Registration Dossier
Registration Dossier
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EC number: 810-213-8 | CAS number: 1370461-06-5
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:
- other: Reliable and GLP-conformant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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)
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EU) No 1152/2010
- Qualifier:
- according to guideline
- Guideline:
- other: OECD (2014a) Draft Proposal for a New Test Guideline (EpiOcularTM)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
Test material
- Reference substance name:
- sra-[(2E)-2-butenedioato(2-)hydroxy aluminium]
- EC Number:
- 810-213-8
- Cas Number:
- 1370461-06-5
- Molecular formula:
- C4 H3 Al O5
- IUPAC Name:
- sra-[(2E)-2-butenedioato(2-)hydroxy aluminium]
- Details on test material:
- - Name of test material (as cited in study report): Aluminum, [(2E)-2-butenedioato(2-)- O1]hydroxy-
- Physical state: solid / white
- Analytical purity: 85.8 g/ 100g
- Batch No.: 13-0001-2
- Storage condition of test material: Room temperature
- pH-value: Ca. 4 (undiluted test substance, moistened with de-ionized water or 20% aqueous preparation)
Constituent 1
Test animals / tissue source
- Species:
- other: not applicable (in vitro test)
- Strain:
- other: not applicable (in vitro test)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable (in vitro test)
- Duration of treatment / exposure:
- see "Any other information on materials and methodes incl. tables"
- Observation period (in vivo):
- see "Any other information on materials and methodes incl. tables"
- Number of animals or in vitro replicates:
- not applicable (in vitro test)
Results and discussion
Any other information on results incl. tables
The tested substance did not reduce MTT directly.
Results of EpiOcular test:
Test substance |
|
tissue 1 |
tissue 2 |
mean |
Inter-tissue variability (%) |
NC |
mean OD570 |
1.745 |
1.788 |
1.767 |
|
|
viability (% of NC) |
98.8 |
101.2 |
100.0 |
2.4 |
CAS 1370461-06-5 |
mean OD570 |
1.902 |
2.065 |
1.984 |
|
|
viability (% of NC) |
107.7 |
116.9 |
112.3 |
9.2 |
PC |
mean OD570 |
0.365 |
0.321 |
0.343 |
|
|
viability (% of NC) |
20.6 |
18.2 |
19.4 |
2.5 |
NC, negative control
PC, positive control
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
