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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 943-154-2 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
Eye irritation, Eye Irritection assay, H318: Causes serious eye damage
Skin irritation, Dermal Irritection assay, slight irritant. Overall assessment, not irritant
Key value for chemical safety assessment
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study following in-vitro guideline under validation
- Principles of method if other than guideline:
- Ocular Irritection Assay System (refinement of the former Eyetex method)The system evalutes the ocular hazard effects of test chemicals based on the premise that eye irritation and corneal opacity after exposure to rirritating substances is the result of perturbation or denaturation of corneal proteins. The test method maels use of a macromolecular reagent composed of a mixture of proteins and glycoproteins, carbohydrates, lipids and low molecular weight components, which when rehydrated, form an ordered molecular matrix mimicking the structure of the transparent cornea. Irritatn substances produce a turbidity of the reagent by changing both protein conformation and degree of hydration. Changes in the turbidity of the reagent solution caused by the tested material can be quantified by measuring an increase in the light scattering detected at a wavelenght of 405 nm with the help of a spectrometer. The increase in optical density produced by the test material is compared with that prodcued by a set of calibration substances eahc of which having rpeviously estimated in vivo irritancy potential.
- GLP compliance:
- no
- Details on test animals or tissues and environmental conditions:
- Reagent pH before activation: 8.19Reagent pH after activation: 5.98Reagent temperature: 25°CKit Lot Number: 110700
- Amount / concentration applied:
- 1, 5, 10 and 25%
- Duration of treatment / exposure:
- 5h
- Irritation parameter:
- other: opacity
- Remarks on result:
- other: results are reported in the relevant section
- Interpretation of results:
- irritating
- Remarks:
- Migrated informationunder Regulation 1272/2008
- Conclusions:
- The substance was tested for eye irritation potential by means of Ocular Irritection Assay. Under the experimental conditions the substance showed eye irritation properties.
- Executive summary:
The substance was tested for eye irritation potential by means of Ocular Irritection Assay. Doses of 1, 5, 10 and 25 % of the test item were applied to the matrix mimicking the ordered structure of the cornea for 5h. Irritection score were all in the mild range. Under the experimental conditions the substance showed an increase in turbidity and therefore eye irritation properties classified as H319 Category 2.
Reference
Dose | irritation score | |
1 | 14.3 | |
5 | 14.9 | |
10 | 14.5 | |
25 | 14.5 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
In vitro Irritection tests are available for both eye and skin irritation properties (Ricci; 2002) on the substance and on a group of substances that differ from the target substance only for the lenght of the fatty acid in the final structure.
Eye irritation was determined by Ocular Irritection Assay on the substance (and similar substances) with a result as a mild/modearte eye irritant in the Draize score system.
Skin irritation was determined on a similar substance by Dermal Irritection Assay, which resulted as mild skin irritant. However, based on the considerations reported in the attached document and on the read across considerations no skin irritation potential is considered for the substance while eye irritation potential is classified as H318.
Effect level: empty Endpoint conclusion: Adverse
effect observed
Justification for classification or non-classification
The irritative scores determined by the Irritection Assay (dermal and Ocular) classify the substance as H318 and do not classify the substance for skin irritation under Regulation 1272/2008 ( refer to the attached document).
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.