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EC number: 436-690-9 | CAS number: 220727-26-4
- 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:
- supporting study
- Study period:
- 01 Aug 2001 - 17 Jan 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented GCP study meeting basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: 21 CFR Part 312
- Qualifier:
- according to guideline
- Guideline:
- other: 21 CFR Part 50
- Qualifier:
- according to guideline
- Guideline:
- other: 21 CFR Part 56
- Principles of method if other than guideline:
- Repeated Insult Patch Test of Y-15099 in Human Subjects (Modified Draize)
- GLP compliance:
- yes
- Remarks:
- GCP (good clinical practices)
Test material
- Details on test material:
- - Name of test material (as cited in study report): Y-15099
- Physical state: pale yellow liquid
- Analytical purity: 95.8%
- Purity test date: 2001-10-02
- Lot/batch No.: 18244-52
- Storage condition of test material: at room temperature
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 108, but only 98 subjects completed the study
- Sex: Male and female subjects
- Age: 18 - 75 years (mean age 47.9 years)
- Race: The majority of subjects were Caucasian woman - Clinical history:
- Study population inclusion criteria:
- 18 years of age or older, ingeneral good health
- free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, would have interfered with the study results or increase the risk of adverse events
- skin type or race providing the skin pigmentation would allow discernment of erythema
- completion of a patch study medical screening form as well as a medical/personal history form
- consent agreement
Study population exclusion criteria:
- visible skin disease
- systemic or topical drugs or medication interfering with the study
- asthma
- pregnancy/breast feeding
- known sensitivity to silicone, siloxane, silane, or cosmetics, skin care products, or topical drugs as related to the material being evaluated - Controls:
- Positive control sides were treated with sodium lauryl sulfate 0.1% w/v aqueous solution and Texapon K-1296 (Lot No. 15044).
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: standard repeated insult patch test (epicutaneous test) ;
INDUCTION
- Type of application: semiocclusive
- Number of exposures: 9 at 48-hour intervals (= 18-day period). Before each exposure, application sites were evaluated.
- Duration of exposure: 24 hours
- Description of patch: 2 cm x 2 cm Webril pad, fixed with hypoallergenic tape (Micropore).
- Vehicle / solvent: none
- Concentrations: undiluted
- Volume applied: 0.2 mL
- Application site: infrascapular area of the back, either to the right or left of the midline
When the positive control site to assess subject compliance had a grade of +D, application of SLS 0.1% aqueous solution control was discontinued.
CHALLENGE
- Type of application: semiocclusive
- Number of exposures: 1, after a 10-15 day resting period.
- Duration of exposure: 24 hours
- Application site: previously unexposed site
- Evaluation of application site: 24 and 48 hours after application
Compliance control only: material evaluated under occlusive patch conditions was applied to a 2 cm x 2 cm Webril pad attached to a non-porous, plastic film adhesive bandage (3M medical tape). The patch was secured with hypoallergenic tape (Micropore) as needed.
EXAMINATIONS
- Grading/Scoring system: no reaction (.); minimal or doubtful response (?); definite erythema, no edema (+); definite erythema, definite edema (++); definite erythema, definite edema and vesiculation (+++).
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: One subject experienced a serious non-product-related adverse effect.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1
- Number of subjects with negative reactions: 96
- Number of subjects with equivocal reactions: 1
One subject presented evidence of possible sensitization at challenge. Sensitization was confirmed with rechallenge and provocative use.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions employed in this study, there was evidence of sensitization to Y-15099.
- Executive summary:
Y-15099 was evaluated as provided to determine its ability to sensitize the skin of normal volunteer subjects using a semi-occlusive standard repeated insult patch study procedure with nine 24 -hour induction applications and one 24 -hour challenge application. Ninety-eight subjects completed the study.
One subject presented evidence of possible sensitization at challenge. Re-challenge was conducted under semi-occlusive conditions 2 weeks later. Reactions of erythema and oedema with papules were present. Two weeks after completing re-challenge, the subject participated in a Provocative Use phase. Product application was stopped by the subject after 6 applications due to "itching and redness". She was observed the following day and presented erythema and papules spreading beyond the open application area. Sensitization was confirmed with re-challenge and provocative use. Under the conditions employed in this study, there was evidence of sensitization to Y-15099.
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