Registration Dossier
Registration Dossier
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EC number: 261-222-3 | CAS number: 58353-68-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2012-2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and valid methods and is considered relevant and reliable for classification. It is an in vitro study predicting corrosivity, which is considered adequate in combination with the in vitro irritation testing.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Butanoic acid, 4-amino-4-oxo-2(or 3)-sulfo-, N-(C16-C18 (even numbered), C18 unsaturated alkyl), disodium salts
- IUPAC Name:
- Butanoic acid, 4-amino-4-oxo-2(or 3)-sulfo-, N-(C16-C18 (even numbered), C18 unsaturated alkyl), disodium salts
- Test material form:
- other: liquid to pasty
- Details on test material:
- - Name of test material (as cited in study report): Butanoic acid, 4-amino-4-oxo-2(or 3)-sulfo-, N-(C16-C18 (even numbered), C18unsaturated alkyl)), disodium salts; Sodium tallow sulphosuccinamates
- Physical state: Liquid to pasty; opaque
- Analytical purity: 25.5% active matter (correction factor: Not applicable)
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: February 14, 2012 CoA
- Lot/batch No.: MIBX042332
- Expiration date of the lot/batch: February 14,2013
- Stability under test conditions: Stable
- Storage condition of test material: At +10° to +25 °C
- Other: Manufacturer/Supplier: Huntsman Holland BV, Merseyweg 10, 3197 KG Botlek-Rotterdam, The Netherlands
Constituent 1
Test animals
- Species:
- other: EST1000, CellSystems®Biotechnologie GmbH
- Strain:
- other: human
- Details on test animals or test system and environmental conditions:
- Not applicable
Test system
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL of test item were applied to the skin model with a surface area of 0.6 cm2 to uniformly cover the skin surface. - Duration of treatment / exposure:
- 1st period: 3 min; 2nd period: 60 min
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: cell viability test group
- Basis:
- mean
- Time point:
- other: 3 minutes
- Score:
- 96.7
- Max. score:
- 100
- Remarks on result:
- other: % versus negative control
- Irritation parameter:
- other: cell viability test group
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 102.9
- Max. score:
- 100
- Remarks on result:
- other: % versus negative control group
- Irritation parameter:
- other: cell viability positive control group
- Basis:
- mean
- Time point:
- other: 3 minutes
- Score:
- 2
- Max. score:
- 100
- Remarks on result:
- other: % versus negative control group
- Irritation parameter:
- other: cell viability positive control group
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 5
- Max. score:
- 100
- Remarks on result:
- other: % versus negative control group
Any other information on results incl. tables
The test item was applied to the skin surface. Water for injection was used as the negative control. 8 N KOH was used as the positive reference item. Two exposure times of 3 minutes or 1 hour were employed.
In comparison to the negative controls, the mean viability of cells exposed to the test item was 96.7% after a 3-minute exposure period and 102.9% after a 1-hour exposure. The OD540 values were well above the cut-off percentage cell viability values distinguishing corrosive from non-corrosive test items of <50% or <15% for a 3-minute or 1-hour treatment, respectively. Therefore, the test item was non-corrosive in this skin model and is predicted to be non-corrosive to human skin.
The mean viability of cells treated with the positive reference item 8 N KOH were 2.0% (3-minute incubation) and 5.0% (1-hour incubation) of the negative controls and were below the cut-off values. Hence, 8 N KOH caused pronounced corrosion in this skin model and is predicted to be corrosive to human skin.
Applicant's summary and conclusion
- Interpretation of results:
- other: predicted non-corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the present test conditions the test item tested at two exposure times of 3 minutes or 1 hour was non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.
- Executive summary:
The purpose of this study was to determine cytotoxic properties to skin cells which might lead to corrosion by the test item to human skin, in an experiment with an artificial three-dimensional model of human skin. The EST-1000 model was employed. The test item was applied to the skin surface. Water for injection was used as the negative control. 8 N KOH was used as the positive reference item. Two exposure times of 3 minutes or 1 hour were employed. In comparison to the negative controls, the mean viability of cells exposed to the test item was 96.7% after a 3-minute exposure period and 102.9% after a 1-hour exposure. The OD540 values were well above the cut-off percentage cell viability values distinguishing corrosive from non-corrosive test items of <50% or <15% for a 3-minute or 1-hour treatment, respectively. Therefore, the test item was non-corrosive in this skin model and is predicted to be non-corrosive to human skin.
The mean viability of cells treated with the positive reference item 8 N KOH were 2.0% (3-minute incubation) and 5.0% (1-hour incubation) of the negative control and were below the cut-off values. Hence, 8 N KOH caused pronounced corrosion in this skin model and is predicted to be corrosive to human skin.
Under the present test conditions the test item tested at two exposure times of 3 minutes or 1 hour was non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.
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