ピグメント レッド 4

TERRESTRIAL FATE: Based on a classification scheme(1), an estimated Koc value of 2.3X10+5(SRC), determined from a structure estimation method(2), indicates that C.I. Pigment Red 4 is expected to be immobile in soil(SRC). Volatilization of C.I. Pigment Red 4 from moist soil surfaces is not expected to be an important fate process(SRC) given an estimated Henry's Law constant of 9.3X10-13 atm-cu m/mole(SRC), using a fragment constant estimation method(3). C.I. Pigment Red 4 is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 1.6X10-10 mm Hg(SRC), determined from a fragment constant method(4). Biodegradation data were not available(SRC, 2009).

AQUATIC FATE: Based on a classification scheme(1), an estimated Koc value of 2.3X10+5(SRC), determined from a structure estimation method(2), indicates that C.I. Pigment Red 4 is expected to adsorb to suspended solids and sediment(SRC). Volatilization from water surfaces is not expected(3) based upon an estimated Henry's Law constant of 9.3X10-13 atm-cu m/mole(SRC), developed using a fragment constant estimation method(4). According to a classification scheme(5), an estimated BCF of 10(SRC), from an estimated log Kow of 6.6(6) and a regression-derived equation(7), suggests the potential for bioconcentration in aquatic organisms is low(SRC). Biodegradation data were not available(SRC, 2009).

ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), C.I. Pigment Red 4, which has an estimated vapor pressure of 1.6X10-10 mm Hg at 25 °C(SRC), determined from a fragment constant method(2), is expected to exist solely in the particulate phase in the ambient atmosphere. Particulate-phase C.I. Pigment Red 4 may be removed from the air by wet or dry deposition(SRC). C.I. Pigment Red 4 contains functional groups that are typically chromophores which absorb at wavelengths >290 nm(3); therefore C.I. Pigment Red 4 may be susceptible to direct photolysis by sunlight(SRC).

Using a structure estimation method based on molecular connectivity indices(1), the Koc of C.I. Pigment Red 4 can be estimated to be 2.3X10+5(SRC). According to a classification scheme(2), this estimated Koc value suggests that C.I. Pigment Red 4 is expected to be immobile in soil.

An estimated BCF of 10 was calculated for C.I. Pigment Red 4(SRC), using an estimated log Kow of 6.6(1) and a regression-derived equation(2). According to a classification scheme(3), this BCF suggests the potential for bioconcentration in aquatic organisms is low(SRC).

The Henry's Law constant for C.I. Pigment Red 4 is estimated as 9.3X10-13 atm-cu m/mole(SRC) using a fragment constant estimation method(1). This Henry's Law constant indicates that pigment red 4 is expected to be essentially nonvolatile from water surfaces(2). The Henry's Law constant of C.I. Pigment Red 4 indicates that volatilization from moist soil surfaces is not expected(SRC). C.I. Pigment Red 4 is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 1.6X10-10 mm Hg(SRC), determined from a fragment constant method(3).

/LABORATORY ANIMALS: Chronic Exposure or Carcinogenicity/ D&C Red No. 36, a drug and cosmetic dye commonly used for coloring lipsticks, was evaluated for its carcinogenic potential in male and female Wistar rats. ... In the present study, 50 male and 50 female rats in each group were given diets containing D&C Red No. 36 at 2 different concentrations, 1,000 ppm and 2,000 ppm, for 78 weeks and sacrificed at week 98. It was found that dye treatment had no significant effect on the survival of either male or female animals /nor on/ body weight gain in males. However, body weight gain of treated females was slightly lower than that of the control group. Histopathological assessment demonstrated a number of benign and malignant tumors to have developed in various organs of both dye treated and control groups. In male rats, benign liver tumors were found at incidences of 16.7% and 18.8% of the low (1,000 ppm) and high (2,000 ppm) dose groups, respectively, similar to the 20% for the control group. Malignant tumors of the thyroid gland were observed only in the low dose and control groups, at 4.2% and 2%, respectively. In the high dose group, the incidences of lung, liver, urinary bladder and soft tissue cancers were 4.2%, 2.1%, 2.1% and 2.1%, respectively, only one soft tissue cancer being observed in a control group animal. In females, benign tumors were observed in the liver and mammary glands. The incidences of liver tumors in the low and high dose groups were 12.8% and 16%, respectively, and 6% in the control group. Values for mammary gland tumors were 10.6%, 10%, and 18% respectively. Malignant tumors were also observed in various other organs, including the uterus, lung, kidney, thyroid, thymus and salivary gland, but the incidences were very low (about 2-4%) and in dye treated male and female rats were not statistically different from those in the control animals. The results of the present study thus demonstrated that D&C Red No. 36 at the concentrations of 1,000 ppm and 2,000 ppm in the diet is not carcinogenic either to male or female Wistar rats. While the occurrence of benign liver tumors in female rats may be related to dye treatment, the lack of any apparent dose-dependence or any statistically significant difference from the control group (P = 0.06) suggests that this is unlikely.

/GENOTOXICITY/ This dye has been shown to exhibit mutagenic activity towards Salmonella typhimurium TA 98 in the presence of S9 mix.

/GENOTOXICITY/ ... The Salmonella/mammalian microsome assay was used to test a number of colorants commonly used in drugs and cosmetics. These agents were mostly lakes, which are dye-alumina complexes, or insoluble salts from which the dyes were solubilized prior to mutagenicity testing. Agents causing mutations in Salmonella typhimurium were D & C Red No. 19, D & C Red No. 36 and D & C Orange No. 17. Rat liver microsomes were used.

C.I. Pigment Red 4 is not expected to undergo hydrolysis in the environment due to the lack of functional groups that hydrolyze under environmental conditions(1). C.I. Pigment Red 4 contains functional groups which are typically chromophores that absorb at wavelengths >290 nm(1); therefore C.I. Pigment Red 4 may be susceptible to direct photolysis by sunlight(SRC).

Occupational exposure to C.I. Pigment Red 4 may occur through inhalation of dust and dermal contact with this compound at workplaces where C.I. Pigment Red 4 is produced or used. Use data indicate that the general population may be exposed to C.I. Pigment Red 4 via dermal contact with consumer products and ingestion of limited drugs containing this compound. (SRC)

C.I. Pigment Red 4's production and use in printing inks, resins, paper, cosmetic lip products, and limited use as a drug colorant may result in its release to the environment through various waste streams. If released to air, an estimated vapor pressure of 1.6X10-10 mm Hg at 25 °C indicates C.I. Pigment Red 4 will exist solely in the particulate phase in the atmosphere. Particulate-phase C.I. Pigment Red 4 will be removed from the atmosphere by wet or dry deposition C.I. Pigment Red 4 contains functional groups that are typically chromophores which absorb at wavelengths >290 nm; therefore C.I. Pigment Red 4 may be susceptible to direct photolysis by sunlight. If released to soil, C.I. Pigment Red 4 is expected to be immbobile based upon an estimated Koc of 2.3X10+5. Volatilization from moist soil surfaces is not expected to be an important fate process based upon an estimated Henry's Law constant of 9.3X10-13 atm-cu m/mole. C.I. Pigment Red 4 is not expected to volatilize from dry soil surfaces based upon its vapor pressure. Biodegradation data were not available. If released into water, C.I. Pigment Red 4 is expected to adsorb to suspended solids and sediment based upon the estimated Koc. Volatilization from water surfaces is not expected to be an important fate process based upon this compound's estimated Henry's Law constant. An estimated BCF of 10 suggests bioconcentration in aquatic organisms is low. Hydrolysis is not expected to be an important environmental fate process since this compound lacks functional groups that hydrolyze under environmental conditions. Occupational exposure to C.I. Pigment Red 4 may occur through inhalation of dust and dermal contact with this compound at workplaces where C.I. Pigment Red 4 is produced or used. Use data indicate that the general population may be exposed to C.I. Pigment Red 4 via dermal contact with consumer products and ingestion of limited drugs containing this compound. (SRC)

/SRP:/ Immediate first aid: Ensure that adequate decontamination has been carried out. If patient is not breathing, start artificial respiration, preferably with a demand valve resuscitator, bag-valve-mask device, or pocket mask, as trained. Perform CPR if necessary. Immediately flush contaminated eyes with gently flowing water. Do not induce vomiting. If vomiting occurs, lean patient forward or place on the left side (head-down position, if possible) to maintain an open airway and prevent aspiration. Keep patient quiet and maintain normal body temperature. Obtain medical attention. /Poisons A and B/

/SRP:/ Basic treatment: Establish a patent airway (oropharyngeal or nasopharyngeal airway, if needed). Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if needed. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for pulmonary edema and treat if necessary ... . Monitor for shock and treat if necessary ... . Anticipate seizures and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with 0.9% saline (NS) during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 mL/kg up to 200 mL of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool ... . Cover skin burns with dry sterile dressings after decontamination ... . /Poisons A and B/

/SRP:/ Advanced treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious, has severe pulmonary edema, or is in severe respiratory distress. Positive-pressure ventilation techniques with a bag valve mask device may be beneficial. Consider drug therapy for pulmonary edema ... . Consider administering a beta agonist such as albuterol for severe bronchospasm ... . Monitor cardiac rhythm and treat arrhythmias as necessary ... . Start IV administration of D5W /SRP: "To keep open", minimal flow rate/. Use 0.9% saline (NS) or lactated Ringer's if signs of hypovolemia are present. For hypotension with signs of hypovolemia, administer fluid cautiously. Watch for signs of fluid overload ... . Treat seizures with diazepam or lorazepam ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Poisons A and B/