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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-10-31 to 2018-01-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001-12-17
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco
- EC Number:
- 500-303-2
- EC Name:
- 4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco
- Cas Number:
- 115340-85-7
- IUPAC Name:
- 4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco
- Test material form:
- liquid
Constituent 1
- 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
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: lnVivos Pte Ltd
9 Perahu Road, Lim Chu Kang, Singapore 718793
- Age at study initiation: 8-12 weeks at dosing
- Weight at study initiation: 200 - 248 g
- Fasting period before study: overnight
- Housing: individual ventilated cage system
- Diet (e.g. ad libitum): Altromin maintenance diet #1324 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26 °C
- Humidity (%): 30 - 70 %
IN-LIFE DATES: From: 2017-10-26 To: different for dosing groups, but always euthanized at end of the 14 d observation period
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: starting dose 300 mg/kg bw based upon OECD 423 - Doses:
- 300 mg/kg bw
2000 mg/kg bw - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation after 30', 1, 2 and 4 h, then daily. Weighing once a week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: behaviour
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed
- Clinical signs:
- other: Animals of Group 1 and Group 2 were dosed at 300 mg/kg body weight. No adverse effect was observed on all the test animals in these two groups during dosing and observation period. Necropsy findings were normal on all the test animals in these two groups.
- Gross pathology:
- Necropsy findings were normal in all animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results and CLP for acute toxicity hazard categories, the acute oral toxicity of the test item - 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, Lot No: 170825, is considered as Unclassified; based on OECD Guideline 423, the LD50 cut-off value of the of test item - 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, Lot No: 170825, is 5000 mg/kg body weight or Unclassified.
- Executive summary:
The acute oral toxicity of 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco was examined in a guideline study according to OECD 423.
Based on the results and CLP for acute toxicity hazard categories, the acute oral toxicity of the test item - 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, Lot No: 170825, is considered as Unclassified; based on OECD Guideline 423, the LD50 cut-off value of the of test item - 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, is 5000 mg/kg body weight or Unclassified.
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