Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-867-5 | CAS number: 111-41-1
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Original reference in Japanese, study summary and tables in English.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: guidelines for 28-Day Repeat Dose Toxicity Test of Chemicals (Japan)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-(2-aminoethylamino)ethanol
- EC Number:
- 203-867-5
- EC Name:
- 2-(2-aminoethylamino)ethanol
- Cas Number:
- 111-41-1
- Molecular formula:
- C4H12N2O
- IUPAC Name:
- 2-[(2-aminoethyl)amino]ethan-1-ol
- Details on test material:
- 2-(2-aminoethylamino)ethanol, purity 99.9 %
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 weeks
- Weight at study initiation: males: 358-440 g ; females 221-275 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 60; 250; 1000 mg/kg bw / day
Basis:
nominal in water
- No. of animals per sex per dose:
- 6 rats
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: 14 days in a recovery group (6/sex) in dosis groups 0, 250 and 1000 mg/kg bw / day
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations: every 3 days
FOOD CONSUMPTION AND COMPOUND INTAKE
- food consumption was recorded
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: once during the treatment and recovery periods
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: all animals
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: not further described
- Animals fasted: No data
- How many animals: all animals
URINALYSIS: Yes
- Time schedule for collection of urine: not further described
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
NEUROBEHAVIOURAL EXAMINATION: No
- Sacrifice and pathology:
- - Animals were sacrificed at day 29 and day 43 after a 14-day recovery period.
- GROSS PATHOLOGY: Yes
- HISTOPATHOLOGY: Yes - Statistics:
- The data were subjected to statistical analysis. However, it is not clear which method was used because this is not described in the English language sections of the paper.
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):
- effects observed, treatment-related
- Food efficiency:
- not examined
- 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:
- effects observed, treatment-related
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- (1) 28-day treatment groups
BODY WEIGHT AND WEIGHT GAIN
Body weight development was very similar in all treated groups and not influenced by the treatment.
FOOD CONSUMPTION
A temporary decrease in the food consumption was noted in females given 250 mg/kg bw / day and in both sexes given 1000 mg/kg bw / day duringthe early administration period
HAEMATOLOGY
Hematology revealed a decrease in hemoglobin concentration in both sexes given 1000 mg/kg bw / day (p<0.01 in males, p<0.05 in females).
CLINICAL CHEMISTRY
Blood chemistry revealed an increase in GOT activity in males given 250 and 1000 mg/kg bw / day (both p<0.05), a decrease in total cholesterol in females given 1000 mg/kg bw / day (p<0.05) and a decrease in chloride concentration in males given 1000 mg/kg bw / day (p<0.05).
URINALYSIS
Urinalysis revealed an increase in protein concentration in females given 250 mg/kg bw / day and in both sexes given 1000 mg/kg bw / day, an increase in the specific gravity in females given 250 and 1000 mg/kg bw / day (p<0.05 and p<0.01, resp.), and a decrease in urinary volume in females given 1000mg/kg bw / day (p<0.05).
ORGAN WEIGHTS
Kidneys: increased absolute and relative kidney weights were noted in males and increased relative kidney weights in females p<0.01) given 1000mg/kg bw / day. The relative adrenal weights were decreased in males given 1000 mg/kg (p<0.05) but no associated histopathological lesions were found.
HISTOPATHOLOGY:
Histopathologically, deposition of amphophilic bodies and swelling in the renal proximal tubules in the cortico-medullary junction were noted in males given 250 mg/kg bw / day and in both sexes given 1000 mg/kg bw / day. Mucosal thickening of the stomach at the limiting ridge was noted in both sexes given 250 and 1000 mg/kg bw / day.
(2) 14-day recovery groups
Compound-related changes were reversible except for those in the kidney and stomach after a 14-day recovery period, without gaining a level of statistical significance.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 60 other: mg/kg bw / day
- Sex:
- male/female
- Basis for effect level:
- other: urinalysis; kidney weight and kidney histopathology at 250 mg/kg bw/d
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
|
Dose [mg/kg bw / d] |
|||||||
Endpoint |
Males |
Females |
||||||
|
0 |
60 |
250 |
1000 |
0 |
60 |
250 |
1000 |
|
|
|
|
|
|
|
|
|
Weight data at day 28 |
|
|
|
|
|
|
|
|
Body weight [g] |
389 |
412 |
386 |
394 |
237 |
248 |
238 |
234 |
Kidneys [g] |
2.8 |
2.95 |
2.97 |
3.19** |
1.87 |
1.90 |
1.94 |
2.12 |
Kidneys [%] |
0.72 |
0.72 |
0.78 |
0.81** |
0.79 |
0.77 |
0.82 |
0.91** |
Adrenals [mg] |
69 |
65 |
64 |
58 |
75 |
75 |
80 |
75 |
Adrenals [%] |
18 |
16 |
17 |
15* |
32 |
31 |
34 |
32 |
|
|
|
|
|
|
|
|
|
Clinical chemistry |
|
|
|
|
|
|
|
|
Hemoglobin [g/l] |
15.8 |
15.7 |
16.0 |
14.9** |
15.9 |
15.5 |
15.2 |
14.8* |
GOT [IU/l] |
65 |
61 |
76* |
76* |
67 |
70 |
70 |
69 |
Chloride [mEq/l] |
110 |
108 |
110 |
107* |
111 |
111 |
112 |
110 |
Cholesterol [mg/dl] |
66 |
64 |
51* |
55 |
85 |
72 |
78 |
57* |
|
|
|
|
|
|
|
|
|
Urinalysis |
|
|
|
|
|
|
|
|
Volume [ml] |
14.8 |
17 |
14.7 |
13.4 |
11.4 |
9.6 |
7.8 |
4.5* |
Gravity [g/ml] |
1.062 |
1.06 |
1.069 |
1.07 |
1.053 |
1.073 |
1.081* |
1.1** |
Applicant's summary and conclusion
- Executive summary:
Repeated Dose 28 - Day Oral Toxicity:
In a subacute toxicity study AEEA (99,9 % a.i.) was administered to six Crj:CD (SD) rats per sex per dose by gavage at dose levels of 0, 60, 250 or 1000 mg/kg bw/day for a period of 28 days (Okazaki, 1996). The NOEL was considered to be 60 mg/kg bw/day for both males and females.
In the 28-day treatment a temporary decrease in the food consumption was noted in females given 250 mg/kg bw/day and in both sexes given 1000 mg/kg bw/day during the early administration period. Hematology revealed a decrease in hemoglobin in both sexes given 1000 mg/kg bw/day. Blood chemistry revealed an increase in GOT in males given 250 and 1000 mg/kg bw/day, a decrease in total cholesterol concentration in females given 1000 mg/kg bw/day and a decrease in chloride concentration in males given 1000 mg/kg bw/day. Urinalysis revealed an increase in protein concentration in females given 250 mg/kg bw/day and in both sexes given 1000 mg/kg bw/day, an increase in the specific gravity in females given 250 and 1000 mg/kg bw/day and a decrease in urinary volume in females given 1000 mg/kg bw/day. Increased absolute and relative kidney weights were noted in males and increased relative kidney weights in females given 1000 mg/kg bw/day. The relative adrenal weights were decreased in males given 1000 mg/kg bw/day but no associated histopathological lesions were found. Histopathologically, deposition of amphophilic bodies and swelling in the renal proximal tubules in the corticomedullary junction were noted in males given 250 mg/kg bw/day and in both sexes given 1000 mg/kg bw/day. Mucosal thickening of the stomach at the limiting ridge was noted in both sexes given 250 and 1000 mg/kg bw/day. In the 14 -day recovery groups compound-related changes were reversible. After the 14 -day recovery period minimal (grade 1) focal basophilic changes in the proximal tubule was noted in 2/6 and 5/6 males at 250 and 1000 mg/kg bw/d, respectively. The relevance of this finding is questionable since this effect was observed in males of the recovery group, but neither in males of the 1000 mg/kg bw/d group nor in the 1000 mg/kg bw/d females dosing and recovery group and was also present in 1/6 control females.
This subacute toxicity study in the rat is acceptable and satisfies the guideline requirement for a repeated dose oral toxicity study in rodents (OECD guideline 407).
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.