Registration Dossier
Registration Dossier
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EC number: 236-124-9 | CAS number: 13177-41-8
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)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- LAUS GmbH Auf der Schafweide 20 D-67489 Kirrweiler
Test material
- Reference substance name:
- Dimethyloctadecyl(3-sulphopropyl)ammonium hydroxide
- EC Number:
- 236-124-9
- EC Name:
- Dimethyloctadecyl(3-sulphopropyl)ammonium hydroxide
- Cas Number:
- 13177-41-8
- Molecular formula:
- C23H49NO3S
- IUPAC Name:
- dimethyl(octadecyl)(3-sulfopropyl)azanium hydroxide
- Test material form:
- solid
1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Slaughtered cattle that were between 12 and 60 months old
Test system
- Vehicle:
- physiological saline
- Controls:
- yes
- Duration of treatment / exposure:
- 1 h
- Observation period (in vivo):
- 4 h
- Number of animals or in vitro replicates:
- 3 bovine corneas were used.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 20.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
According to the guideline, the test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean.
The negative or solvent control has to show an IVIS <= 3: 0.71
Values for positive controls were within the range of historical data of the test facility 75.32 -143.16: 104.42
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of this test, the test item Stearyl Sulfobetaine showed effects on the cornea of the bovine eye. The calculated mean IVIS was 20.70.
According to OECD Guideline no. 437 (Jun. 2020), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category with the BCOP test only. In this case no prediction can be made.
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