Beta-Sitosterol

The Basics On Beta-Sitosterol

What is Beta-Sitosterol?

Beta-sitosterol is a fatty acid-type ingredient derived from plants, and is similar to cholesterol.

What are other names for Beta-Sitosterol?

(3 BETA)-STIGMAST-5-EN-3-OL, (3B)-STIGMAST-5-EN-3-OL, 24-A -ETHYLCHOLESTEROL, B-SITOSTEROL, BETA SITOSTEROL, BETA-SITOSTEROL, STIGMAST-5-EN-3-BETA-OL, and STIGMAST5EN3OL, (3B)

What is Beta-Sitosterol used for?

A fatty acid-type ingredient derived from plants. Beta-sitosterol occurs naturally in many fruits, vegetables, nuts, and seeds. It is similar to cholesterol, which occurs naturally in skin. Applied to skin, it is considered a good moisturizing and skin-soothing ingredient.

How Beta-Sitosterol is classified

Skin-Soothing, Plant Extracts, Skin-Replenishing

Recommendations for using Beta-Sitosterol during pregnancy and breastfeeding

Limited data suggests no known risk

 

Beta-Sitosterol During Pregnancy

What we know about using Beta-Sitosterol while pregnant or breastfeeding

Limited information available.

In a two-generation feeding study, the no observed adverse effect level (NOAEL) for phytosterol esters was ≥8.1% (the highest dose tested) in the diet.63,64 Wistar rats, F0 generation, (n = 28/sex) were administered phytosterol esters (0, 1.6%, 3.2%, 8.1%) in feed for 10 weeks before mating, and continuing through gestation and weaning. The F1 generation (n = 28/sex) were fed the same diet as their F0 parents and mated after 10 weeks. The analysis of the phytosterols revealed the following breakdown: brassicasterol (2.9%), campesterol (26.7%), stigmasterol (17.7%), β-sitosterol (51.0%), cholesterol (0.2%), and unknowns (1.5%). There were no maternal or teratogenic effects attributed to the test substance. There were no effects on fertility and reproductive parameters, including sexual maturity, estrous cycle length, precoital time, and the histopathology of reproductive tissues in either generation. There were no developmental or reproductive effects observed in either generation. Necropsies were unremarkable. In the F1 generation, the body weights of male rats in the low-dose group were decreased in weeks 6 Р9 and 11 Р14. In the high-dose groups of the F0 and F1 generations, body weights of the male rats were reduced when compared to the body weights of control group males. Decreased weights were observed in weeks 2 Р7 and on occasions during weeks 5 Р15 and 18 Р19. No differences in the times to reach preputial separation were observed among F1 males. In F0 males, statistically significant increase in the relative liver weights (low- and mid-dose groups), increase in the relative adrenal weights (low dose group), and statistically significant increase in relative brain weights (low- and high-dose groups) in F1 males were considered small changes and not dose-related so were considered to be of no biological or toxicological significance. The NOAEL (8.1%) is equivalent to 3.3 Р6.5 g phytosterol esters/kg/d during the 10-week pre-mating period (~ 2.1 Р4.1 g phytosterols/kg/d or 400 Р900 mg stigmasterol/kg/d) and 2.5 Р9.1 g phytosterol esters/kg/d during gestation (~1.4 Р5.7 g/kg/d or 300 Р1200 mg stigmasterol/kg/d). The authors concluded that 2.5 Р9.1 g phytosterol esters/kg/d and 1.54 Р5.62 g phytosterols/kg/d (~ 335 Р1219 mg stigmasterol/kg/d), dependent on the phase of the study, was the NOAEL of daily oral administration of phytosterol esters for two successive generations.63,64 There were no signs of reproductive toxicity to American minks (n = 70/sex) orally administered β-sitosterol (at 0, 5, 10 or 50 mg/kg/d) for 10 months. 65 In the second part of the study, after 7 months of exposure, males (n = 10, 11) were mated with 4 – 5 females each. There were no differences in number of pregnant females, litter and kit numbers, postnatal mortality and development and there were no treatment-related changes. After 3 months of exposure, 15 males/group were killed and investigated for organ weights and hematological and clinical chemistry parameters. Males exhibiting low quality fur were selected for this part of the study. There were differences in body fat masses (omental, mesenteric, retroperitoneal, intra-abdominal fat) reported, but increases in fat masses were not dose dependent. There were increased blood hemoglobin and serum high-density lipoprotein cholesterol concentrations observed. Subcutaneous injections of β-sitosterol (5 mg/kg/d) for 16 to 48 days decreased sperm concentrations and fertility, and decreased testis and accessory sex tissue weights in a time-dependent manner in male Wistar rats.66 Rats administered 0.5 mg/kg/d had a decrease in sperm concentration of the caput epididymis after 48 days of treatment, but no reduction in fertility. The observed decreases in sperm concentration persisted after termination of treatment, and appeared to be due to a reduction in the rate of spermatogenesis.

General safety info about Beta-Sitosterol from CIR

Phytosterols functions in cosmetics include skin-conditioning agents, hair conditioning agents, viscosity increasing agents, skin protectants, antioxidants, and fragrances. The Panel reviewed relevant animal and human data related to these ingredients including results of tests for relevant estrogenic activity. Industry should use good manufacturing practices to limit impurities. The Panel concluded that phytosterols were safe in the present practices of use and concentration described in this safety assessment.

Use this, not that!

Products where you might find Beta-Sitosterol

N/A