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Description of key information

Acute oral toxicity: Key study: The oral LD50 in female rats was 2700 mg/kg bw (test method according to OECD 401).
Acute inhalation toxicity: Key study: The (4h) LC50 in male/female rats was greater than 5.6 mg/L air (test method equivalent to OECD 403).
Acute dermal toxicity: Key study: Read-across from experimental data on the analogue Fumaric Acid. The LD 50 for Calcium Acetate is calculated to be greater than 27247.2 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A scientifically defensible approach was used to conduct the study performed similar to OECD 423 guideline.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
(The pre-specified fixed doses were not use. The test substance was administrated to non-fasted animals)
Principles of method if other than guideline:
The doses are arranged in a logarithmic series differing by a factor of two instead of using the pre-specified doses of 5, 50, 300 or 2000 mg/kg bw, as is indicated in the guideline 423.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
not specified
Route of administration:
oral: gavage
Vehicle:
water
Doses:
The dosages are arranged in a logarithmic series differing by a factor of two.
No. of animals per sex per dose:
Five animals per dose.
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 280 mg/kg bw
Based on:
test mat.

The single oral LD50 for rats is 4.28 g/Kg bw.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 estimated was 4.28 g/Kg bw of calcium acetate monohydrate.
Executive summary:

The Acute Oral Toxicity test of calcium acetate monohydrate was performed in Carworth-Wistar male rats.

The dosages are arranged in a logarithmic series differing by a factor of two.

The single oral dose toxicity was estimated by the gastric intubation of a 0.100 g/ml water solution test substance to groups of five non-fasted rats.

The LD50 estimated was 4.28 g/Kg bw of calcium acetate monohydrate

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 700 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1982-01-26 to 1982-02-09.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test was realized using a method equivalent to OECD 403 guideline.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Chbb Thom (from THOMAE GmbH) Biberach/Riss
- Age at study initiation: 8 weeks
- Weight at study initiation: males: 228+/-9g and females. 195+/-20g.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2ºC
- Humidity (%): 55+/-5%
- Photoperiod (hrs dark / hrs light):12h/12h
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Vibratomat - (BASF) generating air -dust mixture.
- Exposure chamber volume: 55L
- Source and rate of air: flow rates were set: 1500 L/h air through the injector and 1500 L/ h induced air as dilution air.
- Method of conditioning air: was established that the substance-air mixture in the breathing zone the animals are not diluted by laboratory air
- System of generating particulates/aerosols: to generate a dust aerosol of the test substance a dust generator ( Vibratomat)was used, which sent the dust to the inhalation device.
- Method of particle size determination: The experimental group sample was collected earlier than 30 minutes after the test, for particle size analysis. Effective cutoff aerodynamic diameter 50% was determinated.
- Temperature, humidity, pressure in air chamber: controlled


TEST ATMOSPHERE
- Brief description of analytical method used: the dust concentration was calculated from the difference between filters.
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
5.6 mg/L
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing: 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Sex:
female
Dose descriptor:
LC50
Effect level:
> 5.6 mg/L air (analytical)
Based on:
test mat.
95% CL:
0.5
Exp. duration:
4 h
Remarks on result:
other: CL values corresponds to SD value.
Mortality:
No mortality observed.
Clinical signs:
other: No changes observed.
Body weight:
female 0 days:195
female 7 days:205
female 14 days:224
male 0 days:228
male 7 days:257
male 14 days:292
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LC50 value for 4 hours exposition at rat (male and female) is higher than 5.6 mg/L. At the dose no mortality was observed as well as any change during the pathology observations realized at the end of the study at 14 days.
Executive summary:

Calcium acetate LC50value for 4 hours exposition at rat (male and female) is higher than 5.6 mg/L. At the dose no mortality was observed as well as any change during the pathology observations realized at the end of the study at 14 days.The substance is considered as nontoxic.

Endpoint conclusion
Dose descriptor:
LC50
Value:
5 600 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
27 247.2 mg/kg bw

Additional information

Acute oral toxicity:

Key study:

Experimental results: Test method was according to OECD 401.

The oral LD50 of Calcium acetate was 2700 mg/kw/bw (in female rats was 1943 mg/kg bw, and LD50 for male rats was between 3160 and 4640 mg/kg bw).

Acute inhalation toxicity:

Key study:

Experimental results: Test method was similar to OECD 403.

The LC50 value for 4 hours exposition at rat (male and female) is higher than 5.6 mg/L. At this dose no mortality was observed as well as any change during the pathology observations realized at the end of the study at 14 days.

Acute dermal toxicity:

Key study:

Experimental results from a study similar to OECD 402 guideline on the analogue Fumaric Acid. The LD50 for Fumaric Acid is greater than 20000 mg/kg bw for rabbits.

Based on this experimental result and the molecular weights, the read-across approach is applied and the LD 50 for Calcium Acetate is calculated to be greater than 27247.2 mg/kg bw.

Justification for classification or non-classification

Acute toxicity:

Oral: LC50>2000mg/kg bw: non- classification

Dermal: LC50>2000mg/kg bw: non- classification

Inhalation: LC50>5 mg/L: non-classification