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Toxicological information

Developmental toxicity / teratogenicity

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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

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)

open allclose all
Dose descriptor:
NOAEL
Effect level:
>= 867.98 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: maternal toxicity
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.