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EC number: 500-075-4 | CAS number: 31694-55-0 1 - 6.5 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- 37208-53-0
- Cas Number:
- 37208-53-0
- IUPAC Name:
- 37208-53-0
- Reference substance name:
- 2,2',2''-Nitrilotriethanol, propoxylated
- EC Number:
- 500-094-8
- EC Name:
- 2,2',2''-Nitrilotriethanol, propoxylated
- IUPAC Name:
- 500-094-8
- Reference substance name:
- 2,2',2''-Nitrilotriethanol, propoxylated
- IUPAC Name:
- 2,2',2''-Nitrilotriethanol, propoxylated
- Details on test material:
- - Name of test material (as cited in study report): Polyether V 579
- Molecular weight (if other than submission substance): (Mm = approx. 340 g/mol)
- Physical state: liquid
- Content: > 99% (test material is a mixture of oligomers which comprises more than 99% of the test substance and is formed by a polyaddition reaction between 2,2',2''-Nitrilotriethanol, propoxylated and 3.2 molar equivalents propyleneoxide.)
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- - Amount of vehicle (if gavage): 5 ml/kg bw
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The content of the test item was assumed to be nominally 100% for calculation.
Before the start of the study formulations containing the test item in concentrations
of 2 mg/mI and 200 mg/ml were analyzed to determine homogeneous distribution
(not for the 2mg/ml formulation as it was a solution), content and stability of the test
item in tap water. During the study homogeneity and content was checked twice. - Duration of treatment / exposure:
- 31 days
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300 and 1000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- five
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
The dose levels used were based on the results of a pilot study. During this study Wistar rats (2 males and 2 females per dose group) received the test substance in doses of O, 65, 160, 400, 1000 mg/kg for a period of two weeks. No clinical findings or relevant effects on body weight development were observed in this study. - Positive control:
- no positive control
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes (incl. Open Field Observations (OFO))
- Time schedule: day 8, 15, 22, 28
BODY WEIGHT: Yes
- Time schedule for examinations: daily
FOOD CONSUMPTION: YES
- Time schedule for examinations: weekly
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: once, day 30
- How many animals: all dose groups incl. controls
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: once, day 30
- How many animals: all dose groups incl. controls
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: FOB: once, day 25; MA: once, day 29
- Dose groups that were examined: all dose groups incl. controls
- Battery of functions tested: Functional Observational Battery (FOB); Motor Activity (MA) - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (all dose groups and controls)
ORGAN Weights:
Adrenals, brain, epididymides, heart, kidneys, Liver, Ovaries, Spleen, Testes, Thymus, uterus
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.
HISTOPATHOLOGY: Yes (high dose group and controls)
- Microscopic: Adrenals, brain (cerebrum, cerebellum, ponslmedulla), epididymides, 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.
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):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Haematology:
Differential blood count revealed as the only conspicuous finding, that the number of leucocytes and lymphocytes was highest in high dose males but was lowest in high dose females. However, these differences were slight compared to the differences between the means of historical control values and the upper 2 s-range in males and the lower 2s-range in females, respectively. Furthernore, the deviations from control value were in opposite directions in males and females and histopathological examinations revealed no corresponding findings. For these
reasons a toxicological relevance was not inferred from these data.
Clinical chemistry:
Clinical aboratory tests revealed a significantly increased activity of alanine aminotransferase in females at 1000 mg/kg. However, the difference to control was relatively slight and histopathological examination of the liver produced no evidence for a treatment-related effect. Therefore, a toxicological relevance is not assumed. Determination of substrates showed the plasma creatinine concentration in males at 1000 mg/kg to be significantly decreased and in all treated female groups to be significantly increased. However, the differences to the respective control value were slight, no dose dependence was present in females, the deviation from the respective control group pointed in opposite directions in males and females and histopathological examination of kidneys produced no corresponding finding. On the basis of these results this was was not considered to be of toxicological relevance.
Histopathology:
The histopathological evaluation revealed a slightly more pronounced hypertrophy of the follicular cell epithelium in the thyroid gland of fernales ofthe high dose, in which not only centrally located follicles appeared hypertrophic but also follicles of the periphery. Hypertrophy was observed to a minimal degree also in females of the other dose groups including one control animal. Due to the slightly increased severity grade in females ofthe high dose group, an effect of the test substance cannot be completely ruled out. Such minimal changes are regarded to be caused by substances that interfere with general metabolic processes and are so far assessed as indirect and adaptive effects. If at all the findings in the present study were related to the treatment, they are therefore not considered as a primary adverse effect on thyroids. However, due to the missing dose response (incidence for follicular cell hypertrophy was: 1 /3/ 1 /3) and the lack of any other treatment-related changes a spontaneous occurrence e.g. by a general variability seems more likely.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for the given test substance was 1000 mg/kg bw/day.
- Executive summary:
In a repeated dose oral toxicity study in rats (Wistar, OECD TG 407), 2,2',2" -Nitrilotriethanol, propoxylated was adiministered via gavage to 5 rats/sex/dose at 0, 100, 300, 1000 mg/kg bw for 4 weeks.. No death was observed in either sex. No clinical effects were observed in both sex of all dose groups.There was no effect observed upon haematological, clinical biochemistry or macroscopic examination at any dose. Based on these results the NOAEL was considered to be 1000 mg/kg bw/day. If at all the slight changes in thyroids of females at 1000 mg/kg were related to the treatment, they are regarded as an indirect and adaptive effect.
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.
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