Registration Dossier
Registration Dossier
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EC number: 285-249-5 | CAS number: 85049-76-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vitro
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The complete read across justification is detailed in section 13; source study has reliability 1.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- test substance minimally moistened with de-ionized water or PBS
- Details on test system:
- Three dimensional human epidermis model
The EpiDerm™ model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm™ tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm Ø) and commercially available as kits (EpiDerm™ 200), containing 24 tissues on shipping agarose.
Tissue model: Epi-200
Origin: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- after 3 min. treatment
- Run / experiment:
- corrosion test
- Value:
- 117
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- after 1 hour treatment
- Run / experiment:
- corrosion test
- Value:
- 101
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- after 1 h treatment with about 42 h post-incubation
- Run / experiment:
- irritation test
- Value:
- 105
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Due to the intense color of the test substance it could not be determined whether the test substance is able to reduce MTT directly. Therefore an additional MTT reduction control was introduced. However, the result of the control tissues inactivated by freezing (KC) did not indicate an increased MTT reduction.
In both tests minimal compound residues remained on the tissues after the washing procedure. However, this did not interfere with the colorimetric test as was demonstrated in a pretest.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Based on the observed results and applying the evaluation criteria it was concluded that test substance does not show a skin irritation potential in EpiDerm™ in vitro skin irritation and corrosion tests under the test conditions chosen.
- Executive summary:
Method
Two in vitro assays were part of this in vitro skin irritation and corrosion test strategy: The Skin Corrosion Test (SCT) and Skin Irritation Test (SIT).
The potential of test substance to cause dermal corrosion/irritation was assessed by a single topical application of 25 μl bulk volume (about 12 mg) of the undiluted test substance to a reconstructed three dimensional human epidermis model (EpiDerm™).
For the corrosion test 2 EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, respectively. The irritation test was performed with 3 EpiDerm™ tissue samples, which were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period.
Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
Results
Due to the intense color of the test substance it could not be determined whether the test substance is able to reduce MTT directly. Therefore an additional MTT reduction control was introduced. However, the result of the control tissues inactivated by freezing (KC) did not indicate an increased MTT reduction.
In both tests minimal compound residues remained on the tissues after the washing procedure. However, this did not interfere with the colorimetric test as was demonstrated in a pretest.
Corrosion test: the mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 117 %, and it was 101 % after an exposure period of 1 hour.
Irritation test: the mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 105 %.
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