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Diss Factsheets
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EC number: 283-619-0 | CAS number: 84695-99-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Castanea sativa, Fagaceae.
- 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:
- July - August 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Remarks:
- Human Repeat Insult Patch Test using generally-accepted methods, performed according to Good Clinical Practice
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Repeated Insult Patch Test was performed to confirm that repeated applications of the product under maximized conditions, in healthy subjetcs, does not induce delayed contact allergy reactions. A secondary objective is to determine the irritating potential of the product first after a single application and second after repeated applications.
- GLP compliance:
- no
- Remarks:
- study has been conducted in the spirit of the good Clinical Practice
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Subjects:
- Number of subjects empanelled: 56
- Number of subject satisfactorili completed the test procedure: 50
- Sex: 44 Females; 6 Males
- Age: 18-64 years
- 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. - Clinical history:
- None
- Controls:
- Patch containing no product was applied to serve as a non-treated control.
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: Total occlusive
- 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 scapulae 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.
Frequency: Induction phase: 3 times a week during 48 h; Challenge phase: once during 48 h
Duration: Induction phase: 3 weeks; Rest phase: 2 weeks; Challenge phase: 1 week
Challenge phase: After a rest period of 2 weeks (no applications of the test article), the Challenge patch was applied to a previously unpatched (virgin) and patched (inductor) test site.
- Removal of test substance: Application site was scored 30 minutes, 24 and 48 h after removal.
EXAMINATIONS
- Grading/Scoring system:
Induction phase: after each application, the patch is removed and the clinical examination is performed by the investigatior later in order to eliminate the pressure and the occlusion effects. The results of examination is negative if the skin loks normal. The following criteria are evaluated by the dermatologist according to a quotation from 0 to 3:
0 = absence : normal aspect
1 = slight (Erythema: Slight pinkish colour of all tested surface or visible on only part of this surface, Oedema: more palpable than visible, Dryness: subtile desquamation, frosted aspect, Vesicles: more palple than visible)
2 = Marked (Erythema: marked erythema covering all tested surface, Oedema: visible, Desquamation: visible, scally aspect, Vesicles:visible)
4 = Severe (Erythema: intense erythema covering all tested surface, Oedema: Cover more than all tested surface, Desquamation: important desquamation, cracking, Vesicles: vesicles covering more than all tested surface or blisters)
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):
0 = Negative, no reaction
? = Doubtful reaction
+ = Erythema and oedema
++ = Erythema, oedema and vesicles
+++ = severe reaction with blisters - Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
4 volunteers suffered irritations during the induction phase, but the study continued without problem throught to the challenge phase
no volunteers demonstrated slight skin reations resulting irritation. - 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 56 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.
No reaction were observed during the challenge phase.
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".
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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