ChemForward Alternatives

GLUCONOLACTONE

CASRN#

90-80-2

INCI Name

GLUCONOLACTONE

Alternate Names

gluconolactone, delta-gluconolactone, D-glucono-1,5-lactone, 1,5-Gluconolactone, D-Gluconic acid lactone

Common Trade Names

Glucono-Delta-Lactone

Molecular Weight

178.14 g/mol

Functional Uses

Drug product (veterinary/ animal pharmaceutical), Food additive (sequestering agent), Catalyst for acid colloid resins, conditioning agent for hair and skin products, inert pesticide ingredient,

Common Impurities

Is this a VOC?

Is this an exempt VOC?

Vapor Pressure

0.0868 mm Hg

Octanol-water partition coefficient (log Kow)

-1.98

Solubility at 25 C

32421.48 mg/l

Boiling Point

219 °C

Particle size range as aerodynamic diameter

1E+2 - 4.2E+2 μm

Hazard Summary

C2C Chemical Rating

grey/c

GHS Health

None

GHS Enviro

None

Assessed by

GRADIENT

Assessment Date

Apr 21, 2020

Assessment Expires

Apr 20, 2025

Verification Status

verified

Executive Summary

Gluconolactone is a naturally occurring polyhydroxy acid that is used cosmetic products due to its moisturizing and antioxidant activity. It's ability to scavenge free radicals may also offers some protection from UV radiation. No human health hazards were identified on acute or chronic toxicity, reproductive or developmental toxicity following oral exposure to gluconolactone and several read-across. Data gaps exist for inhalation exposure across all endpoints and for dermal exposure reproductive/developmental toxicity and neurotoxicity. No data are available for carcinogenicity for oral, dermal, or inhalation routes of exposure, however, gluconolactone is not mutagenic or genotoxic. Gluconolactone is not a dermal and ocular irritant or a dermal sensitizer. No environmental hazards were identified for gluconolactone based on read-across and modeled data.

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 read-across data were identified for oral carcinogenicity; however, gluconic acid and its derivatives are naturally occurring substances and 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 ingredient via the dermal exposure route. Therefore, classification not possible. CNP Rationale No long-term carcinogenicity data were identified for the ingredient via the inhalation exposure route. Therefore, classification not possible.	NC Rationale The CoI is not classified based on CoI-specific negative Ames assay as well as read-across-specific negatives Ames, in vitro mammalian genotoxicity, in vitro mammalian chromosome aberration, and in vivo chromosome aberration assays. Low confidence is assigned based on the use of read-across.	NC Rationale No reproductive toxicity studies were identified for gluconolactone or read-cross. However, a number of reproductive endpoints were assessed as part of CoI-specific developmental toxicity studies in mice, rats, hamsters, and rabbits. In addition, read-across-specific short-term repeated dose oral studies in the rat and in Beagle dogs included some reproductive toxicity endpoints. Several CoI-specific developmental studies reported no effects on some reproductive parameters such as number of implantations and resorptions. Based on the lack of effects on some reproductive parameters in six CoI-specific developmental toxicity studies in mice, rats, hamsters, and rabbits and read-across-specific short term oral toxicity studies in rats and beagles, the CoI is not classified as a reproductive toxicant. However, confidence is low due to the lack of studies specifically assessing reproductive toxicity for the CoI or read-across. 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 effects in six developmental toxicity studies 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 CoI and for other species, no adverse treatment-related developmental effects were noted up to 780 mg/kg-day. 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 The ingredient is not classified based on multiple acute oral toxicity studies with LD50 values greater than 2,000 mg/kg of read-across, potassium gluconate and sodium gluconate. Low confidence is assigned based on the use of read-across. 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 data 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 and above of sodium gluconate and potassium gluconate, gluconolactone is not classified as a single exposure oral toxicant under GHS. Low confidence is assigned based on the use of read-across. 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 The ingredient is not classified based on a lack of biologically relevant effects in a 6-month subchronic oral toxicity study conducted in rats. The study noted effects in the forestomach of the rodents; however, since the forestomach is unique to rodents, this was not seen to be biologically relevant for humans. A NOAEL was determined to be greater than or equal to 4000 mg/kg-day. In addition, observations in humans indicate gluconic acid and its derivatives are nontoxic and well-tolerated in humans. An ADI of "not specified" has been determined for this group of substances (JECFA, 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 and above of read-across, potassium gluconate and sodium gluconate, the CoI is not classified for neurotoxicity via a single oral exposure. In addition, observations in humans indicate gluconic acid and its derivatives are nontoxic and well-tolerated in humans. Low confidence is assigned based on the use of read-across. 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 inhalation single dose toxicity studies were identified for the ingredient or read-across. Therefore classification is not possible.	NC Rationale Based on a lack of neurotoxic effects observed in a 6-month study in SD rats exposed to up to 4000 mg/kg-day, the CoI is not classified as a neurotoxicity hazard via repeated oral exposure. 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.	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 low eye irritation (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.	NC Rationale Only one acute toxicity study was identified for the CoI, but the study was reported as "unreliable" in the ECHA dossier. Therefore, experimental data for a surrogate, sodium gluconate (CAS 527-07-1), was used to assess the endpoint. The CoI is not classified as acutely toxic to algae based on two acute toxicity studies for sodium gluconate in algae that reported 72-hour EC50s greater than 100 mg/L. Due to reliance on read-across data, low confidence is assigned.	NC Rationale No experimental data were available for the CoI. Modeled chronic values ranging between 896 mg/L and 4,045 mg/L in freshwater indicates no chronic toxicity. In addition, a 72-hour NOEC of 560 mg/L based on growth rate was reported for read-across, sodium gluconate. Furthermore, gluconolactone's bioaccumulation potential is low and it is readily biodegradable based on surrogate data. Therefore, the CoI is not expected to be an chronically toxic; however, due to the lack of experimental data, low confidence is assigned.	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: Classification not possible (Data gap or insufficient data)
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)

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 CoI does not display endocrine activity or disruption based on a lack of endocrine effects from repeated dose and developmental toxicity studies in mice, rats, hamsters, and rabbits. Confidence is low due to the lack of guideline reproductive toxicity studies for the CoI or surrogates.	G	G	-	G G -	G	G	G	G	G	G	G Rationale The CoI is classified as readily biodegradable based on three biodegradation studies for read-across sodium gluconate (CAS 527-07-1). 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. However, due to the reliance on surrogate data, low confidence is assigned.	G Rationale Based on the low estimated log Kow value (-1.98) 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.	Y	G Rationale No data on dermal absorption was 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.

GLUCONOLACTONE

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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