Registration Dossier
Registration Dossier
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EC number: 272-221-2 | CAS number: 68784-12-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Remarks:
- a skin corrosion test was included in the test design
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP- and guideline compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 431 Commission Regulation (EC) No 440/2008 OECD Draft for corrosion test
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.
- EC Number:
- 272-221-2
- EC Name:
- 2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.
- Cas Number:
- 68784-12-3
- Molecular formula:
- Due to a mixture of numerous isomers a specific molecular formular cannot be provided ( UVCB-substance) .
- IUPAC Name:
- 2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): ASA
- Substance type: organic
- Physical state: Yellowish clear liquid
- Analytical purity: 97.1%
- Lot/batch No.: 5500001727
- Stability under test conditions: stable
- Storage condition of test material: RT
Constituent 1
In vitro test system
- Test system:
- human skin model
- Cell type:
- non-transformed keratinocytes
Test system
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL (corrosion test), 30 µL (irritation test)
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 1 hour
- Observation period:
- 2 days
- Number of animals:
- not applicable
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- corrosion 3 min exposure
- Value:
- 101
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- no indication of corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- corrosion 1 hour exposure
- Value:
- 86
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- no indication of corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- irritation 1 hour exposure
- Value:
- 110
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
1. Corrosion test
| Exposure: 3 min | Exposure: 1 hour | ||||||||
| Test article | tissue 1 | tissue 2 | KC | mean | |||||
| NC | mean OD570 | 1.7627 | 1.7522 | 0.2267 | 1.7574 | 1.7657 | 1.6962 | 0.1762 | 1.7309 |
| viability[% of NC] | 100.3 | 99.7 | - | 100 | 102.0 | 98.0 | - | 100 | |
| ASA | mean OD570 | 1.8112 | 1.7222 | 0.2012 | 1.7667 | 1.3892 | 1.6027 | 0.1867 | 1.4959 |
| viability[% of NC] | 103.1 | 98.0 | - | 101 | 80.3 | 92.6 | - | 86 | |
| PC | mean OD570 | 0.4438 | 0.3498 | - | 0.3968 | 0.1597 | 0.1867 | - | 0.1732 |
| viability[% of NC] | 25.3 | 19.9 | - | 23 | 9.2 | 10.8 | - | 10 | |
Due to the ability of the test substance to reduce MTT directly, a KC was applied in parallel.
However, the result of the KC did not indicate an increased MTT reduction (difference to KC
of NC is not greater than 0.1; see section 3.6.4). Thus the KC was not used for viability
calculation.
2. Irritation test
| Test article | tissue 1 | tissue 2 | tissue 3 | mean | SD | |
| NC | mean OD570 | 1.6795 | 1.6125 | 1.5725 | 1.6215 | |
| viability[% of NC] | 103.6 | 99.4 | 97.0 | 100 | 3.33 | |
| ASA | mean OD570 | 1.7575 | 1.7070 | 1.8980 | 1.7875 | |
| viability[% of NC] | 108.4 | 105.3 | 117.1 | 110 | 6.10 | |
| PC | mean OD570 | 0.1165 | 0.1320 | 0.1215 | 0.1233 | |
| viability[% of NC] | 7.2 | 8.1 | 7.5 | 8 | 0.49 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- substance is not corrosive and not irritating to the skin
- Conclusions:
- Based on the observed results and applying the evaluation criteria it is concluded, that substance does not show a skin irritation potential in the EpiDerm ™ skin corrosion/irritation test under the test conditions chosen.
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