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Diss Factsheets
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EC number: 943-730-3 | 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:
- weight of evidence
- Study period:
- 14 Dec 1998-01 February 1999
- 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- draft
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, UK
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Test material
- Reference substance name:
- 647028-25-9
- Cas Number:
- 647028-25-9
- IUPAC Name:
- 647028-25-9
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, United Kingdom
- Age at study initiation: 8–12 weeks
- Weight at study initiation: 335 – 440 g
- Housing: individually or in pairs in solid-floor polypropylene cages furnished with woodflakes.
- Diet: Guinea Pig FD1, Special Diets Services Limited, Witham, United Kingdom; ad libitum
- Water: ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 44-57
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: unchanged and arachis oil BP
- Concentration / amount:
- intradermal: 25%
epicutaneous: undiluted
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: unchanged and arachis oil BP
- Concentration / amount:
- 100% and 75%
- No. of animals per dose:
- 5 (controls), 10 (test group)
- Details on study design:
- RANGE FINDING TESTS (selection of concentration):
INDUCTION EXPOSURE (INTRADERMAL)
Four guinea pigs were intradermally injected with 1%, 5%, 10% and 25% w/v in arachis oil BP. The grade of erythema at the injection site was assessed approximately 24, 48 and 72 hours and 7 days after injection according to the Draize scale. The highest concentration that caused only mild to moderate skin irritation, and was well tolerated systemically, was selected for the intradermal induction phase of the main study.
INDUCTION EXPOSURE (TOPICAL)
Two guinea pigs, previously injected with Freund’s Complete Adjuvant (eighteen days earlier), were applied to the clipped flanks under occlusive dressing with undiluted test item and 75%, 50% and 25% v/v of the test item in arachis oil BP for 48 hours. The degree of erythema and oedema was assessed approximately 1, 2 and 48 hours after dressing removal. The highest concentration producing only mild to moderate dermal irritation was selected for the topical induction stage of the main study.
CHALLENGE
Two guinea pigs were treated with undiluted test material and 75%, 50% and 25% v/v in arachis oil BP to the clipped flanks under occlusive conditions for an exposure period of 24 hours. Erythema and oedema score were observed approximately 1, 24, and 48 hours after dressing removal. The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge phase of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 hours
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: test substance in arachis oil BP
Injection 3: test substance in a 1:1 mixture (v/v) FCA/water
Epicuteneous: test substance in arachis oil BP
- Control group:
Intradermal (3 pairs of injections)
Injection 1: a 1:1 mixture (v/v) FAC/water
Injection 2: arachis oil BP
Injection 3: arachis oil BP at 50% in a 1:1 mixture (v/v) FCA/water
Epicuteneous: arachis oil BP
- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-7
- Concentrations: intradermal 25%, epicutaneous undiluted
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: right flank (test substance undiluted) and left flank (test substance 75%)
- Concentrations: undiluted and 75%
- Evaluation (hr after challenge): 24 and 48 h after patch removal - Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole (Intradermal induction concentration of 10% in arachis oil, topical induction concentration of 50% in acetone/PEG400; challenge concentration of 50 and 25% in acetone/PEG400)
Results and discussion
- Positive control results:
- The incidence of sensitisation in the historical positive controls was 70-100 % (based on 6 individual experiments).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 25%; challenge: 75 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 25%; challenge: 75 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 10
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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