Registration Dossier
Registration Dossier
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EC number: 219-323-5 | CAS number: 2414-98-4
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:
- other: Comparable to guideline study, basic data given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- only males tested, increased number of animals
- GLP compliance:
- no
- Remarks:
- not yet stipulated at that time
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Magnesium ethanolate
- EC Number:
- 219-323-5
- EC Name:
- Magnesium ethanolate
- Cas Number:
- 2414-98-4
- Molecular formula:
- C2H6O.1/2Mg
- IUPAC Name:
- magnesium ethanolate
- Details on test material:
- - Name of test material (as cited in study report): Magnesium ethylate
- Molecular formula (if other than submission substance): Mg(OC2H5)2
- Molecular weight (if other than submission substance): 114.43
- Substance type: organometallic
- Physical state: solid
- Analytical purity: no data
- Lot/batch No.: no data
- Stability under test conditions: not stable
- Storage condition of test material: Sensitive to hydrolysis and air
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Willi Gassner (WIGA), Versuchstierzuchtanstalt Sulzfeld/Germany
- Weight at study initiation: 162 g (geom. mean, control group) / 178 g (geom. mean, test group)
- Fasting period before study: overnight until 6 h after administration
- Housing: Plastic cage (Macrolon)
- Diet: ad libitum except fasting period (see above)
- Water: ad libitum
- Acclimation period: 3 - 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-2
- Humidity (%): 55 +-10
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Remarks:
- anhydrous
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 3160 mg/10 mL (maximum achievable dose in the vehicle)
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: The TS remained stable until administration (no hydrolysis).
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual): Briefly before administration - mortar-ground test substance was suspended in anhydrous peanut oil
using a shear-blade blender (ULTRA-TURRAX). The test substance suspension was stirred with a
magnetic stirrer just before administration in each case. - Doses:
- 3160 mg/kg bw
- No. of animals per sex per dose:
- control 10
test 30 - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: OBSERVATION: the first 6 h throughout, 24 h p.a, then daily /
WEIGHT: before treatment, 7 d and 14 d p.a.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 3 160 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: 0 - 6 h p.a.: Reduced spontaneous activity and soft stool 24 h p.a.: No particular findings 2-14 d p.a.: No particular findings
- Gross pathology:
- Autopsy of 19/30 animals revealed no particular histomorphological effects. In a few treated animals, one or more of the following changes were found: gray-pink discolorations of the lung, collapsed right lung (atelectasis), petechia in the lung, reddening of the gastric mucosa, enlarged liver.
No pathological changes were noted in the control group. - Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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