| GHS-Einstufung | This chemical does not meet GHS hazard criteria for 98.3% (117 of 119) of all reports.Not ClassifiedReported as not meeting GHS hazard criteria by 117 of 119 companies (only 1.7% companies provided GHS information). For more detailed information, please visit ECHA C&L website.Aggregated GHS information provided per 119 reports by companies from 3 notifications to the ECHA C&L Inventory.Reported as not meeting GHS hazard criteria per 117 of 119 reports by companies.There are 2 notifications provided by 2 of 119 reports by companies with hazard statement code(s).Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. For more detailed information, please visit ECHA C&L website. |
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| Regulatorische Informationen | Chemical: L-LysineRegulation (EC) No 1831/2003 (amended)L-Lysine: Does not have an individual approval but may be used under an appropriate group standard |
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| Weitere Sicherheitsinformationen | IMAP assessments - L-Lysine: Environment tier I assessmentIMAP assessments - L-Lysine: Human health tier I assessment |
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| Gefahrenübersicht | Safe when used as a flavoring agent in food[JECFA] May cause irritation[Sigma-Aldrich MSDS] |
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| FDA-Anforderungen | L-Lysine is a food additive permitted for direct addition to food for human consumption, as long as 1) the quantity of the substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritive, or other technical effect in food, and 2) any substance intended for use in or on food is of appropriate food grade and is prepared and handled as a food ingredient.Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: lysine hydrochloride is included in digestive aid drug products. /Lysine hydrochloride/Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: lysine is included in weight control drug products.Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: lysine hydrochloride is included in weight control drug products. /Lysine hydrochloride/Lysine used as a nutrient and/or dietary supplement in animal drugs, feeds, and related products is generally recognized as safe when used in accordance with good manufacturing or feeding practice. |
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| Special Reports | NAS, Food and Nutrition Board, Institute of MedicineDietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients). National Academy Press, Washington, D.C. (2005). [Table#3863][Available from, as of March 10, 2010: http://www.nap.edu/catalog/10490.html] |
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| Hazard Classes and Categories | Not Classified |
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| Entsorgungsverfahren | SRP: Criteria for land treatment or burial (sanitary landfill) disposal practices are subject to significant revision. Prior to implementing land disposal of waste residue (including waste sludge), consult with environmental regulatory agencies for guidance on acceptable disposal practices. |
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| Wechselwirkungen | Lysine 10 mmol/kq given to mice for 1 to 10 days significantly increased clonic and tonic seizure latencies caused by 60 mg/kg pentylenetetrazol (PTZ). On day 1 the clonic and tonic seizure latencies were increased from 160.4 +/- 26.3 and 828.6 +/- 230.8 s to 286.1 +/- 103.3 and 982.3 +/- 98.6 respectively. Both clonic and tonic seizure latencies increased steadily with additional L-lysine treatment without significant change in survival rate. On day 10, the anticonvulsant effect reached its highest level with a block of tonic seizures and survival rate of 100% without tolerance developing. Acute L-lysine significantly increased the mean clonic latency from 85.8 +/- 5.24 to 128.2 +/- 9.0 s and the mean tonic seizure from 287.2 +/- 58.7 to 313.5 +/- 42.2 s with 80 mg/kg of PTZ. On day 10 of treatment, the anticonvulsant effect of L-lysine was highest, with a significant incr of 155 and 184% in clonic and tonic latencies over control, respectively. After 15 and 20 day treatment, clonic and tonic seizure latencies and survival rate decreased, suggesting development of tolerance ...Acute intake of high levels of lysine interferes with dietary protein metabolism and competes with the transport of arginine, suggesting that adverse effects from high levels of lysine are more likely to occur if protein intake or dietary arginine intake is low.Intravenous L-lysine (16.5 to 41.3 g/day in young men) has been shown to inhibit renal tubular protein reabsorption. L-Lysine shares an intestinal transport system with L-arginine, and competes with L-arginine for reabsorption from renal tubules.Increased liver total lipids, triacylglycerol, and cholesterol concentrations were seen in rats fed 5% L-lysine and 15% casein for 2 weeks, an effect that can be reversed by feeding arginine.... The aim of the present study was to study the effects of L-arginine transport inhibition, using acute and repeated L-lysine treatment, on phencyclidine (PCP)-induced disruption of PPI in mice. RESULTS: Subchronic, and to some extent acute, pretreatment with L-lysine blocked a PCP-induced deficit in PPI without affecting basal PPI. CONCLUSIONS: L-lysine has been shown to block L-arginine transport in vitro, most likely via a competitive blockade and down regulation of cationic amino acid transporters. However, the importance of L-arginine transport as a regulatory mechanism in NO production in vivo is still not clear. The present results lend further support to the notion that some of the effects of PCP in the central nervous system are mediated via NO and that L-arginine transport may play a role in the regulation of NO production in the brain. |
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| Gesundheitliche Auswirkungen | Chronically high levels of lysine are associated with at least 5 inborn errors of metabolism including: D-2-Hydroxyglutaric Aciduria, Familial Hyperlysinemia I, Hyperlysinemia II, Pyruvate carboxylase deficiency and Saccharopinuria. |
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| Ökotoxizitätswerte | LC50Species: Eisenia fetida (earthworm, mature) direct application using filter paper 100-1000 ug/sq cm for 48 hr |
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| Expositionspfade | Absorbed from the lumen of the small intestine into the enterocytes by an active transport process |
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| Milk Concentrations | EXPERIMENTAL: Available lysine content is an indicator of protein quality and nutritional value of milk. Many studies have examined the effects of extraction, treatment and storage of human milk upon its components, though no references are found regarding the possible changes in milk quality as defined by its content in essential amino acids such as lysine. The present study investigates the available lysine content in human milk and the variations in lysine resulting from milk manipulation as follows: (a) Cold storage (refrigeration at 4 °C for 48 hours, and frozen for 15 days at -20 °C)(b) Thermal treatment under conditions of low (Holder)(63 °C/30 minutes) and high pasteurization (75 °C/15 seconds). The results obtained show a decrease in milk lysine concentration after storage in both refrigerated and frozen samples. Pasteurization causes a highly significant loss of available lysine. The lysine losses were greater on applying low pasteurization versus the more gentle conditions of high pasteurization. Conclusions: While manipulation through cold storage or thermal treatment does not affect the protein content of human milk, its protein quality is modified. When human milk must be subjected to hygienization, it is preferable to apply high temperature treatment (75 °C, 15 seconds) than habitual pasteurization (63 °C, 30 minutes). |
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| Toxizitätsübersicht | Safe in the present practices of use and concentration. Ingredient, concentration, and use information are available in documents discoverable at https://cir-reports.cir-safety.orgProteins of the herpes simplex virus are rich in L-arginine, and tissue culture studies indicate an enhancing effect on viral replication when the amino acid ratio of L-arginine to L-lysine is high in the tissue culture media. When the ratio of L-lysine to L-arginine is high, viral replication and the cytopathogenicity of herpes simplex virus have been found to be inhibited. L-lysine may facilitate the absorption of calcium from the small intestine. |
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| Ökotoxizitätsauszüge | /AQUATIC SPECIES/ /This/ study aimed to test whether lysine (Lys) intake at low (LL = 2.85 g/16 gN), medium (ML = 4.91 g/16 gN) and high levels (HL=9.19 g/16 gN) affected the expression of genes related to the GH-IGF system (i.e. GH receptor, GH-R, IGF-I, IGF-II, IGF binding protein 1, IGFBP-1, IGF-I receptor IGF-IR) in Atlantic salmon during seawater growth phase. Salmon fed the HL diet significantly up-regulated hepatic IGF-I mRNA level by a factor of 2.2 as compared to those with medium Lys intake. In addition a significant up-regulation of 2.7-fold in muscle IGF-II mRNA was present. Low Lys intake decreased the nitrogen deposition and muscle protein accretion in fish and significantly down-regulated hepatic IGFBP-1 as well as muscle GH-R and IGF-II, as compared to those fed the ML diet. mRNA of IGF-IR on the other hand was not affected by Lys intake. High Lys intake resulted in a 7-fold up-regulation of muscle IGF-II mRNA level as compared to low Lys intake, and thus might be an important local anabolic regulator in fast muscle tissue. The single indispensable amino acid Lys indeed affected signalling through the genes of IGF-I, IGFBP-1 in hepatic tissue and GH-R, IGF-II in fast muscle in Atlantic salmon. Concomitantly the higher Lys intake increased nitrogen deposition to a certain level. |
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| Plant Concentrations | Plants with the highest amount of Lysine(1). [Table#3861] |
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| Natural Pollution Sources | Lysine is an essential amino acid for human developmentprobably the most limited in the food chain(1). It is a natural constituent in: beans, peas, lentils, red meat, pork, poultry, brewer's yeast, cheese (especially parmesan), cod fish, sardines, nuts, eggs, soy beans, spirulina, fenugreek seeds and dairy products(2). |
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| Human Toxicity Excerpts | /HUMAN EXPOSURE STUDIES/ Studies of lysine tolerance of human infants have not found adverse effects. In one study, six infants (4 to 11 months of age) were given 60 to 1,080 mg of lysine monohydrochloride per 8 ounces of milk in a series of seven incremental doses for 3 to 4 days at each dose. No behavioral effects were observed, nor was there anorexia, diarrhea, or other signs of gastrointestinal upset, and no evidence of cystinuria. Similarly, no adverse effects were reported when 1- to 5-month-old infants were given up to 220 mg/kg body weight of lysine for 15 days./HUMAN EXPOSURE STUDIES/ Higher plasma and urinary concentrations of carnitine were found in six healthy adult males given a single 5-g oral dose of lysine./HUMAN EXPOSURE STUDIES/ In another study of eight healthy males (15 to 20 years of age) given a single oral dose of 1.2 g of L-lysine hydrochloride, growth hormone release was not significantly stimulated and no side effects were reported. /L-lysine hydrochloride//ALTERNATIVE and IN VITRO TESTS/ Essential amino acids, such as L-Arginine (Arg) and L-Lysine (Lys), are involved in bone metabolism and growth. ... Primary human osteoblast cultures were divided into four groups: the Arg Group received 0.625 mg/mL per day of Arg, the Lys Group 0.587 mg/ml per day of Lys, the Arg-Lys Group received both amino acids, whereas the Control Group was sham-treated. After 7 days, the following parameters were tested in all groups: alkaline phosphatase (ALP), nitric oxide (NO), calcium (Ca), phosphorus (P), osteocalcin (OC), type I collagen (PICP), interleukin-6 (IL-6), transforming growth factor-beta 1 (TGF-beta 1) on culture supernatant, platelet derived growth factor (PDGF), insulin-like growth factor-I (IGF-I), and MTT proliferation test on cells. Arg administration significantly increased ALP, NO, PICP and IGF-I production and reduced the level of IL-6. Lys administration over the same time interval mainly affected cell proliferation, as evidenced by the MTT test and immunostaining for PDGF. The same positive effects evidenced by the single administrations of the two amino acids resulted from their simultaneous administration. However, synergism could be demonstrated only for the decrease in the level of IL-6. Arg and Lys show a positive effect on human osteoblasts, which is related partly to the production of those factors required for matrix synthesis, and partly to the direct or mediated activation of cell proliferation./ALTERNATIVE and IN VITRO TESTS/ The retrovirus human T-cell lymphotrophic virus type-1 (HTLV-1) causes adult T-cell leukemia (ATL), which remains with no cure. This study evaluates the effects of l-lysine on proliferation and induction of apoptosis using non-cytotoxic concentrations of the test compound against HTLV-1 positive and negative malignant cell lines. The anti-proliferative effect of lysine was established and confirmed by studying the effects of the test compound on the expression of TGF mRNA expression by RT-PCR. To investigate the effect of l-lysine on the induction of apoptosis, DNA flow cytometry analyses was done and the results verified by cell death ELISA. The results indicated that a significant increase in the preG(1) phase and a decrease in the S phase of the cell cycle in all of the ATL cells tested. l-Lysine up-regulated p53, p21, and Bax protein levels and a down-regulation of Bcl-2alpha in all the cell lines tested. l-Lysine was found to exert its effect through the NF-kappaB pathway by inhibiting the p65 subunit specifically. Also l-lysine caused a decrease in the levels MMP-2 and MMP-9 as well as their enzymatic activity. |
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| Carcinogen Classification | No indication of carcinogenicity to humans (not listed by IARC). |
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| Non-Human Toxicity Excerpts | /LABORATORY ANIMALS: Developmental or Reproductive Toxicity/ Administration of lysine to pregnant rats does not appear to result in gross morphological changes, but higher fetal mortality and decreases in maternal and fetal body and brain weights have been found./GENOTOXICITY/ Of 20 amino acid pyrolysates tested, those of tryptophan, ornithine, glutamic acid, serine, lysine, and creatine showed strong mutagenicity by the modified Ames test./ALTERNATIVE and IN VITRO TESTS/ Accumulation of lysine (Lys) in tissues and biochemical fluids is the biochemical hallmark of patients affected by familial hyperlysinemia (FH) and also by other inherited neurometabolic disorders. ... The in vitro effect of Lys on various parameters of energy metabolism in cerebral cortex of 30-day-old Wistar rats/was investigated/ ... Total (tCK) and cytosolic creatine kinase activities were significantly inhibited by Lys, in contrast to the mitochondrial isoform which was not affected by this amino acid. Furthermore, the inhibitory effect of Lys on tCK activity was totally prevented by reduced glutathione, suggesting a possible role of reactive species oxidizing critical thiol groups of the enzyme. In contrast, Lys did not affect (14)CO2 production from U-(14)C- glucose (aerobic glycolytic pathway) and 1-(14)C-acetic acid (citric acid cycle activity), neither the various activities of the electron transfer chain and synaptic Na(+)K(+)-ATPase at concentrations as high as 5.0 mM. Considering the importance of creatine kinase (CK) activity for brain energy metabolism homeostasis and especially ATP transfer and buffering, the results suggest that inhibition of this enzyme by Lys may contribute to the neurological signs presented by symptomatic patients affected by FH and other neurodegenerative disorders in which Lys accumulates./ALTERNATIVE and IN VITRO TESTS/ ... L-lysine increased force of contraction in a concentration- and time-dependent manner in isolated electrically paced left atrium of mouse ... It further increased heart rate and left ventricular pressure in the isolated perfused mouse heart. In isolated adult mouse cardiomyocytes, the contractility as assessed by edge detection was increased as well as the Ca(2+) transients after electrically pacing by field stimulation. However, using the patch clamp technique, no effect of L-lysine on action potential duration from a constant holding potential or on current through L-type calcium channels could be observed. However, L-lysine led to a depolarization of unclamped cells. Furthermore, effects of L-lysine were stereospecific, as they were not elicited by D-lysine. The inotropic effects of L-lysine were not abrogated by additionally applied L-ornithine or L-arginine (known inhibitors of lysine transport). However, L-lysine (5 mM) shifted the concentration-response curve for a positive inotropic effect of 5-hydroxytryptamine (5-HTserotonin) in atrium of transgenic mice (with cardiac specific overexpression of 5-HT(4) receptors) to higher concentrations ...For more Non-Human Toxicity Excerpts (Complete) data for L-Lysine (7 total), please visit the HSDB record page. |
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| UN-Transportnummer | UN 2910 7 |
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| Gefahrensymbole | R |
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