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EC number: 473-160-6 | 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
The read across substance Blue MGi 1037, a structural analogue of the target substance, does not cause skin sensitisation.
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:
- 6 June 2000 - 14 July 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 96/54/EEC, B.6 Maximisation test
- Version / remarks:
- 1996
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The OECD TG 429 was first adopted in 2002.
- Species:
- guinea pig
- Strain:
- other: Ibm:GOHI
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Switzerland
- Females nulliparous and non-pregnant: yes
- Microbiological status of animals: SPF
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 310 - 420 g
- Housing: individually in Makrolon type-4 cages
- Diet: ad libitum, pelleted standard Nafag Ecosan 845 25 W4 guinea pig breeding/maintenance diet, containing Vitamin C
- Water: ad libitum, tap water
- Acclimation period: 1 week
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 23
- Humidity (%): 37-64
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 10%
- 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:
- 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:
- 10%
- Day(s)/duration:
- Day 22/24h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three pairs of intradermal injections (0.1 mL per site)
- Test groups:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) The test item, at 10 % in bi-distillcd water.
3) The test item at 10 % in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- Control group:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline
2) Bi-distilled water
3) 1:1 (w/w) mixture of bi-distilled water in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- Site: dorsal skin from scapular region
B. INDUCTION EXPOSURE
- No. of exposures: one epidermal application/occlusive
One week after the injections, the scapular area (approximately 6x8 cm) was again clipped and shaved free of hair prior to the application. A 2 x 4 cm patch of filter paper was saturated with the test item (50 % in bi-distilled water) and placed over the injection sites of the test animals. The volume of test item preparation applied was approximately 0.3 mL. The patch was covered with aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The occlusive dressings were left in place for 48 hours. The epidermal application procedure described ensures intensive contact of the test item.
The guinea pigs of the control group were treated as described above with bi-distilled water only, also applied at a volume of approximately 0.3 mL.The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema according to the method of Magnusson and Kligman.
C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 hours
- Test groups: 10%
- Control group: bi-distilled water
- Site: left and right flank
- Evaluation (hr after challenge): 24 and 48 hours after removal of the bandage - Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- other:
- Group:
- positive control
- Dose level:
- -
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance Blue MGi 1037, a structural analogue of the target substance, does not cause skin sensitisation.
- Executive summary:
In order to assess the cutaneous allergenic potential of BLUE MGi 1037, the Maximization- Test was performed in 15 (10 test and 5 control) female albino guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 96/54/EEC, B.6.
The intradermal induction of sensitization in the test group was performed in the nuchal region with a 10 % dilution of the test item in bi-distilled water and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 50 % in bi-distilled water one week after the intradermal induction. The animals of the control group were intradermally induced with bi-distilled water and FCA/physioIogical saline and epidermally induced with bi-distilled water under occlusion.
Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 10 % in bi-distilled water and bi-distilled water alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.
None of the control and test animals showed skin reactions after the challenge treatment with BLUE MGi 1037 at 10 % (w/w) in bi-distilled water.
Based on the findings in an adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 96/54/EECT BLUE MGi 1037 has not to be classified and labelled as a skin sensitizer.
Reference
Maximum concentration not causing irritating effects in preliminary test: 10 %
Signs of irritation during induction:
Test group:
No animals showed oedema after induction. As the test item at 50
% stained the skin blue, it was not possible to
determine whether erythema was present or not.
Control group:
No animals showed oedema or or erythema after induction.
Evidence of sensitisation of each challenge concentration:
10 % concentration: 0/10 (10 %) of tested animals showed sensibilisation.
Other observations:
MORALITY:
There were no deaths during the course of the study.
CLINICAL SIGNS:
No signs of systemic toxicity were observed in the animals.
BODY WEIGHT:
The body weight was within the range.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In order to assess the cutaneous allergenic potential of the structural analogue BLUE MGi 1037, the Maximization- Test was performed in 15 (10 test and 5 control) female albino guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 96/54/EEC, B.6.
The intradermal induction of sensitization in the test group was performed in the nuchal region with a 10 % dilution of the test item in bi-distilled water and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 50 % in bi-distilled water one week after the intradermal induction. The animals of the control group were intradermally induced with bi-distilled water and FCA/physioIogical saline and epidermally induced with bi-distilled water under occlusion.
Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 10 % in bi-distilled water and bi-distilled water alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.
None of the control and test animals showed skin reactions after the challenge treatment with BLUE MGi 1037 at 10 % (w/w) in bi-distilled water.
Based on the findings in an adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 96/54/EECT BLUE MGi 1037 has not to be classified and labelled as a skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this information, the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.
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