Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 603-436-5 | CAS number: 13076-17-0
- 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

Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Lactides rapidly hydrolyse to lactoyl lactic acid and subsequently to lactic acid in aqueous media. This is independent from stereochemistry. Lactic acid is a ubiquitous and essential biological molecule, in humans and other mammals, but also in most if not all vertebrate and invertebrate animals, as well as in many micro-organisms. As such the biokinetics, metabolism and distribution of lactic acid have to be considered in the context of its normal biochemistry; exogenous lactic acid will be indistinguishable from endogenous lactic acid and will follow the same biochemical pathways as endogenous lactic acid, at least up to a certain systemic level.
The biochemistry of lactic acid has been reviewed and summarized in Sterenborg, 2007.
Hydrolysis of lactide
The hydrolysis rate of lactide in aqueous environments at pH 2 was determined in-house, to simulate the fate of lactide in gastric fluids. The results obtained in the PURAC study are in excellent agreement with the results presented by Conn et al. (1995), and it can be concluded that the hydrolytic half life of lactide in strongly acid environments, such as gastric fluid, and at physiological temperature, is in the order of 45 minutes to 1 hour. (half-life of 0.4 hr in a 0.1 N HCI solution at 37°C according to Conn, 1995).
The average residence time of stomach contents is in the order of hours. As such, a significant fraction of orally administered lactide will leave the stomach, and enter the small intestine, substantially as hydrolysis products, initially lactoyl lactide, and ultimately lactic acid and its equilibrium oligomers. Since the intestines also present an aqueous environment, hydrolysis will not stop after passage through the stomach, but will proceed, only slightly more slowly (average half life ca 1.5 hours). In addition, lactide is subject to microbial degradation. Thus, it can be concluded that after oral administration, lactide is rapidly converted into lactic acid and its oligomers; the systemic toxicity of lactide can therefore be understood in terms of the systemic toxicity of lactic acid.
From the Purac in-house study (Verhaar 2010) it can furthermore be concluded that the hydrolysis product of lactide is lactoyl lactic acid. Lactoyl lactic acid is a major species in the spontaneous equilibrium that gets established when lactic acid in dissolved in water, and is therefore part of any normal aqueous solution of lactic acid, including the lactic acid solutions used for toxicological and ecotoxicological testing. In fact, a solution of lactoyl lactic acid in water will itself establish an equilibrium in which lactic acid, lactoyl lactic acid, and longer oligomers are present. As such, lactoyl lactic acid falls fully under the (toxicological) definition of lactic acid.
Dermal fate of lactide
Dermally applied lactide is susceptible to hydrolysis in the sweat layer that is always present on the skin as well as in epidermal, dermal and transdermal compartments. At low concentrations, dermal toxicity of lactide can therefore be understood in terms of the dermal toxicity of lactic acid.
Lactic acid is a natural constituent of the human dermis and epidermis. Lactic acid is frequently used as a humectant in leave-on skin cosmetics, where its main mode of action is through its sequestration in the stratum corneum, where it will aid in attracting water into the SC and holding it there. Skin absorption of lactic acid can be substantial, with up to 25 % being present in skin after prolonged exposure to low doses of high concentration formulations. However, the dermal uptake of lactic acid leading to systemic exposure is only a small fraction (Sah 1998).
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.