ChemForward Alternatives

SODIUM GLUCONATE

CASRN#

527-07-1

INCI Name

SODIUM GLUCONATE

Alternate Names

D-Gluconic acid, monosodium salt, D-Gluconic acid sodium salt, Gluconic acid sodium salt, Monosodium gluconate

Common Trade Names

Molecular Weight

218.14 g/mol

Functional Uses

Food additives, animal feed, fertilizer, corrosion inhibitor, personal care products, cleaning products

Common Impurities

Is this a VOC?

Is this an exempt VOC?

Vapor Pressure

7.23E-18 mm Hg

Octanol-water partition coefficient (log Kow)

-5.99

Solubility at 25 C

5.9E+5 mg/l

Boiling Point

N/A

Temperature Chemical Degrades at

196 °C

Particle size range as aerodynamic diameter

- - - μm

Hazard Summary

C2C Chemical Rating

GHS Health

None

GHS Enviro

None

Assessed by

GRADIENT

Assessment Date

Apr 17, 2020

Assessment Expires

Apr 17, 2025

Verification Status

verified

Executive Summary

Sodium gluconate is a sodium salt of gluconate used as a chelating and skin conditioning agent in cosmetic formulations. No human health or environmental hazards are identified for sodium gluconate. However, data gaps exist for carcinogenicity (all three routes of exposure), reproductive/developmental toxicity (dermal and inhalation routes), inhalation mammalian toxicity, endocrine activity and disruption, and neurotoxicity (inhalation route). Data from sodium gluconate and read-across indicate low concern for mutagenicity, reproductive and developmental toxicity (oral route), mammalian toxicity (oral and dermal routes), skin and eye irritation, and skin sensitization. No environmental hazards are identified using experimental and modeled data. Sodium gluconate is considered to be readily biodegradable and have a low potential for bioaccumulation.

Hazard Tables

How to read the GHS Hazard Summary Table

	Carcinogenicity	Mutagenicity	Reproductive Toxicity	Developmental Toxicity	Acute Toxicity	STOT-Single	STOT-Repeated	STOT- Neurotoxicity-Single	STOT- Neurotoxicity-Repeated	Skin Sensitizer	Respiratory Sensitizer	Skin Corrosion/Irritation	Serious Eye Damage/Eye Irritation	Acute Aquatic Toxicity	Chronic Aquatic Toxicity	Ozone Depletion
Oral Dermal Inhalation	CNP Rationale No CoI specific data or surrogate data were identified for oral carcinogenicity; however, gluconate occurs endogenously in mammals. Due to the fact that gluconate is an endogenously occurring compound utilized in normal physiological processes, it is not expected to be carcinogenic. However, in the absence of data, classification not possible is assigned. CNP Rationale No long-term carcinogenicity data were identified for the CoI via the dermal exposure route. Therefore, classification not possible. CNP Rationale No long-term carcinogenicity data were identified for the CoI via the inhalation exposure route. Therefore, classification not possible.	NC Rationale Based on negative results from an in vivo chromosome aberration test and an in vitro reverse gene mutation assay, the CoI is not considered a mutagen. The in vitro and in vivo mutagenicity studies with sodium glunconate produced negative results. In addition, as sodium gluconate is naturally present in cells, it was decided that further testing of the potential genotoxicity of this substance was not necessary as genotoxic effects are not expected (OECD SIDS, 2004). The negative Ames test indicates that the CoI does not induce point mutations. The negative results in the in vivo chromosome aberration test in mouse bone marrow indicates the substance does not induce chromosomal aberrations.	NC Rationale Based on the lack of reproductive effects in six developmental toxicity studies of the read-across gluconolactone (CAS 90-80-2) in mice, rats, hamsters, and rabbits and short term oral toxicity studies of the CoI in rats and beagles, the CoI is not classified as a reproductive toxicant. Confidence is low because the endpoint is relies on read-across and due to the lack of one/two-generation reproductive toxicity studies. CNP Rationale No CoI specific data or surrogate data were identified. Therefore, classification was not possible. CNP Rationale No inhalation reproductive studies were identified for the CoI or read-across. Therefore, classification not possible.	NC Rationale Based on the lack of teratogenic or developmental effects in six developmental toxicity studies of the read-across gluconolactone (CAS 90-80-2) in mice, rats, hamsters, and rabbits, the CoI is not classified as a developmental toxicant. Among rats and mice, no effects were noted on developmental or maternal endpoints at doses up to 4000 mg/kg-day of the read-across (gluconolactone) and for other species no adverse treatment-related developmental effects were noted up to 780 mg/kg-day for the surrogate. Confidence is low because the assessment is based on read-across. CNP Rationale No dermal developmental studies were identified for the CoI or read-across. Therefore, classification was not possible. CNP Rationale No inhalation developmental studies were identified for the CoI or read-across. There classification was not possible.	NC Rationale Based on LD50 values greater than 2000 mg/kg determined in two studies (one in rats and one in dogs), the CoI is not classified as an acute oral toxicant under GHS. NC Rationale The ingredient is not classified based on an LD50 > 2000 mg/kg in rats dermally exposed to a surrogate, gluconic acid (CAS 526-95-4). Low confidence is assigned based on the use of a read-across. CNP Rationale No acute inhalation toxicity studies were identified for the ingredient or read-across. Therefore, classification not possible.	NC Rationale Based on a lack of clinical signs and organ effects in acute oral studies in rats and dogs administered 2000 mg/kg, the CoI is not classified as a single exposure oral toxicant under GHS. In addition, observations in humans indicate gluconic acid and its derivatives (including sodium gluconate) are nontoxic and well-tolerated in humans. An ADI of "not specified" has been determined for this group of substances (JEFCA, 2999). NC Rationale The ingredient is not classified based on a lack of adverse effects in rats dermally exposed to the surrogate, gluconic acid (CAS 526-95-4). Low confidence is assigned based on the use of a read-across. CNP Rationale No CoI or read-across data were identified.	NC Rationale Based on sub-chronic oral studies Sprague Dawley (SD) rats and Beagle dogs, the CoI is not classified on this endpoint. These studies reported various effects (of relatively minor severity such as changes in urinalysis and vomiting) at > 1000 mg/kg-day, which is well above the GHS cut-off for classification (100 mg/kg-day). In addition, observations in humans indicate gluconic acid and its derivatives (including sodium gluconate) are nontoxic and well-tolerated in humans. An ADI of "not specified" has been determined for this group of substances (JEFCA, 1999). CNP Rationale No dermal repeated dose toxicity studies were identified for the ingredient or read-across. Therefore, classification not possible. CNP Rationale No inhalation repeated dose toxicity studies were identified for the ingredient or read-across. Therefore, classification not possible.	NC Rationale Based on a lack of clinical signs and nervous sytem organ effects in acute oral studies in rats and dogs administered 2000 mg/kg, the CoI is not classified for neurotoxicity via a single oral exposure. In addition, observations in humans indicate gluconic acid and its derivatives (including sodium gluconate) are nontoxic and well-tolerated in humans. NC Rationale The CoI is not classified based on a lack of adverse effects in rats dermally exposed to the surrogate, gluconic acid (CAS 526-95-4). Low confidence is assigned based on the use of a read-across. CNP Rationale No inhalation single dose toxicity studies were identified for the ingredient or read-across. Therefore classification is not possible.	NC Rationale Based on sub-chronic oral studies SD rats and Beagle dogs, the CoI is not classified for neurotoxicity via repeated oral exposure. These studies reported various effects (of relatively minor severity such as changes in urinalysis and vomiting) at > 1000 mg/kg-day, which is well above the GHS cut-off for classification (100 mg/kg-day). In addition, observations in humans indicate gluconic acid and its derivatives (including sodium gluconate) are nontoxic and well-tolerated in humans. CNP Rationale No dermal repeated dose toxicity studies were identified for the ingredient or read-across. Therefore classification is not possible. CNP Rationale No inhalation repeated dose toxicity studies were identified for the ingredient or read-across. Therefore classification is not possible.	NC Rationale No ingredient specific data was identified; thus, a surrogate, gluconic acid (CAS 526-95-4) was used to assess the endpoint. The ingredient is not classified based on a lack of sensitization (mean SI <1) in a mouse LLNA study. Low confidence is assigned based on the use of a read-across.	CNP Rationale No CoI or read-across data were identified.	NC Rationale No ingredient specific data were identified; thus, a surrogate, gluconic acid (CAS 526-95-4), was used to assess the endpoint. The ingredient is not classified based on a lack of skin irritation (erythema and edema) in rabbits dermally exposed to gluconic acid. Low confidence is assigned based on the use of a read-across. In addition, it should be noted that the use of gluconic acid is conservative for irritation endpoints since the CoI is buffered with a salt.	NC Rationale No ingredient specific data were identified; thus, a read-across, gluconic acid (CAS 526-95-4), was used to assess the endpoint. The ingredient is not classified based on a low eye irritation (mean effect scores <1 and full reversibility within 72 hrs) in in vivo and in vitro studies. Low confidence is assigned based on the use of a read-across. In addition, it should be noted that the use of gluconic acid is conservative for irritation endpoints since the CoI is buffered with a salt.	NC Rationale The ingredient is not classified as acutely toxic to algae based on two acute toxicity studies in algae that reported 72-hour ErC50s greater than 100 mg/L and 1000 mg/L, both based on growth rate.	NC Rationale Based on a 72-hour NOEC in algea of 560 mg/L and modeled chronic value of 38,220.629 mg/L in freshwater, CoI is not expected to be chronically toxic to algae . Further, sodium gluconate's bioaccumlation potential is low and it is readily biodegradable.	NC Rationale The CoI is not listed as an ozone depletor according to the Montreal Protocol or a greenhouse gas according to IPCC report.

Other

Explosives: Classification not possible (Data gap or insufficient data)
Flammable Gases: Not classified
Aerosols: Not classified
Oxidizing Gases: Not classified
Flammable Liquids: Not classified
Flammable Solids: Classification not possible (Data gap or insufficient data)
Self-reactive substances and mixtures: Classification not possible (Data gap or insufficient data)
Pyrophoric Liquids: Not classified
Pyrophoric Solids: Classification not possible (Data gap or insufficient data)
Self-heating Substances and Mixtures: Classification not possible (Data gap or insufficient data)
Substances and Mixtures which in contact with water, emit flammable gases: Classification not possible (Data gap or insufficient data)
Oxidizing Liquids: Not classified
Oxidizing Solids: Classification not possible (Data gap or insufficient data)
Organic Peroxides: Classification not possible (Data gap or insufficient data)
Corrosive to Metals: Classification not possible (Data gap or insufficient data)
Desensitized Explosives: Classification not possible (Data gap or insufficient data)
Lactation Toxicity: Classification not possible (Data gap or insufficient data)
Aspiration: Not classified

How to read the C2CC Hazard Summary Table

Human Health											Environmental							Other
	Carcinogenicity	Mutagenicity	Reproductive & Developmental Toxicity	Endocrine Activity / Disruption	Oral Toxicity	Dermal Toxicity	Inhalation Toxicity	Neurotoxicity	Skin, Eye, and Respiratory Corrosion/Irritation	Sensitization of Skin and Airways	Fish Toxicity	Daphnia Toxicity	Algae Toxicity	Terrestrial Toxicity	Persistence	Bioaccumulation	Climatic Relevance	Other (Human Health)	Organohalogens	Toxic Metals	Other (Environmental Health)
Oral Dermal Inhalation	- - -	G	G - -	- Rationale The CoI does not display endocrine activity or disruption based on a lack of dose-dependent effects on endocrine organs in chronic and subchronic studies with the CoI in rats and a lack of reproductive and developmental effects in prenatal developmental studies with the surrogate gluconolactone (CAS 90-80-2) in mice, rats, hamsters, and rabbits. Confidence is low due to the use of read-across and lack of guideline reproductive toxicity studies.	G	G	-	G G -	G	G	G	G	G	G	G Rationale The ingredient is classified as readily biodegradable based on three biodegradation studies. One was conducted under aerobic conditions and measured 89% degradation by O2 consumption after 28 days, one was conducted under anaerobic conditions and measured 100% degradation by CH4 evolution after 36 days, and one followed OECD Guideline 302 B and measured 98.3% degradation by COD in 3 days.	G Rationale Based on the low estimated Log Kow value (-5.99) and the low estimated BAF (Arnot-Gobas upper trophic: 0.893 L/kg wet-wt), the CoI is predicted to have a low potential for bioaccumulation. Due to the lack of experimental bioaccumulation data, low confidence is assigned.	G	G Rationale No data on dermal absorption were located for the CoI or read-across.	G	G	G

The Cradle to Cradle Material Health Assessment Methodology assigns hazard ratings to 24 individual human and environmental health endpoints. The system is largely based on GHS with the addition of endpoints including but not limited to Persistence, Bioaccumulation Potential and Endocrine Activity/Disruption. The possible C2C Chemical Ratings that can result from ChemForward’s simplified C2C chemical rating logic are:

C2C Chemical Rating	Color	Short Definition	Rules Summary
a	green	preferred in all applications	Chemical has no YELLOW or RED hazards or Cancer data gaps.
b	green	preferred in all applications	Chemical has no YELLOW hazards but lacks long-term cancer studies.
c/b	yellow/ green	acceptable in all applications	Chemical has one or more YELLOW risk flags before considering application. Applications where exposure is possible would result in a ‘c’ rating. Applications where exposure is unlikely or expected to be negligible would result in a ‘b’ rating.
grey/c	grey/ yellow	insufficient information available	Chemical has one or more GREY risk flags before considering application. Applications where exposure is possible would result in a ‘grey’ rating. Applications where exposure is unlikely or expected to be negligible would result in a ‘c’ rating.
x/c	red/ yellow	may be acceptable or problematic depending on application	Chemical has one or more RED risk flags before considering application. Applications where exposure is possible would result in a ‘x’ rating. Applications where exposure is unlikely or expected to be negligible would result in a ‘c’ rating.
N/A	red	problematic in all applications	Chemical is on a regulatory concern list, is climatically active, and/or is an organohalogen.
x-PBT	red	problematic in all applications	Chemical has a RED hazard for Persistence, Bioaccumulation, and another endpoint.
N/A	red	problematic in all applications	Chemical is a toxic metal, all of which have a RED hazard for Cancer, Mutagenicity, or Reproductive toxicity.
N/A	red	problematic in all applications	Chemical is on a regulatory concern list and has a RED hazard for Cancer, Mutagenicity, or Reproductive toxicity.
N/A	purple	banned in all applications	Chemical is on the C2C Certified banned list.

SODIUM GLUCONATE

Hazard Summary

Hazard Tables

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C2C Chemical Ratings

GHS

Verification Status

How to read the GHS Hazard Summary Table

How to read the C2CC Hazard Summary Table