type:
fixed concentration procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
not specified
Mass median aerodynamic diameter (MMAD):
>= 1.67 - <= 3.21 µm
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
0.05, 0.5 mg/L
No. of animals per sex per dose:
10 (5 males and 5 female)

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.206 - < 0.508 mg/L air
Based on:
test mat.
Exp. duration:
4 h

Applicant's summary and conclusion

Interpretation of results:
Category 2 based on GHS criteria
Conclusions:
An acute inhalation toxicity test was conducted with rats to determine the potential for IR9804 to produce toxicity from a single exposure via the inhalation (nose-only exposure) route. Under the conditions of this study, the 4-hour exposure acute inhalation LC50 of the test substance (calculated as a Time Weighted Average) appears to be between 0.206 and 0.508 mg/L in male and females rats.