Registration Dossier
Registration Dossier
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EC number: 210-734-5 | CAS number: 622-40-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP and non guideline study, but similar to EU and OECD guideline. The study is sufficient for risk assessment together with other oral toxicity studies available.
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute Toxicological Evaluation of Hydroxyethylmorpholine
- Author:
- Papciak, R.J. and Mallory, V.T.
- Year:
- 1 990
- Bibliographic source:
- Acute Tox. Data 1, 16-17 (1990)
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-morpholinoethanol
- EC Number:
- 210-734-5
- EC Name:
- 2-morpholinoethanol
- Cas Number:
- 622-40-2
- Molecular formula:
- C6H13NO2
- IUPAC Name:
- 2-(morpholin-4-yl)ethan-1-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 180 to 360 g
- Fasting period before study: yes
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DOSAGE PREPARATION: Administered undiluted.
- Doses:
- 4000, 5000, 6300, 8000, 10000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes - Statistics:
- Calculation of LD50 according to Litchfield J.T. and Wilcoxon F.J. (1949): A simplified method of evaluating dose-effect experiments, Pharmacol. Exp. Ther., 96, 99-115
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality pattern : 4/10 @ 4000 mg/kg bw; 3/10 @ 5000 mg/kg bw; 8/10 @ 6 300 mg/kg bw; 9/10 @ 8000 mg/kg bw and 10/10 @ 10000 mg/kg bw.
- Clinical signs:
- other: No data
- Gross pathology:
- Necropsy findings (study deaths) : Diffused red and fluid-filled stomachs and distended, discolored, and congested intestines were observed.
Terminal necropsy : No visible lesions were observed. - Other findings:
- None
Applicant's summary and conclusion
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