Registration Dossier
Registration Dossier
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EC number: 205-487-5 | CAS number: 141-52-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study described in sufficient detail.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Sodium ethanolate
- EC Number:
- 205-487-5
- EC Name:
- Sodium ethanolate
- Cas Number:
- 141-52-6
- Molecular formula:
- C2H6O.Na
- IUPAC Name:
- sodium ethanolate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Bor:WISW(SPF Cpb)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, 4799 Borchen
- Weight at study initiation: 188 g (mean)
- Fasting period before study: 16 h
- Housing: Makrolon Typ III
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/-1°C
- Humidity (%):60% +/-5%
- Air changes (per hr):15 oer hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark /12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5-10%
- Amount of vehicle (if gavage): volume 10 cm3/kg - Doses:
- 501 mg/kg bw
566 mg/kg bw
631 mg/kg bw
794 mg/kg bw - No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Statistics:
- For body weights mean values were calculated. LD50 were calculated according to Litchfield and Wilcoxon with 95% confidence intervals.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 598 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 549 - 652
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 630 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 568 - 699
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 560 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 523 - 599
- Mortality:
- 501 mg/kg: female 0/5; male 0/5
566 mg/kg: female 3/5; male 1/5
631 mg/kg: female 5/5; male 2/5
794 mg/kg: female 5/5; male 5/5 - Clinical signs:
- Animals showed a hunched posture, closed eyes, pilo-erection, uncontrolled moves, agressive behaviour, decreased respiration rate, diarrhea, lethargy, ptosis pallor of the extremities, red/brown staining around the snout, emaciation and ataxie.
- Body weight:
- Body weights were reduced compared to the beginning of the study.
- Gross pathology:
- Dissection showed a dark brown to black colour of the spleens and the livers. Mucosa of the forestomach and stomach were corroded. Strong hyperemia and swelling of the gastric epithelium. Stomach, liver, spleen, pancreas, and the intestine sticked together.
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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