옥틸 디메틸 파바

Wear self contained breathing apparatus for fire fighting if necessary.

Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

SRP: The most favorable course of action is to use an alternative chemical product with less inherent propensity for occupational exposure or environmental contamination. Recycle any unused portion of the material for its approved use or return it to the manufacturer or supplier. Ultimate disposal of the chemical must consider: the material's impact on air quality; potential migration in soil or water; effects on animal, aquatic, and plant life; and conformance with environmental and public health regulations.

Avoid contact with skin and eyes. Avoid inhalation of vapor or mist. Normal measures for preventive fire protection.

Use personal protective equipment. Avoid breathing vapors, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas.

Hesperetin is one of the flavonoids and possess anti-inflammatory, UV-protecting and antioxidant effects. Permeation issues for topical delivery systems of such effects are occasionally problematic, and in view of the fact that microemulsions are potential carriers for transdermal delivery system, the objective of this study was to design an optimal microemulsion formulation by in vitro permeation study for hesperetin topical dosage form and determine its topical photoprotective effect and skin irritation by in vivo study. The hesperetin-loaded microemulsion showed an enhanced in vitro permeation compared to the aqueous and isopropyl myristate (IPM) suspension dosage form of hesperetin. In comparison, the effect of co-surfactant on the drug permeation capacity, propylene glycol showed highest permeation rate, followed by ethanol, glycerol and polyethylene glycol (PEG 400). Sunscreen agent padimate O, as a transdermal enhancer could increase the permeation rate of hesperetin.

Agricultural workers are encouraged to use sunscreen to decrease the risk of UV-related skin cancer. /The authors'/ previous studies have shown certain commercial sunscreens to be penetration enhancers. The focus of this project is to determine whether active ingredients in sunscreen formulations (i.e., the UV absorbing components and insect repellants for the sunscreen/bug repellant combinations) also act as dermal penetration enhancers for herbicides in vitro. The total percentages of 2,4-dichlorophenoxyacetic acid (2,4-D) penetrating through hairless mouse skin in 24 hr ranged from 54.9 +/- 4.7 for the no sunscreen control to 86.9 +/- 2.5 for padimate-o. Of the active ingredients tested (7.5% octyl methoxycinnamate, 7% octocrylene, 0.6% oxybenzone, 5% homosalate, 5% octyl salicylate, 8% padimate-o, 10% sulisobenzone, and 9.5% and 19% N,N-diethyl-m-toluamide [DEET]), all but octocrylene led to a significant increase in total 2,4-D penetration as compared to the control (P < 0.05), and only octocrylene and oxybenzone did not significantly decrease the corresponding lag time. Octyl salicylate (P < 0.01) and octyl methoxycinnimate (P < 0.05) significantly increased the (3)H2O penetration across mouse skin, indicating physical damage to the stratum corneum. Additional studies demonstrated that the penetration enhancement seen across hairless mouse skin also occurred with human skin. Thus, the active ingredients of sunscreen formulations enhance dermal penetration of the moderately lipophilic herbicide 2,4-D.

Diminish the penetration of ultraviolet (UV) light through the epidermis by absorbing UV radiation within a specific wavelength range. The amount and wavelength of UV radiation absorbed are affected by the molecular structure of the sunscreen agent. /Sunscreen agents, topical/

TERRESTRIAL FATE: Based on a classification scheme(1), an estimated Koc value of 2200(SRC), determined from a structure estimation method(2), indicates that Padimate O is expected to have slight mobility in soil(SRC). Volatilization of Padimate O from moist soil surfaces is not expected to be an important fate process(SRC) given an estimated Henry's Law constant of 4X10-6 atm-cu m/mole(SRC), using a fragment constant estimation method(2). Padimate O is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 5.1X10-4 mm Hg at 25 °C(SRC), determined from a fragment constant method(2). No relevant data were available to assess the importance of biodegradation in the environment(SRC).

AQUATIC FATE: Based on a classification scheme(1), an estimated Koc value of 2200(SRC), determined from a structure estimation method(2), indicates that Padimate O is expected to adsorb to suspended solids and sediment(SRC). Volatilization from water surfaces is expected(3) based upon an estimated Henry's Law constant of 4X10-6 atm-cu m/mole(SRC), developed using a fragment constant estimation method(2). Using this Henry's Law constant and an estimation method(3), volatilization half-lives for a model river and model lake are 15 and 117 days, respectively(SRC). Volatilization from water surfaces may be attenuated by adsorption to suspended solids and sediment in the water column. According to a classification scheme(4), an estimated BCF of 2960(SRC), from an estimated log Kow of 5.77(2) and a regression-derived equation(2), suggests the potential for bioconcentration in aquatic organisms is very high(SRC), provided the compound is not metabolized by the organism(SRC). A base-catalyzed second-order hydrolysis rate constant of 3.7X10-4 L/mole-sec(SRC) was estimated using a structure estimation method(2); this corresponds to half-lives of 590 and 59 years at pH values of 7 and 8, respectively(2). Padimate O absorbs UV light in the sunlight spectrum(5) and, therefore, may be susceptible to direct photolysis by sunlight(SRC). Aromatic amines are susceptible to sensitized photolysis in natural waters exposed to sunlight through reaction with hydroxy and peroxy radicals(6). No relevant data were available to assess the importance of biodegradation in the environment(SRC).

ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), Padimate O, which has an estimated vapor pressure of 5.1X10-4 mm Hg at 25 °C(SRC), determined from a fragment constant method(2), is expected to exist primarily as a vapor in the ambient atmosphere at 25 °C. At temperatures below 10 °C, the model of gas/particle partitioning(1) indicates that Padimate O will exist in both the vapor and particulate phases(SRC). Vapor-phase Padimate O is degraded in the atmosphere by reaction with photochemically-produced hydroxyl radicals(SRC); the half-life for this reaction in air is estimated to be 2.9 hours(SRC), calculated from its rate constant of 1.3X10-10 cu cm/molecule-sec at 25 °C(SRC) that was derived using a structure estimation method(2). Particulate-phase Padimate O may be removed from the air by wet and dry deposition(SRC). Padimate O absorbs UV light in the sunlight spectrum(3) and, therefore, may be susceptible to direct photolysis by sunlight(SRC).

Industry reported the results of analytical tests on the occurrence of Padimate O (2-ethylhexyl-4-dimethylaminobenzoate) in a number of food products packaged in cartons printed with UV-cured inks containing Padimate O as a photoinitiator(1); in the milk and soy based products tested, not specifically intended for babies, the level of Padimate O ranged from 27 to 134 ug/L, for pack sizes of 1000 mL; in a chocolate milk sample (200 mL pack size) Padimate O level was 148 ug/L(1); in fruit juices, fruit nectars and drinks indicated as "cloudy" due to the presence of fruit pulp and fibres, the levels of Padimate O ranged from <5 ug/L to 125 ug/L(1).

In a chocolate milk sample (200 mL pack size) Padimate O level was 148 ug/L(1).

Researchers in Europe analyzed samples of human milk for the presence of sunscreens and other chemicals with possible endocrine activity. Mothers were asked about their use of sunscreens and cosmetics that contained sunscreen ingredients (benzophenone 2, benzophenone 3, 3-benzylidene camphor, 4-MBC, OMC, homosalate, octocrylene, and octyl-dimethyl PABA). Responding to questionnaires, 78.8% of the women reported using products that contained sunscreens; 76.5% of human milk samples contained these chemicals. There was a high correlation reported between mothers' use of these chemicals and their concentrations in human milk. The authors concluded that except for lipsticks (the ingestion of which is probably important), their results agree with studies in animals and humans showing dermal absorption of sunscreens. Given that some of these chemicals have endocrine activity in animals, the authors suggested that exposure could be lessened if mothers abstained from using these products during their children's sensitive life stages.

Based on a potential concentration of 125 ug/L of Padimate O in affected food products, potential dietary exposure in adults is 3 ug/kg bw/day(1); based on a potential concentration of 62 ug/L in affected products, potential dietary exposure in adults is 1.5 ug/kg bw/day(1). Based on a potential concentration of 63 ug/L of Padimate O would lead to a potential dietary exposure of 6 ug/kg bw/day in young children at the 95th percentile of consumption(1).

Using a structure estimation method based on molecular connectivity indices(1), the Koc of Padimate O can be estimated to be 2200(SRC). According to a classification scheme(2), this estimated Koc value suggests that Padimate O is expected to have slight mobility in soil.

2-Ethylhexyl-p-dimethylaminobenzoate (EHDMAB; CAS# 21245-02-3) was evaluated for subchronic toxicity when administered daily to groups of male and female rats (10-15 rats/sex/group). Dose levels of 100, 300, or 1000 mg EHDMAB/kg/day were administered by gavage using a corn oil vehicle for a period of 4 weeks. Following the treatment period, five rats of each sex from the control and the high dose group were selected and maintained for a 4 week recovery period. There were no treatment-related mortalities. Clinical signs of treatment-related toxicity were seen in males and females receiving 1000 mg/kg/day (Group 4). These included salivation and significantly depressed mean body weight gain compared to controls for weeks 0-4 (males and females), urine-stained fur (females), and significantly lower body weights than controls in weeks 3 and 4 (males). An evaluation of hematology data at the end of the treatment period revealed significant decreases in erythrocyte count, hemoglobin and hematocrit in the high dose males and females. Females receiving 1000 mg/kg showed significant increases in absolute and percent reticulocyte counts at week 5, but by week 9 (recovery sacrifice) there were no significant differences in the hematology values of the high dose group and controls. Examination of the clinical chemistry values at week 5 revealed small but significant differences in globulin and the ratio of albumin to globulin in males and females in Group 4. By week 9 there was a statistically significant increase noted in alanine aminotransferase only in Group 4 animals. All other clinical chemistry parameters were comparable to controls at week 9. Gross examination at sacrifice following the treatment period (week 5) revealed test compound-related changes in the testis (atrophy, severe hypospermia, presence of syncytial cells, and lumenal cellular debris) of males from Group 4. Also, changes were noted in the epididymis from males in Groups 3 and 4, spleen from Group 4 males and Groups 3 and 4 females, and liver from Group 4 males and females. The incidence and severity of these changes was greatly reduced after the recovery period, with the exception of hypospermia, which was observed in the epididymis of 5/5 male rats.

/ENDOCRINE MODULATION/ The in vitro and in vivo estrogenicity of 5 UV B-filters, benzophenone-3 (Bp-3), homosalate (HMS), 4-methyl-benzylidene camphor (4-MBC), octyl-methoxycinnamate (OMC) and octyl-dimethyl-PABA (OD-PABA) and 1 UVA-filter, butyl-methoxydibenzoylmethane (B-MDM) were studied. A general screening assay (E-screen) with a human breast cancer cell line, MCF-7 cells, was carried out. A positive test was based upon the binding of the test compound with the estrogen receptor leading to cell proliferation. As a positive control, 17 b -estradiol, was used and it was, as expected, positive in the assay. The 5 UV-B filters were found to be positive in the assay and caused cell proliferation. The UV-A filter gave a negative result. EC 50 values for 17 b -estradiol, Bp-3, 4-MBC, OMC, OD-PABA and HMS were found to be 1.22 pM, 3.73 uM, 3.02 uM, 2.37 uM, 2.63 uM and 1.56 uM, respectively. The results were supported by the expression of the estrogen-dependent pS 2 protein and by an inhibition of effects with the anti-estrogen ICI 182,780.The potency of the positive control is in the order of picomoles; the in vitro potency of the UV-filters tested lays in the range of uM, which means a difference of 1 million units. The in vitro potency of the UV-filters is thus importantly lower than the one observed for 17 b -estradiol. Probably a lot of industrial chemicals would show some in vitro estrogenic effects when this type of comparisons is taken seriously. It should be emphasized here that in vitro assays can only demonstrate whether UV-filters bind on the estrogen receptor or not, but they do not provide evidence whether the compounds have estrogenic activity or not. In vitro assays are therefore screening tests useful in setting priorities for further in vivo testing. ...Claiming that 5 UV-filters have estrogenic properties based on an in vitro test is premature. The in vitro ranking for the UV-filters going from Bp3, 4-MBC, OMC, OD-PABA to HMS, did not correspond with the in vivo results. Indeed, in the latter test 4-MBC was most active, followed by OMC and Bp-3. The most active UV-filter in vitro displayed only a weak activity in vivo. In addition OD-PABA and HMS were found to be inactive. Only precise toxicokinetic data can link the in vitro and in vivo data, a conclusion that was also reached by the authors.

/GENOTOXICITY/ ... applying an SPF-15 sunscreen which contains Padimate-O to human skin followed by exposure to only 5 minimum erythemal doses (MED) of sunlight could, while suppressing the formation of UV-endonuclease-senitive sites (ESS), increase /DNA/ strand breaks in cells under the epidermis by at least 75-fold compared to exposure to 1 MED in the absence of sunscreen.

/ALTERNATIVE and IN VITRO TESTS/ Sunscreen skin penetration and safety assessment should be considered together in order to ensure that in vitro cytotoxicity studies examine relevant doses of these organic chemical UV filters to which viable epidermal cells are realistically exposed. In this study, /investigators/ sought to determine whether sufficient topically applied sunscreens penetrated into human viable epidermis to put the local keratinocyte cell populations at risk of toxicity. The penetration and retention of five commonly used sunscreen agents (avobenzone, octinoxate, octocrylene, oxybenzone and padimate O) in human skin was evaluated after application in mineral oil to isolated human epidermal membranes. Sunscreen concentration-human keratinocyte culture response curves were then defined using changes in cell morphology and proliferation (DNA synthesis using radiolabelled thymidine uptake studies) as evidence of sunscreens causing toxicity. Following 24 hr of human epidermal exposure to sunscreens, detectable amounts of all sunscreens were present in the stratum corneum and viable epidermis, with epidermal penetration most evident with oxybenzone. The concentrations of each sunscreen found in human viable epidermis after topical application, adjusting for skin partitioning and binding effects, were at least 5-fold lower, based on levels detected in viable epidermal cells, than those appearing to cause toxicity in cultured human keratinocytes. It is concluded that the human viable epidermal levels of sunscreens are too low to cause any significant toxicity to the underlying human keratinocytes.

An estimated BCF of 2960 was calculated in fish for Padimate O(SRC), using an estimated log Kow of 5.77(1) and a regression-derived equation(1). According to a classification scheme(2), this BCF suggests the potential for bioconcentration in aquatic organisms is very high(SRC), provided the compound is not metabolized by the organism(SRC).

The Henry's Law constant for Padimate O is estimated as 4X10-6 atm-cu m/mole(SRC) using a fragment constant estimation method(1). This Henry's Law constant indicates that Padimate O is expected to volatilize from water surfaces(2). Based on this Henry's Law constant, the volatilization half-life from a model river (1 m deep, flowing 1 m/sec, wind velocity of 3 m/sec)(2) is estimated as 15 days(SRC). The volatilization half-life from a model lake (1 m deep, flowing 0.05 m/sec, wind velocity of 0.5 m/sec)(2) is estimated as 117 days(SRC). However, volatilization from water surfaces may be attenuated by adsorption to suspended solids and sediment in the water column. The volatilization half-life from a model pond is about 1400 days when adsorption is considered(3). Padimate O's Henry's Law constant indicates that volatilization from moist soil surfaces is not expected to be an important fate process(SRC). Padimate O is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 5.1X10-4 mm Hg(SRC), determined from a fragment constant method(1).

Sunscreen active ingredients. The active ingredient of the product consists of any of the following, within the concentration specified for each ingredient, and the finished product provides a minimum SPF value of not less than 2 as measured by the testing procedures established in subpart D of this part: Padimate O up to 8 percent is included on this list.

Used as ultraviolet screen; [Merck Index]

Used as an ultraviolet absorber in US cosmetics at concentrations of 1.4-8%

Used as a synergistic agent-photoinitiator for UV-curable inks

THERAPEUTIC CATEGORY: Esters as ultraviolet screen

2023: 274,428 lb

Benzoic acid, 4-(dimethylamino)-, 2-ethylhexyl ester is listed as a High Production Volume (HPV) chemical (65FR81686). Chemicals listed as HPV were produced in or imported into the U.S. in >1 million pounds in 1990 and or 1994. The HPV list is based on the 1990 Inventory Update Rule. (IUR ) (40 CFR part 710 subpart B; 51FR21438).

Production volumes for non-confidential chemicals reported under the Inventory Update Rule.[Table#6792]

Production volume for non-confidential chemicals reported under the 2006 Inventory Update Rule. Chemical: Benzoic acid, 4-(dimethylamino)-, 2-ethylhexyl ester. Aggregated National Production Volume: 500,000 to < 1 million pounds.

Non-confidential 2012 Chemical Data Reporting (CDR) information on the production and use of chemicals manufactured or imported into the United States. Chemical: Benzoic acid, 4-(dimethylamino)-, 2-ethylhexyl ester. National Production Volume: Withheld.

Sunscreens are available in a variety of dosage forms and formulations. ... Because these formulations frequently change and the manufacturers often are reluctant to reveal specific ingredients in their formulations, a listing of commercially available sunscreens is not included in this monograph.

Plastics Material and Resin Manufacturing

Benzoic acid, 4-(dimethylamino)-, 2-ethylhexyl ester: ACTIVE

The drug is the 2-ethylhexyl ester of p-(dimethylamino) benzoic acid, occurs as a clear to yellow, oily liquid having a faint aromatic odor and is insoluble in water and soluble in alcohol.