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EC number: 500-303-2 | CAS number: 115340-85-7 1 - 4.5 moles ethoxylated
- 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
The substance is neither irritating or corrosive to the skin and eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Remarks:
- Both skin irritation and skin corrosion
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-05-31 to 2018-06-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 2017-10-09
- Qualifier:
- according to guideline
- Guideline:
- other: 4.2.2 DB-ALM Protocol n° 190: SkinEthicTM HCE Eye Irritation Test Liquid (EITL)
- Version / remarks:
- 2017-06-07
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: R-127. Lot 170825
- Expiration date of the lot/batch: 2019-07-26
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Solubility and stability of the test substance in the solvent/vehicle: soluble - Species:
- human
- Strain:
- other: RhCE
- Details on test animals or tissues and environmental conditions:
- Test system: Reconstructed Human Corneal Epithelium, small, age day 5 (area: 0.5 cm2)
Source:
EPISKIN SNC
4, rue Alexander Fleming
69366 - Lyon Cedex 7
FRANCE - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- Application HCE unit Substance
Test substance 2 living units 10 ± 1 µl 0.01M PBS pH = 7.4 and 30 ± 2 µl test item 30 ± 2 min
Test substance 2 killed units 10 ± 1 µl 0.01M PBS pH = 7.4 and 30 ± 2 µl test item
Negative control 2 living units 30 ± 2 µl 0.01M PBS pH = 7.4
Negative control 2 killed units 30 ± 2 µl 0.01M PBS pH = 7.4
Positive control 2 living units 10 ± 1 µl 0.01M PBS pH = 7.4 and 30 ± 2 µl methyl acetate
Duration was 30 ± 2 min - Duration of treatment / exposure:
- 30 ± 2 min
- Duration of post- treatment incubation (in vitro):
- 37 ± 2 oC, 5 ± 1 % CO2, ≥ 90% humidity for 3 hours ± 15 minutes
- Number of animals or in vitro replicates:
- 2
- Irritation parameter:
- other: OD mean value, mean viability %
- Run / experiment:
- T1- (final), 30 min exposure
- Value:
- 98.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: OD mean value, mean viability %
- Run / experiment:
- T-2 (final) 30 min exposure
- Value:
- 95.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: OD mean value, mean viability %
- Run / experiment:
- Mean viablity both runs
- Value:
- 98.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the SkinEthicTM HCE EIT (for the liquid’s protocol) Validated Reference Method (VRM) and associated with UN GHS classification system, the test item- 4, 4’-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco, is considered to be not irritating or corrosive to the eye.
- Executive summary:
The substance 4, 4’-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco, was examined to eye irrittaing and eye damaging properties in a study according to OECD 492.
Based on the SkinEthicTM HCE EIT (for the liquid’s protocol) Validated Reference Method (VRM) and associated with UN GHS classification system, the test item- 4, 4’-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco, is considered to be not irritating or corrosive to the eye
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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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