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Registration Dossier
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EC number: 686-016-4 | CAS number: 881302-73-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: 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:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-(dihydroxyboranyl)benzene-1,3-dicarboxylic acid
- Cas Number:
- 881302-73-4
- Molecular formula:
- C8H7BO6
- IUPAC Name:
- 5-(dihydroxyboranyl)benzene-1,3-dicarboxylic acid
- 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)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test item was applied, as supplied, at the dose of 25 mg to the epidermal surface of the 2 living human skin models previously moistened with 25 μL of distilled water.
- Duration of treatment / exposure:
- 3 minutes at room temperature and during 1 hour at 37°C ± 1°C, 5% ± 1% CO2.
- Duration of post-treatment incubation (if applicable):
- 3 minutes and 1 hour after the test item application the human epidermis were washed 20 times with 1 mL of DPBS (DPBS – Dutscher, Batch No. 5181219). The rinsed tissues were checked for any coloration and noted to be whitish, comparable coloration to that of the negative control tissues.
- Number of replicates:
- 2 / test item
1 / positive or negative control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- ca. 87.69
- 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:
- 1
- Value:
- ca. 99.35
- 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:
- 3 minutes and 1 hour after the test item application, the mean percent viability of the epidermis skins treated with the test item were 87.69% and 99.35%, versus 18.61% and 1.01%, respectively, with the positive control item (potassium hydroxide 8N).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item 3,5-DICARBOXYBENZENEBORONIC ACID does not have to be classified in Category 1 “Corrosive”.
The hazard statement “H314: Causes severe skin burns and eye damage” with the signal word “Danger” are not required. - Executive summary:
The aim of the study was to evaluate the possible corrosive effects of the test item after topical administration on in vitro human reconstituted epidermis (epiCS®, supplied by CellSystems®).
The test item 3,5-DICARBOXYBENZENEBORONIC ACID was applied, as supplied, at the dose of 25 mg to 2 living Human skin model surfaces (epiCS®, supplied by CellSystems®) during 3 minutes and 1 hour, followed by a rinse with 20 mL of DPBS. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues. The experimental protocol was established in accordance with the O.E.C.D. Test Guideline No. 431 dated 18 June 2019.
3 minutes and 1 hour after the test item application, the mean percent viability of the epidermis skins treated with the test item were 87.69% and 99.35%, versus 18.61% and 1.01%, respectively, with the
positive control item (potassium hydroxide 8N).
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item 3,5-DICARBOXYBENZENEBORONIC ACID
does not have to be classified in Category 1 “Corrosive”. The hazard statement “H314: Causes severe skin burns and eye damage” with the signal word
“Danger” are not required.
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