Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 610-765-8 | CAS number: 52013-44-2
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:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Nickel, compound with Titanium (1:1)
- EC Number:
- 610-765-8
- Cas Number:
- 52013-44-2
- Molecular formula:
- NiTi
- IUPAC Name:
- Nickel, compound with Titanium (1:1)
- Details on test material:
- 100% Equiatomic NiTi intermetallic compound
Physical State: free wire
Colour: black
Batch 1048
Expiry Date: not applicable
Constituent 1
Test animals / tissue source
- Species:
- other: bovine corneal
Test system
- Controls:
- other: 3 corneas as positive control treated with ethanol 100%
- Amount / concentration applied:
- The test item was extracted and the test item extract was tested at 100% concentration.
The extraction of the test item was performed according to ISO 10993-12 [8].
In total a ratio of 60 cm2 of sample to 20 mL of extraction medium was used.
The test item was extracted under agitation at 37 ± 1 °C for 72 ± 2 h
The extraction vehicle was physiological saline 0.9% NaCl, B. Braun Melsungen, lot no. 13014404, expiry date: 12/2015
After the extraction procedure neither the test item nor the extraction medium showed any abnormalities. No turbidity, no colour changes and no particles occurred in the extraction medium. - Number of animals or in vitro replicates:
- Test Groups
3 corneas for the test item
3 corneas as negative controls treated with physiological saline 0.9% NaCl
3 corneas as positive control treated with ethanol 70%
3 corneas as positive control treated with ethanol 100%
The BCOP assay is considered to be valid if the in vitro irritation score obtained with the positive control falls within the two standard deviations of the current historical mean.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Remarks:
- in vitro
- Basis:
- mean
- Score:
- -0.57
- Reversibility:
- not specified
- Remarks on result:
- other: non irritant
Any other information on results incl. tables
The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the evaluation criteria the test item Nitinol H/W/1.000/C is classified as non-irritant to eyes.
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.
