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EC number: 280-489-7 | CAS number: 83567-04-8
- 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
Skin sensitisation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From November 12, 1998 to December 04, 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A GPMT study was submitted as this was already available before the requirement for LLNA testing was published.
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- red powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- From: Harlan Winkelmann
Bodyweight (mean): 368 g
Temperature: 20 +/- 3°C and Relative humidity: 50 +/- 20%
Lighting time: 12 h daily
Food and water: ssniff Ms-H (V2233) and tap water (ad libitum)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Remarks:
- deionized
- Concentration / amount:
- - 50% Freund's Complete Adjuvant emulsion
- 5% test substance (treatment group) or vehicle (control group)
- 50% Freund's Complete Adjuvant emulsion mixed with an equal volume of the test substance treatment group) or vehicle (control group) - Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- deionized
- Concentration / amount:
- 25% in 0.5 mL test substance (treatment group) or vehicle (control group)
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- deionized
- Concentration / amount:
- 5% in 0.5 mL test substance (treatment group) or vehicle (control group)
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- - Range finding test:
Determination of the primary non-irritant concentration: 3
Determination of the tolerance of the intradermal injections :2
- Main study
Control group 5
Test substance group 10 - 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: the administration area was examined for local tolerance. Any toxic effects were recorded.
B. Challenge exposure: examinations of the skin ca. 24 and 48 h after removal of patches (= 48 and 72 h after start of challenge)
NB. Body weights of the test animals were determined as well - Challenge controls:
- left flank
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Observations:
- Determination of the primary non-irritant concentration:
After application of 25% test substance concentration discrete or patchy erythema were observed in one animal. No signs of irritation occurred at 5% and 1% test concentrations.
- Determination of the tolerance of the intradermal injections:
The intradermal injections with the 5.0% preparation caused slight to well-defined erythema and oedema. The intradermal injections with the 1.0% preparation caused slight erythema.
The intradermal injections with the 0.2% preparation caused no signs of irritation.
- Intradermal induction:
The intradermal injections with Freund's Adjuvant (with or without test substance) caused severe erythema and edema as well as indurations and encrustations. When the test substance was administered with deionized water, slight erythema and oedema were observed. The vehicle alone did not cause any sign of irritation.
- Dermal induction:
After removal of the patches, severe erythema and edema, indurated, scabbed and encrusted skin as well as necrosis were observed at the sites peviously treated with Freund's Adjuvant. The daministration sites treated with the test substance showed slight erythema. The vehicle alone showed no signs of irritation.
- Dermal challenge:
No skin reactions were observed in the control and treatment groups, 24 and 48 h after removal of the occlusive bandage.
- The body weight gains of the animals animals were not impaired. The treated animals showed no clinical signs of intoxication throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the substance was not considered to be sensitizing to guinea pig skin.
- Executive summary:
A study was conducted to determine the in vivo skin sensitisation potential of the substance according to OECD Guideline 406 and EU Method B.6, in compliance with GLP. Female Pirbright-White guinea pigs (5 per control group and 10 per test group) were first exposed to the substance intradermally (injections of 50% Freund’s Adjuvant, 5% test substance in deionized water or 5% test substance in 50% Freund’s Adjuvant) and dermally (25.0% test substance in deionized) for 48 h. The dermal challenge consisted of application of an occlusive bandage for 24 h with 5.0% test substance in deionized water. Examinations were conducted 24 and 48 h after removal of the patches. None of the ten treated animals showed a positive skin response after the challenge procedure. Under the study conditions, the substance was not considered to be sensitizing to guinea pig skin (Seeberger, 1999).
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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