Magnesium di(acetate)

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

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 Magnesium Acetate, also has comparable values for the relevant molecular properties for the toxicity to reproduction 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 an in vivo teratology screen on the analogue Sodium Acetate.

GLP compliance:

not specified

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
- Structural formula attached as image file (if other than submission substance): see Fig.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:no effects

Details on maternal toxic effects:
Based on the experimental results obtained with the analogue Sodium Acetate (NOAEL >= 1000 mg/kg bw/day (basis for effect: mortality, pregnancy and resorption) in Pregnant CD-1 mice treated by oral gavage on days 8-12 of gestation), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Magnesium acetate is calculated to be equal or greater than 867.98 mg/kg bw/day.

The analogue Sodium acetate which shares the same functional group with Magnesium 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 Magnesium acetate,
- a high water solubility, which is 1.25 g/mL at 25 ºC for Sodium acetate and 16600 mg/L at 25 ºC for Magnesium acetate, and
- similar molecular weights, which are 82.0 for Sodium acetate and 142.40 for Magnesium acetate.

Effect levels (maternal animals)

1

Dose descriptor:

NOAEL

Effect level:

>= 867.98 mg/kg bw/day

Based on:

test mat.

Basis for effect level:

other: maternal toxicity

2

Dose descriptor:

NOAEL

Effect level:

>= 867.98 mg/kg bw/day

Based on:

test mat.

Basis for effect level:

other: other:

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
Based on the experimental results obtained with the analogue Sodium Acetate (NOAEL >= 1000 mg/kg bw/day (basis for effect: mortality and body weight on neonatals) in Pregnant CD-1 mice treated by oral gavage on days 8-12 of gestation), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Magnesium acetate is calculated to be equal or greater than 867.98 mg/kg bw/day.

The analogue Sodium acetate which shares the same functional group with Magnesium 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 Magnesium acetate,
- a high water solubility, which is 1.25 g/mL at 25 ºC for Sodium acetate and 16600 mg/L at 25 ºC for Magnesium acetate, and
- similar molecular weights, which are 82.0 for Sodium acetate and 142.40 for Magnesium acetate.

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Any other information on results incl. tables

The NOAEL with the substance Magnesium acetate is calculated to be equal or greater than 867.98 mg/kg bw/day (based on maternal toxicity: mortality, pregnancy and resorption; and on neonatal effects: mortality and body weight).

Applicant's summary and conclusion

Conclusions:

The NOAEL with the substance Magnesium acetate is calculated to be equal or greater than 867.98 mg/kg bw/day (based on maternal toxicity: mortality, pregnancy and resorption; and on neonatal effects: mortality and body weight).

Executive summary:

Based on the experimental results (reported under the endpoint record 07.08.02_01 NaAc) obtained with the analogue Sodium Acetate (NOAEL >= 1000 mg/kg bw/day in Pregnant CD-1 mice treated by oral gavage on days 8-12 of gestation, based on maternal toxicity: mortality, pregnancy and resorption; and on neonatal effects: mortality and body weight), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Magnesium acetate is calculated to be equal or greater than 867.98 mg/kg bw/day.