Registration Dossier
Registration Dossier
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EC number: 222-012-7 | CAS number: 3317-67-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Corrosion study + Weight of Evidence
- 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:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
- Deviations:
- yes
- Remarks:
- The TER value at the reading time 24 hours for the positive control was slightly higher than the range 0.5 - 1.0 defined in OECD test guideline (1.2 versus 1.0 kW). This deviation was without any impact in the results of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt
- EC Number:
- 222-012-7
- EC Name:
- [29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt
- Cas Number:
- 3317-67-7
- Molecular formula:
- C32H16N8Co
- IUPAC Name:
- [29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt
1
In vitro test system
- Test system:
- isolated skin discs
- Source species:
- rat
- Source strain:
- Sprague-Dawley
- Details on animal used as source of test system:
- Young rats (Sprague Dawley strain) were required for the preparation of skin discs. Two animals were supplied by the Elevage Janvier Labs (F-53941 Le Genest Saint Isle).
The dorsal and flank hair were carefully removed with small animal clippers. The animals were then washed by careful wiping, whilst submerging the area in 0.5 mL of antibiotic solution (Batch No.: 067M4815V) at D-5, D-2 and D-1. - Vehicle:
- unchanged (no vehicle)
- Remarks:
- 150 µl of distilled water was added on top of the solid
- Details on test system:
- The skin discs were prepared from three SPF female Sprague Dawley rats, which were 4 weeks old
the day of the test and were identified Rf2220 and Rf2221.
The dorsal skin was placed over a PTFE (polytetrafluoroethylene) tube with a rubber ‘O’ ring. The tube was placed inside a receptor chamber containing a magnesium sulfate solution (154 mM).
Each skin disc had been validated with the measures of the transcutaneous electrical resistance value (values higher than 10 kW). - Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- 0.03g of the test item. Just after the treatment, 150 µL of distilled water was added on top of the solid.
- Duration of treatment / exposure:
- 24 hours
- Number of replicates:
- 3 epidermal surfaces of skin disc.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- clipped
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Remarks:
- After 24 hours
- Value:
- 22.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Remarks:
- At T0
- Value:
- 25.61
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- For further details, please refer to the illustration hereafter
Applicant's summary and conclusion
- Interpretation of results:
- other: Non-corrosive
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item Cobalt Phtalocyanine (PcCo) does not have to be classified as corrosive, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol or the danger labels are required. In accordance with the Regulation EC No. 1272/2008, the test item does not have to be classified in category 1 “Corrosive”.
Under test conditions, the test item is not considered as corrosive.
Please refer to endpoint summary for justification on classification.
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