Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
GLP compliance:
yes
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Food availability: Ad libitum
Drinking water: Tap water
Watering: Bottles
Quality control: Certificate of analysis will be included in the final report
Water availability: Ad libitum

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
Oxygen concentration in the exposure chamber will be at least 19% and carbon dioxide will not exceed 1%.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Gravimetric determination of the aerosol concentration
Duration of exposure:
ca. 4 h
No. of animals per sex per dose:
6 animals for the first step (3 males and 3 females) and 2 spare animals. Each additional step will contain 3 males and 3 females.
Control animals:
yes
Details on study design:
- Observation period of at least 14 days
- Frequency of observations and weighing: No diet or drinking water will be available during exposure.
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
ca. 10 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Clinical signs:
other:

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria