Octinoxate (Octylmethoxycinnamate) has been detected in human urine, blood and breast milk and is known for moderate risk of skin allergy. Some studies suggest that Octinoxate has estrogen like effects however less than 1% skin penetration has been found in human laboratory studies. As not much study has been done on effects of Octinoxate during breast feeding its recommended to use safe alternatives.
Octyl Methoxycinnamate (OMC) is a frequently used UV-filter in sunscreens and other cosmetics. Octinoxate can be systemically absorbed after skin application, being found in the deeper layers of the stratum corneum as well as urine, plasma, and breast milk. The mean maximum plasma concentration detected after application of 2mg/cm2 sunscreen was 7ng/mL in women and 16ng/mL in men. FDA study found blood levels 13 times above cutoff for systemic exposure.
Several studies indicated that OMC acts as an endocrine disruptor due to the ability to interfere with endocrine system at different levels. In humans OMC exposure has minor, but statistically significant effects on the levels of testosterone and estradiol. Moreover, some studies suggested that OMC can interact with the hypothalamo-pituitary-thyroid (HPT) axis.
Moreover, a study of offspring of dams treated with OMC (500–1000 mg/kg/day) showed sex-dependent behavioral changes, namely decreased motor activity in females, but not in males, and improved spatial learning in males, suggesting that OMC can affect neuronal development, however the doses used in these experiments were extremely high, not relevant to possible human exposure.Note: Study and data for tropical use only
Based on the current available safety data, octocrylene used as a UV filter in cosmetic products at a concentration of 10% can be considered as safe. There was no evidence of any endocrine disruption potential from experimental studies which demonstrated no adverse effects on reproductive (e.g. oestrus cycle, epididymal and testicular sperm parameters) and developmental parameters. Effects on thyroid reported in repeated toxicity studies conducted in rats at very high doses are species?specific and not relevant considering the doses at which octocrylene is used in human.
Four studies on the transdermal absorption of octocrylene are available in the scientific literature, and an additional study is available in ECHA summaries of safety data. Dermal absorption studies of octocrylene showed that most octocrylene concentrations are found in the stratum corneum and that very few quantities are found in the epidermis (0.4%) and in the receptor fluid (<0.05%). In vivo, a very recent study in human volunteers showed systemic exposure to octocrylene with maximal concentrations ranging from 2.9 to 7.8 ng/mL under indoor maximal use conditions. Octocrylene has been found at very low amounts in human milk, and some metabolites of octocrylene were primarily detected in urine of volunteers using sunscreen products.
No systemic effects were reported after dermal exposure to octocrylene in rabbits at very high dose (534 mg/kg bw/day) compared with those used in cosmetic products. After oral exposure, effects on liver and thyroid were reported in a study conducted in rats at high doses (340 and 1085 mg/kg bw/day in males). These effects were investigated in an additional mechanistic study which showed that effects on thyroid were indirect and due to hepatic enzyme induction potential of octocrylene in rats at very high oral doses.
Based on available animal data, octocrylene does not induce developmental or teratogenic effects. In an extended one?generation reproductive toxicity study, only rats treated with the highest dose of octocrylene via oral route showed a decrease in the number of implantation sites and consequently a low number of pups. This very high dose of 550 mg/kg bw/day cannot be considered to be relevant to the dermal use of octocrylene as a cosmetic ingredient. Moreover, no other effects on male and female fertility and reproductive parameters such as oestrus cycle, epididymal and testicular sperm parameters were observed in all groups tested. Regarding pups, no effects on sexual and neurodevelopmental parameters were observed.Note: Study and data for tropical use only
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Yes, Extra monitoring is required if mother is using Korres Quercetin And Oak Hydrating Antiageing And Antiwrinkle Day Spf4 and breastfeeding as it is considered unsafe for baby.
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week