Registration Dossier
Registration Dossier
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EC number: 700-869-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From August 2 to August 4, 2011
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Solid Recovered Fuel (Municipal Solid Waste and similar wastes, processed)
- EC Number:
- 700-869-2
- Molecular formula:
- Not applicable
- IUPAC Name:
- Solid Recovered Fuel (Municipal Solid Waste and similar wastes, processed)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Product: CarboNeXT
Physical state: solid
Batch: 08-07-2011
Constituent 1
Results and discussion
In vitro
Results
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
INTERPRETATION OF RESULTS
According to EU classification, the irritancy potential of test substances is predicted for distinguish between R38 skin irritating and no-label (non skin irritating) test substance OECD 404 and Regulation (EC) No 1272/2008. In this study the irritancy potential of test substances is predicted by mean tissue viability of tissues exposed to the test substance.
The test substance is considered to be irritant to skin (R38), if the mean relative viability after 42 minutes exposure and 42 hours post incubation is less or equal to 50% of the negative control.
ACCEPTABILITY CRITERIA
The negative control data meet the acceptance criteria if the mean OD value of the 3 tissues at 570 nm is:
1.2 ≤ OD ≤ 2.5
The positive control data meet the acceptance criteria if the mean viability, expressed as % of the NC, is ≤ 40%.
In both case, the standard deviation value will be considered valid if it is ≤ 18% according to the performance standard (ECVAM SIVS, 2007).
RESULTS
Optic density (OD) at 570nm
REPLICA | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
Black | 0.089 | 0.092 | 0.089 | 0.088 | 0.087 | 0.089 | - | - | - |
Negative Control | 1.535 | 1.614 | 1.638 | 1.61 | 1.592 | 1.461 | 1.54 | 1.536 | 1.544 |
Positive Control | 0.124 | 0.13 | 0.123 | 0.131 | 0.12 | 0.122 | 0.128 | 0.121 | 0.122 |
Sample | 1.37 | 1.462 | 1.473 | 1.462 | 1.452 | 1.448 | 1.431 | 1.426 | 1.407 |
| Average OD | Acceptability | Result | SD% | Acceptability (%) | Result |
Negative Control | 1.47 | 1.2 ≤ OD ≤ 2.5 | Complying | 3.519 | ≤ 18 | Complying |
Positive Control | 2.43 | < 40 % | Complying | 3.200 | ≤ 18 | Complying |
SAMPLE | % VIABILITY | ACCEPTABILITY |
CarboNeXT | 91.68 | > 50% |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance must be considered NOT IRRITANT for the skin.
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