Registration Dossier
Registration Dossier
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EC number: 224-699-9 | CAS number: 4454-16-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April-May 2015
- Reliability:
- 1 (reliable without restriction)
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 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- yes
- Remarks:
- : A standard deviation of 18.5% concerning the viability of the negative control was recorded instead of 18%.
- Qualifier:
- according to guideline
- Guideline:
- other: Test method B.40bis Council regulation n°440/2008
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Nickel bis(2-ethylhexanoate)
- EC Number:
- 224-699-9
- EC Name:
- Nickel bis(2-ethylhexanoate)
- Cas Number:
- 4454-16-4
- Molecular formula:
- C8H16O2.1/2Ni
- IUPAC Name:
- nickel(2+) bis(2-ethylhexanoate)
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
- Details on test material:
- Identification: Nickel 2-ethylhexanoate
Batch n° L7282
Composition : 16.02%w/w Ni
Purity ≥ 94% w/w
Impurities : Nickel acetate (EC n° 239-086-1) ≤ 6% w/w
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 3 minutes and 1 hour exposure
- Observation period:
- Not applicable
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 132.9
- Remarks on result:
- other: 3 minutes exposure
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 92.55
- Remarks on result:
- other: 1 hour exposure
Any other information on results incl. tables
The mean viability of epidermis skins treated with the positivecontrol item (potassium hydroxide 8N) was 8.28% and 0.52% respectively 3 minutes and 1 hour after the application.
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In accordance with Regulation EC 1272/2008, the test item does not have to be classified in category 1 'Corrosive'.
Nickel 2-ethylhexanaote does not have to be classified also as 'Corrosive' according to the criteria for classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45.
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