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EC number: 203-049-8 | CAS number: 102-71-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- 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-[bis(2-hydroxyethyl)amino]ethan-1-ol
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 / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- 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
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 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.
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 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.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- There were no significant differences notes in organ to body weight ratios.
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No lesions were found which followed a pattern of agent-induced toxicity. Tissue alterations observed were mild and were not considered significant.
- Details on results:
- 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.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: no significant effects at highest dose tested
Target system / organ toxicity
- Key result
- 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
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