Registration Dossier
Registration Dossier
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EC number: 700-503-1 | CAS number: 101238-01-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study that is suitable for classification and labelling
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 439 and OECD 431
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2,6,6-tetramethylpiperidin-4-yl dodecanoate
- EC Number:
- 700-503-1
- Cas Number:
- 101238-01-1
- Molecular formula:
- C21 H41 N O2
- IUPAC Name:
- 2,2,6,6-tetramethylpiperidin-4-yl dodecanoate
- Details on test material:
- Purity: 96.4%
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- EPIDERM(TM) 200 kit from MaTek Corp, Ashland MA, USA
reconstructed epidermis, surface 0.6cm2 and cultured in vessels of 1 cm diameter.
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: not applicale
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin tissue
- Amount / concentration applied:
- 30 μl applied to each tissue, spread to match tissue size.
- Duration of treatment / exposure:
- 60 min
- Observation period:
- 48h (recovery period, including 3h MTT incubation)
- Number of animals:
- not applicable
- Details on study design:
- To determine whether the test substance is able to reduce MTT directly, the test substance was incubated with the substrate.
Three tissues were treated with each test substance, positive and negative controls, espectively.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: viability of reconstituted epidermis (corrostion test)
- Value:
- 97
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 min. Max. score: 100.0. Reversibility: other: not applicable. Remarks: Score given in %. (migrated information)
- Irritation / corrosion parameter:
- other: other: viability of reconstituted epidermis (irritation test)
- Value:
- 53
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 min. Max. score: 100.0. Reversibility: other: not applicable. Remarks: Score given in %. (migrated information)
- Irritation / corrosion parameter:
- other: other: Absorbance 570 nm (OD) (corrosion test)
- Value:
- 1.847
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 min. Reversibility: other: not applicable. Remarks: Negative Control: 1.909; Positive Control: 0.14. (migrated information)
- Irritation / corrosion parameter:
- other: other: Absorbance 570 nm (OD) (irritation test)
- Value:
- 0.974
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 min. Reversibility: other: not applicable. Remarks: Negative Control: 1.83; Positive Control 0.07. (migrated information)
Any other information on results incl. tables
| Irritation experiment | Tissue 1 | Tissue 2 | Tissue 3 | mean | SD | |
| Negative control | OD570 nm | 1.839 | 1.850 | 1.787 | 1.826 | |
| viability [% of negative control] | 100 | 7.83 | ||||
| test substance | mean OD570 nm | 0.952 | 0.979 | 0.99 | 0.974 | |
| viability [% of negative control] | 53 | 1.08 | ||||
| Positive control5% (w/v) sodium dodecyl sulfate | OD570 nm | 0.061 | 0.07 | 0.08 | 0.07 | |
| viability [% of negative control] | 4 | 0.51 | ||||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance causes effects in the vitro-skin irritation assay. These effects are below the threshold for classification as a skin irritant (GHS Category 1 or 2).
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