Registration Dossier
Registration Dossier
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EC number: 214-230-6 | CAS number: 1115-70-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-04-03 to 1984-06-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Metformin hydrochloride
- EC Number:
- 214-230-6
- EC Name:
- Metformin hydrochloride
- Cas Number:
- 1115-70-4
- Molecular formula:
- C4H11N5.ClH
- IUPAC Name:
- N,N-dimethylimidodicarbonimidic diamide hydrochloride
- Test material form:
- solid: bulk
Constituent 1
- Specific details on test material used for the study:
- Metformin Hydrochloride
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: young
- Weight at study initiation: 288.2g (males) and 216.4g (females)
- Fasting period before study: overnight
- Housing: single in mesh bottom cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Air changes (per hr): 12-15 / hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1984-04-04 To: day 1984-04-24
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25 %
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: dose range finding - Doses:
- 1000, 1320, 1730, 2280, 3000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: no
- Other examinations performed:
clinical signs: frequently during the day of dosing and then daily thereafter for 14 days
body weight: prior to dosing and after 7 and 14 days
gross necropsy to all animals dying during the 14-day observation period - Statistics:
- Probit analysis was used for LD50 calculation.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 770 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 510 - < 2 100
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 600 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality was observed starting at the lowest dose of 1000 mg/kg bw
- Clinical signs:
- other: decreased activity, ataxia, tremors, diarhea, salivation
- Gross pathology:
- no test item related leasions were reported
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- In an oral toxicity study in rats equivalent to OECD 401, the acute oral LD50 of the test article for both sexes combined was calculated to be 1.77 g/kg body weight with a 95% confidence interval of 1.51 to 2.10 g/kg.
- Executive summary:
The test material was evaluated for acute oral toxicity in male and female Sprague-Dawley rats. The substance was orally administered (gavage) dissolved in water as the vehicle to animals (5 per sex per group) at dose levels of 1000, 1320, 1730, 2280 and 3000 mg/kg bw. After administration, the rats were observed for mortality and clinical signs up to 14 days after treatment. All animals were weighed before treatment (day1) and therafter on day 8 and day 15. All animals dying during the study were subjected to a gross necropsy.
Mortalities were dose dependent and observed starting at the lowest dose of 1000 mg/kg bw. All deaths occurred within 24 hours following dose administration. Decreased activity, ataxia, tremors, diarrhea, salivation were noted as clinical signs.
Under the conditions of this study, the acute oral LD50 of the test article in rats in both sexes combined was calculated to be 1770 mg/kg bw (1,77 g/kg body weight) with a 95% confidence interval of 1,51 to 2,10 g/kg.
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