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EC number: 905-898-6 | CAS number: -
- 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: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July 17 - September 05 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
- Reference Type:
- publication
- Title:
- The inhalation toxicity of di- and triethanolamine upon repeated exposure.
- Author:
- Gamer AO, et al.
- Year:
- 2 008
- Bibliographic source:
- Food and Chemical Toxicology, 46(6), 2173-2183
- Reference Type:
- secondary source
- Title:
- Sub-acute Inhalation and Neurotoxicity of Triethanolamine (TEA)
- Author:
- Gamer AO, et al.
- Year:
- 1 998
- Bibliographic source:
- unpublished
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Principles of method if other than guideline:
- Groups of 10 Wistar rats/sex were head-nose exposed to clean air (control ) and target concentrations of 0.02; 0.1 and 0.5 mg/l Triethanolamine (test groups). The substance was administered as a 1 i quid aerosol during a period of 28 days (20 exposures). Based on the recommendation of 0ECD Guidelines for the "Testing of Chemicals", method 412, clinical, hematological, clinicochemical examinations were carried out. Furthermore, neurofunctjonal tests (functional observational battery) were performed before and 4 times at about weekly intervals during exposure period. At the end of the study 3 animals/sex and group were perfusion fixed for eventual further neuropathology which, however, was not performed because no neurotoxic findings were observed clinically and in routine histopathology of brain and sciatic nerve. The remaining 7 animals/sex and group were subjected to conventional necropsy. 7 animals per sex of the high concentration group and of the controls were subjected to hi stopathol ogi cal examination, the scope of organs of 0ECD 412 being extended by brain and peripheral nerve.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2,2',2''-nitrilotriethanol
- EC Number:
- 203-049-8
- EC Name:
- 2,2',2''-nitrilotriethanol
- Cas Number:
- 102-71-6
- Molecular formula:
- C6H15NO3
- IUPAC Name:
- 2,2',2''-nitrilotriethanol
- Details on test material:
- - Name of test material (as cited in study report): Triethanolamine; Substance No. 89/711
- Physical state: liquid/colourless
- Analytical purity: 98.9 %
- Date of manufacture: June 29, 1989
- Lot/batch No.: Probe 912
- Stability under test conditions: ensured
- Storage condition of test material: under nitrogen
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: 7 weeks
- mean weight at study initiation: males: 239; females 168 g
- Fasting period before study: none
- Housing: individually
- Diet: KLIBA rat/mouse/hamster Iaboratory diet 24-343-4 10 mm pellets, KlingentalmuehIe AG, Kaiseraugst, Switzerland ad libitum
- Water: tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- Generation of an inhalation atmosphere:
The substance to be tested was supplied to a two-component atomizer by means of a continuous infusion pump and was atomized with compressed air. Having passed a glass separator, the liquid aerosol was diluted with conditioned blast air which was conducted via a glass bottle filled with bidist. water for humidification and was supplied to the exposure apparatus. In order to decrease the viscosity of the substance the two-component atomizers were warmed.
The following amounts of air were set:
Test group Compressed air [m³/h] Blast air [m³/h] Exhaused air [m³/h]
0 - 3.0 ± 0.3 2.7 ± 0.3
1 1.5 ± 0.3 1.5 ± 0.3 2.7 ± 0.3
2 1.5 ± 0.3 1.5 ± 0.3 2.7 ± 0.3
3 1.5 ± 0.3 1.5 ± 0.3 2.7 ± 0.3
Test group Substance flow atomizer [ml/h] Atomizer temperature [° C]
1 0.2 38.9 – 41.2
2 1.2 – 4.0 38.7 – 39.9
3 20 - 35 38.2 – 39.9
Generation of an inhalation atmosphere:
The substance to be tested was supplied to a two-component atomizer by means of a continuous infusion pump and was atomized with compressed air. Having passed a glass separator, the liquid aerosol was diluted with conditioned blast air which was conducted via a glass bottle filled with bidist. water for humidification and was supplied to the exposure apparatus. In order to decrease the viscosity of the substance the two-component atomizers were warmed.
The following amounts of air were set:
Test group Compressed air [m³/h] Blast air [m³/h] Exhaused air [m³/h]
0 - 3.0 ± 0.3 2.7 ± 0.3
1 1.5 ± 0.3 1.5 ± 0.3 2.7 ± 0.3
2 1.5 ± 0.3 1.5 ± 0.3 2.7 ± 0.3
3 1.5 ± 0.3 1.5 ± 0.3 2.7 ± 0.3
Test group Substance flow atomizer [ml/h] Atomizer temperature [° C]
1 0.2 38.9 – 41.2
2 1.2 – 4.0 38.7 – 39.9
3 20 - 35 38.2 – 39.9
Head-nose exposure system
The head - nose exposure technique was preferably selected for this inhalation study to minimize fur contamination of the animals with the substance, which cannot be avoided during whole-body exposure. Fur contamination may lead to an additional dermal- and oral uptake (animals preen as their fur becomes contaminited). Thus an estimation of a nominal dose, taken up by the animals and its correlation to a toxic effect becomes more difficult.
Furthermore, by using the dynamic mode of operation with a Iow-volume chamber, the equilibrium characteristic of this exposure technique is favorable: t99 (the time to reach 99% of the final target concentraiion) is shorter as compared with whole - body chambers with a higher chamber volume.
The aerosol was generated inside an aerodynamic exposure appalatus (INA 20; volume V ~ 55 I, BASF Aktiengesellschaft). The apparatus consists of a cylindrical inhalation chamber of stainless steel sheeting and coneshaped outlets and inlets. The rats were restrained in exposure tubes (glass tubes), their snouts projected into the inhalation chamber and they thus inhaled the aerosol. The apparatus was also connected to an exhaust air system. The exhaust air system was set lower than the supply air system (positive pressure). This ensured that the aerosol in the breathing zones of the animals was not diluted by laboratory air.
In order to accustom the animals to the exposure conditions they were exposed to supply air in head-only exposure systems under comparable flow conditions on 5 days before the exposure period ( preflow period) . Then alI test groups were exposed for 6 hours on workdays over a time period of 28 days (285 days test). The number of exposures was 20.
The animals did not have access to water or feed during the exposure. - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 6 hrs/day, 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.02; 0.1; 0.5 mg/l (Aerosol)
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- Post-exposure period: none
- Positive control:
- not done
Examinations
- Observations and examinations performed and frequency:
- Body weight data
The body weight of the animals was checked at the beginning of the prefolw, one day before beginning of the exposure peride and then once a week alwasy at the same time of the day.
Clinical signs and findings:
The bahaviour and state of health of the test animals were checked on workdays at least 3 times on exposure days and one during the preflow period and the post observation days.
Mortality:
A check for dead animals was made daily.
Neurofunctional tests:
The evaluation on neurofunction was performed on all animals before the beginning of exposure on study days 0, day 1, 8, 14, and 27 (last exposure).
The examination was performed using a functional observational battery which includes various parameters of sensoric and motoric function as follows:
tremors, convulsions, piloerection, lacrimation, secretion of pigmented tears, salivation, pupil size, diarrhea, vocalization, paresis, paralysis, ataxia, general appearance, body tone, posture, animal body (appearance), locomotor activity, respiration, urination, skin color, righting reflex, behavior, grip strenght, pupillary reflex, winking reflex, vision, audition, olfaction, sensitivity of the body surface, pain perception (hot plate test), , tail pinch, toe pinch, visual placing response, miscellaneous.
Clinical chemistry and Hematology
Blood was taken from the retroorbital venous plexus in the morning from non-fasted, not anesthetized animals. The blood samplings and the subsequent analysis of blood and serum was carried out in a randomized sequence. The assays were performed under internal lab quality conditions with commercial reference controls to assure reliable test results. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Means and standard deviation
Statistical relevance was established using methods of AN0VA and DUNNETT
KRUSKALWALLIS test
MANN-WHITNEY U test
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
During the whole study period the animals of test groups 0 to 2 showed no abnormal clinical signs and findings.
Reddish crusts on nasal edges (blood test positive) were detected in the animals of test group 3 after exposure during the second half of exposure period (males on days 21 to 23, 26 and 27, females on days 14 to 16, 20 to 23, 26 and 27).
No deaths were recorded throughout the study.
BODY WEIGHT AND WEIGHT GAIN
Body weight and body weight change of male and female animals from alI test groups showed no statistically significant difference when compared to the control group
HAEMATOLOGY
No substance-induced changes were observed in the hematological parameters or in clotting analysis of both sexes.
CLINICAL CHEMISTRY
No substance-induced changes were observed in the enzyme activities or the blood chemistry parameters of both sexes.
NEUROBEHAVIOUR
The statistjcally significant increased grip strength of forelimbs in males of test group 2 on day 14 and decreased grip strength of hind limbs in females of test group 3 on day 1 were judged to be not substance related because there was no concentration or time dependence. AlI other parameters examined during neurofunctional testing did not show any difference between animals exposed to the test substance and controls. Therefore functional observational battery did not reveal any substance-induced neurofunctional impairment in the treated groups when compared to control.
HISTOPATHOLOGY: NON-NEOPLASTIC
Local effects were characterized histopathologically by focal inflammatory changes in the submucosa of the larynx region, which seems to be the most sensitive part of the respiratory tract after aerosol exposure to Triethanolamine. There was a tendency to concentration dependent increase in incidence and severity of the lesion from mid to high concentration in both sexes. The effect was found in females to a lesser extent. In this sex 0.02 ng/l did not cause larynx irritation anymore. In male animals however minimal to slight effects were observed in the low concentration similar to the mid
concentration. Because of this simiIar grade of the lesion it is concluded that just below 0.02 ng/l no irritation should be present anymore
OTHER FINDINGS
There is a statistically significant inter-group difference between the red blood cells of the male animals of the control and those of test group 2. This deviation is marginal, inconsistent, when compared with the other sex, and lacking dosage-relationship. Accordingly, this finding is considered to be of no toxicological significance.
Effect levels
open allclose all
- Dose descriptor:
- NOAEC
- Remarks:
- systemic effects
- Effect level:
- 0.5 mg/L air
- Sex:
- male/female
- Basis for effect level:
- other: no effects at highest concentration tested
- Dose descriptor:
- NOAEC
- Remarks:
- local effects
- Effect level:
- 0.02 mg/L air
- Sex:
- female
- Basis for effect level:
- other: irritation of the upper respiratory tract
- Dose descriptor:
- NOAEC
- Remarks:
- local effects
- Effect level:
- <= 0.02 mg/L air
- Sex:
- male
- Basis for effect level:
- other: irritation of the upper respiratory tract, minimal to moderate focal inflammatory change in the submucosa of the larynx
Target system / organ toxicity
- Critical effects observed:
- not specified
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.
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