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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 not a skin sensitiser
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-05-24 to 2018-06-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Version / remarks:
- 2010-07-22
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
- 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:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: InVivos Pte Ltd., Singabpore
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: Murine pathogen free (MPF)
- Age at study initiation: 9 weeks
- Weight at study initiation: 18.9 - 21.5 g
- Housing: OptiMICE Caging Systems
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
- Indication of any skin lesions: none
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26 °C
- Humidity (%): 30 - 70 %
- IN-LIFE DATES: From: 2018-05-17 To: 2018-06-06 - Vehicle:
- other: sesame oil, Ph Eur standard
- Concentration:
- 50 % in vehicle.
25 µl administered to each ear - No. of animals per dose:
- 5
- Details on study design:
- Dose interval:
Topical application of 25 µl of test substance/negative control/positive control on the dorsum of each ear once a day for 3 consecutive days.
Administration of BrdU (10 mg/ml):
Administration: Intraperitoneal injection (IP)
Dose level: 5 mg (0.5ml of 10 mg/ml solution) per mice
Dose Interval: Single Dose
ELISA using BrdU colorimetric kit:
Approximately 24 hours after BrdU injection, the animals were euthanized using carbon dioxide. The draining auricular lymph nodes from each mouse ear were dissected and processed separately in phosphate buffered saline (PBS) for each animal. The dissected lymph nodes were trimmed fascia and fat, weighed, immediately used for Lymph node cells (LNC) preparation.
LNC suspension was prepared using #70 nylon cell strainer following the Test facility SOP. Approximately 25 ml of LNC was prepared per animal.
ELISA was performed with stop solution based on instruction manual of supplier (Roche Applied Science, Cat No 11 647 229 001) and Test Facility SOP. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Results for each test and control group were expressed as mean Stimulation Index (SI). The SI was derived by dividing the mean BrdU labelling index of test or positive control group by the mean BrdU labelling index of negative control group. The SI for negative control group was defined as 1.
BrdU labelling index (LI) = (Mean ABS450-Mean ABSblank 450) – (Mean ABS690-Mean
ABSblank 690)
SI = LI test (positive control) / LI negative control - Positive control results:
- SI = 1.692 (> 1.6); valid
- Key result
- Parameter:
- SI
- Remarks:
- mean value
- Value:
- 0.959
- Parameter:
- SI
- Remarks:
- 1st value
- Value:
- 0.487
- Parameter:
- SI
- Remarks:
- 2nd value
- Value:
- 1.451
- Parameter:
- SI
- Remarks:
- 3rd value
- Value:
- 0.415
- Parameter:
- SI
- Remarks:
- 4th value
- Value:
- 1.906
- Parameter:
- SI
- Remarks:
- 5th value
- Value:
- 0.536
- Cellular proliferation data / Observations:
- CLINICAL OBSERVATIONS:
No adverse effect was observed on all the animals, except that very slight erythema at the dorsal part of the ears were observed in all the 5 animals of positive control group throughout all 3 induction days.
BODY WEIGHTS
Normal development - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the above study, using 50% (v/v) of the test item – 4, 4’-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco as test substance and sesame oil, Ph Eur standard as vehicle and negative control, no skin sensitization was produced in mice.
- Executive summary:
The potential to cause skin sensitisation was examined in a study according to OECD 442 B.
Based on the above study, using 50% (v/v) of the test item – 4, 4’-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco as test substance and sesame oil, Ph Eur standard as vehicle and negative control, no skin sensitization was produced in mice.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance did not exhibit skin sensitising properties.
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