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EC number: 952-000-3 | CAS number: -
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 2019-06-18
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: New guidance document on an integrated approach on testing and assessment (IATA) for skin corrosion and irritation, Series on Testing and Assessment No. 203
- Version / remarks:
- 2014-07-11
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The reconstructed human epidermis (RhE) model closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis and has been validated, considered scientifically valid and adopted as OECD test guideline. The test is part of a Turnkey Testing Strategy to assess the skin corrosion and irritation potential of the test material including transport classification.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Three-dimensional human epidermis model (EpiDerm 200, MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia)
- Tissue batch number: 30837
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: for 3 minutes at room temperature or for 1 hour in the incubator at 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: The tissues were washed with sterile PBS to remove residual test material
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Sunrise Absorbance Reader
- Wavelength: 570 nm
- Filter: filter wavelength 570 nm without reference filter
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: See section "ACCEPTANCE CRITERIA" in "Any other information on materials and methods incl. tables".
- Barrier function: See section "ACCEPTANCE CRITERIA" in "Any other information on materials and methods incl. tables".
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues: No
The test substance was added to 0.9 mL MTT solution. The mixture was incubated in the dark at about 37°C for 3 hours. A negative control (deionized water) was tested concurrently. If the color of the MTT solution or (in case of water-insoluble test substances) the border to the water-phase turned blue / purple, the test substance was presumed to reduce MTT directly. In case of direct MTT reduction, three freeze-killed control tissues (KC) were treated additionally with each the test article and the negative control in the same way as described for the test item. Based on the result of the pretest, it was judged that application of killed control tissues is not necessary.
PREDICTION MODEL / DECISION CRITERIA
See section "EVALUATION OF RESULTS" in "Any other information on materials and methods incl. tables". - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 50 µL of undiluted liquid test substance
NEGATIVE CONTROL
- Amount applied: 50 µL
POSITIVE CONTROL
- Amount applied: 50 µL
- Concentration: 8 N potassium hydroxide solution - Duration of treatment / exposure:
- 3 minutes at room temperature or 1 hour in the incubator at 37°C
- Number of replicates:
- 2
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of 2 tissues, exposure period of 3 min
- Value:
- 101
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 1, exposure period of 3 min
- Value:
- 98.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 2, exposure period of 3 min
- Value:
- 103.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no indication of skin corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of 2 tissues, exposure period of 1 hour
- Value:
- 98.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no indication of skin corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 1, exposure period of 1 hour
- Value:
- 97.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no indication of skin corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 2, exposure period of 1 hour
- Value:
- 99.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no indication of skin corrosion
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Direct MTT reduction: No direct MTT reduction occured.
- Colour interference with MTT: No colour interference occured.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes - Interpretation of results:
- GHS criteria not met
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2019-06-18
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2012-07-06
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: New guidance document on an integrated approach on testing and assessment (IATA) for skin corrosion and irritation, Series on Testing and Assessment No. 203
- Version / remarks:
- 2014-07-11
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The reconstructed human epidermis (RhE) model closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis and has been validated, considered scientifically valid and adopted as OECD test guideline. The test is part of a Turnkey Testing Strategy to assess the skin corrosion and irritation potential of the test material including transport classification.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Three-dimensional human epidermis model (EpiDerm 200, MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia)
- Tissue Lot number: 30837
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: At room temperature for 25 minutes, then in the incubator at 37°C for 35 minutes.
- Temperature of post-treatment incubation: 37°C for 24±2 hours, then 37°C for another 18 ± 2 hours
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: The tissues were washed with sterile PBS to remove residual test material after start of application.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Sunrise Absorbance Reader
- Wavelength: 570 nm
- Filter: filter wavelength 570 nm without reference filter
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: See section "ACCEPTANCE CRITERIA" in "Any other information on materials and methods incl. tables".
- Barrier function: See section "ACCEPTANCE CRITERIA" in "Any other information on materials and methods incl. tables".
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues: No
The test substance was added to 0.9 mL MTT solution. The mixture was incubated in the dark at about 37°C for 3 hours. A negative control (deionized water) was tested concurrently. If the color of the MTT solution or (in case of water-insoluble test substances) the border to the water-phase turned blue / purple, the test substance was presumed to reduce MTT directly. In case of direct MTT reduction, three freeze-killed control tissues (KC) were treated additionally with each the test article and the negative control in the same way as described for the test item. Based on the result of the pretest, it was judged that application of killed control tissues is not necessary.
PREDICTION MODEL / DECISION CRITERIA
See section "EVALUATION OF RESULTS" in "Any other information on materials and methods incl. tables". - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 30 µL of undiluted liquid test substance
NEGATIVE CONTROL
- Amount applied: 30 µL
POSITIVE CONTROL
- Amount applied: 30 µL
- Concentration: 5% SDS - Duration of treatment / exposure:
- 25 minutes at room temperature and 35 minutes at 37°C
- Duration of post-treatment incubation (if applicable):
- 24 ± 2 hours + additional 18 ± 2 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of 3 tissues
- Value:
- 99
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 1
- Value:
- 104.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 2
- Value:
- 94.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 3
- Value:
- 97.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Direct MTT reduction: No direct MTT reduction occured.
- Colour interference with MTT: No colour interference occured.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes.
- Acceptance criteria met for positive control: Yes.
- Acceptance criteria met for variability between replicate measurements: Yes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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