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EC number: 436-060-3 | CAS number: - FC 84508 PK
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Aug. 29, 2000 to Nov. 28, 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was already available
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): FC 84508
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White guinea pig (HsdPoc:DH strain)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HARLAN WINKELMANN Gartenstr. 27, D-33178 Borchen, SPF breeding colony
- Weight at study initiation: 362 g
- Housing: Macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet: ssniff Ms-H (V2233), ad libitum
- Water: Tap water in plastic bottles, ad libitum
- Acclimation period: At least 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 50±20 °C
IN-LIFE DATES: From: Aug. 29, 2000 To: Sep. 29, 2000
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Tylose H 4000 G4 PHA (0.5 % in deionized water)
- Concentration / amount:
- 5% / 2 x 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:
- other: Tylose H 4000 G4 PHA (0.5 % in deionized water)
- Concentration / amount:
- 25 % /0.5 mL
- Day(s)/duration:
- Day 8 / 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:
- other: Tylose H 4000 G4 PHA (0.5 % in deionized water)
- Concentration / amount:
- 25 % / 0.5 mL
- Day(s)/duration:
- Day 22 / 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- - Determination of the primary non-irritant concentration: 2
- Determination of the tolerance of the intradermal injections: 3
- Control group: 5
- Treatment group: 10 - Details on study design:
- RANGE FINDING TESTS:
Determination of the primary non-irritant concentration:
The following test concentrations were administered to the flanks of two guinea pigs:
25.0 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
5.0 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
1.0 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
0.5 mL of the test substance preparation was administered to a 2 x 2 cm cellulose patch, which was fixed to the flank and covered occlusively for 24 h with a bandage and film. 24 h after removal of the patches, the treated skin areas were examined for erythema and edema.
Determination of the tolerance of the intradermal injections:
The following preparations were administered twice by intradermal injection to 2 guinea pigs:
Site 1. 2X0.1 mL 5.0 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
Site 2. 2X0.1 mL 1.0 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
Site 3. 2X0.1 mL 0.2 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
24, 48, 72 and 96 h after administration the injection sites were examined for local tolerance.
MAIN STUDY
A. INDUCTION EXPOSURE (Intradermal)
- No. of exposures: 2
- Exposure period: 1-7 d
- Test groups: Yes
- Control group: Yes, (50 % Freund's Adjuvant)
- Site: Dorsal area
- Frequency of applications: 2 in 7 d
- Duration: 7 d
- Concentrations: 5.0 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
INDUCTION EXPOSURE (Dermal)
- No. of exposures: 0.5 mL of the test substance preparation as cellulose patch
- Test groups: Yes, 25.0 % test substance in Tylose H 4000 G4 PHA (0.5 % in deionized water)
- Control group: Yes, Tylose H 4000 G4 PHA (0.5 % in deionized water)
- Site: Dorsal area
- Frequency of applications: Single on Day 8
- Concentrations: 25 % in Tylose H 4000 G4 PHA (0.5 % in deionized water)
B. CHALLENGE EXPOSURE (Dermal)
- No. of exposures: One
- Day(s) of challenge: Day 22
- Exposure period: 24 h under an occlusive bandage covered with an impermeable film and an elastic bandage.
- Test groups: 25.0 % test substance in Tylose H 4000 G4 PHA (0.5 % in deionized water)
- Control group:
- Site: Left flank
- Concentrations: 25 %
- Evaluation (hr after challenge): 24 and 48 h after removal of the patches
OTHER:
The substance is considered to be sensitizing if 30 % or more of the animals in the treatment group definitely showed a positive skin reaction and at the same time no irritant effects have emerged in the control group. - Positive control substance(s):
- yes
- Remarks:
- Alpha-hexyl cinnamic aldehyde
Results and discussion
- Positive control results:
- Alpha-hexyl cinnamic aldehyde was skin sensitiser and proved to be suitable for the determination of dermal sensitizers
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25 % Alpha-hexyl cinnamic aldehyde in PEG 400
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
After the challenge treatment, none of the ten animals of the treatment group showed a positive skin reaction during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.
- Executive summary:
A study was conducted to assess the sensitizing potential of the test substance in female Pirbright-White guinea pigs (Magnusson & Kligman method) according EU Method B.6. and OECD guideline 406 in compliance with GLP.
Intradermal induction was performed using 5 % test substance in Tylose H 4000 G4 PHA (0.5 % in deionized water). Dermal induction and challenge treatment were carried out with 25 % test substance in Tylose H 4000 G4 PHA (0.5 % in deionized water).
The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexyl cinnamic aldehyde for the maximization test.
Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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