Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Environmental Protection Agency: Toxic Substances Control Act Test Guidelines, Part 798-Health Effects Testing Guidelines, Subpart B, Section 798.1150, September 1985.
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Physical form of substance: S
Mass median aerodynamic diameter (for liq.+solid aerosol):
Equivalent Aerodynamic Diameter (mcm): 3.8

Test animals

Species:
other: Rat, Sprague-Dawley

Administration / exposure

Vehicle:
other: Air.
Details on inhalation exposure:
Whole body.
Duration of exposure:
4 h

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5 mg/L air
Exp. duration:
4 h
Mortality:
Male: 5 mg/L; Number of animals: 5; Number of deaths: 0
Female: 5 mg/L; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
The rats appeared normal before and just after exposure, but
could not be observed during exposure due to the dense
aerosol cloud within the chamber. All animals were normal in
appearance throughout the post-exposure observation period,
with the exception of one female which exhibited dark red
material around the nose on post-exposure days 5 and 6. All
animals survived the 14-day post-exposure period.


All animals gained weight normally over the course of the
study.
Gross pathology:
Effects on organs:
No gross lesions were observed in any animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU