Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 816-845-0 | CAS number: 1818326-42-9
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From 6 January 2016 to 12 February 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The method is modified to test 50 panelist and not 200 required in Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, published by the Association of Food and Drug Officials. The method also employs nine inducting patching and not ten
- Deviations:
- not applicable
- Principles of method if other than guideline:
- 0.2 ML of the diluted test item (10% in corn oil) was dispensed onto the occlusive, hypoallergenic patch. The patch was applied directly to the skin of the infracapsular regions of the back to the right or left of the midline and the subject was dismissed with instructions not to wet or expose this area to direct sunlight. After 24 hours the patch was removed by the panelist at home. This procedure was repeated until a series of nine consecutive 24 hours exposures have been made for every Monday, Wednesday and Friday for three consecutive weeks. In the event of adverse reaction, the area of erythema and edema is measured. The edema is estimated by the evaluation of the skin with respect to the contour of the unaffected normal skin. Reactions are scored just before applications two through nine and the next test date following application nine. Subject were then given 10-14 day rest period after which a challenge or retest dose was applied once to a previously unexposed site. The retest dose is equivalent to any one of the original nine exposures. Reactions are scored 24 and 48 hours after application. Comparison was made between the nine inductive responses and the retest dose.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 1818326-42-9
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: supplied by the sponsor, Lot #CB 15026
- Expiration date of the lot/batch: not detailed
- Purity test date: not detailed
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not detailed
- Stability under test conditions: not detailed
- Solubility and stability of the test substance in the solvent/vehicle: not detailed
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: diluted in corn oil
- Preliminary purification step (if any): not specified
- Final dilution of a dissolved solid, stock liquid or gel:10 % in corn oil
FORM AS APPLIED IN THE TEST (if different from that of starting material)
diluted in corn oil and applied in the patch
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 54
- Sex: Male and Female
- Age: 18-70
- Race: Caucasian ; Hispanic ; Asian ; African American
- Demographic information: not detailed
- Clinical history:
- - History of allergy or casuistics for study subject or populations: Individuals with chronic allergies were excluded
- Symptoms, onset and progress of the disease: Individuals who were under doctor's care were excluded
- Exposure history: Individuals with a history of an acute or chronic disease that may have interfered with or increased the risk of study participation were excluded
- Aggravating factors both in home and workplace: not specified
- Family history: not specified
- Medical history (for respiratory hypersensitivity): Individuals who were currently taking any medication (topical or systemic) that may have masked or interfered with the test results were exluded from the study
- Any other allergic or airway disorders: Individuals with chronic allergies were excluded
- Smoking history: not specified - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch ; Parke-Davis Hypoallergenic Readi Bandages (20x20cm Webril affixed to the center of a 40x40 mm adhesive bandage) or the equivalent
- Vehicle / solvent: corn oil
- Concentrations: 10%
- Volume applied: 0.2 mL
- Testing/scoring schedule: At the moment of the application of the second patch through the nine, and the next date following application none
- Removal of test substance: after 24 hours
EXAMINATIONS
- Grading/Scoring system: Not detailed
- Statistical analysis: Not detailed
Results and discussion
- Results of examinations:
- No adverse reactions of any kind were noted during the course of this study
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of the study, the test item HydraSynol was considered as a Non-Primary Irritant and a Non-Primary Sensitizer.
- Executive summary:
This non-GLP compliant study was perform in order to investigate a potential irritation property or sensitizing property of the HydraSynol IDL on human based on an Human Repeated Insult Patch Test method (HRIPT).
54 subjects were used in this study. 0.2 ML of the diluted test item (10% in corn oil) was dispensed onto the occlusive, hypoallergenic patch. The patch was applied directly to the skin of the infracapsular regions of the back to the right or left of the midline and the subject was dismissed with instructions not to wet or expose this area to direct sunlight. After 24 hours the patch was removed by the panelist at home. This procedure was repeated until a series of nine consecutive 24 hours exposures have been made for every Monday, Wednesday and Friday for three consecutive weeks. In the event of adverse reaction, the area of erythema and edema is measured. The edema is estimated by the evaluation of the skin with respect to the contour of the unaffected normal skin. Reactions are scored just before applications two through nine and the next test date following application nine. Subject were then given 10-14 day rest period after which a challenge or retest dose was applied once to a previously unexposed site. The retest dose is equivalent to any one of the original nine exposures. Reactions are scored 24 and 48 hours after application. Comparison was made between the nine inductive responses and the retest dose.
No adverse reactions of any kind were noted during the course of this study
Under the experimental conditions of the study, the test item HydraSynol was considered as a Non-Primary Irritant and a Non-Primary Sensitizer.
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.