Registration Dossier
Registration Dossier
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EC number: 686-016-4 | CAS number: 881302-73-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- 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:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
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 chemico test system
- Details of test system:
- cysteine peptide, (Ac-RFAACAA-COOH)
- lysine peptide (Ac-RFAAKAACOOH)
- Vehicle / solvent:
- 1:1 mix, water:acetonitrile
- Positive control:
- cinnamic aldehyde
Results and discussion
- Positive control results:
- Cinnamaldéhyde Depletion in Lysine peptide Depletion in Cxysteine Peptide
Rep. 1 60.73% 68.57%
Rep. 2 56.20% 68.80%
Rep. 3 54.44% 70.46%
Mean 57.12% 69.28%
Validity criteria 40.2 < depletion< 69.4 60.8
In vitro / in chemico
Resultsopen allclose all
- Group:
- test chemical
- Run / experiment:
- run/experiment 1
- Parameter:
- cysteine depletion
- Value:
- 2.95 %
- At concentration:
- 5 mM
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Group:
- test chemical
- Run / experiment:
- run/experiment 2
- Parameter:
- cysteine depletion
- Value:
- 4.45 %
- At concentration:
- 5 mM
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Group:
- test chemical
- Run / experiment:
- run/experiment 3
- Parameter:
- cysteine depletion
- Value:
- 3.74 %
- At concentration:
- 5 mM
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- cysteine depletion
- Value:
- 3.71 %
- At concentration:
- 5 mM
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Group:
- test chemical
- Run / experiment:
- run/experiment 1
- Parameter:
- lysine depletion
- Value:
- 0.9 %
- At concentration:
- 25 mM
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Group:
- test chemical
- Run / experiment:
- run/experiment 2
- Parameter:
- lysine depletion
- Value:
- 0 %
- At concentration:
- 25 mM
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Group:
- test chemical
- Run / experiment:
- run/experiment 3
- Parameter:
- lysine depletion
- Value:
- 0 %
- At concentration:
- 25 mM
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- lysine depletion
- Value:
- 0.3 %
- At concentration:
- 25 mM
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Outcome of the prediction model:
- no or minimal reactivity [in chemico]
- Other effects / acceptance of results:
- All validity criteria are fulfilled which allow us to validate the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The sensitization of the test item is assessed from the mean depletion percentage of Lysine and Cysteine.
The test item, 3,5-DICARBOXYBENZENEBORONIC ACID / DICARBOXYPHENYLBORONIC ACID code ID-20/04980, presents a mean depletion percentage of 2.01 % reflecting no or a minimal reactivity and thus a negative prediction for the DPRA. - Executive summary:
The skin sentization potential of 3,5-DICARBOXYBENZENEBORONIC ACID was tested according to the OECD Guideline 442C and the Protocol N°154 from ECVAM DB ALM.
The principle is based on the chemical reactivity of the test item with proteins. The interaction between the test item and lysine or cysteine-rich peptides is detected with a high performance liquid chromatography (HPLC). The remaining concentration of peptides is measured after 24 hours of incubation with the test item at room temperature. It is measured with the UV detector of the HPLC system, after gradient elution, at 220 nm. The depletion rates of lysine and cysteine peptides are then used to distinguish the skin sensitizer and non-sensitizer so as to sort and label chemicals according to SGH.
Results are the following:
Depletion in Lysine Peptide % Depletion in Cysteine Peptide %
Repetition 1 2.95 % 0.90 %
Repetition 2 4.45 % 0.00 %
Repetition 3 3.74 % 0.00 %
Mean 3.71 % 0.30 % Mean depletion: 2.01%
SD 0.75% 0.52%
SD validity criteria <11.6% <14.9%
All validity criteria were fulfilled.
The test item, 3,5-DICARBOXYBENZENEBORONIC ACID / DICARBOXYPHENYLBORONIC ACID code ID-20/04980, presents a mean depletion percentage of 2.01 % reflecting no or a minimal reactivity and thus a negative prediction for the DPRA.
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