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EC number: 290-649-8 | CAS number: 90194-39-1
- 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
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Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Diethanolamine absorption, metabolism and disposition in rat and mouse following oral, intravenous and dermal administration
- Author:
- Mathews JM, et al.
- Year:
- 1 997
- Bibliographic source:
- Xenobiotica, 27, 733-746
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The disposition of [14C]diethanolamine (DEA) was determined in rat after oral, i.v. and dermal administration.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2,2'-iminodiethanol
- EC Number:
- 203-868-0
- EC Name:
- 2,2'-iminodiethanol
- Cas Number:
- 111-42-2
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2,2'-iminodiethanol
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories (Raleigh, NC, USA)
- Age at study initiation: adult
- Weight at study initiation: 123-206 g
- Housing: individual in glass metabolism chambers permitting separate collection of CO2, urine and faeces
- Individual metabolism cages: yes
- Diet: furnished Purina Rodent C. diet ad libitum
- Water: ad libitum
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- ethanol
- Duration of exposure:
- Dermal dose formulations contained from 6 to 20 mCi, an appropriate amount of unlabelled DEA and 95% ethanol for a total dose volume of 25 µL per dose. Dermal doses were applied to an area of skin (2 cm²) from which hair had been clipped the previous day. After dosing, a hemispherical dome of wire mesh (histology tissue capsule) was glued over the dose area with cyanoacrylate adhesive to serve a non-occlusive protective appliance.
- No. of animals per group:
- oral dosing studies: 5 rats
intravenous dosing studies: 5 rats
dermal dosing studies: 5 rats
repeated dose studies: four to five rats (as further indicated) - Control animals:
- no
- Remarks:
- no data
- Details on study design:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, blood, adipose, brain, heart, kidney, liver, lung, muscle, skin, spleen,
- Time and frequency of sampling: 48 hours
- Other: The dose site skin was excised and thoroughly rinsed with acetone. The rinsing solutions and gauzes were collected and analyzed. The washed dose site skin was digested in 2N ethanolic sodium hydroxide.
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: urine
Results and discussion
- Absorption in different matrices:
- Dermal absorption was poor (3-16 % in 48 h); most of the material remained at the site of application.
Percutaneous absorptionopen allclose all
- Key result
- Time point:
- 48 h
- Dose:
- 2 mg/kg bw
- Parameter:
- percentage
- Absorption:
- 3 %
- Key result
- Time point:
- 48 h
- Dose:
- 28 mg/kg bw
- Parameter:
- percentage
- Absorption:
- 16 %
Any other information on results incl. tables
Results summary:
Absorption:
Gastrointestinal absorption of single doses up to at least 200 mg/kg bw was nearly complete (measured 48 hours after exposure).
Dermal absorption was poor(3-16 % in 48 h)and most of the "adsorbed" material remained at the site of application.
Distribution:
Similar patterns of distribution was observed following intravenous, oral or dermal application. The highest concentrations of DEA equivalents were present in liver, kidney, heart, lung, brain and spleen with liver and kidney representing the main target organs.
Metabolism:
Single oral and iv doses of the test compound were excreted predominantly unchanged.
Excretion:
The total percentage of excreted test compound was comparable after oral and intravenous application with 25 -30%. Excretion was mainly urinary within 48 hours (about 20-30%). The test substance demonstrated to exhibit a bioaccumulative potential.
Repeated dose experiments:
The tissue distribution after repeated dosing was similar to the tissue distribution after single application of the test substance.
The test substance accumulated with repeated dosing, reaching a steady state between 4 and 8 weeks. At this time excretion profile of the test substance chanced excreting poorly retained metabolites in significant amounts as well as N-methylDEA and one further mor cationic metabolite.
Tissue half lifes of the test substance after repeated exposure were found at highest in blood with 54 days.
Results details:
Absorption and distribution:
Very similar patterns of tissue distribution and retention of [14C]-DEA were observed 48 hours after i.v. and oral administration to rats.
The total percentage of the dose present after 48 h in tissues (adipose, blood, brain, heart, kidney, liver, lung, muscle, skin, and spleen) was 54% after i.v. administration and 57% after oral administration.
The highest concentrations of DEA equivalents were found in liver, kidney, heart, lung, brain and spleen whereas the concentration in blood (ca. 260 ng. equiv./g blood) was relatively low. DEA was observed to have a particularly high affinity for liver and kidney as evidenced by tissue/blood ratios of 150-200. Residues in liver and kidney combined accounted for nearly one-third of the administered dose 48 h after administration.
The data further indicate, that gastrointestinal absorption of single was nearly complete up to oral doses of at least 200 mg/kg bw. in each case excretion was primarily in urine and total excretion accounted for only 20-30% of the dose in 48 hours.
Excretion:
The total percentage of the dose recovered in excreta (urine, faeces, carbon dioxide, and volatiles) was 29% after i.v. and 24% after oral administration to rats. The primary route of excretion was the urine.Only 0.2% of an i.v. dose of DEA was excreted as CO2or other volatile metabolites in 48 h. Excretion was primarily in urine, but 30% of the i.v. or oral doses were excreted in 48 h. Further, HPLC analysis of urine indicated that virtually all the radioactivity in urine was present as the parent compound. Most of the dose remained in the tissues.
Disposition of radioactivity 48 h after administration of [14C]DEA (7 mg/kg bw)
Tissue |
i.v. dose |
oral dose |
||
% dose in total tissue |
Tissue/blood ratio |
% dose in total tissue |
Tissue/blood ratio |
|
adipose |
1.05 ± 0.11 |
4.28 ± 0.43 |
1.64 ± 0.33 |
6.70 ± 1.19 |
blood |
0.18 ± 0.00 |
unity |
0.18 ± 0.01 |
unity |
brain |
0.30 ± 0.02 |
9.85 ± 0.17 |
0.27 ± 0.02 |
8.80 ± 0.41 |
heart |
0.19 ± 0.01 |
17.9 ± 0.60 |
0.19 ± 0.01 |
17.5 ± 1.00 |
kidney |
3.95 ± 0.53 |
148 ± 11.0 |
5.01 ± 1.04 |
197 ± 12.0 |
liver |
27.1 ± 1.50 |
166 ± 17.0 |
27.3 ± 1.20 |
155 ± 7.00 |
lung |
0.76 ± 0.11 |
38.7 ± 14.6 |
0.71 ± 0.02 |
29.4 ± 5.20 |
muscle |
15.3 ± 1.00 |
9.10 ± 0.47 |
16.3 ± 1.19 |
73.0 ± 0.62 |
skin |
4.54 ± 0.13 |
7.61 ± 0.19 |
5.10 ± 0.40 |
8.59 ± 0.44 |
spleen |
0.31 ± 0.04 |
36.8 ± 5.60 |
0.32 ± 0.01 |
36.5 ± 1.20 |
total |
53.7±1.80 |
57.1±2.70 |
||
urine |
28.3 ± 2.50 |
22.0 ± 1.80 |
||
faeces |
0.60 ± 0.03 |
2.4 ± 0.30 |
||
CO2 |
0.2± 0.00 |
- |
||
volatiles |
0.01 |
- |
||
total |
29.1± 2.00 |
24.4± 1.30 |
Values are means± SD for three to five rats
Disposition of radioactivity 48 h after dermal application of[14C]DEA
Percentage of dose |
|||
2.1 mg/kg (n=5) |
7.6 mg/kg (n=5) |
27.5 mg/kg (n=4) |
|
Absorbed |
|||
Tissues |
1.1 ± 0.8 |
4.3 ± 2.0 |
7.3 ± 4.1 |
urine |
0.6 ± 0.4 |
1.7 ± 0.6 |
4.2 ± 2.9 |
Faeces |
0.03 ± 0.02 |
0.2 ± 0.1 |
0.2 ± 0.2 |
Dose site skin |
1.2 ± 0.3 |
4.3 ± 0.9 |
4.5 ± 0.9 |
Total |
2.9 ± 1.3* |
10.5 ± 2.6 |
16.2 ± 7.7 |
unabsorbed |
91.4 ± 2.0 |
82.9 ± 6.5 |
70.2 ± 8.2 |
Total recovery |
94.3 ± 1.3 |
92.9 ± 4.2 |
86.4 ± 2.4 |
Tissue/blood ratio |
|||
Tissues |
|||
adipose |
1.66 ± 0.73 |
4.54 ± 0.72 |
7.22 ± 1.64 |
brain |
2.60 ± 1.11 |
5.36 ± 1.30 |
6.12 ± 1.74 |
heart |
6.76 ± 2.42 |
15.5 ± 2.0 |
17.8 ± 3.0 |
kidney |
47.3 ± 22.9 |
123 ± 25 |
153 ± 26 |
liver |
56.0 ± 24.2 |
135 ±18 |
140 ± 25 |
lung |
10.1 ± 3.9 |
34.2 ± 14.1 |
44.7 ± 13.9 |
muscle |
2.80 ± 1.27 |
6.95 ± 1.03 |
7.29 ± 1.18 |
skin |
2.85 ± 1.38 |
6.34 ± 1.40 |
7.70 ± 1.61 |
*significantly different from the 7.6 and 27.5 mg/kg bw dosing groups
Repeated dose experiments:
At no point of the study period the excretion did keep pace with the rate of administration. Only 40% of the administered dose was excreted during the time period. The tissue distribution after repeated dosing was similar to the tissue distribution after single application of the test substance. Concentration of DEA equivalents in tissues of repeated dose animals were about 3-5 times higher compared to those of single dose animals, but tissue-to-blood ratios were quite similar, indicating a potential for bioaccumulation of the test compound with continued exposure.
After repeated dose exposure for more than 1 week (5 days) examination of residues in tissues indicated that the maximum of tissue equivalents of DEA was reached following 4-8 weeks of administration, since the rats have been found to be near the steady state for bioaccumulation with exception of the blood levels which continued to accumulate DEA.
The liver represented the organ with the highest tissue concentration. The half lives of the test compound after 4 weeks of repeated exposure calculated for the various organs was found to be at highest in blood with 54 days.
Tissue distribution of radioactivity 48 h after the last of five daily oral doses of [14C]DEA (7 mg/kg/day) to the male F-344 rat (n= 4).
Tissue |
eq.DEA per g tissue (in ng) |
Tissue/blood ratio |
% dose in total tissue |
adipose |
6150 ± 870 |
5.81± 0.93 |
1.24 ± 0.16 |
blood |
1060 ± 10 |
Unity |
0.16 ± 0.01 |
brain |
12400 ± 900 |
11.7 ± 0.8 |
0.31 ± 0.02 |
heart |
19100 ± 800 |
18.0 ± 1.9 |
0.18 ± 0.01 |
kidney |
197000 ± 35000 |
188 ± 45 |
4.56 ± 0.48 |
liver |
146000 ± 21000 |
188 ± 45 |
18.2 ± 1.00 |
lung |
37700 ± 7600 |
35.2 ± 4.6 |
0.62 ± 0.03 |
muscle |
9030 ± 1210 |
8.47 ± 0.34 |
12.4 ± 1.20 |
skin |
8480 ± 580 |
8.01 ± 0.75 |
4.18 ± 0.27 |
spleen |
35500 ± 4500 |
33.8 ± 6.4 |
0.25 ± 0.02 |
total |
42.1 ± 1.8 0 |
Values are mean ± SD for four rats
Tissue distribution of radioactivity 72 hours after the final dose administered in repeated oral dosing of [14C]DEA to male F344
Tissue |
eq.DEA per g tissue (in ng) |
Tissue/blood ratio |
% dose in total tissue |
2-week repeated dose |
|||
blood |
1790 ± 110 |
unity |
0.137 ± 0.010 |
brain |
18300 ± 1400 |
10.2 ± 0.7 |
0.191 ± 0.020 |
liver |
205000 ± 16000 |
114 ± 4 |
12.3 ± 1.2 |
spleen |
45900 ± 1700 |
26 ± 1 |
0.154 ± 0.013 |
4-week repeated dose |
|||
blood |
4110 ± 620 |
unity |
0.156 ± 0.020 |
brain |
28100 ± 2400 |
7.0 ± 1.2 |
0.131 ± 0.037 |
liver |
295000 ± 14000 |
73 ± 10 |
7.9 ± 0.4 |
spleen |
60400 ± 3500 |
15 ± 2 |
0.107 ± 0.010 |
8-week repeated dose |
|||
blood |
5750 ± 970 |
unity |
0.115 ± 0.021 |
brain |
31200 ± 2800 |
5.6 ± 1.2 |
0.080 ± 0.010 |
liver |
294000 ± 22000 |
53 ± 10 |
4.12 ± 0.12 |
spleen |
55300 ± 1100 |
9.9 ± 1.7 |
0.06 ± 0.00 |
Values are means ± SD of four to six rats
Tissue distribution of radioactivity 4 weeks after the final dose administered in a 4-week repeated dose study with [14C]DEA (7 mg/kg bw/day)
Tissue |
eq.DEA per g tissue (in ng) |
Half life in tissue (days) |
blood |
2860 ± 840 |
54.0 |
brain |
2690 ± 270 |
8.3 |
liver |
12800 ± 2900 |
6.2 |
spleen |
4210 ± 560 |
7.3 |
Metabolism:
Single oral and iv doses of the test compound were excreted predominantly as unchanged DEA. The profile of metabolites changed following 8 weeks of repeated oral dosing. DEA was still the major metabolite, but there were also significant amounts of poorly retained metabolites, as well as N-methyl DEA and a late eluting presumably more cationic metabolite.
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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