Calcium di(acetate)

Repeated dose toxicity: oral

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 for cross-reference:

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

Test material information

Constituent 1

Reference substance name:

Sodium acetate

EC Number:

204-823-8

EC Name:

Sodium acetate

Cas Number:

127-09-3

IUPAC Name:

sodium acetate

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.