Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
Data available for the test chemical was reviewed to determine the toxic nature of the test chemical. The studies are as mentioned below:
Repeated dose toxicity: Oral
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 kidneys were 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 kidney heavier 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.
Repeated dose toxicity: Inhalation
Rats were exposed to airborne concentrations of 100 mg/m3 and 1000 mg/m3 of test chemical for periods up to 13 weeks. Toxicological, physiological, hematological, blood chemical, and pathological effects were evaluated during the course of the exposures. No significant lesions observed in this study occurred exclusively in exposed animals and the severity of lesions which were found was not dose-related. The test chemical did not induced lesions in rat tissue at the dosage level and exposure/post exposure periods evaluated in this study. Organ:body weight ratios in rats at all concentrtions and for the 6- and 13-week exposure periods and the 30-day postexposure period showed no pattern of significance that could be related to test chemical. The organ:body weights for the 6-week·exposure period are unavailable. No pattern of significance could be related to test chemical exposure for the 13-week or the 30-day postexposure periods. The test chemical did not product any adverse physiological effects on the rats exposed to the 100 and 1000 mg/m 3 concentrations for the various exposure peri ods. This was not unexpected because the test chemical appear to present. There were no consistently 'significant changes in rat blood chemistry at the end of the 6- or 13-week exposures or the 30-day postexposure period. It appears that the test chemical produced no positive effects in the rodents at the 100 and 1000 mg/m3 test chemical concentrations over the 13 weeks of exposure used in this study. Thus it is concluded that the no observed adverse effect concentration (NOAEC) of the test chemical in rats was observed at dose level of 1000 mg/m3.
Repeated dose toxicity: Dermal
The acute dermal toxicity value for Polyethylene glycol (CAS no 25322-68-3) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- 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
- 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
- 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 - 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
- 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
- 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.
- 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.
- 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.
- Critical effects observed:
- not specified
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 8 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is from peer reviewed publication
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: inhalation
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Subchronic Inhalation Toxicity Of Polyethylene Glycol 200 In the Rats
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source:Charles River Breeding Laboratories
- Weight at study initiation:115 gm and females approximately 77 gm - Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- not specified
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:dynamic ~irflow chambers
- Method of holding animals in test chamber:
- Method of conditioning air:air conditioner
- System of generating particulates/aerosols:
- Temperature, humidity, pressure in air chamber:maintained at a constant level. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 hours a day, 5 days a week
- Remarks:
- Doses / Concentrations:
100,1000 mg/m3
Basis:
nominal conc. - No. of animals per sex per dose:
- 216 rats
- Control animals:
- yes, sham-exposed
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
- Time schedule:
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:
BODY WEIGHT: Yes
The .animals used in the PEG 200 study were .weighed individually at approximately 2-week intervals. The average weights for the various groups, i.e., males and females for the controls, low- and high-dose levels, were recorded.
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / No data
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
WATER CONSUMPTION: No data
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations:
- Dose groups that were examined:
HAEMATOLOGY: Yes
- Time schedule for collection of blood:
- Anaesthetic used for blood collection: Yes (identity) / No / No data
- Animals fasted: Yes / No / No data
- How many animals:
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood:
- Animals fasted: Yes
- How many animals:
- Parameters checked in table [No.?] were examined.
URINALYSIS: No data
- Time schedule for collection of urine:
- Metabolism cages used for collection of urine: Yes / No / No data
- Animals fasted: Yes / No / No data
- Parameters checked in table [No.?] were examined.
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations:
- Dose groups that were examined:
- Battery of functions tested: sensory activity / grip strength / motor activity / other:
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Groups of male and female rats were euthanatized following 6 and 13 weeks of exposure to PEG 200 aerosol. Another group of rats and mice was euthanat ized 30 days after exposure to PEG 200. At termination and necropsy, tissues were evaluated grossly and preserved in 10% buffered formalin. The tissues were imbedded in paraffin and subsequently processed for staining with hematoxyl in and eosin. Tissues from the following were evaluated microscopically.
HISTOPATHOLOGY: Yes (see table) / No / No data - Other examinations:
- Organ Weight:brain, eye, adrenal, thyroid, trachea, lung, turbinates, kidney, 1 iver, spleen, heart, esophagus, stomach, small intestine, large intestine, pancreas, urinary bladder, testes, ovaries, and uterus. Before fixing the hearts, lungs, livers, kidneys, and gonads, they were weighed, and organ-to-body-weight ratios were calculated.
- Statistics:
- The data were compared statistically using an analysis of variance (ANOVA) which distinguished differences according to sex, exposure level, and the effect of dose within sexes
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- -Toxic Signs. No obvious pattern of overt toxic signs was seen in the rat s or mi ce exposed to either 100 or 1000 mg/m3 of PEG 200. After each exposure, the fur of the animals exposed to the high dose appeared oi I y.
- MortaIity. None of the test rats died dur i ng the 13-week exposure or the 3D-day postexposure observation.
-Hematology and blood chemistry.
Hematology. During the 13-week exposure or the 3D-day postexposure period there were no consistently significant changes in red blood cell count, total and differential white blood cell count, hematocrit, or hemoglobin in the rats .
-Blood chemistry:There were no consistently 'significant changes in rat blood chemistry at the end of the 6- or 13-week exposures or the 30-day postexposure period.
-In male rats exposed for 13-weeks to the high dose, there appeared to be a slight decrease in the P-R interval in the EKG compared to the control animals. The usual abnormal ity associ ated with the P-P interval is an increase in duration, which indicates a slowing of the atrial conduction system. This interval will vary inversely with heart rate, but heart rate did not appear to he a factor in the present study. In any event, the decrease was not associated with any abnormality and may be considered inconsequential.
-PEG 20:did not product any adverse physiological effects on the rats exposed to the IOn and lnnn mg/m 3 concentrations for the various exposure periods
-Fischer 344 exposed rats, both males and females, showed no definite pattern as to weight loss or gain. At the end of the postexposure period the rats weighed as much as, or slightly greate than, the controls.
-Mild to moderate proliferative interstitial pneumonia was seen in nine rats, (three control males, five exposed males (two low- and three high-dose), and one female - low-dose. Acute to subacute i nf I ammat i on of the turb i nates was observed in one control female and two exposed (low-dose) males.
-Infiltration of foamy macrophages occurred in the lungs of one exposed (high-dose) male. Suppurative inflammation of the turbinates was seen in a contro I fema I e. A rena I cort i ca I cyst was found. in one control female no spontaneous deaths occurred - Dose descriptor:
- NOAEC
- Effect level:
- 1 000 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse toxicological, physiological, hematological, blood chemical, and pathological effects were observed.
- Critical effects observed:
- not specified
- Conclusions:
- The no observed adverse effect concentration (NOAEC) value of the test chemimcal in rats was observed at dose level of 1000 mg/m3.
- Executive summary:
Rats were exposed to airborne concentrations of 100 mg/m3 and 1000 mg/m3 of test chemical for periods up to 13 weeks. Toxicological, physiological, hematological, blood chemical, and pathological effects were evaluated during the course of the exposures. No significant lesions observed in this study occurred exclusively in exposed animals and the severity of lesions which were found was not dose-related. The test chemical did not induced lesions in rat tissue at the dosage level and exposure/post exposure periods evaluated in this study. Organ:body weight ratios in rats at all concentrtions and for the 6- and 13-week exposure periods and the 30-day postexposure period showed no pattern of significance that could be related to test chemical. The mice organ:body weights for the 6-week·exposure period are unavailable. No pattern of significance could be related to test chemical exposure for the 13-week or the 30-day postexposure periods. The test chemical did not product any adverse physiological effects on the rats exposed to the 100 and 1000 mg/m 3 concentrations for the various exposure peri ods. This was not unexpected because the test chemical appear to present. There were no consistently 'significant changes in rat blood chemistry at the end of the 6- or 13-week exposures or the 30-day postexposure period. It appears that the test chemical produced no positive effects in the rodents at the 100 and 1000 mg/m3 test chemical concentrations over the 13 weeks of exposure used in this study. Thus it is concluded that the no observed adverse effect concentration (NOAEC) of the test chemical in rats was observed at dose level of 1000 mg/m3.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 1 000 mg/m³
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Data is from peer reviewed publication
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal, other
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data available for the test chemical was reviewed to determine the toxic nature of the test chemical. The studies are as mentioned below:
Repeated dose toxicity: Oral
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 kidneys were 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 kidney heavier 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.
In another study, the chronic (13 weeks) study was conducted to evaluate the toxic effects of repeated administration of the test chemical to Fischer-344 male/female rat by the oral gavage route. Rats (10/group/sex) were administered the test chemical by gavage at 1.0, 2.5 or 5.0 ml/kg (1100, 2800, 5600 mg/kg bw) body weight/day 5 days/wk for 13 wk. Animals in the control group received water by gavage (5.0 ml/kg body weight/treatment day). An additional 10 rats/sex/group was assigned to the control and high-dose groups for a 6-wk recovery period. Following are the effects observed : There was no mortality or changes in haematology or clinical chemistry measurements attributed to the test chemical toxicity in low dose group. Loose faeces in the mid- dose/or high-dose group of both sexes were attributed to bulk cathartic effects of the test chemical. Slight decreases in food consumption and body weights in the mid- and/or high-dose group of male rats and female rats were attributed to the physical presence of the test chemical in the intestinal tract. Increased water consumption increase in serum osmolality. Small increased in absolute and/or relative kidney weights observed. Although no microscopic changes were observed in the kidneys or urinary bladder, a slight, reversible renal toxicity may have resulted in male rats treated by gavage with 2800 and rats of both sexes treated by gavage with 5600 mg/kg bw kg/day. Thus the NOAEL and LOAEL of the study was considerd to be 1100 mg/kg bw and 2800 mg/kg bw respectively.
Another study was designed to investigate the chronic repeated dose toxicity effects of the test chemical to dogs (male/female) by oral route, in an overall estimation period of one year study period. The breeds used were one male foxhound, one male and one female Doberman Pinscher by Kerry Blue Terrier cross, and one male Beagle. One group (4 animals per dose group) was fed a dog food meal wetted with a solution of the test chemical equivalent to 500 mg/kg/day (2% concentration) in the diet. The second group received the same meal wetted with water only. During the year body weight, blood cytology, bromsulfalein retention, and prothrombin time, gross pathology and micropathology were examined. No abnormalities were found in the gross pathology or micropathology of the organs and the quantitative measurements feed showed no difference between dogs receiving the test chemical in their diets and their specific controls. Thus from an overall dissussion of the study the NOAELs (no observed adverse effect level) for repeated dose oral toxicity was considered to be 500 mg/kg/day.
The study was designed to investigate the chronic repeated dose toxicity effects of the test chemical in Wistar rat (male/female) by oral route, in an overall estimation period of two years. Dose group (20 animals per dose group) was fed a solution of the test chemical equivalent to 0, 500, 1000, 2000 or 4000 mg/kg/day (0%,1%, 2%, 4%, 8%, concentration respectively) the test chemical in the diet. During the two year study body food consumption, body weight, and blood cytology were followed, gross pathology was studied on animals dying from any cause, micropathology was studied on adrenal, heart, small intestine, kidney, liver, lung, pancreas, spleen, and testis, liver and kidney weights (organ weight) were examined. During the two year study male rats grew slightly less than did the male controls receiving the test chemical in their diets. Thus from overall consideration of the study the LOAEL (low observed adverse effect level) for repeated dose oral chronic toxicity was considered to be 2000 mg/kg/day.
Repeated dose toxicity: Inhalation
Rats were exposed to airborne concentrations of 100 mg/m3 and 1000 mg/m3 of test chemical for periods up to 13 weeks. Toxicological, physiological, hematological, blood chemical, and pathological effects were evaluated during the course of the exposures. No significant lesions observed in this study occurred exclusively in exposed animals and the severity of lesions which were found was not dose-related. The test chemical did not induced lesions in rat tissue at the dosage level and exposure/post exposure periods evaluated in this study. Organ:body weight ratios in rats at all concentrtions and for the 6- and 13-week exposure periods and the 30-day postexposure period showed no pattern of significance that could be related to test chemical. The mice organ:body weights for the 6-week·exposure period are unavailable. No pattern of significance could be related to test chemical exposure for the 13-week or the 30-day postexposure periods. The test chemical did not product any adverse physiological effects on the rats exposed to the 100 and 1000 mg/m 3 concentrations for the various exposure peri ods. This was not unexpected because the test chemical appear to present. There were no consistently 'significant changes in rat blood chemistry at the end of the 6- or 13-week exposures or the 30-day postexposure period. It appears that the test chemical produced no positive effects in the rodents at the 100 and 1000 mg/m3 test chemical concentrations over the 13 weeks of exposure used in this study. Thus it is concluded that the no observed adverse effect concentration (NOAEC) of the test chemical in rats was observed at dose level of 1000 mg/m3.
In the same study, mice were also exposed to airborne concentrations of 100 mg/m3 and 1000 mg/m3 of the test chemical for period up to 13 weeks. Toxicological, physiological, hematological, blood chemical, and pathological effects were evaluated during the course of the exposures. No significant lesions observed in this study occurred exclusively in exposed animals and the severity of lesions which were found was not dose-related. The test chemical did not induced lesions in mice tissue at the dosage level and exposure/post exposure periods evaluated in this study. There was no definite pattern in the body weights of male or female mlce. There were weeks when the average weights of the exposed animals were slightly less or greater than the control weights. Both male and female exposed mice weighed more than the controls during the 30-day postexposure period. Fischer 344 exposed rats, both males and females, showed no definite pattern as to weight loss or gain. At the end of the postexposure period the rats weighed as much as, or sligahtly greater than, the controls.It appears that the test chemical produced no positive effects in the rodents at the 100 and 1000 mg/m3 concentrations over the 13 weeks of exposure used in this study. Thus it is concluded that the no observed effect concentration (NOAEC) for the test chemical in mice was observed at dose level of 1000mg/m3.
Repeated dose toxicity: Dermal
The acute dermal toxicity value for Polyethylene glycol (CAS no 25322-68-3) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver.
Based on the data available, the test chemical is not likely to be toxic upon repeated exposure by oral, dermal and inhalaton route of exposure.
Justification for classification or non-classification
Based on the data available, the test chemical is not likely to be toxic upon repeated exposure by oral, dermal and inhalaton route of exposure.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.