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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
Study period:
1975, not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, not carried out according to recognised guideline, although results documented.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as outlined i n 16 CFR 1500.3
Deviations:
not specified
Principles of method if other than guideline:
Test substance was administered by inhalation as supplied by the sponsor and aerosolised to 5 male and 5 female rats. Ten adult albino rats (wistar-derived strain ) equally distributed into five males and five females weighing between 200-300g were exposed to the test material administered as a volume of gas or vapor for one hour in an all glass (72 liter) chamber under the following conditions :

Air Flow: 10 liters per minute
Weight of material aerosolized: 2 g/minute
Nominal concentration of test material: 200 mg per Liter
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Specified only as Product No . X-50; Kronitex 50 ; Lot 5-101.
No other information on the test material is provided within the report.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
The test utilised ten adult albino rats (wistar-derived strain ) equally distributed into five males and five females weighing between 200-300g. No other information is detailed.

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
Ten adult albino rats (wistar-derived strain ) equally distributed into five males and five females weighing between 200-300g were exposed to the test material administered as a volume of gas or vapor for one hour in an all glass (72 liter) chamber under the following conditions :
Air Flow: 10 liters per minute
Weight of material aerosolized: 2 g/minute
Nominal concentration of test material: 200 mg per Liter
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
1 h
Concentrations:
200 mg/l
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
Ten adult albino rats (wistar-derived strain ) equally distributed into five males and five females weighing between 200-300g were exposed to the test material administered as a volume of gas or vapor for one hour in an all glass (72 liter) chamber under the following conditions :
Air Flow: 10 liters per minute
Weight of material aerosolized: 2 g/minute
Nominal concentration of test material: 200 mg per Liter
Statistics:
None

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 200 mg/L air
Based on:
test mat.
Exp. duration:
1 h
Mortality:
1 death on Day 7.
Clinical signs:
other: No data.
Body weight:
No data.
Gross pathology:
No findings.
Other findings:
No acute symptoms were observed prior: to death. Gross examination at autopsy of the one animal that died revealed no noteworthy findings.

Any other information on results incl. tables

Mortality data

Dose level mg/l

No. rats dosed

deaths per day

Mortality after 14 days

1

2

3

4

5

6

7

8

9

10

11

12

13

14

200

5M

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0/5

 

200

5F

0

0

0

0

0

0

1

0

0

0

0

0

0

0

1/5

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance demonstrated a 10% mortality rate and has been completed as a limit test at 200 mg/l The LD50 is considered to be >200 mg/l.
Executive summary:

The test sample was dosed by inhalation to 5 male and 5 female rats at a dose of 200 mg/l. Assessed over a 14 day period, 0 male and 1 female deaths occurred and the study was completed as a limit test. The LC50 is considered >200 mg/l.

 

No classification is applicable based on the results.