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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-02-01 to 2018-07-31
- 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 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 10/2008
- GLP compliance:
- yes
- 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 / batch 180131
- Expiration date of the lot/batch:
2019-01-31
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Dry and dark at ambient temperature (10 – 30 °C)
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
no
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: InVivos Pte Ltd
9 Perahu Road,
Lim Chu Kang,
Singapore 718793
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7 weeks
- Weight at study initiation: males 216 - 298 g, females 162 - 208 g
- Housing: Individual Ventilated Cage System
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 d
DETAILS OF FOOD AND WATER QUALITY:
Altromin Maintenance Diet #1324
Tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26 °C
- Humidity (%): 30 - 70 %
IN-LIFE DATES: From: 2017-12-28 To:2018-01-30
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- The test substance was administered by gavage feeding needle. The test substance and control substance were administered daily, 7 days per week for continuous 4 weeks.
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 28 d
- Frequency of treatment:
- Ddaily administration
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 400 mg/kg bw/day (nominal)
- Dose / conc.:
- 160 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10, of wich 5 males and 5 females
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: results from acute oral toxicity study
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least once per day
- Cage side observations were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: before the first exposure and 1 week thereafter
BODY WEIGHT: Yes
- Time schedule for examinations: days 0, 7, 14, 21 and 28
OPHTHALMOSCOPIC EXAMINATION: Yes (clinical signs in the eyes)
- Time schedule for examinations: before the first exposure and once a week thereafter
- Dose groups that were examined: all
HAEMATOLOGY: Yes
- Time schedule for collection of blood: end of study
- Anaesthetic used for blood collection: No (animals euthaniized before)
- Animals fasted: No
- How many animals: alll
- Parameters checked: haematocrit (HCT), haemoglobin (Hb) concentration, erythrocyte count (RBC), total (WBC) and differential leukocyte count and platelet count (PLT)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: end of study
- Animals fasted: No
- How many animals: all
- Parameters checked: sodium, potassium, glucose, creatinine, total protein and albumin, alanine aminotransferase (ALT), alkaline phosphatase and total bilirubin
URINALYSIS: Yes
number of pools of urine
- Animals fasted:No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: 4th week of exposure
- Dose groups that were examined: all
- Battery of functions tested: Forelimb and hindlimb grip strength / response to visual stimuli / response to sudden sound / pupil response / pinna reflex / proprioception / pain perception / air righting reflex / landing foot splay measurement
IMMUNOLOGY: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
The liver, kidneys, adrenals, testes, epididymides, prostate + seminal vesicles with coagulating glands (as a whole), thymus, spleen, brain and heart of all animals were trimmed of any adherent tissues, and their wet weight were taken and recorded.
HISTOPATHOLOGY: Yes
Full histopathology analysis were carried out on the preserved organs and tissues of all animals in the control and highest dosing group. The following tissues were preserved in 10% formalin or other suitable fixative for histology and pathology analysis:
Gross lesions (if any), brain (representative regions including cerebrum, cerebellum and pons), spinal cord, eye, stomach, small and large intestine (including Peyer’s patches), liver, kidneys, adrenals, spleen, heart, thymus, thyroid, trachea and lungs, gonads (testis and ovaries), accessory sex organs (e.g. uterus and cervix, epididymides, prostate + seminal vesicles with coagulating glands), vagina, urinary bladder, lymph nodes, peripheral nerve (sciatic or tibial), skeletal muscle and bone with bone marrow. - Statistics:
- Data were summarized in tabular form. In each group, the form showed the number of animals at the start of the test, the number of animals showing lesions, the types of lesions and the percentage of animals displaying each type of lesion, if any.
Data for body weight, organ weight, quantitative functional observation, grip strength measurement, haematology and clinical biochemistry were analyzed statistically. Student T-test was used to compare differences of mean values between the control and test group (significance level: two-tailed test, p = 0.05).
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No obvious body weight loss (>10%) was observed on all the test animals during test period.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The t-test indicated that there is no significant difference (p < 0.05) in all the parameters between the male T1, T2 and T3 groups and male negative control group, except that the RBC and HCT value in male T2 group are significantly decreased (p = 0.02) comparing with negative control group.
The t-test indicated that there is no significant difference (p < 0.05) in all the parameters between the female T1, T2 and T3 groups and female negative control group, except that a) the lymphocyte count in female T1 and T3 group is significantly increased (p < 0.05) comparing with negative control group; it is also notable that the p value of lymphocyte count in female T2 group is 0.05 comparing with negative control group; b) the Hb value in female T1 group is signifantly decreased (p = 0.03) comparing with negative control group. - Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The t-test indicated that there is no significant difference (p < 0.05) in all the parameters between the male T1, T2 and T3 groups and male negative control group.
The t-test indicated that there is no significant difference (p < 0.05) in all the parameters between the female T1, T2 and T3 groups and female negative control group, except that a) Alkaline Phosphatase in female T1 group is significantly decreased (p = 0.00) comparing with negative control group; b) Sodium in female T3 group is significantly decreased (p = 0.01) comparing with negative control group. - Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- Forelimps grip strength measurements: No effect
Hindlimps grip strength measurements: No effect
Land foot splay measurement: No effect - Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No significant difference (p < 0.05) in body weight and organ weight between test and control groups, except that significant decreased weight of adrenals in all three female test groups when comparing with female negative control group. Microscopic examination indicated that the decreased weight of adrenals is an incidental finding due to an unusually high weight in the control group.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Description (incidence and severity):
- Macroscopic observation during necropsy
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: all results
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on the study, using both male and female rats as test system, with daily oral administration of 1000 mg/kg, 400 mg/kg and 160 mg/kg body weight per day of the test item- 4, 4’-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco, for a period of 28 days, no systemic toxicity of the test system was observed.
- Executive summary:
The substance 4, 4’-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco, was tested for toxic effects in a repeated-dose 28 day oral study according to OECD 407.
Based on the study, using both male and female rats as test system, with daily oral administration of 1000 mg/kg, 400 mg/kg and 160 mg/kg body weight per day of the test item- 4, 4’-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco, for a period of 28 days, no systemic toxicity of the test system was observed.
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