Registration Dossier
Registration Dossier
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EC number: 814-970-5 | CAS number: 852620-97-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- 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:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-Methyl-1-propylpyrrolidinium Bis(fluorosulfonyl)imide
- EC Number:
- 922-377-9
- Cas Number:
- 852620-97-4
- Molecular formula:
- C8H18F2N2O4S2
- IUPAC Name:
- 1-Methyl-1-propylpyrrolidinium Bis(fluorosulfonyl)imide
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- chicken
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30µl
- Duration of treatment / exposure:
- 10seconds
- Observation period (in vivo):
- 30-75-120-180-240minutes
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Value:
- 0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Value:
- 6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item N-Propyl-N-methylpyrrolidinium bis(fluorosulfonyl)imide does not require classification for eye irritation and serious eye damage as defined by the UN GHS (No Category).
No signal word and hazard statement are required - Executive summary:
The ocular reactions observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 0,0 corresponding to ICE class I;
- mean score of fluorescein retention: 0.5, corresponding to ICE class I;
- maximal mean corneal swelling: 6%, corresponding to ICE class II.
The combination of the three endpoints for the test item N-Propyl-N-methylpyrrolidinium bis(fluorosulfonyl)imide was 1 x II, 2 x I.
The combination of the three endpoints for the positive control, Benzalkonium Chloride 5%, was 3 x IV. Therefore, the positive control is classified as “Corrosive/Severe Irritant”, as expected.
The combination of the three endpoints for the negative control, physiological saline, was 3 x I. Therefore, the negative control is classified as “No Category”, as expected.
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item N-Propyl-N-methylpyrrolidinium bis(fluorosulfonyl)imide does not require classification for eye irritation and serious eye damage as defined by the UN GHS (No Category).
No signal word and hazard statement are required.
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