The Basics On Neopentyl Glycol Dicaprylate/Dicaprate

What is Neopentyl Glycol Dicaprylate/Dicaprate?

Used as an emollient and texture enhancer.

What are other names for Neopentyl Glycol Dicaprylate/Dicaprate?

DECANOIC ACID, MIXED ESTERS WITH NEOPENTYL GLYCOL AND OCTANOIC ACID, MIXED ESTERS WITH NEOPENTYL GLYCOL AND DECANOIC ACID OCTANOIC ACID, MIXED ESTERS WITH NEOPENTYL GLYCOL AND OCTANOIC ACID DECANOIC ACID, NEOPENTYL GLYCOL DICAPRYLATE/ DICAPRATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, NEOPENTYL GLYCOL, ESTERS WITH CAPRYLIC ACID AND CAPRIC ACID, and OCTANOIC ACID, MIXED ESTERS WITH NEOPENTYL GLYCOL AND DECANOIC ACID

What is Neopentyl Glycol Dicaprylate/Dicaprate used for?

How Neopentyl Glycol Dicaprylate/Dicaprate is classified

Texture Enhancer, Emollients

Recommendations for using Neopentyl Glycol Dicaprylate/Dicaprate during pregnancy and breastfeeding

Limited data suggests no known risk

 

Neopentyl Glycol Dicaprylate/Dicaprate During Pregnancy

What we know about using Neopentyl Glycol Dicaprylate/Dicaprate while pregnant or breastfeeding

Limited information available.

Oral Exposure Trimethyl Pentanyl Diisobutyrate In a reproductive/developmental toxicity study, conducted in accordance with Organization for Economic Co-operation Guidelines (OECD GL) 421 (Reproduction/Developmental Toxicity Screening Test), Trimethyl Pentanyl Diisobutyrate (0, 1.5, 4.5, or 15.0 mg/g feed) was administered to Sprague-Dawley (Crl:CD(SD)IGS BR) rats (n = 12/sex) ad libitum in the diet. 7,34 The female rats were treated over 4 phases of the study for a total of 40 to 51 days: premating (14 days), mating (1 to 8 days), gestation (21 to 23 days), and early lactation (4 to 5 days). All male rats were treated from the beginning of the premating period to the final treatment of the female rats for a total of 51 days. Females that delivered a litter, and their offspring, were killed on days 4 or 5 postpartum. Females that had evidence of mating but did not deliver were killed on gestation day (GD) 23. The final calculated dosage rate was approximately 0, 91, 276 and 905 mg/kg/day for male rats and 0, 120, 359 and 1135 mg/kg/day for female rats, respectively. For the females in the high-dose group, there was a decrease in total number of implants, number of live pups on postnatal day 4, and litter weights on postnatal days 0 and 4. There were no adverse effects on reproductive performance, fertility index, fecundity index, precoital interval, gestation duration, percent pup survival, pre- and post-implantation loss, live and dead pups on postnatal day 0, percentage of male and female pups, mean pup body weight and pup body weight change, or reproductive organ weights in the adults. Reductions in body weight and feed consumption values in the high-dose group adults were transient and were not considered toxicologically significant. For the males, there were minimal reductions in sperm counts observed in the testes and/or epididymis of treated male rats, but there were no treatment-related gross or microscopic lesions in any groups and no adverse effect on reproductive performance. The NOAEL for developmental or reproductive toxicity was reported to be 4.5 mg/g feed in the diet, which was equivalent to 276 mg/kg/day for males and 359 mg/kg/day for females.7,34 In a combined repeated dose and reproductive/developmental toxicity study, Trimethyl Pentanyl Diisobutyrate (0, 30, 150 and 750 mg/kg/day in corn oil) was administered to Sprague-Dawley rats (n = 12/sex) by oral gavage for 44 (males) or 40 to 53 (females) days beginning prior to mating. 7,18,34 [See the Subchronic Toxicity Studies section for results related to repeated dose toxicity.] The control group received corn oil. All rats survived and there were no treatment-related clinical signs. One mating pair in the mid- and high-dose groups failed to copulate. Slight increases in feed consumption were observed in females during the gestation period only, but there was no clear relationship to the test substance. There were no gross or microscopic effects observed on any reproductive organ in either sex. All pregnant rats delivered normally and there were no adverse effects on any reproductive parameters observed. A decrease in estrous cycle length in the high-dose female group, compared to controls, was attributed to a larger than normal number of rats in the high-dose group with shorter cycle lengths; there were no differences when data for this study were compared to historical control data (mean estrous cycle 4.0 to 4.4 days for the previous 3 years). The NOAEL for reproductive toxicity of Trimethyl Pentanyl Diisobutyrate under the conditions of this study was reported to be 750 mg/kg/day for male and female rats. There were no treatment-related effects observed in the external examination of pups born, mortalities were similar across the groups, and pup body weights increased until sacrifice on day 4 of lactation. Necropsy of stillborn pups, dead pups, and pups surviving until day 4 of lactation did not demonstrate any treatment-related effects. The NOAEL for embryo/fetal toxicity was reported to be 750 mg/kg/day. In a study conducted in accordance with OECD TG 414 (Prenatal Developmental Toxicity Study), pregnant SpragueDawley Crl:CD(SD) rats (n = 25) were given Trimethyl Pentanyl Diisobutyrate (0, 0.15%, 0.45%, or 1.50%) in feed on GD 6 through 20. 7 The dosage rates were calculated to be 0, 118, 343 and 1077 mg/kg/day, respectively. There were no mortalities among the dams. One female in each test group was not gravid. Net body weight gain in the high-dose group was lower than the control group. There were no macroscopic test substance-related observations reported. There were no adverse effects on the number of corpora lutea, implantation sites, viable fetuses or early/late resorptions observed. There were no dead fetuses in any group. The mean male, female, and combined fetal weights in the high-dose group were lower than those of the control group. However, these weights were within the laboratory’s historical control data range for these study types. Because of lower body weight gains and/or body weight loss, the NOAEL for maternal toxicity was reported to be 343 mg/kg/day. There were no test substance-related external and visceral malformations or developmental variations observed. When the total malformations and developmental variations were evaluated on a proportional basis, no differences from the control group were noted. Test substance-related skeletal malformations (bent scapula) were noted in one fetus from the mid-dose group and in 4 fetuses (3 litters) from the low-dose group. There was a higher mean litter proportion of the skeletal developmental variation in sternebra(e) nos. 5 and/or 6 (unossified) was observed in the high-dose group. The litter proportion of bent rib(s) was considered by the authors to represent skeletal variations rather than malformations. Based on lower mean fetal body weights at 1.50% (1077 mg/kg/day), an exposure level of 0.45% (343 mg/kg/day) was reported to be the NOAEL for embryo/fetal development for Trimethyl Pentanyl Diisobutyrate in the diet of rats.7 Glycol Distearate In a study conducted in accordance with OECD TG 414 (Prenatal Developmental Toxicity Study) and EU Method B.31 (Prenatal Developmental Toxicity Study), Glycol Distearate (0, 100, 300, or 900 mg/kg/day; as a C16-18 mixture) was administered by gavage to pregnant Sprague-Dawley CD rats (n = 24) on GD 6 through 15. 5 The control group received 0.5% sodium carboxymethylcellulose and 0.25% Cremophor¬Æ in distilled water. The dams were killed and necropsied on GD 20. The pups were examined for litter size and weights, viability, sex ratio, and grossly visible abnormalities. The pups were also examined for external, visceral, and skeletal abnormalities. There were no mortalities during the study period. No Glycol Distearate-related symptoms were observed in the treatment groups when compared to the control group. Body weights, body weight gains, and corrected body weights were within expected ranges. There were no differences observed among the mean reproduction data of the test groups compared to the control group. Necropsies revealed no macroscopic changes in the dams of the treatment groups. No test substance-related effects were observed in the treatment groups. Pre-implantation loss, postimplantation loss, mean number of resorptions, embryonic deaths, and total fetuses were not affected by treatment. No treatmentrelated fetal abnormalities were found at necropsy. The NOAEL for maternal toxicity was reported to be > 900 mg/kg/day. The teratogenicity NOAEL was reported to be > 900 mg/kg/day.

General safety info about Neopentyl Glycol Dicaprylate/Dicaprate from CIR

The most common cosmetic function reported for this group of ingredients is as a skin conditioning agent; other reported functions film former, hair conditioning agent, opacifying agent, plasticizer, slip modifier, solvent, surface modifier, and viscosity increasing agent. The Panel reviewed the relevant data for these ingredients and concluded that these monoalkylglycol dialkyl acid esters are safe in cosmetics in the present practices of use and concentration described in this safety assessment.

Use this, not that!

Products where you might find Neopentyl Glycol Dicaprylate/Dicaprate

REN Clean Skincare Glycol Lactic Radiance Renewal Mask; Sol de Janeiro Brazilian Bum Bum Cream; Sol de Janeiro Mini Brazilian Bum Bum Cream

 

 

 

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/

N/A

 

 

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.

As seen in

Join our mailing list

Sign up for access to exclusive promotions, latest news and opportunites to test new pre-release products