Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
no guideline available
GLP compliance:
no
Test type:
other: dynamic and static nebulization inhalation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
other: water and Lutrol (1:1)
Details on inhalation exposure:
Dynamic nebulization inhalation
Tests were performed using an apparatus for dynamic inhalation developed by ourselves. The compound was nebulized in a mixture of water and Lutrol
Static nebulization inhalation
The animals were held in 2m3 rooms and subjected for 4 hours over half-hour periods to the active ingredient nebulized as a solution in water and Lutrol (1:1). The observation period lasted 14 days and the following results were obtained.
Duration of exposure:
4 h
Concentrations:
Dynamic
Male rats: 0.143, 0.400, 0.933 mg/L
Female rats: 0.180, 0.510, 0.940 mg/L

Static
0.108, 0.173, 0.864 mg/L
No. of animals per sex per dose:
20 rats/dose group in dynamic inhalation and 10 rats/dose group for static inhalation were used. The results were obtained over an observation period of 2 weeks.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LC50
Effect level:
> 0.933 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
> 0.94 mg/L air
Based on:
test mat.
Exp. duration:
4 h

Any other information on results incl. tables

Dynamic nebulization inhalation

Air concentration

mg Erkantol BXG/1

Daily test

period in

hours

Number of

test days

Tox. Result

after 14 days

Theoretical

Analytically

determined

male rats

1.0

0.143

4

1

0/0/20

2.5

0.400

4

1

0/20/20

5.0

0.933

4

1

5/20/20

female rats

1.0

0.180

4

1

0/0/20

2.5

0.510

4

1

0/20/20

5.0

0.940

4

1

0/20/20

LC50 male rat 4 h exposure > 0.933 mg/1 air

LC50 female rat 4 h exposure > 0.940 mg/1 air

At higher concentrations the animals exhibited a transient deterioration in their general health. The male rats were more sensitive than the females, and displayed labored breathing at the highest concentration

Static nebulization inhalation

Air concentration

mg Erkantol BXG/1

Animal

species

Tox. Result

after 14 days

Theoretical

Analytically

determined

1.0

0.108

rats

0/0/10

 

 

 

 

2.0

0.173

rats

0/10/10

 

5.0

0.864

rats

1/10/10

       

There were no irritant effects to the mucosa of the eye and nasal region.

Applicant's summary and conclusion

Interpretation of results:
other: classified as harmful (Acute Tox.4) according to the CLP Regulation (EC) No.1272/2008
Conclusions:
For the dynamic inhalation the LC50 is > 0.933 mg/l for male rats and >0.94 mg/l for female rats.
Executive summary:

The toxicity of the substance after exposure through the inhalation route was evaluated. Tests were performed using an apparatus for dynamic inhalation; the compound was nebulized in a mixture of water and Lutrol. The animals were held in 2m3 rooms and subjected for 4 hours over half-hour periods to the active ingredient nebulized as a solution in water and Lutrol (1:1). The observation period lasted 14 days.

During the Dynamic nebulization inhalation male rats were exposed at 0.143, 0.400, 0.933 mg/l, while female rats were exposed at 0.180, 0.510, 0.940 mg/L

During the static nebulization inhalation, rats were exposed at 0.108, 0.173, 0.864 mg/l.

For the dynamic inhalation the LC50 is > 0.933 mg/l for male rats and >0.94 for female rats which correspond to the highest concentration to which the animals were exposed.