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EC number: 309-496-6 | CAS number: 100402-60-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
The substance is expected to be hydrolysed into glycerin and glucose which are nutrients and not suspected to be toxic for reproductive organs.
Short description of key information:
The substance is expected to be hydrolysed into glycerin and glucose which are nutrients and suspected to be toxic for reproductive organs.
Effects on developmental toxicity
Additional information
Glycerin Glucoside is composed of glucosides with glycerine. The chemical is therefore expected to be hydrolyzed and metabolised in mammals to the nutrients glucose and glycerine which are not suspected to be reproductive toxicants. In addition, the toxicological profiles of Glycerin Glucosides and structural related substances like alkyl polyglucosides do not indicate any hazard concern. These arguments are explained in the following chapters:
Hydrolysis:
Toxicokinetic and toxicity studies have been carried out with the structurally related alkyl polyglucosides (registered substance, CAS 110615-47-9) which are non-ionic surfactants used e.g.in personal care products. The substance is composed of a glucoside which bound to a fatty alcohol via an ether bond. Glycerin Glucoside is also composed of a glucoside which is bound to glycerin via an ether bound. Toxicokinetic studies in the mouse proved that alkyl polyglucosides are readily cleaved into glucose and fatty alcohol (Weber and Benning, 1984; cf. EAS, 2007, and US FDA, 2008). The same can be expected for glycerin glucoside as the mechanism should be comparable.
In addition, for digoxin, an endogenic glucoside which is also bound via an ether bound, a complete hydrolysis can occur in within 60-90 min (Gault et al 1977, see chapter 5.1.2).
In summary, it is expected that gylcerin glucoside is hydrolyzed into glycerin and glucoside.
Toxicity profile of Glycerin Glucoside:
Registration data show a low toxicity profile of Glycerin Glucoside. Accordingly, the substance has not been classified. An oral NOAEL of 1000 mg/kg bw/d has been derived from a sub-chronic study. At the dose level of 1000 mg/kg bw/d minor effects were noted which were considered to be non-adverse. In the study reproductive organs were also examined without considering any adverse effects. This is an additional evidence of the absence of effects related to the reproductive organs.
Read-across data:
The structural analogue C12-14 alkylpolyglucoside (CAS CAS 110615-47-9) was tested in a teratogenicity study (OECD 414) and a reproductive screening study (OECD 421).
In the OECD 414 study, teratogenic effects potentially induced by C12-14 alkylpolyglycoside were investigated. The test substance was administered orally by gavage once daily from day 6 to day 15 of gestation The dams tolerated the applied dose levels of up to 1000 mg/kg bw/day without any signs of clinical toxicity. Maternal body weight gain was not affected by the treatment. For maternal toxicity, embryo toxicity and teratogenicity, a NOAEL of 1000 mg/kg bw was deduced. From the studies presented, there is no indication for any impairment of reproduction, either with regard to the development of the progeny or to the effects on fertility both of the structural and functional level. Therefore, a hazard of reproductive toxicity for C12-14 alkylpolyglycoside is not expected.
In a one-generation screening assay according to OECD 421, C12-14 alkylpolyglycoside was applied to 40 males and 40 females Sprague-Dawley rats prior to mating, throughout the gestation and lactation period until post partum day 3. Treatment by gavage with 0, 100, 300 and 1000 mg/kg bw/day began 7 days after allocation for both males and females. Treatment commenced when males and females were approximately 12 weeks of age, 2 weeks before pairing and continuously thereafter, up to the day before sacrifice (study day 53, day 4 post partum). Matings were monogamous. During the study, parameters of general toxicity like clinical signs, food consumption and body weight gain were recorded in the parental generation and in the pups. Effects related to reproduction and hormone balance such as oestrous cycle, mating performance, pregnancy rates and the number of embryo resorptions were registered. Pup losses were recorded and the filial generation was examined for behavioural abnormalities and external growth abnormalities. No effects on the fertility were observed up to the highest dose of 1000 mg/kg bw/day. Under the conditions of a state-of-the-art reproduction/developmental toxicity screening testing according to the OECD guideline 421, no adverse effects were observed regarding male and female reproductive organs even at the very high dose of 1000 mg/kg bw/day.
Conclusion:
Due to hydrolysis data of structural related glucosides, Glycerin Glucoside is expected to be hydrolyzed to glycerin and glucose which are both nutrients. Glycerin and glucose are not suspected to be reproductive compounds. In addition, Glycerin Glucoside was tested in a subchronic toxicity study including additional examinations on the reproductive organs. No adverse effects have been observed. Furthermore, the structural related substance C12-14 alkyl polyglucoside was tested in an OECD 414 and OECD 421 study. The substances were applied via gavage. As no adverse effects were noted up to the maximum dose, a NOAEL of 1000 mg/kg was deduced for embryo/fetotoxicity, teratogenicity and maternal toxicity.
In summary, based on this weight-of evidence approach Glycerin Glucoside is not suspected to be toxic for the reproductive system of humans. A study to investigate the developmental toxicity of the registered substance is therefore scientifically unjustified.
Justification for classification or non-classification
There is no indication for toxicity to reproduction from existing data.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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