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EC number: 292-883-6 | CAS number: 91002-07-2
- 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
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A registration dossier shall contain information on the human health hazard assessment (regulation 1907/2006, Art.10). However, it is considered that the information requirements for stearic acid as laid down in annex VII to IX can be fulfilled by adaptation of the standard testing regime according to Annex XI, points 1.1.3, 1.2, as presented in the following: (1) A large part of human nutrition consists of oils and fats of vegetable and animal origin. The oils and fats contain a mixture of fatty acids with a chainlength distribution of C6-C24 (vegetable sources) and C4-C22 (animal origin). The stearic acid content of widely used oils and fats makes up to: 3.5-6% (palm oil), 15% (beef fat), 13% (cow milk), 12% (bacon fat) (IUPAC 2001) (2) The Scientific Committee on GRAS Substances (SCOGS) of the U.S. FDA concluded on stearic acid: “As a substances that may migrate to foods from cotton or cotton fabrics, there is no evidence in the available information on tallow, hydrogenated tallow, or stearic acid that demonstrates, or suggests reasonably grounds to suspect, a hazard to the public, when they are used at levels that are now current or that might reasonably be expected in the future. There is no evidence in the available information on calcium stearate that demonstrates, or suggests reasonable grounds to suspect a hazard to the public, when it is used as a direct food additive at levels that are now current or that might reasonably be expected in the future.” (SCOGS, 1975) (3) Exposure of breast-fed babies to stearic acid via mother milk: A breast-fed of 3 months age has an average weight of 6.5 kg (WHO 2013) and the infant ingests approx. 180mL/kg bw of milk per day (Riordan 2001), being 1170 mL for a baby at an age of 3 months. The fat content of mother milk is approx. 4.2% (United Nations 1996), with a content of stearic acid of approx. 7.5% (total content of C18 fatty acids: C18:0, C18:1, C18:2 and C18:3 = 58.2%) (Finley et al. 1985). This results in a total “exposure” for a 3 month old baby of 3.7 g stearic acid per day, being 570 mg/kg bw/day. (4) Substances obtained from natural sources are exempt from the obligation to register (in accordance with Annex V, Section 9). Since stearic acid is a substance obtained from natural sources (see point 1 above), thus the chemically unmodified substance is exempt from registration. Based on the above given arguments, one may safely assume that human exposure towards stearic acid exerts any adverse effects of toxicological relevance after acute or chronic exposure is grossly implausible. In conclusion, the conduct of any further toxicity studies with acute or chronic exposure in animals would not contribute any new information and is therefore not considered to be required.
Migrated from Short description of key information:
Sensitisation by or intolerance to an abundantly available essential element such as stearic acid would be grossly implausible and can therefore safely be excluded.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A registration dossier shall contain information on the human health hazard assessment (regulation 1907/2006, Art.10). However, it is considered that the information requirements for stearic acid as laid down in annex VII to IX can be fulfilled by adaptation of the standard testing regime according to Annex XI, points 1.1.3, 1.2, as presented in the following: (1) A large part of human nutrition consists of oils and fats of vegetable and animal origin. The oils and fats contain a mixture of fatty acids with a chainlength distribution of C6-C24 (vegetable sources) and C4-C22 (animal origin). The stearic acid content of widely used oils and fats makes up to: 3.5-6% (palm oil), 15% (beef fat), 13% (cow milk), 12% (bacon fat) (IUPAC 2001) (2) The Scientific Committee on GRAS Substances (SCOGS) of the U.S. FDA concluded on stearic acid: “As a substances that may migrate to foods from cotton or cotton fabrics, there is no evidence in the available information on tallow, hydrogenated tallow, or stearic acid that demonstrates, or suggests reasonably grounds to suspect, a hazard to the public, when they are used at levels that are now current or that might reasonably be expected in the future. There is no evidence in the available information on calcium stearate that demonstrates, or suggests reasonable grounds to suspect a hazard to the public, when it is used as a direct food additive at levels that are now current or that might reasonably be expected in the future.” (SCOGS, 1975) (3) Exposure of breast-fed babies to stearic acid via mother milk: A breast-fed of 3 months age has an average weight of 6.5 kg (WHO 2013) and the infant ingests approx. 180mL/kg bw of milk per day (Riordan 2001), being 1170 mL for a baby at an age of 3 months. The fat content of mother milk is approx. 4.2% (United Nations 1996), with a content of stearic acid of approx. 7.5% (total content of C18 fatty acids: C18:0, C18:1, C18:2 and C18:3 = 58.2%) (Finley et al. 1985). This results in a total “exposure” for a 3 month old baby of 3.7 g stearic acid per day, being 570 mg/kg bw/day. (4) Substances obtained from natural sources are exempt from the obligation to register (in accordance with Annex V, Section 9). Since stearic acid is a substance obtained from natural sources (see point 1 above), thus the chemically unmodified substance is exempt from registration. Based on the above given arguments, one may safely assume that human exposure towards stearic acid exerts any adverse effects of toxicological relevance after acute or chronic exposure is grossly implausible. In conclusion, the conduct of any further toxicity studies with acute or chronic exposure in animals would not contribute any new information and is therefore not considered to be required.
Migrated from Short description of key information:
respiratory sensitisation by or intolerance to an abundantly available essential element such as stearic acid would be grossly implausible and can therefore safely be excluded.
Justification for classification or non-classification
No information of any sensitising potential of stearic acid is available. Stearic acid does not need to be classified for sensitisation.
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.
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