Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Calciumacetat

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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).