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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 irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- Adequate data from a clinical study on volunteers show the substance is not irritation for the skin. See end-point 7.10.5
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- exposure-related observations in humans: other data
- Remarks:
- other data Human single patch test using generally accepted methods
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- Human single patch test using generally-accepted methods
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Type of study / information:
- Acute skin tolerance on volunteers
- Endpoint addressed:
- skin irritation / corrosion
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Skin irritation potential of the test item was studied in volunteers using 48 hour single patch test and skin reactions were evaluated.
- GLP compliance:
- no
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- Volunteers of the demale or male sex from 18 to 65 years of age, with a normal skin , without any dermatological lesion on the experimental area shoul be included in the study
- Exposure assessment:
- measured
- Details on exposure:
- Single application of 0.02 mL of the studied test item, on the outer forearm and the back, a control patch without product was simultaneous applied, maintained for 48 h in contact with the skin, with the help of an occlusive patch (Haye's-Chambers).
Exactey 48h after, patches were removed and the areas rinsed with distilled water. After 30 mins, the dermatologist examination was conducted in daylight. - Results:
- 21 volunteers were included in the study : 19 women and 2 men. Mean age : 34 years. After 48 hours of application, two skin reaction were observed on the treated site and none on the control site. The mean irritation index was 0.07. The test item was considered as non-irritant.
- Conclusions:
- 21 volunteers were included in the study : 19 women and 2 men. Mean age : 34 years. After 48 hours of application, two skin reaction were observed on the treated site and none on the control site. The mean irritation index was 0.07. The test item was considered as non-irritant.
- Executive summary:
In a single patch test, 21 volunteers (men and women) from 19 to 56 years of age, with a normal skin, without any dermatological lesion on the experimental area, have been included in the study. Single application of 0.02 mL of the test item, on the outer forearm and the back, maintained for 48 h in contact with the skin, with the help of an occlusive patch (Haye's-Chambers).
After 48 hours of application, two skin reaction were observed on the treated site and none on the control site. The mean irritation index was 0.07. The test item was considered as non-irritant under the conditions employed in the study.
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.
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.