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Diss Factsheets
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EC number: 802-122-7 | CAS number: 4494-16-0
- 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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 9 - 11 June 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
- Type of study / information:
- Epicutaneous patch test, single application for 48 h
- Endpoint addressed:
- skin irritation / corrosion
- Principles of method if other than guideline:
- A 30% dilution of the test substance was applied to the back skin of human volunteers for 48 h under occlusive conditions. The skin iritation effects were scored according to the Draize scoring system and the study was performed under Good Clinical Practices conditions.
- GLP compliance:
- no
Test material
- Reference substance name:
- 802-122-7
- EC Number:
- 802-122-7
- IUPAC Name:
- 802-122-7
- Reference substance name:
- Octadec-9-enedioic acid
- IUPAC Name:
- Octadec-9-enedioic acid
- Details on test material:
- - Name of test material (as cited in study report): Newdioic 12358
- Physical state: white paste
- Analytical purity: no data
- Batch No.: B1
Constituent 1
Constituent 2
Method
- Ethical approval:
- confirmed and informed consent free of coercion received
- Remarks:
- personal informed consents of the subjects to participate in the study
- Details on study design:
- - Number of subjects exposed: 11
- Sex: 7 female, 4 male
- Age: 18 - 70 years (range); 41 years (mean)
- Type of application: occlusive
- Concentrations: 30% test substance in glycerin
- Exposure duration: 48 ± 4 h
-Other: monocentric randomised clinical study performed open and defined as a non interventional clinical research project according to the French law 2004-806 of 09/08/2004 relating to the policy of public health - Details on exposure:
- TYPE OF TEST: patch test (epicutaneous test)
ADMINISTRATION
- Site: intact back skin
- Description of patch: the test substance was applied to the patch sites by using FinnChamber on Scanpor plasters with an application area of 50 mm². The test solution was applied in the aluminium capsule using a pipette. Plasters were attached to the cleaned, intact back skin of the volunteers.
- Vehicle / solvent: glycerin
- Volume applied: 20 µL
- Testing/scoring schedule: the skin was examined 15 - 30 min after patch removal.
EXAMINATIONS
- Grading/scoring system: equivalent to the Draize scoring system (erythema, edema, maximum grade 4); and dryness, papula, vesicles, bulla, scabs, pruritus, soap effect.
NEGATIVE CONTROL
Water served as the negative control, applied acording to the same protocol as the test substance.
Results and discussion
- Results:
- Single dermal exposure for 48 hours under occlusive conditions to the test substance at 30% concentration did not result in skin reactions in human volunteers.
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.