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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
Basic Blue 99 (CAS no 68123-13-7) does not classify as skinn and eye irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: 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
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- Dermal irritation capability of basic blue 99 was tested on albino rabbits .
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- other: Patch
- Preparation of test site:
- other: Shorn intact or abraded
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g per square inch
- Duration of treatment / exposure:
- 24 Hr
- Observation period:
- 14 day
- Number of animals:
- 3/sex/dose
- Details on study design:
- TEST SITE- Area of exposure: short intact or abraded skin on the back of animal- % coverage: No data available- Type of wrap if used: patchREMOVAL OF TEST SUBSTANCE- Washing (if done): No data available.- Time after start of exposure: No data available.SCORING SYSTEM: No data available
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 Hrs
- Reversibility:
- no data
- Remarks on result:
- other: No observable skin irritation.
- Irritant / corrosive response data:
- No data available
- Other effects:
- No data available
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Basic Blue 99 is non irritating to the skin of New Zealand White rabbits.
- Executive summary:
Dermal irritation study was carried out to test the dermal toxicity of basic blue 99 at the concentration of 0.5g per inch square.Basic Blue 99 (0.5 g per square inch) was applied undiluted to either the shorn intact or abraded skin on the back of animals. The patch was affixed for 24 h. No observable reactions to Basic Blue 99 were noted over the 14-day observation period.According to the CLP classification, the test material Basic Blue 99 does not classify as a skin irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: 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
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- Eye irritation study was performed on New Zealand rabbits to evaluate the irritant nature of the test compound Basic Blue 99
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Details on test animalTEST ANIMALS- Source:- Age at study initiation: No data available- Weight at study initiation: No data available- Fasting period before study: 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
- Vehicle:
- other: Saline
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 0.5% Basic Blue 99 (0.1 ml)
- Duration of treatment / exposure:
- No data available
- Observation period (in vivo):
- 30 and 60 min and 1 and 2 days post instillation
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- TEST SITE- Area of exposure: The conjunctional sac of the left eye- % coverage: No data available- Type of wrap if used: No data availableREMOVAL OF TEST SUBSTANCE- Washing (if done): No data available- Time after start of exposure: No data availableSCORING SYSTEM: Corneal and iris parameters were observed.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 30min and 60min and 1 and 2 days post instillation
- Reversibility:
- not specified
- Remarks on result:
- other: The conjunctivae of the Basic Blue 99 treated eye were discolored, but no effects on the cornea or iris were observed in any animal.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The test material Basic Blue 99 is non irritating to the eyes of rabbits.
- Executive summary:
Eye irritation study was performed on New Zealand rabbits to evaluate the irritant nature of the test compound Basic Blue 99
A solution of 0.5% Basic Blue 99 (0.1 ml) was instilled into the conjunctinal sac of the left eye and the right eye received 0.1 ml of vehicle alone (saline). Eye irritation was read at 30 and 60 min and 1 and 2 days post instillation. The conjunctivae of the Basic Blue 99 treated eye were discolored, but no effects on the cornea or iris were observed in any animal. The study concluded that the mucous membrane injury threshold concentration for the rabbit eye is greater than 0.5% Basic Blue 99.
According to the publication, the test material Basic Blue 99 does not classify as an eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
In a study conducted by American College of Toxicology (2007), skin irritation was evaluated in New Zealand White male and female rabbit by using Basic Blue 99 in the concentration of 0.5g per inch square. No observable reactions to Basic Blue 99 were noted over the 14-day observation period.
Similar to above reference, skin irritation was evaluated in rabbit by using Basic Blue 99 in the concentration of 0.5g per inch square in distilled water to either the shorn intact or abraded skin on the back of animals. The primary irritation index was calculated to be 0.2 and Basic Blue 99 was considered “mildly irritating” to rabbit skin.
Therefore, on the basis of above available information and according to the CLP classification, the test material Basic Blue 99 (CAS no 68123-13-7) does not classify as a skin irritant.
Eye irritation:
In a study conducted by American College of Toxicology (2007), eye irritation was evaluated in New Zealand White rabbit by using Basic Blue 99 in the concentration of 0.5% (0.1 ml) was instilled into the conjunctinal sac of the left eye and the right eye received 0.1 ml of vehicle alone (saline). The conjunctivae of the Basic Blue 99 treated eye were discolored, but no effects on the cornea or iris were observed in any animal. The study concluded that the mucous membrane injury threshold concentration for the rabbit eye is greater than 0.5% Basic Blue 99. Therefore, Basic Blue 99 was considered to be non irritating to New Zealand White rabbit eye.
Thus, on the basis of above available information and according to the CLP classification, the test material Basic Blue 99 (CAS no 68123-13-7) does not classify as eye irritant.Justification for selection of skin irritation / corrosion endpoint:
No observable reactions to Basic Blue 99 were noted over the 14-day observation period.
Justification for selection of eye irritation endpoint:
Basic Blue 99 was considered to be non irritating to New Zealand White rabbit eye.
Justification for classification or non-classification
On the basis of above available information and according to the CLP classification, the test material Basic Blue 99 (CAS no 68123-13-7) does not classify as skin and eye irritant.
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