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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Groups of 10 rats (males and females) were exposed to an aerosol of the test substance at concentrations of 200, 250, 300, and 350 mg/l/hour, for one hour. The test substance was administered via an atomizer configured to provide droplet sizes of 3-10 microns. After the 1-hour exposure period, animals were observed for 3 weeks, prior to sacrifice and necropsy.
GLP compliance:
no
Test type:
other: See principles of method section
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Advastab TM-181FS
- Lot/batch No.: 25L-180

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
This information was not provided in the report.

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Details on inhalation exposure:
Specific information was not provided
Analytical verification of test atmosphere concentrations:
not specified
Remarks:
No data provided in the report
Duration of exposure:
1 h
Concentrations:
200, 250, 300, 350 mg/L/hr
No. of animals per sex per dose:
10 animals consisting of both males and females, with the number of each not available
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days (or other?) 3 weeks
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: at least clinical signs, food consumption.
Statistics:
The acute inhalation LC50 and 95 % (19/20) confidence limits were calculated by the method of Litchfield and Wilcoxon (1949).

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
240 mg/L air
95% CL:
> 212 - < 271
Exp. duration:
1 h
Mortality:
Observed mortality (number of deaths/total number tested), by dose level tested:
200 mg/L/hr: 2/10 animals
250 mg/L/hr: 6/10 animals
300 mg/L/hr: 9/10 animals
350 mg/L/hr: 10/10 animals
Clinical signs:
other: Behavior of the surviving test animals, including food and water consumption and demeanor, remained normal. The lone surviving animal in the 300 mg/l/hr dose group, died on observation day 16.
Body weight:
No data
Gross pathology:
Gross findings included blood in lungs, dark spleen, pale kidneys, fluid in the chest cavity, and heart failure.
Other findings:
Food and water intake, excretions, and demeanor in the colony were all within normal limits.

Any other information on results incl. tables

The slope was 1.22 (1.04-1.43)

Applicant's summary and conclusion

Interpretation of results:
other: Not classified in accordance with EU criteria
Conclusions:
LC50 240 mg/L/hr
Executive summary:

Groups of 10 rats, both male and female, inhaled the test material within a closed chamber of known volume. The test material was sprayed into the chamber by means of an atomiser. Animals were observed for 3 weeks.

Gross autopsy findings included: blood in the lungs, dark spleen, pale kidneys, fluid in the chest cavity and heart failure.

The inhalation LC50 was 240 mg/L/h.