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EC number: 500-038-2 | CAS number: 25322-68-3 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:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Repeated dose oral toxicity study of the test chemical
- Author:
- Smyth et al
- Year:
- 1 955
- Bibliographic source:
- Journal of the American pharmaceutical association
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- The sub acute (90 days) study was conducted to evaluate the toxic effects of repeated administration of the test chemical to rat by the oral diet route.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- EC Number:
- 500-038-2
- EC Name:
- Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Cas Number:
- 25322-68-3
- Molecular formula:
- (C2-H4-O)mult-H2-O
- IUPAC Name:
- Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Details on test material:
- - Name of test material (as cited in study report): Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Substance type: Organic
- Physical state: Liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: N/A
- Age at study initiation: N/A
- Weight at study initiation:N/A
- Fasting period before study:N/A
- Housing:N/A
- Diet (e.g. ad libitum):N/A
- Water (e.g. ad libitum):N/A
- Acclimation period:N/A
ENVIRONMENTAL CONDITIONS
- Temperature (°C): N/A
- Humidity (%):N/A
- Air changes (per hr):N/A
- Photoperiod (hrs dark / hrs light):N/A
IN-LIFE DATES: From: To:N/A
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Dose group : Fed PEG 400 equivalents to 2000,4000,8000,16000,24000 mg/kg/day (2%, 4%, 8%, 16%, 24% respectively) PEG in the diet.
Control group : Fed diet without polyethylene glycol.
DIET PREPARATION
The diet consisted of 60 parts of freshly ground whole wheat, 30.5 parts of dried whole milk, 1.5 parts of dried liver extract U. S. P., 5.0 parts dried inactive brewers' yeast, 1 part calcium carbonate, and 2 parts iodized table salt. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0,2000,4000,8000,16000 and 24000mg/kg/day
Basis:
nominal in diet
- No. of animals per sex per dose:
- Control: 5 males and 5 females
2000 mg/kg/day:5 males and 5 females
4000 mg/kg/day:5 males and 5 females
8000 mg/kg/day:5 males and 5 females
16000 mg/kg/day:5 males and 5 females
24000mg/kg/day:5 males and 5 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Not examined
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes (body weight as a ratio to the amount of nutrient consumed was recorded.)
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not examined
OPHTHALMOSCOPIC EXAMINATION: Not examined
HAEMATOLOGY: Not examined
CLINICAL CHEMISTRY:Not examined
URINALYSIS: Not examined
NEUROBEHAVIOURAL EXAMINATION: Not examined
Organ weight : Liver weight, kidney weight were examined during the study period.
Mortality : Mortality effects was studied. - Sacrifice and pathology:
- HISTOPATHOLOGY: Yes
Micro pathology of liver and kidney was examined. - Statistics:
- It is indicated in the study data was subjected to statistical methods with a 1 in 19 level of significance.
Results and discussion
Results of examinations
- Clinical signs:
- not examined
- Mortality:
- not examined
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Decrease in weight gain of either sex in terms of grams per 100 Gm. nutrients eaten.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effect was observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- At dose concentration 16000 mg/kg/day kidney and liver were heavier than that of control rats.
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- During a 90-day period, effects were studied such as mortality, appetite, body weight both in grams and as a ratio to the amount of nutrient consumed, liver weight, kidney weight, and micro pathology of liver and kidney but no effects were observed up to 8000 mg/kg/day.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 8 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Body weight as a ratio to the amount of nutrient consumed, body weight; liver weight, kidney weight; micro pathology of liver and kidney.
- Dose descriptor:
- LOAEL
- Effect level:
- 16 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Body weight as a ratio to the amount of nutrient consumed, body weight; liver weight, kidney weight; micro pathology of liver and kidney.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a sub acute repeated dose toxicity study, the test chemical showed no effect upon male and female rats when it was present in the diet at a dose level upto 8000 mg/kg/day (8% concentration) during a 90 days study period. But at 16000 mg/kg/day, the test chemical showed effects on organ weight (liver and kidney heavier than that of control rats);and a Decrease in weight gain was observed.
Thus the NOAELs (no observed adverse effect level) for repeated dose oral toxicity was considered to be 8000 mg/kg/day whereas the LOAELs (low observed adverse effect level) for subacute repeated dose was considered to be 16000 mg.kg/day. - Executive summary:
The study was designed to investigate the subacute repeated dose toxicity effects of the test chemical in Wistar rats (male/female) by oral route, in an overall study period of 90 days. Dose group (5 animals per group) was fed a solution of PEG400 equivalent to 0, 2000, 4000, 8000, 16000 or 24000 mg/kg/day in the diet. The control group received no test chemical. During the study period, body weight as a ratio to the amount of nutrient consumed, body weight,liver weight, kidney weight, micro pathology of liver and kidneyswere examined. No effects upon male and female rats were observed when the test chemical was present in the diet at a level up to 8000 mg/kg/day (8%concentration) for 90 days study period. But at 16000 mg/kg/day it showed effects on organ weight (liver and kidneyheavier than that of control rats);and a decrease in weight gain was observed. Thus, from overall conclusion of the study the NOAEL (no observed adverse effect level) for repeated dose oral toxicity was considered to be 8000 mg/kg/day. And the LOAEL (low observed adverse effect level) for subacute repeated dose toxicity was considered to be 16000 mg/kg/day.
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