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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
6 to 7 weeks old
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
single dose at 2000mg/kg
Control animals:
yes
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured
Clinical signs:
No abnormalities observed
Body weight:
Body weight changes within the expected range
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
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
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
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:
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:
Interpretation of results:
Category 3 based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
10 000 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification