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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 601-141-6 | CAS number: 111937-03-2
- 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:
- key study
- Study period:
- 11 - 15 Oct 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test procedure comparable to national standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
- Type of study / information:
- Epicutaneous Patch Test - Single Application 24 h Patch Test according to COLIPA.
- Endpoint addressed:
- skin irritation / corrosion
- Principles of method if other than guideline:
- The trial was based on the method described by Frosch and Kligman (Frosch et al., 1979) and conducted according to the protocol "Single Application 24 h Patch Test" of the sponsor.
- GLP compliance:
- yes
- Remarks:
- GCP Compliance
Test material
- Reference substance name:
- Isononanoic acid, C16-18 (even numbered)-alkyl esters
- EC Number:
- 601-141-6
- Cas Number:
- 111937-03-2
- Molecular formula:
- Unspecified
- IUPAC Name:
- Isononanoic acid, C16-18 (even numbered)-alkyl esters
- Details on test material:
- - Name of test material (as cited in study report): isononanoic acid, C16-18-alkyl ester
- Physical state: colourless liquid
- Analytical purity: no data
- Storage condition of test material: at room temperature
- Expiration date of the lot/batch: 04 Oct 2000
Constituent 1
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: 20
- Sex: 9 female, 11 male
- Age: 21.7-70.7 years (range); 44.5 ± 13.1 years (mean ± SD)
- Type of application: occlusive
- Concentrations: 20% and undiluted test substance
- Exposure duration: 24 h - Exposure assessment:
- not specified
- Details on exposure:
- TYPE OF TEST: patch test (epicutaneous test)
ADMINISTRATION
- Site: intact back skin, on the left and right side of the spine
- Description of patch: 1.1 cm²
- Vehicle / solvent: ethanol
- Volume applied: 75 µL
- Testing/scoring schedule: the skin was examined 6, 24, 48 and 72 hours after patch removal
- Removal of test substance: after 24 hours exposure any test substance residues were carefully removed with a tissue paper
- Other: at least 5 days before start of the study any kind of UV-exposure and treatment with leave-on products on the patch sites had been avoided
EXAMINATIONS
- Grading/scoring system: equivalent to the Draize scoring system (erythema, edema, maximum grade 4); squamation and fissuration were also graded
- Other: lightening of the test room was standardised by illumination with 2 day-light neon tubes (Osram L58W/12) installed vertically on a wall at a distance of approximately 70 cm between the tubes
Skin gradings were performed double-blind; the visual scoring was performed without knowledge of the code of the material (other test substances were tested in parallel)
CONTROLS:
1. Vehicle only: ethanol
2. Texapon N28 (1% AS)
3. SDS 0.5%
OTHER:
The product was applied to the patch sites by using FinnChamber on Scanpor plasters with an application are of 1.1 cm². The protective film was removed from the plaster and 75 µL (or the equivalent) of the test solution was applied in the aluminium capsule using a pipette. A filter paper disk was used as a carrier. Plasters were attached to the clean, dry and intact back skin of the volunteers.
Results and discussion
- Results:
- Following dermal application of 20% and undiluted test substance preparations, no skin irritations were observed (see attached tables).
Applicant's summary and conclusion
- Conclusions:
- Single dermal exposure for 24 hours under occlusive conditions to the test substance at 20% concentration or as 100% undiluted product did not result in skin reactions. According to EU classification criteria, no classification for skin irritation is required.
CLP: not classified
DSD: not classified
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.