Registration Dossier
Registration Dossier
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EC number: 811-523-6 | CAS number: 88992-45-4
Acute Toxicity: inhalation
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:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- {2-hydroxy-3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulfanyl]propyl}trimethylazanium chloride
- EC Number:
- 811-523-6
- Cas Number:
- 88992-45-4
- Molecular formula:
- C14 H19 F13 N O S . Cl
- IUPAC Name:
- {2-hydroxy-3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulfanyl]propyl}trimethylazanium chloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch nº: 2007-0817-15
Analyzed concentration: 99.56% (w/w)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Remarks:
- substance diluted in dimethyl sulphoxide (DMSO)
- Mass median aerodynamic diameter (MMAD):
- >= 2.19 - <= 2.88 µm
- Geometric standard deviation (GSD):
- >= 2.4 - <= 2.85
- Duration of exposure:
- 4 h
- Concentrations:
- concentration 1, 0.168 mg.L-1
concentration 2, 0.135 mg.L-1
concentration 3, 0.051 mg.L-1 - No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 0.16 mg/L air
- Based on:
- test mat.
- 95% CL:
- >= 0.13 - <= 0.18
- Exp. duration:
- 4 h
- Mortality:
- On concentration 1, six exposed animals, three male and three females, died on days 1 to 2 of the observation period.
On concentration 2, three exposed animals, one male and two females, died on days 1 and 2 of the observation period.
On concentration 3, no exposed animal to this concentration died during the exposure or observation periods - Clinical signs:
- other: dyspnea and prostration
- Body weight:
- All surviving animals exceeded their initial body weight at the end of the observation period of 14 days, except the animal number 2 from concentration 1 and animal number 4 from concentration 3.
- Gross pathology:
- On concentration 1, the compound-related macroscopic findings observed were:
presence of gaseous contents in the intestine and stomach and haemorrhagic
foci in the lung. These were acute systemic alterations.
No animal from the concentration 2 and 3 presented compound-related macroscopic
findings on gross necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 based on GHS criteria
- Conclusions:
- The combined (male and female) median lethal concentration in a 4-hour nose-only exposure period
(4-h LC50) to the substance inhaled by Wistar Hannover rats was estimated as 0.16 mg.L-1, with a 95% confidence interval from 0.13 to 0.18 mg.L-1.
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