Registration Dossier
Registration Dossier
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EC number: 238-178-9 | CAS number: 14283-07-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Lithium tetrafluoroborate, anhydrous
- EC Number:
- 238-178-9
- EC Name:
- Lithium tetrafluoroborate, anhydrous
- Cas Number:
- 14283-07-9
- Molecular formula:
- BF4.Li
- IUPAC Name:
- lithium tetrafluoroborate, anhydrous
- Test material form:
- solid: particulate/powder
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:
- 6.4.1 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.
6.4.2 Origin
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Brati-slava.
Designation of the kit: EPI-200-SIT
Day of delivery: 15. May 2018
Batch no.: 28610 - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- 1 mg/mL
- Duration of treatment / exposure:
- 23 hours and 25 minutes
- Duration of post-treatment incubation (if applicable):
- 19 hours and 5 minutes
- Number of replicates:
- 6-well-plate
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 11.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: 2.9%
- Other effects / acceptance of results:
- The test item Lithium Tetrafluoroborate is considered as at least irritant to skin.
After the treatment, the mean value of relative tissue viability was reduced to 11.8%. This value is below the threshold for skin irritation (50%).
The optical density of the negative control was well within the required acceptability crite-rion of 0.8 ≤ mean OD ≤ 2.8.
The positive control has met the acceptance criterion too, for thus ensuring the validity of the test system.
Variation within replicates was within the accepted range for negative control, positive control and test item (required: ≤ 18%).
For these reasons, the result of the test is considered valid.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test item Lithium Tetrafluoroborate is considered as at least irritant to skin.
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