Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 18, 1976 - December 29, 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
A group of ten male albino rats was used in this study. The rats were placed in a 70 liter all glass exposure chamber and exposed to a saturated atmosphere of the test material in air for one hour.
The material was administered as an aerosol with particles 3-5 microns in diameter.

The rate of flow was 10.0 liters per minute at a temperature of 71°f (21.67°c).
The air was passed through a desicant prior to being passed through the test material.
By differential weighing it was calculated that the rats were subjected t o a concentration of 7.5 m g / liter during the exposure period. This is an average value over the one hour period.
GLP compliance:
not specified
Test type:
traditional method
Limit test:
no

Test material

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

Test animals

Species:
rat
Strain:
not specified
Remarks:
albino
Sex:
male

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Mass median aerodynamic diameter (MMAD):
> 3 - <= 5 µm
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Concentrations:
7.5 mg / liter
No. of animals per sex per dose:
10 males in one dose group
Control animals:
no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
> 7.5 mg/L air
Based on:
test mat.
Exp. duration:
1 h
Mortality:
No mortalities observed after 14 days
Clinical signs:
other: No behavioural abnormalities observed.
Body weight:
Not recorded
Gross pathology:
Gross parthologic examonation of all animal revealed nothing remarkable.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study the LC50 for Dabco TMR-2 was found to be greater than 7.5 m g / liter .