Registration Dossier
Registration Dossier
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EC number: 212-741-9 | CAS number: 865-48-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
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:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Version / remarks:
- July 19, 2006
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium 2-methylpropan-2-olate
- EC Number:
- 212-741-9
- EC Name:
- Sodium 2-methylpropan-2-olate
- Cas Number:
- 865-48-5
- Molecular formula:
- C4H10O.Na
- IUPAC Name:
- sodium 2-methylpropan-2-olate
- Details on test material:
- - Name of test material (as cited in study report): Na-tert.-Butylat L (PRD 30153329)
- Analytical purity: 98.1g/100g (homogenous)
- Lot/batch No.: 35694816K0
- Stability under test conditions: stability under storage conditions was guaranteed by the sponsor
- pH-value: ca. 14 (undiluted test substance, moistened with water)
Constituent 1
Test animals
- Species:
- other: in vitro
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- MATERIAL AND TECHNICAL EQUIPMENT:
- Corrositex Kit containing reagents required for qualification and categorization screen, biobarrier matrix powder and diluent, membrane discs and vials containing the Chemical Detection System (InVitro International, Irvine, California)
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative control: 10% Citric Acid, Positive Control: Sodium Hydroxide (solid)
- Amount / concentration applied:
- Qualification Screen:
100 mg
Categorization Screen:
100 mg to tube A and B each
Corrositex Assay:
350 mg - Duration of treatment / exposure:
- Following application of test substance onto the mebranes, time until break through of the substance is monitored (indicated by change in the Chemical Detection System).
- Observation period:
- up to 240 minutes, for substances determined into category 1 by Categorization screen
up to 60 minutes, for substances determined into category 2 by Categorization screen - Number of animals:
- not applicable
- Details on study design:
- TEST SUBSTANCE:
- 4 vials were used for the experiment
- first vials was observed for 3 minutes, if no color change was observed the remaining 3 were treated with test substance and time until break through of the substance was monitored and recorded
POSITIVE CONTROL
- one pellet of Sodium Hydroxide was applied on top of membrane and vial was monitored until break through occured
NEGATIVE CONTROL
- 500 uL of 10% citric acid were applied on top of membrane, vial was observed for 60 minutes, if no break through occured, evaluated as being non-corrosive
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: break through time
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 8 min 16 seconds. (migrated information)
In vivo
- Irritant / corrosive response data:
- Na-tert.-Butylat L showed a mean break through time of 8 minutes and 16 seconds.
- Other effects:
- not applicable
Any other information on results incl. tables
Table2: Findings
Break Through Time [min:s] |
|||||
| vial 1 | vial2 | vial 3 | vial 4 | Mean | |
| 11/0395 -1 | 6:50 | 8:08 | 9:13 | 8:53 | 8:16 |
| Controls: | |||||
| PC: Sodium Hydroxide, solid | 11:50 | - | - | - | - |
| NC: 10% citric acid | NB | - | - | - | - |
Table3: Historical Control Data
| mean [min:s] | SD [min:s] | |
| Positive Control (NaOH, solid) | 12:34 | 02:43 |
| Negative Control (10% citric acid) | NB | - |
NB = No Breakthrough
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive)
- Remarks:
- Migrated information
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