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EC number: 267-636-0 | CAS number: 67905-17-3
- 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
Skin Irritation:
The dye was tolerated without irritation by all rabbits (index = 0). Under the test conditions described under FDA guidelines in the patch test, The test chemical can be assessed as not irritating to skin.
Eye Irritation:
After application of Solvent Blue 122, the highest irritation index of 16 was determined after 7 hours. According to the classification, the test chemical was therefore assessed to be slightly irritating to the eyes.
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- data is from experimental reports
- Qualifier:
- according to guideline
- Guideline:
- other: "1500.41 in Federal Register 38, No. 917, 27, 9, 173, P 27019" Guidelines
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Guidelines
- Principles of method if other than guideline:
- A test for skin compatibility was performed to assess the dermal irritation potential of the test chemical
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: SPF-albino-Himalayan rabbit strain Hoe: HIMK (SPFWiga)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5-2.0 kg
- Housing:The animals were kept in individual cages
- Diet (e.g. ad libitum): compound feed ERKA 8300 of feed plants Robert Koch oHG / Hamm, ad libitum
- Water (e.g. ad libitum): water, ad libitum
IN-LIFE DATES: From: 5.9.1977 To: 8.9. 1977 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Remarks:
- intact and scarified skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 500 mg of the powdered dye
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- after removal of patch 24-hour value) and 48 and 72 hours after the start of the test.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: flank skin
- % coverage: 3 × 3 cm square area
- Type of wrap if used: adhesive strip
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data available
- Time after start of exposure: no data available
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : after removal of patch 24-hour value) and 48 and 72 hours after the start of the test.
SCORING SYSTEM:
- Method of calculation: Based on the findings, the irritation index was determined according to the method described under "1500.41 in Federal Register 38, No. 917, 27, 9, 173, PG 27019" - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The dye was tolerated without irritation by all rabbits (index = 0)
- Interpretation of results:
- other: not irritating
- Conclusions:
- The dye was tolerated without irritation by all rabbits (index = 0). Under the test conditions described under FDA guidelines in the patch test, The test chemical can be assessed as not irritating to skin.
- Executive summary:
A test for skin compatibility was performed to assess the dermal irritation potential of the test chemical. The test was performed according to the "1500.41 in Federal Register 38, No. 917, 27, 9, 173, P 27019" and FDA Guidelines.
6 SPF-albino-Himalayan rabbit strain Hoe: HIMK (SPFWiga) were used for the study. The flank skin of 6 rabbits was depilated with an electric hair trimmer on two adjacent spots on a 3 × 3 cm area respectively. Either one of the clipped skin spots was additionally scarified using a scrape cutter. On 2.5 * 2.5 cm coarse lids of surgical gauze, 500 mg of the powdered dye was applied and glued to the prepared skin areas by means of an adhesive strip. The patches were covered by an infectious, impermeable, 6-8 cm wide PVC foil and then wrapped in an elastic permanent bandage. The exposure time was 24 hours.The dermal reactions were observed and scored after removal of the patches (24 hours) and 48 and 72 hours after the start of the test.
The dye was tolerated without irritation by all rabbits (index = 0). Under the test conditions described under FDA guidelines in the patch test, the test chemical can be assessed as not irritating to skin.
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- data is from experimental reports
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Guidelines(Federal Register Vol. 38, No. 187, S 27019, 1973)
- Principles of method if other than guideline:
- The mucous membrane compatibility of the test chemical was assessed in rabbits
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: SPF-albino-Himalayan rabbit strain Hoe: HIMK (SPFWiga)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5-2.0 kg
- Housing:The animals were kept in individual cages
- Diet (e.g. ad libitum): compound feed ERKA 8300 of feed plants Robert Koch oHG / Hamm, ad libitum
- Water (e.g. ad libitum): water, ad libitum
IN-LIFE DATES: From: 5.9.1977 To: 8.9. 1977 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg of the powdered dye
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- The assessment was performed 1,7,24,48 and 72 hours after the treatment with the help of a magnifying glass.
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data available
- Time after start of exposure: no data available
SCORING SYSTEM:The ocular lesions were observed and scored according to the classification given in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas, p. 51, 1975".
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: The assessment was performed 1,7,24,48 and 72 hours after the treatment with the help of a magnifying glass. After collecting the 24-hour report, all eyes were spooled with physiological saline solution. After 48 hours and 72 hours, after instillation of a drop of fluorescein sodium in the dilution 1: 10000 = 0.001%. - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 hours
- Score:
- 16
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- After application of the powdered dye, the highest irritation index of 16 was determined after 7 hours. According to the classification listed in the annex, the dye is therefore slightly irritating to the mucosa.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- After application of the test chemical, the highest irritation index of 16 was determined after 7 hours. According to the classification, the test chemicalwas therefore assessed to be slightly irritating to the eyes.
- Executive summary:
A test for mucous membrane compatibility of the test chemical was performed in rabbits. The test was performed according to the "1500.41 in Federal Register 38, No. 917, 27, 9, 173, P 27019" and FDA Guidelines.
6 SPF-albino-Himalayan rabbit strain Hoe: HIMK (SPFWiga) were used for the study. Single application of 100 mg of the powdered dye was instilled into the left conjunctival sac of 6 rabbits and the right eye remained untreated and served as control. The assessment for ocular lesions was performed 1, 7, 24, 48 and 72 hours after the treatment with the help of a magnifying glass. After collecting the 24-hour report, all eyes were spooled with physiological saline solution. After 48 hours and 72 hours, after instillation of a drop of fluorescein sodium in the dilution 1: 10000 = 0.001%. The ocular lesions were observed and scored according to the classification given in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas, p. 51, 1975".
For the determination of the irritation index, the evaluations of the cornea (a), the iris (b) and the conjunctiva (c) are added for each rabbit at the respective reading time. The average value of the values of all rabbits is calculated at the corresponding reading time. The highest index determined at one of the reading times is used for grading.
After application of the test chemical, the highest irritation index of 16 was determined after 7 hours. According to the classification, the test chemicalwas therefore assessed to be slightly irritating to the eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
A test for skin compatibility was performed to assess the dermal irritation potential of the test chemical. The test was performed according to the "1500.41 in Federal Register 38, No. 917, 27, 9, 173, P 27019" and FDA Guidelines.
6 SPF-albino-Himalayan rabbit strain Hoe: HIMK (SPFWiga) were used for the study. The flank skin of 6 rabbits was depilated with an electric hair trimmer on two adjacent spots on a 3 × 3 cm area respectively. Either one of the clipped skin spots was additionally scarified using a scrape cutter. On 2.5 * 2.5 cm coarse lids of surgical gauze, 500 mg of the powdered dye was applied and glued to the prepared skin areas by means of an adhesive strip. The patches were covered by an infectious, impermeable, 6-8 cm wide PVC foil and then wrapped in an elastic permanent bandage. The exposure time was 24 hours. The dermal reactions were observed and scored after removal of the patches (24 hours) and 48 and 72 hours after the start of the test.
The dye was tolerated without irritation by all rabbits (index = 0). Under the test conditions described under FDA guidelines in the patch test, the test chemical can be assessed as not irritating to skin.
Eye Irritation:
A test for mucous membrane compatibility of the test chemical was performed (Sustainability Support Services (Europe) AB has letter of access, 1977) in rabbits. The test was performed according to the "1500.41 in Federal Register 38, No. 917, 27, 9, 173, P 27019" and FDA Guidelines.
6 SPF-albino-Himalayan rabbit strain Hoe: HIMK (SPFWiga) were used for the study. Single application of 100 mg of the powdered dye was instilled into the left conjunctival sac of 6 rabbits and the right eye remained untreated and served as control. The assessment for ocular lesions was performed 1, 7, 24, 48 and 72 hours after the treatment with the help of a magnifying glass. After collecting the 24-hour report, all eyes were spooled with physiological saline solution. After 48 hours and 72 hours, after instillation of a drop of fluorescein sodium in the dilution 1: 10000 = 0.001%. The ocular lesions were observed and scored according to the classification given in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas, p. 51, 1975".
For the determination of the irritation index, the evaluations of the cornea (a), the iris (b) and the conjunctiva (c) are added for each rabbit at the respective reading time. The average value of the values of all rabbits is calculated at the corresponding reading time. The highest index determined at one of the reading times is used for grading.
After application of the test chemical, the highest irritation index of 16 was determined after 7 hours. According to the classification, the test chemical was therefore assessed to be slightly irritating to the eyes.
Justification for classification or non-classification
Available studies indicate a possibility of the test chemical to cause eye irritation but no dermal irritation. Hence, comparing the annotations with the CLP regulation, the test chemical can be classified under the category “Not Classified” for skin irritation and “Category 2” for eye irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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