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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 sensitisation, rabbit (OECD 406, Buehler): not sensitising
Read across from structural analogue source substance propane-1,2-diyl diacetate (CAS 623-84-7).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0% Challenge: 0, 1, 5 and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Source: CAS 623-84-7
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 25% Challenge: 0, 1, 5 and 25%
- No. with + reactions:
- 2
- Total no. in group:
- 19
- Clinical observations:
- Diffuse skin reddening at the skin site exposed to 25% (v/v)
- Remarks on result:
- other: Source: CAS 623-84-7
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0% Challenge: 0, 1, 5 and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Source: CAS 623-84-7
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 25% Challenge: 0, 1, 5 and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Source: CAS 623-84-7
- Group:
- positive control
- Remarks on result:
- other: Source: CAS 623-84-7
- Remarks:
- data lacking
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Executive summary:
The skin sensitisation potential of the target substance is estimated based on an adequate and reliable in vivo study of the structural analogue source substance propane-1,2 -diyl diacetate (CAS 623-84-7). In a Buehler test, guinea pigs were first epicutaneously induced and afterwards epicutaneously challenged with the source substance with an occlusive dressing at concentrations of 25, 5, 1 and 0% (v/v).
Two animals exposed to 25% (v/v) of the source substance propane-1,2 -diyl diacetate (CAS 623-84-7) showed a diffuse skin reddening at the treatment site on Day 29. The effect was fully reversible within 24 h, indicating that the effect may be not due to sensitisation. No further skin reactions were observed, therefore the source item was considered not sensitising. As explained in the analogue justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the skin sensitisation potential. Thus, the target substance is also considered to exhibit no skin sensitising properties.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation
No studies are available investigating the skin sensitisation properties of ethylene diacetate (CAS 111-55-7). 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 study was conducted according to OECD guideline 406 in compliance with GLP (NOTOX, 1986). Female guinea pigs (20 in test group, 10 in control group) were induced with nine occlusive epicutaneous exposures at 25% of the test substance in propylene glycol. The epicutaneous challenge was conducted ten days after the last induction using 0.05 mL of a series of test substance concentrations (25, 5, 1 and 0% (v/v)) in propylene glycol. The negative control group was treated with the vehicle propylene glycol only. No positive control data was included in the study for reliability check.
On Day 29, a diffuse skin reddening at the skin site exposed to 25% (v/v) propane-1,2-diyl diacetate was observed in two animals (10.5%). The complete disappearance of the observed skin reddening 24 h later might indicate that the effects were not due to sensitisation. No further skin reactions were observed.
In summary, only two animal of the treatment group (10.5%) showed a positive result for skin sensitisation and thus propane-1,2-diyl diacetate (CAS 623-84-7) was considered to be not sensitising.
Conclusion for skin sensitisation
The structurally related source substance propane-1,2-diyl diacetate (CAS 623-84-7) showed no skin sensitisation potential in guinea pigs. Based on this result, no skin sensitisation potential for ethylene diacetate (CAS 111 -55 -7) was identified.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on read-across from the source substance propane-1,2-diyl diacetate (CAS 623-84-7) following an analogue approach, the available data on skin sensitisation properties of ethylene diacetate (CAS 111-55-7) do not meet the criteria for classification according to Regulation (EC) No. 1272/2008. Thee data are therefore conclusive but not sufficient for classification.
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