Registration Dossier
Registration Dossier
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EC number: 200-540-9 | CAS number: 62-54-4
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: Test method was according to OECD guideline 401. No data on GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Calcium di(acetate)
- EC Number:
- 200-540-9
- EC Name:
- Calcium di(acetate)
- Cas Number:
- 62-54-4
- Molecular formula:
- C2H4O2.1/2Ca
- IUPAC Name:
- calcium diacetate
- Reference substance name:
- calcium acetate
- IUPAC Name:
- calcium acetate
- Details on test material:
- - Name of test material (as cited in study report): Calciumacetat
Constituent 1
Constituent 2
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 Wiga, Sulzfeld.
- Age at study initiation: ca. 12 weeks old
- Weight at study initiation: Similar weights (± 20 %).
- Fasting period before study: 16 hours (no food, but water ad libitum).
- Housing: Animals were housed 5 per cage, in V-II-A steel wire cages, type DK-III (Fa. Becker & Co., Castrop-Rauxel).
- Diet (e.g. ad libitum): Ssniff R, Fa. Ssniff, laboratory animal diet; 4470 Soest.
- Water (e.g. ad libitum): Tap water, ad libitum.
- Acclimation period: At least 1 week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26 ºC
- Humidity (%): 45-75 %
- Air changes (per hr): 15-20 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark
IN-LIFE DATES: From: 26.11.1981 To: 16.04.1982
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- Test substance was administered dissolved in 0.5 % carboxymethyl cellulose aqueous solution.
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw was given only to the highest dose group. Other groups received 10 mL/kg bw. - Doses:
- 1470, 2150, 3160, and 4640 mg/kg bw.
- No. of animals per sex per dose:
- 5 male and 5 female rats per dose group.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical symptoms were observed <15 min, 15 min, 30 min, 1 h, 2 h, 4 h, and 5 h after test substance administration. Thereafter, once a day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology. - Statistics:
- Probit Analysis.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 943 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 160 - 4 640 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 700 mg/kg bw
- Based on:
- test mat.
- Gross pathology:
- In dead animals during the study (male and female): in stomach and intestine: Multiple weakness, with white mucous fluid content.
In sacrificed animals:
Male: Peritonitis chronica circumscripta with adhesions of the liver with the stomach and the lateral abdominal wall.
Any other information on results incl. tables
The LD50 was ca. 2700 mg/kg/bw (female rats was ca. 1943 mg/kg bw, and LD50 for male rats was between 3160 and 4640 mg/kg bw).
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 was 2700 mg/kg/bw (female rats was ca. 1943 mg/kg bw, and LD50 for male rats was between 3160 and 4640 mg/kg bw).
- Executive summary:
An acute oral toxicity test was performed on male and female Sprague-Dawley rats with Calcium Acetate. A single dose of test substance was administered by gavage at concentrations of 1470, 2150, 3160, and 4640 mg/kg bw. 5 male and 5 female rats were used per dose group. Animals were observed for 14 days.
The LD50 was 2700 mg/kg/bw (female rats was ca. 1943 mg/kg bw, and LD50 for male rats was between 3160 and 4640 mg/kg bw).
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