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EC number: 500-085-9 | CAS number: 35176-06-8 1 - 6.5 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
![](https://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:
- weight of evidence
- Study period:
- May-July 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 1a: Guideline study (GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
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:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- 2,2',2''-Nitrilotriethanol, propoxylated
- EC Number:
- 500-094-8
- EC Name:
- 2,2',2''-Nitrilotriethanol, propoxylated
- Cas Number:
- 37208-53-0
- Reference substance name:
- 2,2',2''-Nitriolotriethanol, propoxylated
- IUPAC Name:
- 2,2',2''-Nitriolotriethanol, propoxylated
- Details on test material:
- Molecular Mass: (average Mn = 340 g/mol)
Batch #: 197
Yellowish 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).
Animals were housed individually in Makrolon(R) cages Type II 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
- Duration of treatment / exposure:
- 31 days
- 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: Day25
Motor Activity: Day 29
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 - 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
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- 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:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Clinical observations nor behavioral investigations of the animals revealed no treatment-related findings. Furthermore, survival, body weight and food consumption were also not effected by the treatment. Slight changes were observed in blood counts, clinical laboratory parameters and histopathology, but these were all considered to be adaptive with limited toxicological relevance.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: not applicable
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL > 1000 mg/kg bw/day
- Executive summary:
2,2',2''-Nitrilotriethanol, propoxylated was administered orally by gavage to 5 male and 5 female Wistar rats per dose group, in doses of 0, 100, 300 and 1000 mg/kg bw for a period of 31 days. Clinical observations nor behavioral investigations of the animals revealed no treatment-related findings. Furthermore, survival, body weight and food consumption were also not effected by the treatment. Slight changes were observed in blood counts, clinical laboratory parameters and histopathology, but these were all considered to be adaptive with limited toxicological relevance.
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