Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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Diss Factsheets
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EC number: 700-590-6 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- other: Human volunteer patch test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 04/09/2007 and 05/14/2007.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to guideline and to GCP and adequately reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- To determine the test substance’s skin irritating and sensitizing potential, a Human Repeat Patch Test was conducted on 119 volunteers, following the prodedure described in Protocol-ISM 059.NOV. The regimen called for four 24-h applications of the sample conducted seriatim during each of Weeks Nos. 1, 2, 3 and 7 on assigned skin sites on the right upper arm of each subjects. Clinical adverse effects were recorded. The test regimen was conducted under double blind conditions.
- GLP compliance:
- yes
Test material
Constituent 1
Test animals
- Species:
- other: Human
- Details on test animals or test system and environmental conditions:
- Panel Information - Demographic
Sex Number Age Range
Female 87 18-81
Male 33 18-63
Site Information
Site O6 Site N6 Site M6 SiteL 6
challenge application 2nd alternative site for initial phase 1st alternative site for initial phase 1st site to be exposed
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: The skin around the site in current use was freshly marked at each visit. The marks made it possible for the technicians to locate the site for grading in the absence of the device or other distinguishing features
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- The webril pa of a pathing device was infused with 150 ul of the test material
- Duration of treatment / exposure:
- 24 h/exposure
- Number of animals:
- 119
- Details on study design:
- Application
Initial / Induction Phase:
Week 1: Monday, Tuesday, Wednesday, Thursday
Week 2: Monday, Tuesday, Wednesday, Thursday
Week 3: Monday, Tuesday, Wednesday, Thursday
Week 4: Hiatus, make up
Challenge/Diagnostic Phase:
Week 5: Monday, Tuesday, Wednesday, Thursday
Examination
Initial / Induction Phase:
Week 1: Monday (baseline), Tuesday, Wednesday, Thursday, Friday
Week 2: Monday, Tuesday, Wednesday, Thursday, Friday
Week 3: Monday, Tuesday, Wednesday, Thursday, Friday
Week 4: Hiatus, make up
Challenge/Diagnostic Phase:
Week 5: Monday, Tuesday, Wednesday, Thursday, Friday
Week 6: Monday as needed.
For detailed regimen, see attachement.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: clinical observations
- Basis:
- other: cohort study
- Time point:
- other: week 5
- Score:
- ca. 0
- Reversibility:
- other: No adverse effect observed
- Other effects:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test substance was found to be devoid of clinically significant skin-irritating properties that can be detected under the conditions of this patch test procedures.
- Executive summary:
The test substance was submitted for a patch test to determine the sample's irritating and sensitizing potentials. A procedure based on that described in Protocol-ISM 059.Nov was followed, and 119 qualified volunteers was jointed the test initially.
The regime called for four 24-h application of the sample conducted seriatim during each of weeks Nos 1, 2, 3, and 7 on assigned skin sites o the right upper arm of each subject.
Examinations of the contacted skin and grading of its condition were conducted within moments after devices containing the sample were removed.
Weeks 1, 2, 3, and 4 formed the Initial or Induction phase of the regimen. Data were acquired on 119 subjects during this phase. No clinically significant adverse effects were detected on any of the subjects during this phase.
The challenge or diagnostic phase of the regimen was conducted during week 5. Data were acquired on 114 subjects during this phase. No clinically significant adverse effects were detected on any of the subjects during this phase.
Therefore, the test substance was found to be devoid of clinically significant skin-irritating properties that can be detected under the conditions of this patch test procedures.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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