| GHS 분류 | This chemical does not meet GHS hazard criteria for 99.6% (265 of 266) of all reports.Not ClassifiedReported as not meeting GHS hazard criteria by 265 of 266 companies (only 0.4% companies provided GHS information). For more detailed information, please visit ECHA C&L website.Aggregated GHS information provided per 266 reports by companies from 3 notifications to the ECHA C&L Inventory.Reported as not meeting GHS hazard criteria per 265 of 266 reports by companies.There is 1 notification provided by 1 of 266 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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| 규제 정보 | Chemical: 1H-Thieno[3,4-d]imidazole-4-pentanoic acid, hexahydro-2-oxo-, (3aS,4S,6aR)-Regulation (EC) No 178/2002 (amended)Biotin: Does not have an individual approval but may be used under an appropriate group standard |
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| 기타 안전 정보 | Evaluation - Chemicals that are unlikely to require further regulation to manage risks to environment |
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| 유해성 요약 | May cause irritation[Sigma-Aldrich MSDS] |
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| FDA 요건 | Biotin 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.Biotin used as a nutrient in food for human consumption is generally recognized as safe when used in accordance with good manufacturing practice.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: biotin is included in weight control drug products.The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription drug products, incl biotin, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act. |
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| Toxic Combustion Products | Emits toxic fumes of NOx and SOx when heated to decomp. |
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| Hazard Classes and Categories | Not Classified |
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| Hazardous Reactivities and Incompatibilities | Incompatible with nitrous acid, oxidizing agents, formaldehyde, strong acid, or alkali. |
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| 보관 조건 | Capsules and Tablets: Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. |
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| 처리 방법 | SRP: The most favorable course of action is to use an alternative chemical product with less inherent propensity for occupational exposure or environmental contamination. Recycle any unused portion of the material for its approved use or return it to the manufacturer or supplier. Ultimate disposal of the chemical must consider: the material's impact on air qualitypotential migration in soil or watereffects on animal, aquatic, and plant lifeand conformance with environmental and public health regulations. |
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| 상호 작용 | Carbamazepine, phenytoin, and phenobarbital can accelerate biotin metabolism and may cause reduced biotin status. Long-term use of carbamazepine, phenytoin, phenobarbital and primidone has been associated with reduced plasma concentrations of biotin.Antibiotic use may decrease the biotin contribution to the body made by the microflora of the large intestine.Groups of Holtzman rats were mated and the gravid females were dosed sc with 100 mg D(+)-biotin in 0.2 mL of 0.1 N NaOH/kg body weight on days 0 and 1 of gestation. Nine animals were dosed with biotin only, 7 were given biotin and 0.1 ug 17(beta)-estradiol in 0.05 mL olive oil sc on days 5 to 20 of gestation, and 7 were given biotin and 4 mg progesterone in 0.2 mL olive oil sc on days 5 to 20 of gestation. Nine gravid animals were untreated and used as a negative-control group. Three groups of 6 nongravid animals were dosed in the same manner as the gravid animals and used as nonpregnant treated controls. The animals were killed and examined on day 21 of gestation. Complete resorption of the fetuses occurred in 8 of the 9 rats dosed with biotin onlydosing with estrogen or progesterone prevented the resorptions. Fetal and placental weights from animals dosed with biotin and estrogen or progesterone were decr as compared to controls, but the decr was not statistically significant. Biotin caused a decr in body weights of gravid and nongravid animalsbody weights of gravid animals given biotin and progesterone were similar to gravid untreated control, whereas body weights of gravid animals given biotin and estrogen were incr. The uterine weights of gravid animals given biotin and estrogen were similar to that of gravid untreated controls, whereas the uterine weights of animals dosed with biotin and progesterone were statistically significantly decr....Groups of Holtzman rats were mated, and gravid females were dosed with 100 mg D(+)-biotin in 0.2 mL of 0.1 N NaOH/kg body weight on days 13 and 14 of gestation. Eleven animals were dosed with biotin only, 7 were given biotin and 0.1 ug 17(beta)-estradiol in 0.05 mL olive oil sc until day 20 of gestation, and 7 were given biotin and 4 mg progesterone in 0.2 mL olive oil sc until day 20 of gestation. Nine gravid animals were untreated and used as a negative-control group. The animals were killed and examined on day 21 of gestation. Resorptions occurred in 2 of the 11 animals dosed with biotin only. The maternal body weights and the fetal, uterine, and placental weights of the remaining 9 animals of this group were statistically significantly decr as compared to controls. The maternal body weights and the fetal, uterine, and placental weights of the animals dosed with biotin and estrogen and the maternal body weights and uterine weights of the animals dosed with biotin and progesterone were similar to control values. Hepatic and ovarian weights were similar for animals of the test and control groups.For more Interactions (Complete) data for BIOTIN (6 total), please visit the HSDB record page. |
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| 유해 작용 | Biotin consumption for beneficial means remains unclear, but it has been considered a very difficult drug to overdose on or cause injury to the body. When taking anticonvulsants such as carbamazepine or phenobarbital, the requirements for biotin increase due to these medications inhibiting uptake into the brush borders of membrane vesicles. Smoking also metabolizes biotin quicklytherefore, increased doses may be warranted when indicated if the patient is a smoker. Information on other drug interactions is minimal. There have been no reported injuries for taking too much biotin, but there are documented cases of biotin deficiency.Biotin can interfere with some hormone assays. In immunoassays using the streptavidin-biotin interaction, the interference may induce both false-positive and false-negative results. The hormone levels affected may include thyroid functions, gonadotrophins, and vitamin D. |
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| 노출 경로 | Oral.
Systemic - approximately 50% |
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| Milk Concentrations | The current recommendation for safe and adequate daily dietary intake of biotin for infants is based on measurements of biotin concentration in human milk and calculations of biotin intake that tacitly assume that biotin content of human milk is reasonably uniform for a given subject. This assumption of uniformity was tested by examining the effects of several factors on the biotin concentration. The degree of breast emptying had little effect on biotin concentration. However, in three of five individuals studied, the biotin concentration varied significantly over 24 hr. In two of five subjects, there was a consistent difference between breasts of approximately 16%. In the first 18 day postpartum, the milk concentration of biotin increased steadily in four of the eight individuals studied, remained low in two and increased erratically in two. Rather than reaching a stable plateau in mature milk, biotin concentration varied substantially in most of the subjects. These observations provide evidence that an adequate scheme for estimating total biotin intake of the breastfed infant will require sampling from both breasts frequently over the 24-hr cycle and frequently as a function of time postpartum.Because estimates of the biotin requirement for infants currently are based on the biotin concentration in human milk, we sought to determine whether inactive biotin metabolites are present. Samples were collected for 7 weeks post partum from 15 healthy women. Biotin and the inactive metabolites bisnorbiotin and biotin sulfoxide were measured by means of a high-performance liquid chromatography avidin-binding assay. At 8 days post partum the proportion of biotin was 44%, bisnorbiotin 48%, and biotin sulfoxide 8%. Although biotin content increased post partum (p less than 0.003), the metabolites remained an important portion of the total providing evidence that accurate measurement of biotin in human milk requires an assay that is specific for biotin. |
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| 독성 요약 | 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.orgThere is no specific antidote for overdosing on biotin. Excess in the body is rare, and since biotin is a water-soluble vitamin, it is excreted in the urine when in excess. Signs and symptoms of biotin overdose may include and are not limited to insomnia, excessive thirst, and urination. Since biotin has documentation in playing a role in postprandial glucose control, it bears mention that excess would cause signs and symptoms of a person experiencing hyperglycemia (e.g., increased thirst). Diabetic patients should, therefore, be cautious before taking biotin. Although not impossible, it would be very difficult to overdose on biotin. Anaphylaxis is always a common concern with any medication but would present with systemic signs and symptoms. In rare cases, eosinophilic pleuropericardial effusion, a life-threatening condition, may occur. Poison control centers should always be contacted with a suspected overdose.Biotin is necessary for the proper functioning of enzymes that transport carboxyl units and fix carbon dioxide, and is required for various metabolic functions, including gluconeogenesis, lipogenesis, fatty acid biosynthesis, propionate metabolism, and catabolism of branched-chain amino acids. |
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| Signs and Symptoms | Prolonged skin contact may cause irritation. |
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| Natural Pollution Sources | Growth factor present in very minute amt in every living cell. Plays in indispensable role in numerous naturally occurring carboxylation reactions. Occurs mainly bound to proteins or polypeptides. Richest sources are liver, kidney, pancreas, yeast, and milk. Biotin content of cancerous tumors is higher than that of normal tissue.... biotin acts as a coenzyme for the body's carboxylation reaction and is a factor in maintaining healthy muscle, hair, nails, and skin.BIOTIN IS PRESENT IN MOLASSES...NUTS, VEGETABLES & GRAINS. NATURALLY OCCURRING ISOMER IS D-BIOTINL-BIOTIN HAS NO BIOLOGICAL ACTIVITY. |
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| Human Toxicity Excerpts | /OTHER TOXICITY INFORMATION/ Biotin toxicity has not been reported in man despite administration of large amounts for as long as 6 months./OTHER TOXICITY INFORMATION/ Biotin-responsive basal ganglia disease (BBGD) is a recessive disorder with childhood onset that presents as a subacute encephalopathy, with confusion, dysarthria, and dysphagia, and that progresses to severe cogwheel rigidity, dystonia, quadriparesis, and eventual death, if left untreated. BBGD symptoms disappear within a few days with the administration of high doses of biotin (5 to 10 mg/kg/day). On brain magnetic resonance imaging examination, patients display central bilateral necrosis in the head of the caudate, with complete or partial involvement of the putamen. All patients diagnosed to date are of Saudi, Syrian, or Yemeni ancestry, and all have consanguineous parents. Using linkage analysis in four families ... /the authors/ mapped the genetic defect near marker D2S2158 in 2q36.3 (LOD=5.9theta=0.0) to a minimum candidate region (approximately 2 Mb) between D2S2354 and D2S1256, on the basis of complete homozygosity. In this segment, each family displayed one of two different missense mutations that altered the coding sequence of SLC19A3, the gene for a transporter related to the reduced-folate (encoded by SLC19A1) and thiamin (encoded by SLC19A2) transporters. |
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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: Acute Exposure/ Application of 0.1% d-biotin, pH 7.3, to the eye of rabbits was reported to produce only slight and transient irritation, but details of the study were not provided.[Fiume MZ, Cosmetic Ingredient Review Expert PanelInt J Toxicol 20 (Suppl 4):1-12 (2001)]/LABORATORY ANIMALS: Acute Exposure/ Intramuscular injection of 0.5 or 1.0 mL of 0.1% d-biotin into rabbits did not produce irritation.[Fiume MZ, Cosmetic Ingredient Review Expert Panel/LABORATORY ANIMALS: Acute Exposure/ Intradermal injection of 0.1 cc biotin into the abdominal skin of guinea pigs did not produce irritation at the site of the injection.[Fiume MZ, Cosmetic Ingredient Review Expert Panel/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Groups of Mongolian gerbils (number per group not stated) fed a normal or hypercholesterolemic diet were dosed orally with 1 mg/kg biotin for 3 or 6 wk. At study termination, body weights, adrenal gland weight, liver weight, serum lipids, adrenal gland and hepatic cholesterol, and fecal lipid excretion were determined. Consistently significant changes in serum free fatty acids, triglycerides, or cholesterol were not observed, and little change in adrenal glands or hepatic cholesterol was observed. Body weights of the animals fed normal diet and dosed for 6 wk were significantly decr as compared to control values.[Fiume MZ, Cosmetic Ingredient Review Expert PanelFor more Non-Human Toxicity Excerpts (Complete) data for BIOTIN (16 total), please visit the HSDB record page. |
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| Antidote and Emergency Treatment | /SRP:/ Basic treatment: Establish a patent airway (oropharyngeal or nasopharyngeal airway, if needed). Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if needed. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for pulmonary edema and treat if necessary ... . Monitor for shock and treat if necessary ... . Anticipate seizures and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with 0.9% saline (NS) during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 ml/kg up to 200 ml of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool ... . Cover skin burns with dry sterile dressings after decontamination ... . /Poisons A and B//SRP:/ Advanced treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious, has severe pulmonary edema, or is in severe respiratory distress. Positive-pressure ventilation techniques with a bag valve mask device may be beneficial. Consider drug therapy for pulmonary edema ... . Consider administering a beta agonist such as albuterol for severe bronchospasm ... . Monitor cardiac rhythm and treat arrhythmias as necessary ... . Start IV administration of D5W /SRP: "To keep open", minimal flow rate/. Use 0.9% saline (NS) or lactated Ringer's if signs of hypovolemia are present. For hypotension with signs of hypovolemia, administer fluid cautiously. Watch for signs of fluid overload ... . Treat seizures with diazepam or lorazepam ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Poisons A and B/ |
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| Non-Human Toxicity Values | LD50 Rat oral >1.45 mmol/kgLD50 Mouse oral >10 g/kg |
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