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EC number: 211-077-7 | CAS number: 629-15-2
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion: corrosive
Eye irritation/corrosion: corrosive
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro skin irritation / corrosion
The potential of Ethylene diformate to cause skin corrosion was evaluated using the EPISKIN™ in vitro Reconstructed Human Epidermis (RHE) model in a study performed according to OECD guideline 431 under GLP conditions (Warren, 2012). Duplicate tissues were treated with the undiluted test substance for 3, 60 and 240 min. Concurrent negative (0.9% sodium chloride solution) and positive (glacial acetic acid) were included for an exposure period of 240 min. Following exposure, the mean tissue viability was determined using the MTT reduction assay and compared to that of the negative control.
The relative mean tissue viability after 3, 60 and 240 min exposure was 92.4, 48.4 and 19.7% of the negative control value. The positive control-treated tissues yielded a relative mean tissue viability of 5.7%.
Based on these results and according to the evaluation criteria of the study, the substance is considered to be corrosive to the skin.
In vivo skin irritation / corrosion
This information is not available.
Based on the available in vitro data, the substance fulfils the criteria for classification as skin corrosive (Category 1B) according to Regulation (EC) No 1272/2008. Therefore, an in vivo skin irritation study does not need to be conducted in accordance with Column 2 of Annex VIII, Section 8.1, of Regulation (EC) No 1907/2006.
In vivo eye irritation / corrosion
Ethylene diformate was tested in an in-vivo study applying different volumes of the undiluted test substance to rabbit eyes (Carpenter, 1946). In groups of 5 albino rabbits (no further information given), 0.005 to 0.02 mL of the undiluted test substance were applied in a single application without washing. The eyes were observed and reactions were evaluated 18-24 h after application. The individual numerical scores of each eye treated with a given volume or concentration of a chemical were added together and then divided by the number of eyes to obtain the score of the injury caused by the treatment. The level of 5 was selected as representative of severe injury. This figure corresponded to necrosis, visible after staining and covering about 3/4 of the surface of the cornea; or a more severe necrosis covering a smaller area. The injury grade, after application of 0.005 mL and 0.02 mL of the undiluted test substance resulted in a calculated score of ≥ 5 out of five eyes after 18-24 h.
Based on these results, along with the available data on skin irritation/corrosion, the substance is considered to be corrosive and to cause irreversible effects on the eye.
Conclusion for irritation/corrosion
Ethylene diformate has been tested for skin corrosion in vitro and for eye irritation/corrosion in vivo. The available data consistently show that the substance is corrosive to the skin and eye, causing irreversible effects on the latter.
Justification for selection of skin irritation / corrosion endpoint:
There is only one study available.
Justification for selection of eye irritation endpoint:
There is only one study available.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Justification for classification or non-classification
The available data on the skin and eye irritating/corrosive potential of Ethylene diformate meet the classification criteria for Skin Corrosive Category 1B (H314: Causes severe skin burns and eye damage) and Irreversible Eye Damage Category 1 (H318: causes serious eye damage) according to Regulation (EC) 1272/2008 and for R34 (Causes burns) according to Directive 67/548/EEC.
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.
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