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EC number: 227-217-5 | CAS number: 5718-26-3
- 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
Macrolex Orange R was not sensitizing to the skin in a Guinea Pig Maximization Test according to to Magnussen and Kligman.
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:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Guinea Pig Maximization Test according to to Magnussen and Kligman
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted 1997
- Specific details on test material used for the study:
- Batch No.: A 100941995
Purity: technical grade
solid red powder - Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH, Harlan Winkelmann
- Sex:
- male
- Details on test animals and environmental conditions:
- 20 male Guinea pigs; room temperature: 22+/-3 degree Celsius; relative humidity: 40-60%; light dark cyrcle 12 hartificial light; air exchange rate >0 10 times per hour.
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 1%
- Day(s)/duration:
- single
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 0.5 ml of a 25% suspension
- Day(s)/duration:
- single
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #10
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 6%
- Day(s)/duration:
- 72 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- Guinea Pig Maximization Test according to to Magnussen and Kligman
- Challenge controls:
- Yes
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 6%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- non
- Remarks on result:
- other: control group
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 6%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- non
- Remarks on result:
- other: control group
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 6%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- non
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Dose level:
- 6%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- non
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The Guinea Pig Maximization Test (GPMT) was performed on male guinea pigs to determine whether the test substance MACROLEX ORANGE R exhibits skin-sensitizing properties.
The study was conducted with the following test substance concentrations:
lntradermal induction: 1 %
Topical induction: 25%
Challenge: 6%
For the induction and the challenge treatment the test substance was formulated in propylene glycol to yield a suspension.
72 hours after the challenge the 6% test substance formulation led to skin reddening (grade 1) in 1/10 (10%) animals in the test group, but not after 48 hours. The challenge with a 6% test substance formulation showed no skin effects in the control group animals.
Under the conditions of the maximization test the test substance thus exhibits no skin-sensitization potential.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Additional information:
no study available
Justification for classification or non-classification
Macrolex Orange R was not sensitizing to the skin in a Guinea Pig Maximization Test according to to Magnussen and Kligman. No classification is warranted
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