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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
repeated dose toxicity: oral
Remarks:
other: read-across from a subacute study with an analogue
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The analogue Sodium Acetate which shares the same functional group with Calcium Acetate, also has comparable values for the relevant molecular properties for the repeated dose toxicity endpoint.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
other: read-across
Title:
Unnamed
Year:
2010

Materials and methods

Principles of method if other than guideline:
Read-across approach from published experimental data from a non-standard study on the analogue Sodium acetate.
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): sodium acetate
- Molecular formula (if other than submission substance):NaC2H3O2
- Molecular weight (if other than submission substance): 82.03
- Smiles notation (if other than submission substance):[Na+].[O-]C(C)=O
- InChl (if other than submission substance):InChI=1/C2H4O2.Na/c1-2(3)4;/h1H3,(H,3,4);/q;+1/p-1

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
Based on the experimental results obtained with the analogue Sodium acetate (NOAEL >= 3600 mg/kg bw/day in male Wistar rats treated daily by feed for 4 weeks), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Calcium acetate is calculated to be equal or greater than 3472.02 mg/kg bw/day.

The analogue Sodium acetate which shares the same functional group with Calcium acetate, also has comparable values for the relevant molecular properties. These properties are:
- a low log Pow value, which is -3.72 for Sodium Acetate and -1.38 for Calcium acetate,
- a high water solubility, which is 1.25 g/mL at 25 ºC for Sodium acetate and 1000 g/L at 25 ºC for Calcium acetate, and
- similar molecular weights, which are 82.0 for Sodium acetate and 158.17 for Calcium acetate.

Effect levels

Dose descriptor:
NOAEL
Effect level:
>= 3 472.02 other: mg/kg bw/day (estimated)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: overall effects

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

The NOAEL with the substance Calcium acetate is calculated to be equal or greater than 3472.02 mg/kg bw/day.

Applicant's summary and conclusion

Conclusions:
The NOAEL with the substance Calcium acetate is calculated to be equal or greater than 3472.02 mg/kg bw/day.
Executive summary:

Based on the experimental results (reported under the endpoint record 07.05.01_02 NaAc) obtained with the analogue Sodium acetate (NOAEL >= 3600 mg/kg bw/day in male Wistar rats treated daily by feed for 4 weeks), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Calcium acetate is calculated to be equal or greater than 3472.02 mg/kg bw/day.