Registration Dossier

Toxicological information

Endpoint summary

Currently viewing:

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.