Registration Dossier
Registration Dossier
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EC number: 273-224-1 | CAS number: 68953-70-8 The complex combination of alkanolamines from the distillation of reaction products of ammonia and oxirane. It consists predominantly of triethanolamine, diethanolamine and higher amines from the reaction of triethanolamine and oxirane.
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study which meets basic scientific principles
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- no
- 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
- Analytical purity: 88.5%
- Impurities (identity and concentrations): MEA<0.12; DEA 6.0; TEA-1EO 5.3
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Cox CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 20 male and 20 female per group
Diet: ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: standard chow
- Duration of treatment / exposure:
- 91 days
- Frequency of treatment:
- continuously
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0; 250; 500; 1000 mg/kg bw
Basis:
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Post-exposure period: no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
FOOD EFFICIENCY: Yes
HISTOPATHOLOGY: Yes
HAEMATOLOGY: Yes - Sacrifice and pathology:
- HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Details on results:
- SUMMARY OF DAILY OBSERVATIONS
One rat escaped from its cage during the third week of the test and had to be eliminated because of contamination. One male from the mid-dose group and one female from the low-dose group displayed symptoms of inner ear infection.
AVERAGE BODY WEIGHT GAIN, FEED CONSUMPTION, AND EFFICIENCY
The only adverse significant differences noted were in body weight gain and feed efficiency in the female rats of the mid-dose group.
ORGAN/BODY WEIGHT RATIO
There were no significant differences notes in organ to body weight ratios.
HISTOPATHOLOGY
No lesions were found which followed a pattern of agent-induced toxicity. Tissue alterations observed were mild and were not considered significant.
PATHOLOGY
There do not appear to be any gross or histopathologic indications of a treatment-related effect.
HEMATOLOGY
The only abnormality observed was a slightly elevated WBC in one animal. This change was not considered significant. All other values are within normal limits and there were no significant differences between treatment groups.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 other: mg/kg bw
- Sex:
- male/female
- Basis for effect level:
- other: no significant effects at highest dose tested
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Bodyweight gain
|
males |
females |
Control |
341±30 |
157±23 |
TEA-1 (250 mg/kg) |
339±35 |
170±13 |
TEA-1 (500 mg/kg) |
331±28 |
151±15 |
TEA-1 (1000 mg/kg) |
329±32 |
161±22 |
Feed consumption
|
males |
females |
Control |
2143±155 |
1542±105 |
TEA-1 (250 mg/kg) |
2073±165 |
1592±108 |
TEA-1 (500 mg/kg) |
2076±282 |
5166±115 |
TEA-1 (1000 mg/kg) |
2091±155 |
1604±123 |
Feed efficiency
|
males |
females |
Control |
15.95±0.98 |
10.18±1.1 |
TEA-1 (250 mg/kg) |
16.35±0.97 |
10.72±0.67 |
TEA-1 (500 mg/kg) |
15.56±0.84 |
8.62±2.7 |
TEA-1 (1000 mg/kg) |
15.75±0.99 |
9.99±0.88 |
Organ to bodyweight ratio (LIVER)
|
males |
females |
Control |
38.2±3.3 |
42.1±12.2 |
TEA-1 (250 mg/kg) |
41.6±3.7 |
39.9±3.3 |
TEA-1 (500 mg/kg) |
45.9±6.9 |
44.6±1.0 |
TEA-1 (1000 mg/kg) |
49.6±2.9 |
45.3±2.9 |
Organ to bodyweight ratio (KIDNEY)
|
males |
females |
Control |
7.6±0.6 |
8.1±0.3 |
TEA-1 (250 mg/kg) |
9.3±1.3 |
10.2±1.4 |
TEA-1 (500 mg/kg) |
9.2±0.7 |
11.1±0.7 |
TEA-1 (1000 mg/kg) |
10.4±1.4 |
10.3±1.4 |
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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