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Diss Factsheets
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EC number: 944-405-9 | 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
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Endpoint summary
Administrative data
Description of key information
The test substance, FRET 13-0156, was considered to be non-corrosive to the skin in an In vitro EPIDERM skin corrosion test, but is classified as a dermal irritant according to an EPISKIN reconstructed human epidermis model.
A BCOP study determined that no prediction of eye irritation due to the test material can be made, BUT ocular effects were seen in rabbits (OECD 405 test), including diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation, which were fully reversible within 14 days. The results showed that the substance is an ocular irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
A study was performed to assess the corrosion potential of the test material to the skin using the EPIDERM model. The method used was OECD Guideline 431: In vitro Skin Corrosion: Reconstructed Human EpiDermis (RHE) Test Method. The percentage viability of the test item was 104.0 after 3 minutes exposure, and 77.0 after 60 minutes exposure.
A study was performed to assess the irritantcy potential of the testmaterial to the skin using the EPISKIN model. The method used was OECD 439. The relative mean viability of the test item treated tissues was 4.2% after the 15 Minute exposure period and 42 Hours post‑exposure incubation period. The quality criteria required for acceptance of results in the test were satisfied.
A study was performed to assess the potential of the test material to induce serious eye damage and to identify if classification for eye irritation or serious eye damage was required. The method used was OECD 437 "Bovine Corneal Opacity and Permeability Assay".
The substance was tested in an eye irritation test in rabbits according to OECD 405. Ocular effects included diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation, which were fully reversible within 14 days. The results showed that the substance is an ocular irritant.
Reliability:
The above studies have all been raanked Reliability 1 according to the Klimisch et al system. The ranking was deemed appropriate as the studies were conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies which do not affect the quality of relevant results.
Justification for classification or non-classification
The test material did not meet the criteria for classification as corrosive to the skin according to the EU labelling regulations during an EPIDERM study, but did meet the criteria for classification as a dermal irritant during an EPISKIN study. The following classification criteria apply:
EU CLP and UN GHS Hazard statement H315 “Causes Skin Irritation” Category 2.
In the BCOP eye irritation study, the In vitro eye irritation score as 18.5, meaning that no prediction of eye irritancy can be made.
Based on the positive results in the rabbit eye irritation test (OECD 405) the substance needs to be classified as an eye irritant. According to EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 this results in classification as 'Irritating to eyes (Category 2), "H319: Causes serious eye irritation".
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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