Registration Dossier
Registration Dossier
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EC number: 695-938-6 | CAS number: 678966-16-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Lithium bis[ethanedioato(2-)-κO1,κO2]difluorophosphate(1-)
- EC Number:
- 695-938-6
- Cas Number:
- 678966-16-0
- Molecular formula:
- F2C4PLiO8
- IUPAC Name:
- Lithium bis[ethanedioato(2-)-κO1,κO2]difluorophosphate(1-)
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified
- Source strain:
- not specified
- Details on animal used as source of test system:
- Specification
The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissue consists of 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 representing main
lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.
Origin
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Brati-slava.
Designation of the kit: EPI-200-SIT
Day of delivery: 03. Mar. 2020
Batch no.: 30850 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of post-treatment incubation (if applicable):
- 18 hours and 20 minutes
- Number of replicates:
- 6-well-plates
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 3.3
- Vehicle controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 2.3
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- After the treatment with the test item, the mean value of relative tissue viability was re-duced to 3.3%. This value is below the threshold for skin irritation potential (50%). Test items that induce values below the threshold of 50% are considered at least irritant to skin.
Therefore, the test item Lithium difluorobis(oxalate)phosphate is considered
at least irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
The OECD guideline 439 addresses the human health endpoint skin irritation. Therefore, further testing on skin corrosion potential with another suitable in vitro study (e.g. OECD 431) may be required.
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