Registration Dossier
Registration Dossier
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EC number: 213-195-4 | CAS number: 929-06-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- 10 animals per dose, 7 days post-exposure observation
- Principles of method if other than guideline:
- BASF-test, see details in remarks on material and methods.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 2-(2-aminoethoxy)ethanol
- EC Number:
- 213-195-4
- EC Name:
- 2-(2-aminoethoxy)ethanol
- Cas Number:
- 929-06-6
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2-(2-aminoethoxy)ethan-1-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Aminodiglykol, 2-(2 Hydroxyaethoxy-)aethylamin
- Physical state: liquid
- Analytical purity: > 99 %
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male: 186 - 280 g (mean); female: 166 - 218 g (mean)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2 %, 20 % and 30 %. - Doses:
- 200, 1600, 2000, 2500, 3200, 4000, 5000, 6400 µl/kg bw = 212, 1696, 2120, 2650, 3392, 4240, 5300, 6784 mg/kg bw (conversation is based on the density of 1.06 g/cm3).
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations: several times on the day of application and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 400 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 700 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 000 mg/kg bw
- Mortality:
- See details in remarks on results.
- Clinical signs:
- other: Staggering, abdomial position, apathy, irregular respiration, shallow flanks, closed eyes, ruffled fur.
- Gross pathology:
- 2120 - 6784 mg/kg bw: gastrorrhagia, sagged gastrointestinal tract, serous smeared snouts.
Any other information on results incl. tables
Mortality
| Dose (mg/kg bw) | Conc. (%) | Gender | 1 h | 24 h | 48 h | 8 days | |||||||||
| 6784 | 30 | male | 0/10 | 10/10 | 10/10 | 10/10 | |||||||||
| 6784 | 30 | female | 0/10 | 10/10 | 10/10 | 10/10 | |||||||||
| 5300 | 30 | male | 0/10 | 0/10 | 8/10 | 8/10 | |||||||||
| 4240 | 30 | male | 0/10 | 0/10 | 8/10 | 8/10 | |||||||||
| 3392 | 30 | male | 0/10 | 3/10 | 3/10 | 3/10 | |||||||||
| 3392 | 30 | female | 0/10 | 8/10 | 8/10 | 8/10 | |||||||||
| 2650 | 20 | female | 0/10 | 0/10 | 3/10 | 3/10 | |||||||||
| 2120 | 20 | female | 0/10 | 0/10 | 1/10 | 1/10 | |||||||||
| 1696 | 20 | male | 0/10 | 0/10 | 0/10 | 0/10 | |||||||||
| 1696 | 20 | female | 0/10 | 0/10 | 0/10 | 0/10 | |||||||||
| 212 | 2 | male | 0/10 | 0/10 | 0/10 | 0/10 | |||||||||
| 212 | 2 | female | 0/10 | 0/10 | 0/10 | 0/10 |
The test substance caused systemic toxicity (including mortality) in a dose dependent manner.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- oral LD50 ca. 3400 mg/kg (male/female)
- Executive summary:
In a study comparable to OECD guideline 401, the LD50 for oral acute toxicity in rats was calculated as ca. 3400 mg/kg body weight. Doses of 212, 1696, 2120, 2650, 3392, 4240, 5300, and 6784 mg/kg bw of an aqueous solution were applied by gavage followed by a post dose observation period of 7 days. Main clinical signs observed were staggering, apathy, irregular respiration, shallow flanks, abdomial position, closed eyes, ruffled fur. At necropsy, gastrorrhagia, sagged gastrointestinal tract and serous smeared snouts were observed.
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