The Basics On Choline

What is Choline?

Part of the vitamin B complex and a component of many other biologically important molecules.

What are other names for Choline?

CHOLINE and ETHANAMINIUM, 2-HYDROXY-N,N,N-TRIMETHYL-

What is Choline used for?

Choline-stabilized orthosilicic acid is thought to help restore elasticity and suppleness to sun-damaged skin, as well as strengthen brittle hair and nails. It is available as a nutritional supplement at many health food and drug stores. Water.

How Choline is classified

Vitamins

Recommendations for using Choline during pregnancy and breastfeeding

Limited data on taking choline during pregnancy suggests no known risk

 

Choline During Pregnancy

What we know about using Choline while pregnant or breastfeeding

Limited information available on choline and pregnancy/breastfeeding.

No adverse effects on fertility or reproductive performance were observed in a study in which male and female Wistar rats were dosed orally with up to 500 mg/kg bw Hydroxydecyl Ubiquinone prior to mating, during gestation, and until day 22 post-partum. 47 In several other studies, no statistically significant adverse effects upon reproductive performance or fetal development were seen in rats dosed at up to 1000 mg/kg/d Hydroxydecyl Ubiquinone, although a higher incidence of postimplantation loss was reported in some studies. 3,4 The NOAELs, based on body surface area comparisons, were determined to be up to 1000 mg/kg/d for embryofetal development, and 500 mg/kg/d and 1000 mg/kg/d, for male and female fertility, respectively. 4 Rabbits, dosed at up to 150 mg/kg/d Hydroxydecyl Ubiquinone and observed for teratological abnormalities, displayed chromaturia in the highest dosage group. 3 In Japanese rabbits dosed at up to 500 mg/kg/d Hydroxydecyl Ubiquinone, one abortion was observed in the highest dosage group, but was not considered significant due to the spontaneous abortion rate in the animal strain; no statistically significant embryofetal differences were reported between controls and treated groups.4 No treatment-related changes were observed in the F1 generation, or in the dams, of rats dosed at up to 500 mg/kg/d Hydroxydecyl Ubiquinone. 3,4 The NOAEL for rat pup development was determined to be 500 mg/kg/d Hydroxydecyl Ubiquinone. 4 Treatment with Ubiquinone had no effect on fetal death, weight, or postnatal toxicity in primigravid mice (strain and number not specified) dosed at up to 600 mg/kg/d, from day 7 to day 13 of gestation. 30 Groups of 10 male mice were given up to 10,000 mg/kg bw Ubiquinone, via gavage, for 5 d, followed by a 35-d latency period, to test for defects in sperm morphology.49 No significant differences were found in the incidence of sperm abnormalities between Ubiquinone-treated mice and the negative controls (treated with corn oil). Except for an increase in seminiferous epithelium heights, no biochemical, histological, or morphological differences were observed between 8 male Wistar rats dosed at 10 mg/kg bw/d Ubiquinone for 14 d and negative control and vehicle control groups.51 Treatment with Ubiquinone had no effect on fetal death, weight, or postnatal activity in primigravid rats dosed at up to 600 mg/kg/d, from day 9 to day 15 of gestation. 30

General safety info about Choline from CIR

The safety of Disodium Ubiquinone, Hydroxydecyl Ubiquinone, Ubiquinol, and Ubiquinone, as used in cosmetics, is reviewed in this safety assessment. These ingredients have been grouped together because they share a 2,5-cyclohexadiene- 1,4-dione core, with various alkyl chain substituents at the 2 position of the cyclohexadiene, to comprise the salts or metabolites, thereof. These ingredients are all reported to function in cosmetics as antioxidants, and some are also reported to function as skin protectants, skin conditioning agents, and/or hair conditioning agents. According to 2020 VCRP data, Ubiquinone has the highest reported use amongst these ingredients, in 421 cosmetic products, of which 387 are leave-on formulations. The results of the 2018 concentration of use survey conducted by the Council indicate that the maximum leave-on use concentration in this ingredient group is 0.05% Ubiquinone in body and hand products; please note, a survey has not yet been completed for Ubiquinol. According to VCRP data, Disodium Ubiquinone is not currently in use in cosmetic products. The Norwegian Food Safety Authority calculated MoS values for the use of 1% Ubiquinone in a body lotion (10.2), face cream (52.1), hand cream (38.5), and for the overall exposure from cosmetics (8.5). Based upon the NOAELhypotension and the estimated overall SED for Ubiquinone in cosmetics, the Norwegian Food Safety Authority stated that the overall MoS of 8.5 was sufficient to support the recommended use concentration of 1% Ubiquinone. Based on dermal irritation and sensitization data, Hydroxydecyl Ubiquinone was concluded to be safely used at 0.5% in cosmetic formulations. Dermally applied Ubiquinone, in ethanol, was able to penetrate the stratum corneum of porcine skin, at approximately 20% in the epidermis and 2% in the dermis. A solution of 1% Ubiquinone, in olive oil, was found to reach concentrations of 8 µg/g after 2 h, and 15 µg/g after 4 h, when applied to live rat skin. The average Tmax of orally ingested, solubilized, Ubiquinone being captured between 6 Р8 h (Tmax), suggests slow absorption and limited bioavailability in the intestine. In pharmacokinetic studies, rat plasma levels for Hydroxydecyl Ubiquinone plateaued at 8 h and exhibited a half-life of 4.5 h, while dog plasma levels had a biphasic decline with half-lives of 2.2 and 15.4 h. In both species, elimination was almost complete in 48 h. The range of Ubiquinone half-life in Wistar rats administered up to 1200 mg/kg/d was 10.7 to 15.2 h. After a one-time intravenous injection of 10 mg/kg solubilized Ubiquinone, plasma Ubiquinol levels had increased in Wistar rats by 89%, within one day of injection. Twenty-five healthy male subjects were assigned to receive single doses of 450 or 750 mg/d Hydroxydecyl Ubiquinone, or repeated doses of up to 2250 mg/d Hydroxydecyl Ubiquinone, for 14 d, after eating breakfast. A slightly higher proportion of free and conjugated metabolites were excreted in the 750 mg group. The half-life of Ubiquinol was estimated to be 48 h in 80 healthy subjects who received a single dose of 150 or 300 mg; the Ubiquinol AUC(0-48h) was 74.61 µgh/ml and 91.76 µgh/ml, for the 150 and 300 mg groups. Twenty healthy males were administered, either fasting or post-prandially, 60 mg lipid-soluble Ubiquinone capsules along with 200 ml of water. In the fasting group, the uptake rate was 0.018 ± 0.006 µg/ml/h, while in the post-prandial group the uptake rate was 0.026 ± 0.008 µg/ml/h. The AUC(0-10h) was determined to be 4.9 µg/ml/h, in a single dose study, in which 120 mg lipid-soluble Ubiquinone was administered to 10 healthy subjects. In a pharmacokinetic study, a single, oral dose of 100 mg deuterium-labelled Ubiquinone was administered to 16 healthy male subjects and exhibited an elimination half-life of 33.19 ± 5.32 h. The acute oral LD50 of Hydroxydecyl Ubiquinone was determined to be > 10,000 mg/kg in mice and male rats, and ~ 10,000 mg/kg in female rats. The acute oral LD50 of Ubiquinone was reported to be > 4000 mg/kg in mice, while the LD50 was > 2000 mg/kg in rats. Wistar rats administered up to 500 mg/kg/d Hydroxydecyl Ubiquinone for 4 wk, exhibited a dose-dependent increase in the incidence and severity of forestomach mucosal inflammation, erosions, ulcerations, and hyperkeratosis. In another study, juvenile rats dosed at up to 1000 mg/kg/d Hydroxydecyl Ubiquinone for 4 wk, exhibited slight reduction of body weight in the mid- and high-dose groups, as well as an increased incidence and severity of hyaline droplet accumulation in the renal tubules, and reversible lowered bone density; the NOAEL was determined to be 200 mg/kg/d. The non-toxic dose of Hydroxydecyl Ubiquinone was determined to be 100 mg/kg/d in Beagle dogs, administered with up to 500 mg/kg/d over 5 wk. The highest non-toxic, oral Hydroxydecyl Ubiquinone doses were determined to be 500 mg/kg/d and 20 mg/kg/d, in a 5- wk, and a 26-wk study of rats, respectively. Gastric irritation, forestomach histopathology, and a general reduction of weight was observed in CD-1 mice administered 2000 mg/kg/d Hydroxydecyl Ubiquinone for 13 wk. In a 26-wk study of Wistar rats administered up to 1000 mg/kg/d Hydroxydecyl Ubiquinone, mucosal thickening, hyperkeratosis, red spots, hyperplasia, necrosis, edema, and ulceration observed in the forestomach were reversible and of limited toxicological relevance. Beagle dogs administered 500, 750, or 1000 mg/kg/d Hydroxydecyl Ubiquinone for 39 wk exhibited gastrointestinal disturbances and reduced heart rate across all groups, as well as mild liver hypertrophy and pulmonary hyperplasia in a few animals in the 1000 mg group. These results were not considered statistically significant. Groups of 10 Sprague-Dawley rats were dosed at up to 1200 mg/kg/d Ubiquinol. Fine vacuolation of the hepatic Kupffer cells and statistically significant increases in hepatic blood chemistry enzymes, were observed in rats dosed with ≥ 300 mg/kg Ubiquinol. No deaths, or adverse clinical effects were observed, and the NOAELs were conservatively estimated to be 600 mg/kg/d in males, and 200 mg/kg/d in females. In a follow-up study, groups of 10 female SpragueDawley rats were dosed at up to 1200 mg/kg/d, and no toxicologically significant changes related to the test material were observed. Groups of 3 Beagle dogs were dosed at up to 600 mg/kg/d Ubiquinol for 13 wk. Soft feces were observed in the 300 and 600 mg/kg/d Ubiquinol groups, and estrus hemorrhage in 1 female each in the control and 300 mg Ubiquinol groups. The NOAEL for Ubiquinol was determined to be 600 mg/kg/d in male rats, 200 mg/kg/d in female rats, and 600 mg/kg/d in Beagle dogs. In a 4-wk study, cRj Wistar rats dosed with 1000 mg/kg/d Ubiquinone did not produce noticeable changes in overall condition, body weight gain, or food consumption, in comparison to controls. Upon necropsy, a few abnormalities were observed in the adrenals and lungs of several treated male and female rats in the Ubiquinone-treated group. No mortality or toxicity occurred in rats dosed at up to 2250 mg/kg/d Ubiquinone. Groups of 15 Sprague-Dawley rats which were dosed at up to 3000 mg/kg/d over 90 d exhibited statistically significant changes in hematological markers and ovary weights in the two highest dosage groups. Groups of 10 Sprague-Dawley rats dosed with 1200 mg/kg/d Ubiquinone for 13 wk, showed a statistically significant higher food consumption in females, mild granuloma of the liver in females, as well as yellow lung foci and accumulation of foam cells in lung alveoli in 2 males and 3 females. The NOAEL was determined to be ≥ 1200 mg/kg/d in a 13-wk study of Sprague-Dawley rats. In a 52-wk study, one female and three male Sprague-Dawley rats died from the 600 mg/kg/d group, and one male from the 1200 mg/kg/d group died of malignant lymphoma. No toxic effects and microscopic, or gross, pathologies were found in white rabbits dosed for 23 d with up to 600 mg/kg Ubiquinone. Groups of 3 Beagle dogs dosed with 600 mg/kg/d Ubiquinone for 13 wk, exhibited soft feces with traces of test article, vomiting, and a statistically significant increase in neutrophils. A dark red focus of the heart was observed in 1 male, while 1 male and 1 female exhibited enlarged livers; opacity of the posterior lens capsule in 1 Ubiquinone-treated female was observed, which also occurred in control group animals. No deaths occurred during the treatment of Beagle dogs dosed at up to 1800 mg/kg/d for 39 wk, and gross pathological findings were not considered toxicologically significant. No adverse effects on fertility or reproductive performance were observed in a study in which male and female Wistar rats were dosed orally with up to 500 mg/kg bw Hydroxydecyl Ubiquinone prior to mating, during gestation, and until day 22 post-partum. The NOAELs for embryofetal development, and male and female fertility were determined to be 500 mg/kg/d and 1000 mg/kg/d. In rabbits dosed at up to 500 mg/kg/d Hydroxydecyl Ubiquinone, one abortion was observed in the highest dosage group, but was considered spontaneous, and not significant. In peri/post-natal studies of rats, no treatmentrelated changes were observed in dams, and the NOAEL for pup development was determined to be 500 mg/kg/d Hydroxydecyl Ubiquinone. No effect on fetal death, weight, or postnatal toxicity was observed in primigravid mice dosed with up to 600 mg/kg/d Ubiquinone, from day 7 to day 13 of gestation. No statistically significant differences were found in in the incidence of sperm abnormalities in male mice dosed with up to 10,000 mg/kg bw Ubiquinone for 5 d, via gavage, and were assessed after a 35-d observation period, compared to corn-oil-treated controls. Except for an increase in seminiferous epithelium heights, no biochemical, histological, or morphological differences were observed between 8 male Wistar rats dosed at 10 mg/kg bw/d Ubiquinone for 14 d, and negative control and vehicle control groups. Treatment with Ubiquinone

Use this, not that!

Products where you might find Choline

Paula’s Choice SKIN PERFECTING 2% BHA Liquid Exfoliant (4 fl. oz.); Paula’s Choice SKIN RECOVERY Enriched Calming Toner (6.4 fl. oz.); Paula’s Choice 10% Niacinamide Booster (0.67 oz.); N/A

 

 

 

List of References

General sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/

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Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

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