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EC number: 268-544-3 | CAS number: 68123-13-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- In vivo Skin Prick-Test of Basic Blue 99 in women
- GLP compliance:
- not specified
- Type of study:
- skin painting test
- Species:
- human
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: No data available - Age at study initiation: 57-year-old - Weight at study initiation: No data available- Housing: No data available- Diet (e.g. ad libitum): No data available- Water (e.g. ad libitum): No data available- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available
- Route:
- epicutaneous, open
- Vehicle:
- no data
- Concentration / amount:
- 1% aq.
- Concentration / amount:
- 1% aq.
- No. of animals per dose:
- 1
- Details on study design:
- No data available
- Challenge controls:
- Histamine and physiological serum
- Positive control substance(s):
- yes
- Remarks:
- p-toluenediamine (cross-reacts with PPD), methyldibromo glutaronitrile (actual relevance not known), and several extracts of so-called ‘hypoallergenic leather’
- Positive control results:
- Positive
- Reading:
- 1st reading
- Dose level:
- 1 %
- No. with + reactions:
- 3
- Clinical observations:
- Strong reactions were observed
- Remarks on result:
- other: Reading: 1st reading. Dose level: 1 % . No with. + reactions: 3.0. Clinical observations: Strong reactions were observed .
- Interpretation of results:
- sensitising
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Basic Blue 99 was considered to be Sensitizing when tested by prick test in woman
- Executive summary:
In a in vivo prick test, 57-year-old woman were tested with 1 % Basic Blue 99. Strong reactions (+++, >histamine) were observed within 15 min of test. The same test was repeated after two months which give same results. In addition, Immediate positive reactions were observed in woman tested by using diluted TLC strips and concentrated TLC strip. Therefore, Basic Blue 99 was considered to beSensitizing when tested by prick test in woman.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
In a case study conducted by Katrienet. al.(2014), in vivo skin sensitization was evaluated in 57-year-old woman by using Basic Blue 99 in the concentration of 1 %. Strong reactions (+++, >histamine) were observed within 15 min of test. The same test was repeated after two months which give same results. In addition, immediate positive reactions were observed in woman tested by using diluted TLC strips and concentrated TLC strip. Therefore, Basic Blue 99 was considered to be Sensitizing when tested by prick test in woman. According to the publication, the test material classifies as a skin sensitizer.
In a study report given by American College of Toxicology (2007), in vivo LLNA test was carried out to test the sensitizing potential of basic blue 99 on CBAJ mice applied in the concentration of 0.25%, 0.50%, 1.0%, or 2.0%. Basic Blue 99 at 0.5%, 1.0% and 2.0% gave statistically significantly greater responses than the vehicle control, but not test/control ratios greater than 3. A positive response was also observed in the 0.25% group, but the difference was not statistically significant as compared to the vehicle control. Basic Blue 99 may induce a hypersensitivity response According to the publication, the test material classifies as a skin sensitizer.
In a case report given by American College of Toxicology (2007), 71-year-old woman experienced severe itching of the scalp 3 days after application of a hair-setting lotion containing a hair dye. Wheals developed on her trunk and limbs and disappeared after 1 week. After a second application of the lotion, the patient had itching of the scalp and widespread urticaria, which cleared over several weeks (suppressed by an oral antihistamine). Patch tests were performed again and several wheals were present on skin treated with 1% aqueous Basic Blue 99 and the hair-setting lotion hair dye. Scratch tests were performed and reading after 20 min showed +2 reactions to the hair-lotion dye and 1% aqueous Basic Blue 99. Due to systemic absorption of Basic Blue 99 widespread urticarial were suggested. Therefore, Basic Blue 99 is sensitizing to the skin of 71 yr old woman.
In a case report conducted by Wigger-Albertiet. al.(1996), in vivo skin prick test was performed on 67-year-old man by using Basic Blue 99. Strong immediate-type reaction (+ + + + +) were observed in 15 min of test as compared to control. Therefore, Basic Blue 99 was considered to be Sensitizing when tested by skin prick test in man.
In a case report conducted by Antonet. al.(1990), 46-year-old woman had applied a colored foam product weekly for 6 months without any side effects, but that 8 h after applying a liquid version of the product unintentionally to the scalp, the patient noticed burning and itching of the scalp and forehead, with redness and swelling of the forehead and upper eyelids. An exudative eruption on the scalp was seen. After 4 days, the patient had significant temporary hair loss from the allergic reaction. She was first treated 7 weeks post exposure and had thinner hair with localized seborrhoeic-like dermatitis. An open test with the product in the elbow fissure resulted in papular dermatitis after 2 days. A positive reaction was noted to 1% Basic Blue 99 in petrolatum. Seven months later the patient was patch tested using Basic Blue 99 at concentrations 0.1% and 1% in water and petrolatum. 0.1% pet. -/+; 1% pet. ?+/++; 0.1% aq. ? +/+++; 1% aq. ? +/+++. Therefore, Basic Blue 99 is found to be sensitizing when applied to a 46 yr old female as an ingredient of hair dye product.
In a study report given by American College of Toxicology (2007), Guinea pig maximisation test was performed to evaluate the sensitizing potential of Basic Blue 99 on 10 female albino Hartley/ Dunkin guinea pigs. No evidence of delayed type hypersensitivity were observed. Therefore, Basic Blue 99 is non sensitizing to the skin of Guinea pigs.
In a study from the above same reference, Mouse local lymphnode assay (LLNA) was performed to evaluate the contact allergenic potential of Basic Blue 99 when administered to the dorsum of both ear lobes of CBA/J female mice in the concentration of 1%, 5%, and 25% Basic Blue 99. An increased incorporation of 3H-thymidine were observed at 0.7-, 1.1-, and 1.1-fold, respectively as compared to positive-control mice had an increased incorporation of 3H-thymidine at 2.4-, 3.7-, and 7.0-fold, respectively as compared to the solvent control. Therefore, Basic Blue 99 is non sensitizing to the skin of Guinea pigs.
Hence, based on the above initial 4 case study and 1 animal study, it can be concluded that the substance Basic Blue 99 (CAS no 68123-13-7) classify as a skin sensitizer.
Though, negative skin sensitizer studies are also available but the positive skin sensitizer studies are on human and of Klimisch 2.
Thus, as per the CLP regulation, Basic Blue 99 (CAS no 68123-13-7) classify as a skin sensitizer.
Migrated from Short description of key information:
Basic Blue 99 was considered to be Sensitizing when tested by prick test in woman.
Justification for selection of skin sensitisation endpoint:
It is a resent case report of good data and of Klimisch 2
Justification for classification or non-classification
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