Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21/06/2017-21/06/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Raction product of 2-Ethyl-1-hexylamine and 3-(2-Ethylhexyloxy)propylamine with 4-bromo-1,8 naphthalic anhydride
- Cas Number:
- 1971906-58-7
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Raction product of 2-Ethyl-1-hexylamine and 3-(2-Ethylhexyloxy)propylamine with 4-bromo-1,8 naphthalic anhydride
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine
- Strain:
- not specified
Test system
- Vehicle:
- physiological saline
- Amount / concentration applied:
- TEST MATERIAL
It was not possible to get a 20% concentration of solution/suspension with the test item in physiological saline 0.9% NaCl. Therefore the test item was administered directly and moistened with physiological saline 0.9% NaCl.
VEHICLE
Physiological saline 0.9% NaCl (AlleMan Pharma, lot no. 609709, expiry date: 21/06/2017) - Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Value:
- 13.09
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- No prediction can be made regarding the classification of the test substance YELLOW 2747 according to the evaluation criteria. Further testing in another suitable method is required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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