Yellow needles from alcohol. Solutions are brownish and when diluted are fluorescent.
Löslichkeit
Red needles, hygroscopic. Sol in 300 parts cold water, in 1 part boiling waterslightly sol in alc. Practically insol in ether. pH of satd soln is 6-8. pH of 0.1 percent soln is 2.5 /Sulfate/Soluble in ethanol. Practically insoluble in benzene and ether.Soluble in water.1.04e-01 g/LDMSO: 23 mg/mL (109.92 mM)Ethanol: 2 mg/mL (9.56 mM)
Decomposition
When heated to decomposition it emits toxic fumes of /nitric oxides/
WarningH302 (97.5%): Harmful if swallowed [Warning Acute toxicity, oral]P261, P264, P264+P265, P270, P271, P280, P301+P317, P302+P352, P304+P340, P305+P351+P338, P319, P321, P330, P332+P317, P337+P317, P362+P364, P403+P233, P405, and P501 (click each P-code to see the statement)Aggregated GHS information provided per 40 reports by companies from 3 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.
Gefahrenübersicht
Proflavine and its salts are used as topical antisepticsNo epidemiological studies available and animal data inadequate for evaluation[IARC] Allergic contact dermatitis has been reported[HSDB] Intraperitoneal LD50 (mouse) = 50 mg/kg[Sax] An irritant[MSDSonline]
Hazard Classes and Categories
Acute Tox. 4 (97.5%)
Ongoing Test Status
The following link will take the user to the National Toxicology Program (NTP) Test Agent Search Results page, which tabulates all of the "Standard Toxicology & Carcinogenesis Studies", "Developmental Studies", and "Genetic Toxicity Studies" performed with this chemical. Clicking on the "Testing Status" link will take the user to the status (i.e., in review, in progress, in preparation, on test, completed, etc.) and results of all the studies that the NTP has done on this chemical. /Proflavin hydrochloride/ [http://ntp-apps.niehs.nih.gov/ntp_tox/index.cfm?fuseaction=ntpsearch.searchresults&searchterm=952-23-8]
Human Toxicity Excerpts
/SPECIAL STUDIES/ The induction of unscheduled DNA synthesis (UDS) and the alteration of semiconservative DNA replication by the structurally related intercalating agents proflavine and 9-aminoacridine were studied in MRC-5 human fibroblasts in culture ... Proflavine affected DNA synthesis, but did not elicit any UDS.
Non-Human Toxicity Excerpts
/LABORATORY ANIMALS: Acute Exposure/ A study of the photosensitizing effects of 8-methoxypsoralen (MOP), neutral red (NR), and proflavine (PF) on the skin of female Swiss albino mice, strain 955, was carried out using fractionated exposure to long ultraviolet light (300-400 nm) and visible light (tungsten emission). The results (1) confirmed MOP photocarcinogenicity, (2) demonstrated that both NR and PF are photocarcinogens, and, further, (3) showed that the above UV light with 2.6% of fluence at 313 nm is a long-term carcinogenic agent even though the total dose of 313 nm was 100 times less than the minimal UV tumorigenic dose in mice. The tumors were mammary adenocarcinomas, carcinomas of skin appendages, carcino-mixo-sarcomas, lymphomas, and one case of thyroid adenocarcinoma. The implications of the above data regarding the controversy about oncogenic risks in photochemotherapy are discussed.
/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ In a study in which the tumor promoting effect of sclerosing agents was investigated on skin initiated with 2,10-dimethyl-1,2-benzanthracene, a control group of 20 male albino 's' strain mice were given weekly skin applications of 0.3 ml of a 1% solution of proflavine hemisulfate (B.P.) alone in 1:2 water:carbowax 300 for 24 weeks. No tumors were found in this group within 31 weeks. In addition, no tumor-promoting effet of proflavine hemisulfate was noted in this experiment. /Proflavine hemisulfate/
/LABORATORY ANIMALS: Chronic Exposure or Carcinogenicity/ Proflavine monochloride, as the hemihydrate (percentage of amine, 103.4 + or - 0.3% of the theoretical amount
minor unidentified impurities present), was administered in the diet at concentrations of 300 or 600 mg/kg diet to groups of 50 male and 50 female Fischer 344/ CR rats, 5-6 weeks of age, for 109 weeks. In male rats in the high-dose group, 3/48 leiomyosarcomas of the small intestine, 1/48 adenocarcinoma of the small intestine, 1/48 sarcoma of the large intestine and 1/49 hepatocellular carcinoma occurred
1/50 females in the high-dose grup developed a hepatocellular carcinoma. Hepatocellular carcinomas occurred in 1/50 males and 2/50 females in the low-dose group. None of these tumors occurred in the control group. The incidences of other neoplasms in treated animals were approximately the same or lower than those reported for controls. /Proflavine monochloride hemihydrate/
/LABORATORY ANIMALS: Chronic Exposure or Carcinogenicity/ Groups of 50 male and 50 female B6C3F1 mice, 5-6 weeks of age, were fed diets containing 200 or 400 mg/kg diet proflavine monohydrochloride, as the hemihydrate, for up to 104 weeks. (The percentage of amine was 103.4 + or - 0.3% of the theoretical amount
minor unidentified impurities were present.) Of the treated mice, 20/49 females (p < 0.001) and 28/49 males in the low-dose groups and 22/50 females (p < 0.01) and 30/50 males (p = 0.04) in the high-dose group developed hepatocellular carcinomas, compared with 4/50 and 20/49, respectively, in the controls. Hemangiosarcomas of the liver developed in 0/49 females and 6/49 males in the low-dose group and in 2/50 females and 3/50 males in the high-dose group, compared with 1/50 and 6/49, respectively, in the controls. The overall incidence of malignant lymphomas was high: 16/50 females and 11/50 males in the low-dose group, and 20/50 and 11/50, respectively, in the controls. Because a positive control carcinogen, N-2-fluorenylacetamide, was tested in the same room with these animals, the authors questioned the validity of these bioassay results
the statistical inference was made, however, that in female mice there was a strong association of development of hepatocellular carcinomas with the dose of proflavine monohydrochloride hemihydrate administered. /Proflavine monohydrochloride hemihydrate/
For more Non-Human Toxicity Excerpts (Complete) data for PROFLAVINE (12 total), please visit the HSDB record page.
Evidence for Carcinogenicity
Classification of carcinogenicity: 1) evidence in humans: no data2) evidence in animals: limited. Overall summary evaluation of carcinogenic risk to humans is Group 3: The agent is not classifiable as to its carcinogenicity to humans. /Proflavine saltsFrom table/
Antidote and Emergency Treatment
/SRP:/ Basic treatment: Establish a patent airway. 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 normal saline 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 ... . /Poison 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 respiratory arrest. Positive pressure ventilation techniques with a bag valve mask device may be beneficial. Monitor cardiac rhythm and treat arrhythmias as necessary ... . Start an IV with D5W /SRP: "To keep open", minimal flow rate/. Use lactated Ringer's if signs of hypovolemia are present. Watch for signs of fluid overload. Consider drug therapy for pulmonary edema ... . For hypotension with signs of hypovolemia, administer fluid cautiously. Watch for signs of fluid overload ... . Treat seizures with diazepam (Valium) ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Poison A and B/
National Toxicology Program Studies
A bioassay of the carcinogenicity of proflavine monohydrochloride hemihydrate was conducted using Fischer 344/CR rats and B6C3F1 mice. The compound was administered in the diet at concentrations of 300 and 600 ppm to groups of 50 rats for 109 weeks and at concentrations of 200 and 400 ppm to groups of 50 mice for 104 weeks. The animals were subjected to necropsy and histopathologic evaluation as they died or at the end of their periods of treatment. Average weights attained by high-dose groups were consistently lower than those of control groupsweights of low-dose groups showed essentially no differences from those of the controls. Survival rates of the treated rats and mice did not differ from those of the controls except for a lower rate among the female mice. Five malignant neoplasms of the intestinal tract consisting of three leiomyosarcomas of the small intestine, a sarcoma near the colon area, and an adenocarcinoma of the small intestine were observed in five of the high-dose male rats. None were observed in other treatment or control groups. If these five intestinal neoplasms are considered together, they aresignificant at the P=0.026 level using the Fisher exact test. A positive dose-related trend (P=0.034) was also present for the three leiomyosarcomas. The observed incidence of hepatocellular carcinoma in female mice was 4/50 (8%) in the control group, 20/49 (41%) in the low-dose group, and 22/50 (44%) in the high-dose group. The test for dose-related trend showed a level of significance of P<0.001. In male mice, the observed incidence of hepatocellular carcinoma was 20/49 (41%) in the control group 28/49 (57%) in the low-dose group, and 30/50 (60%) in the high-dose group. The dose-related trend was significant at P=0.057, and the high dose was significant at P=0.044. The unusually high incidence of hepatocellular carcinomas and hemangiosarcomas in control male mice and the unusually high incidence of malignant lymphomas in all groups of female mice in conjunction with the fact that a positive-control carcinogen was tested in the same room with these animals, raises a question of the validity of these bioassay results. /Proflavine monohydrochloride hemihydrate (CAS No. 952-23-8)/
