Registration Dossier
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EC number: 500-035-6 | CAS number: 25214-63-5 1 - 5.5 moles propoxylated
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- May-July 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a: Guideline study (GLP)
- Justification for type of information:
- Read across to an analogue based on structural similarity. An analogue justification is attached to section 13 of the dataset.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May-July 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a: Guideline study (GLP)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- (July 1995)
- Deviations:
- yes
- Remarks:
- Protein and creatinine excretion was not measured (as an error). These measurements performed in the study T8073730 (OECD 421) were also reported in this dossier.
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals were supplied by 'Harlan GmbH', Borchen, Germany and were about 4 weeks old. Males had an initial weight of 97 (83-114)g and females of 101 (95-108).
Housing in groups of 2 or 3 rats in Makrolon(R) cages Type IV on wood granules. All animals or the study were kept in the same room with no other animals from other studies and in an 20 Pa overpressure environment at 22°C, 55 +/-5% relative humidity and a 12 hour light/dark cycle and low-noise music.
Diet was standard diet "Provimi Kliva 3883.0.15" pellets supplied by Provimi Kliva SA, Kaiseraugst, Switzerland ad libitum. Water was provided ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- vehicle: demineralized water
administration volume: 10 ml/kg bw - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- not applicable
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg/body weight
Basis:
actual ingested - No. of animals per sex per dose:
- 5 males + 5 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- 5 male and 5 female Wistar rats/dose and control group
ADMINISTRATION/EXPOSURE:
vehicle: demineralized water
administration volume: 10 ml/kg bw - Positive control:
- not applicable
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATION AND FREQUENCY:
Inspection of Animals:
for morbidity and mortality: Twice daily, once daily on weekends and public holidays
general clinical examinations (in cage): Daily
detailed clinical examinations: Weekly
open field observation (OFO): Once before start and once weekly thereafter
Ophthalmology: At study begin: All rats.
At termination: Control and high dose
Functional Observational Battery: Day 19-20 (relative)
Motor Activity: Day 18-19 (absolute)
Determination of body weight(s): Daily
food consumption: Weekly
water consumption: Weekly
CLINICAL PATHOLOGY at the end of study:
HEMATOLOGY:
Leukocytes, Erythrocytes, Hemoglobin, Hematocrit, Reticulocytes, Differential blood count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), HQUICK, Platelets
CLINICAL CHEMISTRY:
Alanine aminotransferase, Alkaline phosphatase,Aspartate aminotransferase,Gamma glutamyl transferase, Glutamate dehydrogenase, Lactate dehydrogenase, Creatin kinase, Albumin, Cholesterol, Creatinine, Glucose, Total protein, Urea, Potassium, Sodium, Calcium, Chloride, Inorganic Phosphate
URINALYSIS
- Quantitatively: Density and Volume (Protein and creatinine excretion was not measured as an error.
- Semi-quantitatively: pH, Glucose, Blood, Bilirubin, Ketone bodies, Urobilinogen, Protein
- Microscopy of sediment - Sacrifice and pathology:
- ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Gross Pathology:
Fixed organs: Adrenals, aorta, brain (cerebrum, cerebellum, ponslmedulla), epididymides, esophagus, eyes, eyelids, extraorbital lachrymal glands, femur, harderian glands, head (with nasal and paranasal cavities), heart, intestine (duodenum, jejunum, ileum, cecum, colon, rectum and remaining intestine), kidneys, larynx, liver, lymph nodes (mandibular, bronchial/hilus, and mesenteric), lung, mamma, optical nerves, ovaries, oviducts, pancreas, pharynx, pituitary, prostate, salivary glands, sciatic nerve, seminal vesicles (incl. coagulating glands), skeletal muscle (thigh), skin (mammary and muzzle), spinal cord (cervical, thoracic, lumbar), spleen, sternum, stomach (forestomach and glandular stomach), testes, thymus, thyroids (including parathyroid glands), tongue, trachea, ureter, urethra, urinary bladder, uterus with uterine cervix, vagina, Zymbal’s glands and all organs or tissues with macroscopic findings.
- Microscopic: Adrenals, aorta, brain (cerebrum, cerebellum, ponslmedulla), epididymides, esophagus, femur, heart, intestine (duodenum, jejunum, ileum, cecum, colon, rectum and remaining intestine), kidneys, liver, lung, lymph nodes, ovaries, oviducts, pancreas, pituitary, prostate, salivary glands, sciatic nerve, seminal vesicles (incl. coagulating glands), skeletal muscle (thigh), skin (mammary and muzzle), spinal cord (cervical, thoracic, lumbar), spleen, sternum, stomach (forestomach and glandular stomach), testes, thymus, thyroids (including parathyroid glands), trachea, urinary bladder, uterus with uterine cervix, and all organs or tissues with macroscopic findings. Slides were prepared from the first five animals of all groups and evaluated from the control and the high concentration group.
ORGAN Weights:
Adrenals, brain, epididymides, heart, kidneys, Liver, Ovaries, Spleen, Testes, Thymus, uterus - 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):
- no effects observed
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- The water intake was slightly increased in 1000 mg/kg males. There was no correlate to this finding and a toxicological relevance is excluded.
Hematology: at 1000 mg/kg MCH was slightly increased in females (p<0.01) and MCHC was sligthly increased in both sexes (p<0.05).
Clinical chemistry: females exhibited a decreased mean LDH activity. - Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: not applicable
- Dose descriptor:
- NOEL
- Effect level:
- ca. 300 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: increased mean corpuscular hemoglobin in females and increased mean corpuscular hemoglobin concentration in both sexes at 1000 mg/kg bw.
- Critical effects observed:
- not specified
NOAEL: 1000 mg/kg b.w./d (nominal);
NOEL 300 mg/kg b.w./d (nominal) increased MCH in females and increased MCHC in both sexes.
MORTALITY:
No animal died up to and including 1000 mg/kg bw.
CLINICAL SIGNS
No clinical signs were observed up to and including 1000 mg/kg bw.
BODY WEIGHTS:
No statistically significant and dose-depending changes in body weights or body weight gain were evident up to and including 1000 mg/kg bw in males and females. As result of blood and urin sampling body weights were reduced from day 25 to day 27.
FOOD CONSUMPTION:
No toxicologically relevant changes in food intake were observed up to and including 1000 mg/kg in males and females.
WATER CONSUMPTION:
No toxicologically relevant changes in water intake were observed up to 300 mg/kg in males and 1000 mg/kg in females. At 1000 mg/kg a slight increase (13%) of water intake per kg body weight was seen in males.
HEMATOLOGY and CLINICAL PATHOLOGY:
Hematological parameters were not influenced by the test substance up to 300 mg/kg. At 1000 mg/kg slightly elevated MCH (females, p=0.01) and MCHC (both sexes) were measured (p=0.05).
The parameters of clinical chemistry were unchanged up to 300 mg/kg. At 1000 mg/kg females exhibited a decreased mean for the LDH activity. Bearing in mind that, generally, an increased but not decreased LDH activity reflects a toxic effect, this finding is of no toxicological relevance.
None of the urine parameters was treatment-related changed up to and including 1000 mg/kg.
OPHTHALMOLOGY:
No treatment-related changes at 1000 mg/kg
FUNCTIONAL OBSERVATIONAL BATTERY (FOB)/MOTOR ACTIVITY (MA/LMA):
FOB: No statistically significantly and dose-dependently differing up to and including 1000 mg/kg.
MA/LMA: No indication of test substance-related changes up to and including 1000 mg/kg.
GROSS PATHOLOGY:
No macroscopical organ changes attributable to the test substance were detected up to and including 1000 mg/kg.
ORGAN WEIGHTS:
None of the absolute and relative organ weights were statistically significantly and dose-dependently changed up to and including 1000 mg/kg.
HISTOPATHOLOGICAL FINDINGS:
An increased hemopoiesis in the spleen by severity (mean severities with ascending dose: 1.6-2.0-2.0-2.6) was detected in females at 1000 mg/kg, which is interpreted as an adaptive response to the treatment. Indications on an anemia were not noted.
In the adrenal glands vacuolation of the zona fasciculata was raised (incidence with ascending dose: 1-1-0-4) in males at 1000 mg/kg. Due to their localization in the upper adrenal cortex the vacuoles may probably derive from accumulations with cholesterol and/or glucocorticosteroids (lipidosis).
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- (July 1995)
- Deviations:
- yes
- Remarks:
- Protein and creatinine excretion was not measured (as an error). These measurements performed in the study T8073730 (OECD 421) were also reported in this dossier.
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- 26316-40-5
- Cas Number:
- 26316-40-5
- IUPAC Name:
- 26316-40-5
- Reference substance name:
- Ethylenediamine, ethoxylated and propoxylated
- IUPAC Name:
- Ethylenediamine, ethoxylated and propoxylated
- Details on test material:
- Voranol RA 800; Molecular Mass: (average Mn = 280 g/mol)
; Units of Propylene oxide, approx: 70-90%, Units of ethylene oxide: approx 10-30%
Lot #: UB06083011
Colourless viscous Fluid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals were supplied by 'Harlan GmbH', Borchen, Germany and were about 4 weeks old. Males had an initial weight of 97 (83-114)g and females of 101 (95-108).
Housing in groups of 2 or 3 rats in Makrolon(R) cages Type IV on wood granules. All animals or the study were kept in the same room with no other animals from other studies and in an 20 Pa overpressure environment at 22°C, 55 +/-5% relative humidity and a 12 hour light/dark cycle and low-noise music.
Diet was standard diet "Provimi Kliva 3883.0.15" pellets supplied by Provimi Kliva SA, Kaiseraugst, Switzerland ad libitum. Water was provided ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- vehicle: demineralized water
administration volume: 10 ml/kg bw - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- not applicable
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg/body weight
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 males + 5 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- 5 male and 5 female Wistar rats/dose and control group
ADMINISTRATION/EXPOSURE:
vehicle: demineralized water
administration volume: 10 ml/kg bw - Positive control:
- not applicable
Examinations
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATION AND FREQUENCY:
Inspection of Animals:
for morbidity and mortality: Twice daily, once daily on weekends and public holidays
general clinical examinations (in cage): Daily
detailed clinical examinations: Weekly
open field observation (OFO): Once before start and once weekly thereafter
Ophthalmology: At study begin: All rats.
At termination: Control and high dose
Functional Observational Battery: Day 19-20 (relative)
Motor Activity: Day 18-19 (absolute)
Determination of body weight(s): Daily
food consumption: Weekly
water consumption: Weekly
CLINICAL PATHOLOGY at the end of study:
HEMATOLOGY:
Leukocytes, Erythrocytes, Hemoglobin, Hematocrit, Reticulocytes, Differential blood count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), HQUICK, Platelets
CLINICAL CHEMISTRY:
Alanine aminotransferase, Alkaline phosphatase,Aspartate aminotransferase,Gamma glutamyl transferase, Glutamate dehydrogenase, Lactate dehydrogenase, Creatin kinase, Albumin, Cholesterol, Creatinine, Glucose, Total protein, Urea, Potassium, Sodium, Calcium, Chloride, Inorganic Phosphate
URINALYSIS
- Quantitatively: Density and Volume (Protein and creatinine excretion was not measured as an error.
- Semi-quantitatively: pH, Glucose, Blood, Bilirubin, Ketone bodies, Urobilinogen, Protein
- Microscopy of sediment - Sacrifice and pathology:
- ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Gross Pathology:
Fixed organs: Adrenals, aorta, brain (cerebrum, cerebellum, ponslmedulla), epididymides, esophagus, eyes, eyelids, extraorbital lachrymal glands, femur, harderian glands, head (with nasal and paranasal cavities), heart, intestine (duodenum, jejunum, ileum, cecum, colon, rectum and remaining intestine), kidneys, larynx, liver, lymph nodes (mandibular, bronchial/hilus, and mesenteric), lung, mamma, optical nerves, ovaries, oviducts, pancreas, pharynx, pituitary, prostate, salivary glands, sciatic nerve, seminal vesicles (incl. coagulating glands), skeletal muscle (thigh), skin (mammary and muzzle), spinal cord (cervical, thoracic, lumbar), spleen, sternum, stomach (forestomach and glandular stomach), testes, thymus, thyroids (including parathyroid glands), tongue, trachea, ureter, urethra, urinary bladder, uterus with uterine cervix, vagina, Zymbal’s glands and all organs or tissues with macroscopic findings.
- Microscopic: Adrenals, aorta, brain (cerebrum, cerebellum, ponslmedulla), epididymides, esophagus, femur, heart, intestine (duodenum, jejunum, ileum, cecum, colon, rectum and remaining intestine), kidneys, liver, lung, lymph nodes, ovaries, oviducts, pancreas, pituitary, prostate, salivary glands, sciatic nerve, seminal vesicles (incl. coagulating glands), skeletal muscle (thigh), skin (mammary and muzzle), spinal cord (cervical, thoracic, lumbar), spleen, sternum, stomach (forestomach and glandular stomach), testes, thymus, thyroids (including parathyroid glands), trachea, urinary bladder, uterus with uterine cervix, and all organs or tissues with macroscopic findings. Slides were prepared from the first five animals of all groups and evaluated from the control and the high concentration group.
ORGAN Weights:
Adrenals, brain, epididymides, heart, kidneys, Liver, Ovaries, Spleen, Testes, Thymus, uterus
Results and discussion
Results of examinations
- 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):
- no effects observed
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- The water intake was slightly increased in 1000 mg/kg males. There was no correlate to this finding and a toxicological relevance is excluded.
Hematology: at 1000 mg/kg MCH was slightly increased in females (p<0.01) and MCHC was sligthly increased in both sexes (p<0.05).
Clinical chemistry: females exhibited a decreased mean LDH activity.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: not applicable
- Dose descriptor:
- NOEL
- Effect level:
- ca. 300 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: increased mean corpuscular hemoglobin in females and increased mean corpuscular hemoglobin concentration in both sexes at 1000 mg/kg bw.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
NOAEL: 1000 mg/kg b.w./d (nominal);
NOEL 300 mg/kg b.w./d (nominal) increased MCH in females and increased MCHC in both sexes.
MORTALITY:
No animal died up to and including 1000 mg/kg bw.
CLINICAL SIGNS
No clinical signs were observed up to and including 1000 mg/kg bw.
BODY WEIGHTS:
No statistically significant and dose-depending changes in body weights or body weight gain were evident up to and including 1000 mg/kg bw in males and females. As result of blood and urin sampling body weights were reduced from day 25 to day 27.
FOOD CONSUMPTION:
No toxicologically relevant changes in food intake were observed up to and including 1000 mg/kg in males and females.
WATER CONSUMPTION:
No toxicologically relevant changes in water intake were observed up to 300 mg/kg in males and 1000 mg/kg in females. At 1000 mg/kg a slight increase (13%) of water intake per kg body weight was seen in males.
HEMATOLOGY and CLINICAL PATHOLOGY:
Hematological parameters were not influenced by the test substance up to 300 mg/kg. At 1000 mg/kg slightly elevated MCH (females, p=0.01) and MCHC (both sexes) were measured (p=0.05).
The parameters of clinical chemistry were unchanged up to 300 mg/kg. At 1000 mg/kg females exhibited a decreased mean for the LDH activity. Bearing in mind that, generally, an increased but not decreased LDH activity reflects a toxic effect, this finding is of no toxicological relevance.
None of the urine parameters was treatment-related changed up to and including 1000 mg/kg.
OPHTHALMOLOGY:
No treatment-related changes at 1000 mg/kg
FUNCTIONAL OBSERVATIONAL BATTERY (FOB)/MOTOR ACTIVITY (MA/LMA):
FOB: No statistically significantly and dose-dependently differing up to and including 1000 mg/kg.
MA/LMA: No indication of test substance-related changes up to and including 1000 mg/kg.
GROSS PATHOLOGY:
No macroscopical organ changes attributable to the test substance were detected up to and including 1000 mg/kg.
ORGAN WEIGHTS:
None of the absolute and relative organ weights were statistically significantly and dose-dependently changed up to and including 1000 mg/kg.
HISTOPATHOLOGICAL FINDINGS:
An increased hemopoiesis in the spleen by severity (mean severities with ascending dose: 1.6-2.0-2.0-2.6) was detected in females at 1000 mg/kg, which is interpreted as an adaptive response to the treatment. Indications on an anemia were not noted.
In the adrenal glands vacuolation of the zona fasciculata was raised (incidence with ascending dose: 1-1-0-4) in males at 1000 mg/kg. Due to their localization in the upper adrenal cortex the vacuoles may probably derive from accumulations with cholesterol and/or glucocorticosteroids (lipidosis).
Applicant's summary and conclusion
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.

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