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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

REACH_negative | S. typhimurium TA 98, TA100, TA 1535, TA 1537 | OECD 471 | with and without | Sodium Sulfite #Analogy#


REACH_negative | S. typhimurium TA 1535, TA 1537, TA 98, TA 100, E. coli WP2 uvrA | OECD 471 | with and without | Ammonium Thiosulfate #Analogy#


REACH_positive | S. typhimurium TA 98, TA100, TA 1535, TA 1537, E. coli WP2 uvr A | OECD 471 | with and without | Sodium Polysulfide #Analogy#


REACH_negative | S. typhimurium TA 98, TA100, TA 1535, TA 1537 | OECD 471 | with and without | Sodium Sulfide #Analogy#

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented guideline study. Purity of the test substance is not stated. Only four test strains were used instead of five (E.coli WP2 strains or S. typhimurium TA102 should be used in addition acc. to OECD guideline).
Justification for type of information:
Read-across Hypothesis
The reaction mass is composed of the following substances: sodium sulfite, sodium thiosulfate, sodium polysulfide and disodium sulfide, with residual amounts of sodium sulfate (see detailed description in section 1.2).
The read-across hypothesis is that the reaction mass can be considered as a mixture of the different salts and all the members of the reaction mass are various salts with sodium as cation and S-compounds as anion.
The main assumption is that the cationic species do not contribute significantly to any differences in solubility or toxicity and thus will not influence the toxicological endpoints under consideration. In dilute aqueous conditions the salts will be fully dissociated. Hence the properties as expressed in aqueous media for the mixture of the given salts can be directly read across with suitable mass correction to the individual components of the mixture which are as well dissociated.
As some toxicological data and classification of the individual constituents as well as the quantitative composition are known, data are evaluated in a weight-of-evidence approach for the mixture of those constituents.

Category justification
The salts of the reaction mass all have high water solubility. Their behavior in water and biological systems is dominated by their ionization. Measured data was available for health endpoints for sodium sulfite, sodium polysulfide, calcium thiosulfate, disodium tetra sulfide, disodium disulfide, disodium sulfide, and ammonium thiosulfate. Thus, data is read across to the mixture of all salts in the reaction mass.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Only minor deviations from the test guideline: 4 bacteria strains were tested instead of 5 strains.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Target gene:
not applicable
Key result
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: Reduced his- background growth was observed at doses >=2500µg/plate using TA1535, TA1537 and TA98. With TA100 there was only a slight decrease in the number of his+ revertants in the preincubation test at 2500µg/plate.
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Conclusions:
According to the results of the study, the test substance sodium sulfide is not mutagenic in the Ames test under the experimental conditions chosen here.
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
11 February 2010 - 22 February 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Justification for type of information:
Read-across Hypothesis
The reaction mass is composed of the following substances: sodium sulfite, sodium thiosulfate, sodium polysulfide and disodium sulfide, with residual amounts of sodium sulfate (see detailed description in section 1.2).
The read-across hypothesis is that the reaction mass can be considered as a mixture of the different salts and all the members of the reaction mass are various salts with sodium as cation and S-compounds as anion.
The main assumption is that the cationic species do not contribute significantly to any differences in solubility or toxicity and thus will not influence the toxicological endpoints under consideration. In dilute aqueous conditions the salts will be fully dissociated. Hence the properties as expressed in aqueous media for the mixture of the given salts can be directly read across with suitable mass correction to the individual components of the mixture which are as well dissociated.
As some toxicological data and classification of the individual constituents as well as the quantitative composition are known, data are evaluated in a weight-of-evidence approach for the mixture of those constituents.

Category justification
The salts of the reaction mass all have high water solubility. Their behavior in water and biological systems is dominated by their ionization. Measured data was available for health endpoints for sodium sulfite, sodium polysulfide, calcium thiosulfate, disodium tetra sulfide, disodium disulfide, disodium sulfide, and ammonium thiosulfate. Thus, data is read across to the mixture of all salts in the reaction mass.

Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay
Key result
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
except for TA98 in the presence of S9-mix
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Conclusions:
Based on the results of this study it is concluded that Sodium polysulfide solution is not mutagenic in the Salmonella typhimurium reverse mutation assay and that Sodium polysulfide solution is mutagenic in the Escherichia coli reverse mutation assay.
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
May 3 - May 21 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only robust study summary available (original report at data owner)
Justification for type of information:
Read-across Hypothesis
The reaction mass is composed of the following substances: sodium sulfite, sodium thiosulfate, sodium polysulfide and disodium sulfide, with residual amounts of sodium sulfate (see detailed description in section 1.2).
The read-across hypothesis is that the reaction mass can be considered as a mixture of the different salts and all the members of the reaction mass are various salts with sodium as cation and S-compounds as anion.
The main assumption is that the cationic species do not contribute significantly to any differences in solubility or toxicity and thus will not influence the toxicological endpoints under consideration. In dilute aqueous conditions the salts will be fully dissociated. Hence the properties as expressed in aqueous media for the mixture of the given salts can be directly read across with suitable mass correction to the individual components of the mixture which are as well dissociated.
As some toxicological data and classification of the individual constituents as well as the quantitative composition are known, data are evaluated in a weight-of-evidence approach for the mixture of those constituents.

Category justification
The salts of the reaction mass all have high water solubility. Their behavior in water and biological systems is dominated by their ionization. Measured data was available for health endpoints for sodium sulfite, sodium polysulfide, calcium thiosulfate, disodium tetra sulfide, disodium disulfide, disodium sulfide, and ammonium thiosulfate. Thus, data is read across to the mixture of all salts in the reaction mass.

Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Key result
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100, E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Conclusions:
According to the results of the present study, the test substance is not mutagenic in the Ames Test.
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study. Minor deviations: Instead of five strains of bacteria only 4 strains were used. No GLP, because at the time of the study conduct, GLP was not compulsory.
Justification for type of information:
Read-across Hypothesis
The reaction mass is composed of the following substances: sodium sulfite, sodium thiosulfate, sodium polysulfide and disodium sulfide, with residual amounts of sodium sulfate (see detailed description in section 1.2).
The read-across hypothesis is that the reaction mass can be considered as a mixture of the different salts and all the members of the reaction mass are various salts with sodium as cation and S-compounds as anion.
The main assumption is that the cationic species do not contribute significantly to any differences in solubility or toxicity and thus will not influence the toxicological endpoints under consideration. In dilute aqueous conditions the salts will be fully dissociated. Hence the properties as expressed in aqueous media for the mixture of the given salts can be directly read across with suitable mass correction to the individual components of the mixture which are as well dissociated.
As some toxicological data and classification of the individual constituents as well as the quantitative composition are known, data are evaluated in a weight-of-evidence approach for the mixture of those constituents.

Category justification
The salts of the reaction mass all have high water solubility. Their behavior in water and biological systems is dominated by their ionization. Measured data was available for health endpoints for sodium sulfite, sodium polysulfide, calcium thiosulfate, disodium tetra sulfide, disodium disulfide, disodium sulfide, and ammonium thiosulfate. Thus, data is read across to the mixture of all salts in the reaction mass.

Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
; Instead of five strains of bacteria only 4 strains were used.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay
Target gene:
not applicable
Key result
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
No bacteriotoxic effect was observed.
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Conclusions:
According to the results of the present study, the test substance Natriumsulfit wasserfrei A is not mutagenic in the Ames test under the experimental conditions chosen here.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Four genotoxicity studies in bacteria are available (Ames tests). They overall demonstrate that the constituents of the reaction mass are not mutagenic to Salmonella typhimurium strains with and without metabolic activation. Sodium polysulfide was positive to Escherichia coli strain WP2 uvr A, whereas the read-across substance ammonium thiosulfate was negative to this strain. From the chemical structures, there is no structural alert for genotoxicity for all constituents of the mixture. Therefore, considering that a positive result was only observed in one strain and for one component, the weight-of-evidence allows to conclude that the reaction mass is not considered to be mutagenic in the Ames test.