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Diss Factsheets
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EC number: 607-053-4 | CAS number: 223751-74-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- A clinical study on human volunteers show that the substance has no skin sensitization potential. See end-point 7.10.4
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 2006 - January 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Qualifier:
- according to guideline
- Guideline:
- other: Method of Marzulli-Maibach
- Deviations:
- no
- Principles of method if other than guideline:
- Repeated Insult Patch Test was performed to determine the irritation and/or sensitization potential of the tested product after repeated topical application under occlusive patch test conditions to the skin of human subjects with all type of skin.
- GLP compliance:
- yes
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Subjects:
- - Number of subjects empanelled: 58
- Number of subject satisfactorili completed the test procedure: 58
- The subjects chosen were dependable and able to read and understand instructions. The subjects
did not exhibit any physical or dermatological condition that would have precluded application of the
test article or determination of potential effects of the test article. - Controls:
- Patch containing no product was applied to serve as a non-treated control
- Route of administration:
- dermal
- Details on study design:
- - Application area: The back: homolateral (Induction site) and contralateral (challenge site)
- Description of patch: Haye's chamber occlusive patch
- Vehicle / solvent: No data
- Concentrations: pure
- Volume applied: 25 μL
- Testing schedule:
Induction phase: A sufficient amount of the tested product to cover the surface of the patch was placed into a Haye's chamber occlusive patch and applied to the back of each subject between the sc
apulae and waist, adjacent to the spinal mid-line. This procedure was performed by the investigator and repeated every Monday, Wednesday and Friday until 9 applications. the subjects were instructed to remove patch 48h after application on Sundays.
The subjects returned to test facility and the patch was removed each Tuesday and Thursday then the site was coped by the investigator just prior to the next patch application.If subject developed a positive reaction of a level 2 erythema or greater during the Induction phase or if, at the discretion ofthe investigator, the skin response warranted a change in site, the patch was applied to a previously unpatched, adjacent site for the next application. If a level 2 reaction or greater occurred at the new site, no further applications were made. However, any reactive subjects were subsequently Challenge patch tested.
Challenge phase:
After a rest period of 2 weeks (no application of the test article), the Challenge patch was applied to a previously unpatched (virgin) and patched (inductal) site. The site was scored 30 minutes, 24 and 48 hours after the removal. All subjects were instructed to report any delayed skin reactivity that occurred after the final Challenge patch reading.
EXAMINATIONS
- Grading/Scoring system:
Induction phase: Dermal responses for the Induction phase of the study were scored according to the
following scale:
- = No evidence of any effect
1 = Mild (Pink, uniform erythema covering most of the contact site)
2 = Moderate (Pink-red erythema uniform in the entire contact site)
3 - Marked (Bright red erythema with/ without petechiae or papules)
4 = Severe (Deep red erythema with/ without vesiculation or weeping)
All other observed dermal sequelae (eg. oe, dryness, hypo or hyperpigmentation) were appropriately
recorded on the data sheet and described as mild, moderate or severe.
Challenge phase: Dermal responses for the Challenge phase of the study were scored according to the following criteria of I.C.D.R.G. (the International Contact Dermatitis Research Group):
- = Negative
+? = Doubtful reaction a (Slight erythema)*
+ = Weak (non-vesicular) reaction**
++ = Strong (oedematous or vesicular) reaction
+++ = Extreme (bullous or ulcerative)***
NT = Not tested
IR = Irritant reaction of different types
* ?+ is a questionable faint or macular (non-palpable) erythema and is not interpreted as proven allergic reaction
** + is a palpable erythema, suggestive of a slight oedematous reaction
*** From coalescing vesicles - Results of examinations:
- - Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 58; There were no responses to any subject during the induction phase and the challenge phase. - Conclusions:
- Under the conditions employed in this study, the test item did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis. The test item can be considered as "hypoallergenic".
- Executive summary:
A panel of 58 men and women human volunteers participated in a repeat insult patch test in which a test item applied as such, to the back of the subjects under occlusive patches. 58 subjects completed the study. During the induction phase 9 patches were applied, separated by a 48 h interval. The patches were removed 48 h after application.
Following 2 weeks rest period, a challenge patch was applied and the sites scored 30 minutes, 48 and 72 h after application.
No reaction were observed during the induction and the challenge phases.
Under the conditions of a repeated insult (occlusive) patch test procedure conducted in a panel of 58 subjects, with all type of skin, the product was "Dermatologist-tested" and did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis. The test item can be considered as "hypoallergenic".
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.
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