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Diss Factsheets
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EC number: 273-453-7 | CAS number: 68966-86-9
- 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:
- 25 March 2013 - 3 May 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- A skin sensitiser is an agent that will lead to an allergic response in susceptible individuals following skin contact. Human experimental studies are not recommended to fulfil REACH Annex VII information requirements. However, all existing available information should be evaluated, including any available human data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- other: Human Repeat Insult Patch Test in volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Guideline E6
- Principles of method if other than guideline:
- Study was conducted according to CPTC procedure CP-01.01S
- GLP compliance:
- no
- Remarks:
- Good Clinical Practice (GCP)
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- 111 qualified subjects, male and female, ranging in age from 16 to 78 years, were selected for evaluation and 107 completed the study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material
- Clinical history:
- INCLUSION CRITERIA:
- male and female subjects aged 16 and over
- absence of visible skin disease
- prohibition of use of topical systemic steroids and/or antihistamines for 7 days prior to study initiation (acclimatisation)
- complete medical history and informed consent
- considered reliable and capable of following directions
EXCLUSION CRITERIA:
- ill health
- receiving medical attention which could influence the outcome of the study
- females who are pregnant or nursing
- a history of adverse reactions to topical ointments - Controls:
- Subjects acted as their own control i.e. challenge control was the untreated skin
- Route of administration:
- dermal
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9 applications
- Site: upper back between the scapulae
- Frequency of applications: 0.2ml of test material was applied three times per week for a total of nine applications
- Exposure period: 24 hours (9 x 24 hour exposure)
- Rest periods: 24-48 hours
- Duration: 3 weeks
- Concentrations: 4% test substance in EtOH/DEP solution
B. CHALLENGE EXPOSURE (two weeks after the final induction patch application)
- No. of exposures: one
- Exposure period: 24 hours
- Site: virgin test site adjacent to induction exposure sites on the upper back between the scapulae
- Concentrations: 4% test substance in EtOH/DEP solution
- Evaluation (hr after challenge): 24 and 72 hours post-application
Results and discussion
- Results of examinations:
- The observations for each participant remained negative throughout the test interval
Applicant's summary and conclusion
- Conclusions:
- The human repeated insult patch test (HRIPT) is a confirmatory test in the safety evaluation of skin sensitisers, that can substantiate no-effect levels and ensure that matrix effects are not making an unexpected contribution to sensitising potency. HRIPT demonstrated that the test item does not have the potential to irritate or sensitise the dermis in 107 human participants. No adverse events were observed.
- Executive summary:
Human Repeat Insult Patch Test (HRIPT) aims to determine sensitisation potential via repeat epidermal contact induction phases and latent challenge. Small quantities (0.2ml) of test material were applied to occlusive patches of 3/4" absorbent pads in adhesive dressing between the scapulae on the upper back and sealed with a hypoallergenic adhesive tape. Signs of irritation were recorded by a dermatologist at 48 and 72 hours, following 9 applications with 24-48 hour rest periods.
No adverse events effects were observed in 107 participants following a 24-hour challenge test, subsequent to an induction phase of nine 24 hour applications (0.2ml of 4% test material in DEP/EtOH). No adverse events were observed and the test item did not demonstrate potential to irritate or sensitise the dermis in human participants.
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