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EC number: 204-934-1 | CAS number: 129-17-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Adverse reactions to patent blue V dye – The NEW START and ALMANAC experience
- Author:
- L. Barthelmes , A. Goyal , R.G. Newcombe , F. McNeill c, R.E. Mansel on behalf of the NEW START and ALMANAC study groups
- Year:
- 2 010
- Bibliographic source:
- EJSO 36 (2010) 399-403
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Data is from Journal with permission
- Principles of method if other than guideline:
- The allergic potential of patent blue V in 7,917 patients who participated in the NEW START training Programme and the ALMANAC trial was determined in the skin sensitization experiment conducted.
- GLP compliance:
- not specified
- Type of study:
- not specified
Test material
- Reference substance name:
- Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt
- EC Number:
- 204-934-1
- EC Name:
- Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt
- Cas Number:
- 129-17-9
- Molecular formula:
- C27H32N2O6S2.Na
- IUPAC Name:
- hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt
- Details on test material:
- - Name of test material (as cited in study report): Patent Blue V- Molecular formula : C27H31N2O6S2.Na- Molecular weight : 566.672 g/mol- Substance type: Organic- Physical state: Solid- Purity: No data available- Impurities (identity and concentrations): No data available
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- female
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: ALMANAC study: Close to the tumour NEW START training programme: Subdermally at the areola skin margin of the index quadrant
- Vehicle:
- other: Normal saline
- Concentration / amount:
- ALMANAC study: 2 ml of 2.5% aqueous solution of patent blue V diluted to 5 ml NEW START training programme: undiluted 2 ml of 2.5% patent blue V dye or 2 ml of 2.5% aqueous solution of patent blue V diluted to 5 ml
Challenge
- Concentration / amount:
- ALMANAC study: 2 ml of 2.5% aqueous solution of patent blue V diluted to 5 ml NEW START training programme: undiluted 2 ml of 2.5% patent blue V dye or 2 ml of 2.5% aqueous solution of patent blue V diluted to 5 ml
- No. of animals per dose:
- 7917 patients
- Details on study design:
- Details on study designRANGE FINDING TESTS:MAIN STUDYA. INDUCTION EXPOSURE :ALMANAC TREATMENT- No. of exposures: 1- Exposure period: No data available- Test groups: 7917- Control group: No data available- Site: - Frequency of applications: Around the tumour- Duration: No data available- Concentrations: 2 ml of 2.5% aqueous solution of patent blue V diluted to 5 ml with normal salineNEW START training programme: - No. of exposures: 1- Exposure period: No data available- Test groups: 7917- Control group: No data available- Site: - Frequency of applications: subdermally at the areolaskin margin of the index quadrant.- Duration: No data available- Concentrations: 2 ml of 2.5% patent blue V dye or 2 ml of 2.5% aqueous solution of patent blue V diluted to 5 ml with normal salineB. CHALLENGE EXPOSURE- No. of exposures: No data available- Day(s) of challenge: No data available- Exposure period: No data available- Test groups: No data available- Control group: No data available- Site: No data available- Concentrations: No data available- Evaluation (hr after challenge): No data availableOTHER: No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Group:
- test chemical
- Dose level:
- ALMANAC study: 2 ml of 2.5% aqueous solution of patent blue V diluted to 5 ml NEW START training programme: undiluted 2 ml of 2.5% patent blue V dye or 2 ml of 2.5% aqueous solution of patent blue V diluted to 5 ml
- No. with + reactions:
- 72
- Total no. in group:
- 7 917
- Clinical observations:
- Total allergicDnon-allergic reactions72
- Remarks on result:
- other: see Remark
- Remarks:
- Group: test group. Dose level: ALMANAC study: 2 ml of 2.5% aqueous solution of patent blue V diluted to 5 ml NEW START training programme: undiluted 2 ml of 2.5% patent blue V dye or 2 ml of 2.5% aqueous solution of patent blue V diluted to 5 ml . No with. + reactions: 72.0. Total no. in groups: 7917.0. Clinical observations: Total allergicDnon-allergic reactions72.
Any other information on results incl. tables
Clinical observations:
Allergic reactions | ||
Grade I | Urticaria, blue hives, pruritis, or generalised rash | 23 patients |
Grade II | Transient hypotension/bronchospasm/ laryngospasm | 16 patients |
Grade III | Severe hypotension (requiring vasopressor support) and/or change/abandoning of planned procedure and/or HDU/ITU admission | 5 patients |
Grade IV | Cardio-respiratory arrest and/or death | - |
Unspecified |
| 24 patients |
Non-allergic reactions | ||
Skin tattooing |
| 1 patients |
Bluish hue persisting for few hours |
| 3 patients |
Total allergicDnon-allergic reactions | 72 | |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Conclusions:
- The favourable allergic potential of patent blue V suggests the test material to be sensitizing to the skin of patients.
- Executive summary:
The adverse reactions of patent blue V in 7,917 patients who participated in the NEW START training programme and the ALMANAC trial was studied. All patients underwent sentinel lymph node biopsy for breast carcinoma using patent blue V.
In the ALMANAC study, the test compound was injected around the tumour. In the NEW START training programme, the test compound was injectedsubdermally at the areola skin margin of the index quadrant.
In total, 72 of 7,917 (0.9%) patients experienced adverse reactions : non-allergic reactions were observed in 4 (0.05%) patients, 23 (0.3%) patients had minor grade I allergic skin reactions (urticaria, blue hives, pruritis, or generalised rash) and 16 (0.2%) had grade II reactions (transient hypotension/ bronchospasm/ laryngospasm). Severe Grade III reactions (severe hypotension requiring vasopressor support and/or change/abandoning of planned procedure and/or HDU/ITU admission) were noted in 5 (0.06%) patients. The type of adverse reaction was not specified in 24 (0.3%) patients. No mortality was recorded.
The favourable allergic potential of patent blue V suggests the test material to be sensitizing to the skin of patients.
According to the publication, the test material is positive to induce skin sensitization.
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