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Diss Factsheets
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EC number: 429-370-5 | CAS number: 220410-74-2
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-06-09 to 2003-07-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Clinical study according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Modified Draize procedure: Marzulli, F.N. and Maibach, H.I. (1977) Contact Allergy: Predictive Testing in Humans. In Advances in Modern Toxicology. Dermatotoxicology and Pharmacology. Eds. Marzulli, F.N. and Maibach, H.I 4, 353-372.
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 429-370-5
- EC Name:
- -
- Cas Number:
- 220410-74-2
- Molecular formula:
- C34H67N3O13
- IUPAC Name:
- tris(1,4-dihydroxy-2,2,6,6-tetramethylpiperidin-1-ium) 2-hydroxypropane-1,2,3-tricarboxylate
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: One hundred twenty-five subjects (36 male, 89 female) enrolled. One hundred and four subjects (32 male, 72 female) completed all phases of the study.
- Sex: male and female
- Age: 18 or older
- Race: not specified - Clinical history:
- Exclusion criteria:
a. Insulin-dependent diabetes
b. Bilateral mastectomy for cancer involving removal of Iymph nodes
c. Clinically significant skin diseases which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, and active cancer
d. Asthma that requires chronic medication
e. Immunological disorders such as HTV positive, AIDS and systemic lupus erythematosus
f. Treatment for any type of cancer within the last six months
g. Use of any prescribed anti-inflammatory drug, immunosuppressive drugs or antihistamine medication (steroid nose drops and/or eye drops are permitted). Any over-the-counter pain medication that is ingested in quantities exceeding label instructions
h. Topical drugs used at patch site
I. Pregnancy, lactation, or planning a pregnancy
j . Medical condition which, in the Investigator's judgement, makes the subject ineligible or places the subject at undue risk
k. Participation in any patch test for irritation or sensitization within the last four weeks or known sensitization to adhesives. Current participation in any clinical testing, including other studies being conducted at Hill Top Research, Inc.
l. Damaged skin in or around test sites which include sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles or other disfiguration of the test site - Controls:
- Distilled water or 0.1% dilution (w/v) sodium lauryl sulfate in distilled water
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test, modified Draize)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: nonwoven cotton pad (Webril®) covered by and secured on all sides by hypoallergenic tape (BlendermTM)
- Vehicle / solvent: distllled water
- Concentrations: 0.1% or 0.5% (w/v)
- Volume applied: 0.2 mL
- Testing schedule:
Induction: three times per week for three weeks, each exposure approximately 24 hours
Rest period: 10 to 17-days
Challenge: 24 hours exposure to a naive site
- Removal of test substance: wipe the patch sites with water to remove any residual test material (subject instructions) .
EXAMINATIONS
- Grading/Scoring system: Inflammatory Responses: 0, +, 1, 2, 3; Superficial Effects (glazing, peeling, scab, dried film of serous exudate, hyperpigmentation, hypopigmentation, fissuring, additional comments)
- Statistical analysis: not performed
Results and discussion
- Results of examinations:
- Under the conditions of this study, the test article does not appear to exhibit the potential for contact sensitization at either test concentration. In addition, the test article did not appear to cause significant irritation potential during the three week induction period or during the challenge phase of the study.
Applicant's summary and conclusion
- Conclusions:
- Not sensitizing
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