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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study
Justification for type of information:
The basis for the read-across concept for this project is the equilibrium between sulfates, hydrogensulfates, and sulfuric acid in aqueous solutions depending on pH value which is clearly described in published literature and summarised in the following equations:
H2SO4 <-> HSO4- + H+ HSO4- <-> H+ + SO42-
As the nature of the cation should make no significant difference in this case concerning toxicity and solubility (all compounds are very soluble in water), only the chemical and biological properties of the anion are considered relevant. Based on the described equilibrium correlations, we propose unrestricted read-across between the groups of sulfates, hydrogensulfates and sulfuric acid concerning systemic toxicity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Principles of method if other than guideline:
Method: other: Salmonella/Microsome test, Ames et al, Mutation Res. 31, 347-364 (1975)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium sulphate
EC Number:
231-820-9
EC Name:
Sodium sulphate
Cas Number:
7757-82-6
Molecular formula:
H2O4S.2Na
IUPAC Name:
disodium sulfate
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4

Method

Species / strain
Species / strain / cell type:
other: S. Typhimurium TA1535, TA1537, TA100, TA98
Metabolic activation:
with and without
Test concentrations with justification for top dose:
312.5 to 5000 µg per plate with 4 dilutions
Details on test system and experimental conditions:
IUCLID4 Type: Ames test

Results and discussion

Test results
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: no cytotoxicity observed
Remarks on result:
other: other: S. Typhimurium TA1535, TA1537, TA100, TA98
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

RS-Freetext:
EFFECTS: 
- With metabolic activation: both tests, no effects
- Without metabolic activation: both tests, no effects
FREQUENCY OF EFFECTS: n.a.
PRECIPITATION CONCENTRATION: not described 
MITOTIC INDEX: not described
CYTOTOXIC CONCENTRATION: no toxicity observed up to 5000
mg/l
TEST-SPECIFIC CONFOUNDING FACTORS: not described
STATISTICAL RESULTS: n.a.

Applicant's summary and conclusion

Conclusions:
EFFECTS:  - With metabolic activation: both tests, no effects - Without metabolic activation: both tests, no effects.
Sodium sulfate did not show mutagenic effects in the Ames test.