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EC number: 203-881-1 | CAS number: 111-55-7
- 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, rabbit: not irritating
Read across from structural analogue source substance propane-1,2-diyl diacetate (CAS 623-84-7).
eye irritation, rabbit: not irritating
Data obtained with the registered substance and read-across from structural analogue source substance propane-1,2-diyl diacetate (CAS 623-84-7).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all 5 animals
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: skin injury, no effect observed at 0.01 mL, Source CAS 623-84-7
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 5 animals
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: skin injury, no effect observed at 0.01 mL, Source CAS 623-84-7
- Interpretation of results:
- other: inconclusive
- Executive summary:
The skin irritation / corrosion potential of the target substance is estimated based on an in vivo study of structural analogue source substances propane-1,2 -diyl diacetate (CAS 623-84-7). 0.01 mL of the undiluted test substance was applied to the shaved bellies of 5 rabbits for a period of 24 h under open conditions. No skin irritation was observed up to 24 h after exposure. As only a tenth of the dose used according to OECD guideline 404 was applied and no scoring was performed, the study does not fulfill standard requirements which are sufficient for hazard assessment. However, the available study on acute dermal toxicity from the read-across source substance propane-1,2 -diyl diacetate (CAS 623-84-7) does not indicate skin irritation or corrosion up to the limit dose level (see Acute toxicity). As explained in the analogue justification, the differences in molecular structure between the target and the source substance are unlikely to lead to differences in the skin irritation / corrosion potential. Therefore, the target substance is also considered to exhibit no significant skin irritating properties.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: Source: CAS 623-84-7
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: Source: CAS 623-84-7
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: Source: CAS 623-84-7
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: Source: CAS 623-84-7
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Executive summary:
The eye irritation potential of the target substance is estimated based on adequate and reliable in vivo studies of structural analogue source substances propane-1,2 -diyle diacetate (CAS 623-84-7). The undiluted test item was applied to the eyes of three female rabbits. The eyes were observed and reactions were evaluated 1, 24, 48 and 72 h after application. No effects on cornea, iris and no conjunctival redness were observed in any animal during the study period. No further local or systemic effects were reported. As explained in the analogue justification, the differences in molecular structure between the target and the source substance are unlikely to lead to differences in the eye irritation potential. Therefore, the target substance is also considered to exhibit no significant eye irritating properties.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
There are no data on skin irritation available for ethylene diacetate. Thus, a read across was performed from the structurally related substance propane-1,2-diyl diacetate (CAS 623-814-7). In a non-GLP study 0.01 mL of the undiluted test substance was applied to the shaved bellies of 5 rabbits for a period of 24 h under open conditions (Union Carbide Corporation, 1965). No skin irritation was observed up to 24 h after exposure. However, only a tenth of the dose used according to OECD guideline 404 was applied and no scoring of skin reaction was performed. Therefore, the study did not meet important criteria of today's standard methods and was thus not taken into account for hazard assessment.
However, the available study on acute dermal toxicity from the read-across source substance propane-1,2-diyl diacetate (CAS 623-84-7) does not indicate skin irritation or corrosion up to the limit dose level (refer to IUCLID section 7.2, acute toxicity). Therefore, the substance is considered to be not irritating to skin.
Eye irritation
A publication with limited data investigating the eye irritation properties of ethylene diacetate (CAS 111-55-7) is available. The eye irritation properties of ethylene diacetate were tested in a non-guideline in vivo study (Carpenter, 1946). In groups of 5 albino rabbits (no further information given), 0.5 mL 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 the test substance were added together and then divided by the number of eyes to obtain a 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 0.5 mL of undiluted ethylene diacetate resulted in a calculated score of ≥ 0 to ≤ 1 out of five eyes after 18-24 h corresponding to the lowest injury grade of the test.
In order to fulfil the standard information requirement, read-across from the structurally related analogue substance propane-1,2-diyl diacetate (CAS 623-84-7) is conducted. The eye irritation properties of propane-1,2-diyl diacetate were tested in a study according to OECD guideline 405 under GLP conditions (Hazleton, 1984). In a group of 3 female rabbits (New Zealand White), 0.1 mL of the undiluted test substance was applied into one eye. The eyes were observed and reactions were evaluated 1, 24, 48 and 72 h after application. No effects on cornea, iris and no conjunctival redness were observed in any animal during the study period. No further local or systemic effects were reported.
Under the experimental conditions described, it was concluded, that no evidence of eye irritation properties were seen after treatment with propane-1,2-diyl diacetate.
Conclusion
In conclusion, ethylene diacetate (CAS 111-55-7) is considered to be not irritating to the skin based on read-across data for acute dermal toxicity (refer to IUCLID section 7.2, acute toxicity). One study from ethylene diacetate and one study from the structurally related source substance propane-1,2-diyl diacetate (CAS 623-84-7) did not show eye irritation properties.
Based on this result, no skin or eye irritation potential for ethylene diacetate (CAS 111-55-7) was identified.
Justification for classification or non-classification
Based on read-across from the source substance propane-1,2-diyl diacetate (CAS 623-84-7) and substance specific data on ethylene diacetate (CAS 111-55-7), the available data on skin and eye irritation properties do not meet the criteria for classification according to Regulation (EC) No. 1272/2008. The data are therefore conclusive but not sufficient for classification.
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