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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 4, 4'lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, did not show acute oral or acute dermal toxicity. Exposure of humans by the inhalation route is unlikely.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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
- 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
- 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:
- 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 - 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 - 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.
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- K1
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-10-31 to 2018-01-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- 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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: nVivos Pte Ltd
9 Perahu Road,
Um Chu Kang, Singapore 718793
- Age at study initiation: young adult
- Weight at study initiation: 200 - 300 g
- Fasting period before study: none
- Housing: OptiMICE Caging Systems for rats
- Diet (e.g. ad libitum): Altrom in Maintenance Diet #1324 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22 °C
- Humidity (%): 30 - 70 %
IN-LIFE DATES: From: 2017-10-26 To: 2017-11-21 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: < 10 % of entire body surface
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 432 - 472 mg with femalles; 488 - 540 mg with males
- Concentration (if solution): 2000 mg/kg bw
- Constant volume or concentration used: yes (constant concnetration) - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: 30', 1, 2 an 4 h, then daily. Weighing: once per week
- Necropsy of survivors performed: yes
- Other examinations performed: body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: No abnormality was observed on all animals during the necropsy.
- Gross pathology:
- No abnormality was observed on all animals during the necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the condition of this study and based on CLP for acute dermal toxicity hazard categories, the test item - 4, 4'lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, Lot No: 170825 is considered as Unclassified, the LD50 value of the test item - 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, is more than 2000 mg/kg body weight.
- Executive summary:
The acute dermal toxicity of 4, 4'lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, was examined ina guideline study according to OECD 402.
Under the condition of this study and based on CLP for acute dermal toxicity hazard categories, the test item - 4, 4'lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, Lot No: 170825 is considered as Unclassified, the LD50 value of the test item - 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, Lot No: 170825 is more than 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- K1
Additional information
Justification for classification or non-classification
The substance 4, 4'lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, did not show acute oral or acute dermal toxicity.
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