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EC number: 406-077-0 | CAS number: -
- 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
Reaktivblau 1483 does not have a sensitizing effect on the skin of the guinea pig
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:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Method was not available
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Remarks:
- Pirbright White, Dunkin Hartley HOE DHPK [SPF-LAC] BÖ
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal 1, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Age at study initiation: young adults
- Weight at study initiation: 273 - 337 g
- Housing: 5/cage
- Diet (e.g. ad libitum): Kliba Labordiät 341 (Kaninchen-Meerschweinchen-Haltungsdiät) ad libitum
- Water (e.g. ad libitum): Water ad libitum (tap water; about 2 g of ascorbic acid per 10 L water was added to the drinking water twice a week)
- Acclimation period: at least 7 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
- In-life dates: From March 27, 1990 To April 27, 1990. - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5%: four injections a 0.1 mL
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50%
- Day(s)/duration:
- on Day 8 - 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25%
- Day(s)/duration:
- on Day 15 - for 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25%
- Day(s)/duration:
- on Day 22 - for 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Main test
Number of animals per control group: 10
Number of animals of the test group: 20 - Details on study design:
- RANGE FINDING TESTS:
Determination of the primary non-irritant concentration
Determination of the tolerance of the intradermal injections
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal + 1 epicutaneous
- Exposure period: intradermal: 24 hours; epicutaneous: 48 hours
- Test groups: 1
- Control group: 2
- Site: shoulder
- Frequency of applications: Day 1; Day 8
- Duration: 24 and 48 hours
- Concentrations: 5 and 50%
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: Day 22 and Day 29
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1 + 1
- Site: flank
- Concentrations: 25%
- Evaluation (hr after challenge): 24, 48 and 72 h after the beginning of application
1st challenge:
- treatment of the test group and of control group 1 with the test substance formulation (control group 2 remained untreated)
2nd challenge:
- treatment of the test group and of control groups 1 and 2 with the test substance formulation
OTHER:
Weight check of the individual animals: before intradermal induction and before the end of the study.
Clipping of the test animals: if required, about 3 to 5 hours before each reading and before each test substance application at the appropriate application sites.
Clinical examinations: no detailed examinations; check for sick animals and for those showing a deteriorated general state each workday. - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- a separate study is performed twice a year
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 18
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 18
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 18
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 18
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen
- Executive summary:
The substance Reaktivblau 1463 was tested for its sensitizing effect on the skin of the guinea pig in the maximization test based on the method of Magnusson and Kligman.
After intradermal induction distinct erythema and oedema were observed at the injection sites of the control and the test animals at which only Freund's adjuvant/0.9% aqueous NaCl-solution (1 : 1) was applied. Injection of the test substance preparation in 0.9% aqueous NaCl-solution or in Freund's adjuvant/0.9% aqueous NaCl-solution (1 : 1) caused distinct oedema in the test animals. The irritation index for erythema could not be determined because of staining due to the colour of the test substance. The control animals injected with 0.9% aqueous NaCl-solution (vehicle) did not show any skin reactions.
The percutaneous induction was only carried out in the test group, because with aqua dest. a vehicle was used that was not expected to influence the result of the study. Incrustation, partially open (caused by the intra-dermal induction) could be observed in addition to distinct oedema. The index for erythema could not be determined because of staining due to the colour of the test substance.
The number of animals with skin findings after the 1st challenge (20 days after intradermal induction) and after the 2nd challenge (27 days after intradermal induction) is summarized in the following table:
1stchallenge
2ndchallenge
25% in aqua dest.
25% in aqua dest.
Control group
1
0/10
0/10
Control group
2*
no application of test substance
0/9
Test group**
1/18
1/18
x/y: number of positive reactions/number of animals tested; readings 48 h after the beginning of application
* one animal died 9 days after intradermal induction cause of death: pneumonia
** two animals died 10 and 12 days after intradermal induction; cause of death: pneumonia
After the first challenge with the 25% test substance preparation in aqua dest. one test animal exhibited distinct erythema. Control group animals did not show any skin reactions.
The second challenge with the 25% test substance preparation in aqua dest. caused slight erythema in one animal of the test group. Animals of control groups one and two did not show any skin reactions.
Under these test conditions and following the results described above Reaktivblau 1483 does not have a sensitizing effect on the skin of the guinea pig.
Reference
Body weights: The expected body weight gain has generally been observed in the course of the study.
Mortality: One animal of control group 1 and 2 animals of the test group died 9, 10 or 12 days after the beginning of the study. Macroscopic examination revealed that the animals suffered from pneumonia.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The substance Reaktivblau 1463 was tested for its sensitizing effect on the skin of the guinea pig in the maximization test based on the method of Magnusson and Kligman.
After intradermal induction distinct erythema and oedema were observed at the injection sites of the control and the test animals at which only Freund's adjuvant/0.9% aqueous NaCl-solution (1 : 1) was applied. Injection of the test substance preparation in 0.9% aqueous NaCl-solution or in Freund's adjuvant/0.9% aqueous NaCl-solution (1 : 1) caused distinct oedema in the test animals. The irritation index for erythema could not be determined because of staining due to the colour of the test substance. The control animals injected with 0.9% aqueous NaCl-solution (vehicle) did not show any skin reactions.
The percutaneous induction was only carried out in the test group, because with aqua dest. a vehicle was used that was not expected to influence the result of the study. Incrustation, partially open (caused by the intra-dermal induction) could be observed in addition to distinct oedema. The index for erythema could not be determined because of staining due to the colour of the test substance.
The number of animals with skin findings after the 1st challenge (20 days after intradermal induction) and after the 2nd challenge (27 days after intradermal induction) is summarized in the following table:
1stchallenge
2ndchallenge
25% in aqua dest.
25% in aqua dest.
Control group
1
0/10
0/10
Control group
2*
no application of test substance
0/9
Test group**
1/18
1/18
x/y: number of positive reactions/number of animals tested; readings 48 h after the beginning of application
* one animal died 9 days after intradermal induction cause of death: pneumonia
** two animals died 10 and 12 days after intradermal induction; cause of death: pneumonia
After the first challenge with the 25% test substance preparation in aqua dest. one test animal exhibited distinct erythema. Control group animals did not show any skin reactions.
The second challenge with the 25% test substance preparation in aqua dest. caused slight erythema in one animal of the test group. Animals of control groups one and two did not show any skin reactions.
Under these test conditions and following the results described above Reaktivblau 1483 does not have a sensitizing effect on the skin of the guinea pig.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on a local lymph node assay in mice, the test substance does not require classification for sensitization according to CLP (EC 1272/2008) criteria.
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