Iodopropynyl Butylcarbamate

The Basics On Iodopropynyl Butylcarbamate

What is Iodopropynyl Butylcarbamate?

A synthetic preservative that is typically used in concentrations of 0.1% or less.

What are other names for Iodopropynyl Butylcarbamate?

3-IODO-2-PROPYNYL BUTYLCARBAMATE, BUTYL-3-IODO-2-PROPYNYL ESTER CARBAMIC ACID, BUTYL-3-IODO-2-PROPYNYLCARBAMATE, BUTYLCARBAMIC ACID, 3-IODO-2-PROPYNYL ESTER, CARBAMIC ACID, BUTYL, 3IODO2PROPYNYL ESTER, CARBAMIC ACID, BUTYL-3-IODO-2-PROPYNYL ESTER, IDOPROPYNL BUTYLCARBAMATE, IODOPROPYL BUTYLCARBAMATE, IODOPROPYNL BUTYLCARBAMATE, IODOPROPYNYL BUTYLCARBAMATE, and IPBC

What is Iodopropynyl Butylcarbamate used for?

A preservative used in wet wipes, paint, primers, coating and cosmetics to prevent bacteria and fungi’s in the products. It has been approved by the FDA for use as a component of adhesive that may safely be used in articles intended for use in packing and holding food.

How Iodopropynyl Butylcarbamate is classified

Preservatives

Recommendations for using Iodopropynyl Butylcarbamate during pregnancy and breastfeeding

Limited data suggests no known risk

 

Iodopropynyl Butylcarbamate During Pregnancy

What we know about using Iodopropynyl Butylcarbamate while pregnant or breastfeeding

Limited information available.

IPBC was administered to Sprague-Dawley rats by diet to determine its effects on the P and Fi generations, as well as their offspring, Fia and Flb. Each of four groups included 50 rats, 25 male and 25 female. P males and females weighed 175-235 g and 140-85 g, respectively. Rats were fed diet containing 120, 300, or 750 ppm IPBC for 293 days. Test and control diets were available to the rats ad libitum. At the conclusion of the dosing period, the rats were killed for necropsy. No treatment-related effects were observed in clinical condition, necropsy findings, fertility, mating performance, postnatal viability, or postnatal growth. Physical and functional development were similar to controls. The mean feed consumption of 750 ppm-dosed P and FI males decreased slightly during the rats’ premating period. During the same period, P males at 300 and 750 ppm and Fl males at 750 ppm had reduced body weight gains. No effects were observed in either males or females administered 120 ppm IPBC (Inveresk Research International, Ltd. 1987). Mated female mice, eight in each group, received oral doses of 20, 50, or 125 mg/kg IPBC in corn oil, and eight control mice received the vehicle alone, from days 6-15 post coitum. No signs of maternal toxicity, embryotoxicity, or developmental toxicity were observed in the mice fed 20 and 50 mg/kg. A dose of 125 mg/kg IPBC caused slight maternal toxicity (reduced weight gain from days 10-15), but there was no evidence of embryotoxic or teratogenic effects. The NOAEL was set at 50 mg/kg/day (Henderson 1992). Mated female Sprague-Dawley rats that received IPBC by gavage were also examined for reproductive effects. Groups of 28, 33, and 30 rats were given 20, 50, and 125 mg/kg/day from days 6-15 of gestation, respectively, then were necropsied. No intergroup differences were observed, either in clinical condition or in necropsy findings. Slight maternal toxicity (reduced body weight) occurred at the high dose at days 17 6-10, but no other effects were noted. Doses of 20 and 50 mg/kg did not cause reproductive toxicity (Henderson 1992). Dietary administration of 120, 300, and 750 ppm IPBC to groups of 25 male and female rats per generation (P and F1) had no effect on fertility or general reproductive performance in either generation. After a 14-week premating treatment period, the parental rats were mated and the offspring kept until weaned. Slight toxicity was observed in P males in the intermediate and high-dose groups, which had reduced body weight gain and reduced feed consumption before mating. Fl males given 750 ppm also had similar signs during the premating period. No evidence of toxicity was observed in rats fed 120 ppm. Postnatal development of offspring was not affected during the lactation period, but the live birth index was slightly lower in both generations at the highest dose (Henderson 1992). Groups of 35 pregnant Crl:NMRI Br mice were administered 20, 50, or 125 mg/kg doses of IPBC by gavage. Mice were dosed once daily with 2.0, 5.0, or 12.5 mg/kg IPBC in corn oil on days 6-15 of gestation to give a dose volume of 10 ml/kg/day There was no positive control. On day 18 of gestation, all mice were killed for necropsy. The results of maternal and fetal examinations are summarized in Table 3. No significant differences were noted between the negative control (0 mg/kg) and the other groups. No treatment-related effects on clinical condition and necropsy findings were observed. IPBC dosing also had no effects on maternal body weight gain or feed consumption, incidence of pregnancy, pre- or postimplantation loss, or the number, weight, or sex distribution of fetuses. Additionally, the incidence of malformations did not change as a result of the study (Hazleton Laboratories, Deutschland 1988a; Henderson 1992). Pregnant Sprague-Dawley rats were tested in a similar study. Group 1 (28 rats) received 20 mg/kg IPBC in corn oil, Group 2 (33 rats) was Table ~. Reproductive and developmental toxicity results-mice 18 Table 4. Reproductive and developmental toxicity results-rats administered 50 mg/kg, and Group 3 (30 rats) 124 mg/kg. The three groups received 2.0, 5.0, or 12.5 mg/ml, respectively, and all were given a dose volume of 10 mg/ml/day. All rats were administered one dose per day on days 6-15 of gestation, then sacrificed at day 20 for necropsy. Table 4 is a summary of the results of the maternal and fetal examinations. Incidence of malformations and skeletal variations in both the negative control and dosed groups were observed to be comparable. Rats that received the 125 mg/kg dose had a higher incidence of incompletely ossified cranial bones, but this was thought to be temporary or caused by maternal effects (Hazleton Laboratories, Deutschland 1986). Groups of eight mated female NMRI mice received daily doses of 20, 50, or 125 mg/kg IPBC by gavage from gestational days (gd) 6-15 and were killed for necropsy on gd 18. No treatment-related changes were noted in maternal clinical condition or in necropsy findings. From gd 10-15, body weight gain was slightly reduced at the high dose. There were no effects of IPBC treatment on pregnancy incidence, implantation, postimplantation loss, or the number, weight, and sex distribution of the fetuses. No external malformations were observed in the treated groups. The low and intermediate doses did not induce maternal toxicity, embryotoxicity, or teratogenicity. The high dose produced slight maternal toxicity (reduced weight gain), but was not embryotoxic or teratogenic (Hazleton Laboratories, Deutschland 1988b).

General safety info about Iodopropynyl Butylcarbamate from CIR

Iodopropynyl Butylcarbamate (IPBC) functions as a preservative in a wide variety of cosmetic formulations. Although concentrations as high as 0.1% have been reported, most applications appear to require this preservative at less than 0.0125%. IPBC readily penetrates through the skin. The average acute oral LD50 in rats is 1.47 g/kg. Rats fed IPBC for 4 weeks had increased liver weights and decreased plasma cholinesterase activity, and rats fed IPBC for 13 weeks had transient behavior alteration, increased liver weights, hepatocyte enlargement, stomach lesions, and decreased weight gain. Rats administered IPBC as dusts and liquid aerosols had labored breathing—lung edema, emphysema, and reddened lungs were observed after exposure. Dermal irritation, but no evidence of skin sensitization, was seen in animal studies. At concentrations of 0.5%, IPBC caused iritis and conjunctival irritation in rabbit eyes, but exposure to concentrations up to 0.015% produced only slight conjunctival redness. IPBC was not genotoxic, with or without metabolic activation. No evidence of carcinogenic potential was found in a 104-week chronic oral toxicity study using rats. Reductions in weight gain were observed, along with inflammation of the nonglandular stomach and lesions in the submaxillary salivary gland. In reproductive and developmental toxicity studies using rats and mice, IPBC had no significant effect on fertility, reproductive performance, or on the incidence of fetal malformations. IPBC was found to be mildly irritating, but not sensitizing in clinical testing. At concentrations up to 0.1%, IPBC was not comedogenic in clinical tests. Given the acute inhalation toxicity observed in animals, the potential for mild irritation, and the absence of any data on comedogenicity at concentrations higher than 0.1 % in clinical tests, the Expert Panel concluded that IPBC is safe as a cosmetic ingredient at concentrations ≤0.1 %, but that it should not be used in products intended to be aerosolized.

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Products where you might find Iodopropynyl Butylcarbamate

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