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[A hygienic evaluation of the new flocculant polyhexamethyleneguanidine]
Abstract
Sanitary and toxicological study of some guanidine containing polymers was done. Moderate toxicity of the polymers and absence of any specific effects were noted.
... Therefore, only animal experiments can be taken as a basis for risk assessment of PHMG. The LD 50 for PHMG was found to be 450 mg/ kg for mice and 630 mg/kg for rats (Condrashov, 1992). In these experiments, liver, spleen and stomach injuries were reported. ...
... In these experiments, liver, spleen and stomach injuries were reported. The NOAEL in a 6-month oral study with rats was found to be 0.1 mg/kg bodyweight/day by Condrashov (1992). The animals in the 1.0 mg/kg bodyweight/day and 10 mg/kg bodyweight/day dose groups showed an increase in liver and spleen weights and also changes in blood enzyme levels. ...
Unrecorded alcohol consumption in Russia: toxic denaturants and disinfectants pose additional risks
In 2005, 30% of all alcohol consumption in Russia was unrecorded. This paper describes the chemical composition of unrecorded and low cost alcohol, including a toxicological evaluation. Alcohol products (n=22) from both recorded and unrecorded sources were obtained from three Russian cities (Saratov, Lipetsk and Irkutsk) and were chemically analyzed. Unrecorded alcohols included homemade samogons, medicinal alcohols and surrogate alcohols. Analysis included alcoholic strength, levels of volatile compounds (methanol, acetaldehyde, higher alcohols), ethyl carbamate, diethyl phthalate (DEP) and polyhexamethyleneguanidine hydrochloride (PHMG). Single samples showed contamination with DEP (275-1269 mg/l) and PHMG (515 mg/l) above levels of toxicological concern. Our detailed chemical analysis of Russian alcohols showed that the composition of vodka, samogon and medicinal alcohols generally did not raise major public health concerns other than for ethanol. It was shown, however, that concentration levels of DEP and PHMG in some surrogate alcohols make these samples unfit for human consumption as even moderate drinking would exceed acceptable daily intakes.
... Reportedly, the mean lethal dose of Extrasept-1 in animal experiments is not much lower than that of purified ethanol: 9.7 vs. 12.3 mg/kg [31]. The median lethal dose (LD 50 ) of PHMG, administered orally, has been around 450 mg/kg for mice and 630 mg/kg for rats [32], while the animals died with signs of injury not of the liver but of the nervous system [33][34][35][36]. Lung lesions due to PHMG used in household humidifiers have been reported [37]. ...
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... Reportedly, the mean lethal dose of Extrasept-1 in animal experiments is not much lower than that of purified ethanol (9.7 vs. 12.3 mg/kg); the concentrations are not given (Kuchina 2008). LD50 of PHMG, administered orally, has been around 450 mg/kg for mice and 630 mg/kg for rats (Lachenmeier et al. 2012), while the animals died with signs of injury to the nervous system (Asiedu-Gyekye et al. 2014Kondrashov, 1992;Tsisanova & Salomatin, 2010). Lung lesions due to PHMG used in household humidifiers have been reported (Kim et al. 2016). ...
During the anti-alcohol campaign in the former Soviet Union (1985-1989), consumption of inexpensive colognes and technical alcohol-containing liquids was widespread. Drinking of non-beverage alcohol decreased abruptly after the campaign, when vodka and beer became readily available and inexpensive. Alcohol consumption predictably increased after the campaign. The upsurge in alcohol consumption facilitated economical reforms of the early 1990s: workers did not oppose privatization of factories partly thanks to their drunkenness. Following abolition of the state alcohol monopoly in 1992, the country was flooded by beverages of poor quality, sold through legally operating shops and kiosks, which caused severe poisonings. Thereafter, the quality of beverages has improved while the consumption tended to decrease. Besides, several aspects of treatment including invasive procedures applied with questionable indications are discussed here. A concluding point is that the society should care of its weaker members, including those suffering of alcohol use disorder and alcohol-related dementia, because they can be maltreated, abused and expropriated. In regard to the future research, toxicity of some alcoholic beverages sold in Russia is of particular importance.
... In this context, Kondrashov (Kondrashov, 1992) stated that the LD 50 of the polymer at a 30% concentration was 450 mg/kg and 650 mg/kg in mice and rats, respectively, corroborating the results of Asiedu-Gyekye et al. (Asiedu-Gyekye et al., 2014) after single administration of the polymer by gavage in rodents, suggesting low toxicity. In the present study, the acute oral toxicity test showed that 5% PHMGH presented a LD 50 greater than 2000 mg/kg in rats. ...
The synthetic polyhexamethylene guanidine hydrochloride (PHMGH) polymer presents antifungal and antimicrobial activities in vitro. However, in vivo reports regarding its antiseptic and healing activity are scarce in the scientific literature. Thus, the present study aimed to evaluate the antimicrobial and healing effects, as well as toxicological parameters, of a topical solution containing 0.5% PHMGH (Akwaton®⁾ in the treatment of superficial skin wounds experimentally induced on the dorsum of rodents. In addition, non-clinical safety studies were also conducted for use in human health, such as acute oral toxicity and genotoxicity tests. Animals did clinically not present dermatitis. After two days of topical treatment, PHMGH showed a significant antiseptic effect compared to the untreated group, reducing the number of colony-forming units by 72%, reaching 100% on the fourth day of treatment. The animals treated with PHMGH showed a significant area reduction of the skin lesions in relation to the untreated group, indicating a healing effect of the polymer. Moreover, PHMGH treatment led to a significant increase in fibroblasts when compared to the untreated group, revealing its healing action. No significant differences were observed between the biochemical indicators of hepatoxicity and nephrotoxicity, nor genotoxicity between the PHMGH-treated and the negative control groups. The results of acute oral toxicity showed that PHMGH at 5% presents a lethal dose 50% greater than the 2000 mg/kg. At a concentration of 5%, PHMGH did not show genotoxicity nor cytotoxicity at doses up to 1500 mg/kg through the micronucleus assay in mice. Therefore, 0.5% PHMGH showed an antimicrobial and healing effect, with no toxicity, and could be a promising adjunct in the microbial control of healing wounds.
... Apart from PHMG, "chloride compounds", i.e. organochlorides have been discussed as possible causative factors (Khaltourina & Korotayev, 2016;Nuzhnyi et al., 2010). The latter seems to be more probable as PHMG has no strong hepatotoxicity; its LD50, when administered orally, has been around 450 mg/kg for mice and 630 mg/ kg for rats (Lachenmeier et al., 2012) or somewhat higher, while the animals died with signs of injury to the nervous system (Asiedu-Gyekye et al., 2014, 2015Kondrashov, 1992;Tsisanova & Salomatin, 2010). Lung lesions due to PHMG used in household humidifiers have been reported (Kim et al., 2016), but no reports on liver injury in humans have come to our attention. ...
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https://www.researchgate.net/publication/321146092_Popular_alcoholic_beverages_in_Russia_with_special_reference_to_quality_and_toxicity_J_Addiction_Prevention
In Russian: https://www.researchgate.net/publication/297677195_Alkogol_i_alkogolizm_v_Rossii_s_1970-go_po_2015_god_Alcohol_and_alcoholism_in_Russia_1970-2015
... Even low doses of PHMG, such as 13 lg/mL, have an effective bactericidal effect (Zhou et al., 2010). Epidemiologically, the lethal dose of 50% mortality (LD 50 ) value for PHMG has been reported as 450 mg/kg in mice and 630 mg/kg in rats (Condrashov, 1992). ...
In Korea, lung disease of children and pregnant women associated with humidifier disinfectant use has become a major concern. A common sterilizer is polyhexamethylene guanidine (PHMG), a member of the guanidine family of antiseptics. This study was done to elucidate the putative cytotoxic effect of PHMG and the PHMG-mediated altered gene expression in human alveolar epithelial A549 cells in vitro. Cell viability analyses revealed the potent cytotoxicity of PHMG, with cell death evident at as low as 5 μg/mL. Death was dose- and time-dependent, and was associated with formation of intracellular reactive oxygen species, and apoptosis significantly, at even 2 μg/mL concentration. The gene expression profile in A549 cells following 24 h exposure to 5 μg/mL of PHMG was investigated using DNA microarray analysis. Changes in gene expression relevant to the progression of cell death included induction of genes related to apoptosis, autophagy, fibrosis, and cell cycle. However, the expressions of genes encoding antioxidant and detoxifying enzymes were down-regulated or not affected. The altered expression of selected genes was confirmed by quantitative reverse transcription-polymerase chain reaction and Western blot analyses. The collective data suggest that PHMG confers cellular toxicity through the generation of intracellular reactive oxygen species and alteration of gene expression.
Anxiety and mood disorders have become very significant affections in the last decades. According to WHO at least one mental disease occurred per year in 27% of EU inhabitants (more than 82 mil. people). It is estimated that by 2020, depression will be the main cause of morbidity in the developed countries. These circumstances call for research for new prospective drugs with anxiolytic and antidepressive properties exhibiting no toxicity and withdrawal effect and possessing beneficial properties, like antioxidant and/or neuroprotective effects. The aim of this study was to obtain information about psychopharmacological properties of pyridoindole derivatives SMe1EC2 and SMe1M2, using non-invasive behavioral methods in rats.
The battery of ethological tests (open field, elevated plus-maze, light/dark box exploration, forced swim test) was used to obtain information about anxiolytic and antidepressant activity of the pyridoindole derivatives. The substances were administered intraperitoneally 30 minutes before the tests at doses of 1, 10 and 25 mg/kg.
In the behavioral tests, SMe1EC2 was found to exert anxiolytic activity in elevated plus maze with no affection of locomotor activity. The highest dose of SMe1M2 increased the time spent in the lit part of the Light/Dark box, however this result was influenced by inhibition of motor activity of the rats. Similar findings were observed also in elevated plus-maze, although these results were not statistically significant.
In conclusion, from the results of our study it is evident that both pyridoindoles acted on the CNS. In the highest dose, SMe1M2 was found to possess rather sedative than anxiolytic or antidepressant activity.
We read with great interest the study of Ostapenko et al. 1 reporting about an outbreak of acute cholestatic liver injury in Russia con- nected to the consumption of unrecorded alcohol. As background, it has to be mentioned that alcohol consumption is the most im- portant risk factor for death and burden of disease in Russia (see Rehm et al. 2 and Zaridze et al. 3 ). Of course alcohol-attributable liver disease plays an important role in this relationship. In the study of Ostapenko et al., 1 the alcohol that was consumed by the patients was an antiseptic liquid for indoor disinfection, which contained ethanol (93%), diethyl phthalate (DEP) (0.08 – 0.15%) and polyhexamethyleneguanidine hydrochloride (PHMG, CAS #57029-18-2) (0.10 – 0.14%). PHMG is an effective antiseptic and is commonly used for suppression of hospital infection in the Russian Federation, 4 and DEP is added to denature the alcohol. 5 Several previous studies had also detected PHMG together with DEP in disinfectants that were used as an ethanol source in other poisoning cases in Russia. 4,6,7 On the basis of clinical manifestations and laboratory fi nd- ings of 579 poisoned patients, Ostapenko et al. 1 concluded that the cholestatic hepatits was caused by PHMG, while a history of alcohol-induced hepatitis and cirrhosis contributed to a more se- vere course of the poisoning. Other factors such as DEP or chronic viral hepatitis may have further contributed to multifactorial liver damage. While we agree with the authors that the outbreak may have been caused by PHMG, we disagree with the conclusion of an almost causal relationship. At least, the paper lacks adequate dis- cussion of the alternative hypothesis, that is, that the outbreak was purely caused by extreme amounts of ethanol ingestion and high- risk drinking patterns.
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