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Diss Factsheets
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EC number: 461-670-1 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- and Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Breeder: Charles River Laboratories France
- Age at study initiation: 1-2 months
- Weight at study initiation: males: 351 ± 11 g; females 349 ± 16 g
- Housing: individually in polycarbonate cages with stainless steel lid (48 x 27 x 20 cm) equipped with a polypropylene bottle
- Diet (e.g. ad libitum): ad libitum, 106 pelleted diet (SAFE, Villemoisson, Epinoy-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum, drinking water filtered
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12 cycles
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- 0.1 (w/v) % (test item in corn oil) for intradermal induction
30 (w/v) % (in acetone) for dermal induction and challenge treatment
Challengeopen allclose all
- Route:
- other: topical, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 0.1 (w/v) % (test item in corn oil) for intradermal induction
30 (w/v) % (in acetone) for dermal induction and challenge treatment
- No. of animals per dose:
- 2 males and 2 females for the preliminary test
10 males and 10 females for the main test and 5 males and 5 females as controls - Details on study design:
- RANGE FINDING TESTS:
Intradermal: 0.1 ml doses of the test item 0.1 % were injected into the interscapular region and local reactions were evaluated
approx. 24, 48 hours and 6 days after the injections.
Cutaneous route: a filter paper (~8 cm2) was fully loaded with a dosage form preparation and was then applied to the clipped area of the skin.
(It was held in place by means of an occlusive dressing for 48 hours.)
Cutaneous reactions were evaluated 24 and 48 hours after removal of the dressings.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: intradermal route: day 1 - 6 inj. 3 inj. of 0.1 ml into both side ie. 3 pairs of sites: Antenior (FCA alone), Middle (test item) Posterior (FCA+Test item)
cutaneous route: one (Day 8).
- Exposure period: 48 hours
- Test groups: 10 males and 10 females
- Control group: 5 males and 5 females
- Duration: intradermal: 6 days, cutaneous: 14 days
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 22
- Exposure period: 24 hours
- Test groups: 10 males and 10 females
- Control group: 5 males and 5 females
- Evaluation (hr after challenge): 24 and 48 hours - Positive control substance(s):
- no
- Remarks:
- mercaptobenzothiazole (laboratory historical data)
Results and discussion
- Positive control results:
- --
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema (grade 1) together with dryness of the skin
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30 %. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: discrete erythema (grade 1) together with dryness of the skin.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema (grade 1) together with dryness of the skin
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: discrete erythema (grade 1) together with dryness of the skin.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: both control and test group
- Dose level:
- 30 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema (grade 1) together with dryness of the skin persisted
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: both control and test group. Dose level: 30 %. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: discrete erythema (grade 1) together with dryness of the skin persisted.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- No delayed contact hypersensitivity in guinea pigs.
Not classified as sensitizing to the skin.
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