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Diss Factsheets
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EC number: 291-063-5 | CAS number: 90320-37-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Prunus amygdalus sativa, Rosaceae.
- 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
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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:
- 2014
- 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 Repeat Insult Patch Test using generally-accepted methods
- 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
- Specific details on test material used for the study:
- Tested diluted at 15% in water
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- 110 healthy subjects were selected according to the inclusion and non-inclusion criteria, and 107 subjects completed study
- Controls:
- Patch without product
- Route of administration:
- dermal
- Details on study design:
- ADMINISTRATION
- Type of application: occlusive
- Application area: Scapular zones: homolateral (Induction site) and contralateral (challenge site)
- Description of patch: Finn's chamber occlusive (8 mm) (50 mm²)
- Volume applied: 25 μL
The studied product was applied to a cleansed (with physiological saline or water) and dry skin.
- Application frequency:
Induction phase: 3 times a week during 48 hours (72 h for the week-end)
Challenge phase: once during 48 hours
- Study schedule:
Induction phase: 3 weeks
Rest phase: 2 weeks
Challenge phase : 1 week
EXAMINATIONS
After each application, the patch is removed and the clinical examination is performed by the investigator 30 minutes later in order to eliminate the pressure and the occlusive effects. The resulf ot the examination if negative if the skin looks normal. The clinical examination is made on the back using the following criteria and scale:
Clinical criteria regarding the irritating potential (induction phase)
- Grading/Scoring system:
0 = No erythema, no edema
0.5 = very slight = erythema: barely perceptible: pinkish coloration of one part of the tested area and palpable and barely visible edema
1 =Slight = erythema: pinkish coloration of the complete tested area or rather visible on one part of the tested area, and palpable and visible edema
2 =obvious = obvious erythema covering the whole tested arean and obvious edema (thickness <1mm) with or without blister or vesible
3 = important = severe erythema covering all the tested area or obvious erythema diffusion outside the tested area, and severe edema (thickness > 1mm of diffusiong outside the tested area) with our without vesicle or blister.
Clinical criteria regarding the sensitizing potential ( challenge phase), the occurrence of allergic reactions was assessed according to the following scale:
Absence of reaction: ICDRG (International Contact Dermatitis Research Group) quotation : 0, numetic score quotation: 0
Doubtful reaction: ICDRG (International Contact Dermatitis Research Group) quotation : ?, numetic score quotation: 0.5
Erythema and edema: ICDRG (International Contact Dermatitis Research Group) quotation : +, numetic score quotation: 1
Erythema, edema and vesicles: ICDRG (International Contact Dermatitis Research Group) quotation : ++, numetic score quotation: 2
Severe reaction with blister or post-blisters ulcerations: ICDRG (International Contact Dermatitis Research Group) quotation : +++, numetic score quotation: 3
A score superior or equal to 2 represents a contact allergy - Results of examinations:
- under these study conditions, the test item shows a score 0.01. It canthus be considered as non-irritating.
- Conclusions:
- Under these study conditions, the product can be considered non-irritating and non-sensitizing
- Executive summary:
A panel of 110 male and female human volunteers participated in a repeat insult patch test in which a test product applied to the back of the subjects under occlusive patches. 107 subjects completed the study.
During the induction or challenge phase, no skin reactions were observed. The test item showed a score of 0.01. It can thus be considered as non-irritating.
No reaction ++ nor +++ was observed, so the product can be considered as non-sensitizing.
Under these study conditions, the product can be considered non-irritating and non-sensitizing
At the end of the 9 readings of the induction phase, the average score of each subject (Cumulative irritation index CII) is calculated by adding the scores obtained for each readings and by dividing this sum by the actual number of readings.
The irritating potential of the product is estimated by calculating the mean of the reactions observed during the induction phase in order to obain the Mean cumulative Irritation Inde (MCII). the obtained index allows to arbitrarily classify the studied product according to the following scale:
M.C.I.I. |
Classe |
M.C.I.I. < 0.25 |
Non irritating (NI) |
0.25 ≤M.C.I.I. < 0.50 |
Very slightly irritating (VSI) |
0.5≤ M.C.I.I. < 1 |
Slightly irritating (SI) |
1 ≤M.C.I.I. < 2 |
Moderately irritating (MI) |
M.C.I.I. ≥2 |
Irritating (I) |
Challenge phase:
A possible reaction during the induction or challenge phase is assessed from 0 to 3 according to ICDRG (International Contact Dermatitis Research Group). During the Challenge phase, the reading is done 30 minutes after patch-tests removal and 48 hours later. The sensitizing potential of the product is assessed by the readings on D37 and D39 according to the following criteria reaction++ or +++ in the absence of added irritation phenomenon. The presence of only one case of active sensitization or controlateral side leads to the conclusion "Potentially sensitizing product".
Under these study conditions, no reaction ++ nor +++ was observed, so the test item can be considered non sensitizing.
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.
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