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Chemwatch:4650-8 Page 9 of 14 Issue Date:11/12/2018 Version No:6.1.1.1 API Pond Ammonia Test Solution#2 Print Date:06/21/2019 The material may produce moderate eye irritation leading to inflammation.Repeated or prolonged exposure to irritants may produce conjunctivitis. Most of the data for toxicity of hypochlorites by the oral route are from studies performed with sodium hypochlorite or chlorine gas.In biological systems,characterised by pH values in the range of 6-8,the most abundant active chemical species is(hypochlorous acid)HOCI,in equilibrium with hyochlorite anion(CIO-).Such available chlorine is readily absorbed via the oral route and distributed into plasma,bone marrow,testis,skin,kidney and lung.Only about.50%is excreted mainly with the urine followed by excretion with faeces.HOCI is not enzymatically metabolised. Acute toxicity:The acute oral LD50 of calcium hypochlorite was 790 mg/kg in male rats.Inhalation exposures to concentrations of greater than about 500 ppm(10 min or more)may be fatal for rats.Based on human experience and control studies in volunteers,it can be concluded that the acute NOAEL for humans was considered to be 0.5 ppm(1.5 mg/m3). Hypochlorite salts are extremely corrosive and can cause severe damage to the eyes and skin.Calcium hypochlorite is reported to be corrosive to the skin and has severe effects that can be expected from exposure to the eyes,which is ascribable to the alkalinity of calcium cation(pH=12.0 at 1 %as free available chlorine(FAC*)).Moderate to severe lesions in the respiratory tract were reported after exposure to chlorine that may emerge in case of accidental misuse of hypochlorite salts.Exposure to chlorine at 9 ppm(27 mg/m3)for 6 h/day during 1,3 and 5 days was reported to cause epithelial necrosis,cellular exfoliation,erosion,ulceration and squamous metaplasia in the nasal passage of rats and mice.For either of Ca or Na salt,reliable skin sensitisation studies are not available and case reports are available but no reliable case report could be found showing a sensitisation potential in humans. Repeat dose toxicity: In a 13-week study,male and female F-344 rats(10/sex/group)received sodium hypochlorite (NaCIO)in drinking water at level of 0.025,0.05,0.1,0.2,or 0.4%.A weight gain was significantly decreased in male rats at 0.2 and 0.4%and in females at 0.4%.These effects were dose related and obviously correlated with reduced water consumption.No histopathological changes attributable to the treatment were found.But an increase of AAT in the blood gave evidence of the adverse effects on the liver.Based on significant body-weight reduction at the top dose,a subchronic NOAEL of 59.5 mg/kg bw/day as free available chlorine(FAC*)(at 0.1%NaCIO level in the drinking water)can be calculated for male rats. For female rats a subchronic NOAEL of 215.7 mg/kg bw/day as FAC(at 0.2%NaCIO level in the drinking water)can be calculated.A NOAEL of 950 ppm available chlorine(59.5 mg/kg bw/day)can be derived from a 13-week rat study with sodium hypochlorite in drinking water. In a life-time guideline NTP-study,70 male and female F344 rats and B6C3F1 mice were administered chlorine via drinking water at dose levels of 0,70,140 and 275 mg(equivalent to FAC)/L in buffered water.These concentrations were equivalent to 0,4.8,7.5 and 13.9 mg/kg bw/day for male rats and 0,3.8,6.9 and 13.2 mg/kg bw/day for female rats.Mean body weights of male and female rats were similar among treated and control groups at both 14-week and 66-week interim evaluations.Those of male mice were significantly lower at week 66.Dose-related decrease in water consumption was observed throughout the study in both species and sexes.Food consumption was comparable among chlorine-treated and control groups.There were no clinical findings,alterations in haematological parameters and biologically significant differences in relative organ weights attributable to the treatment at 14/15-week and 66-week interim evaluations.Survival rate in chlorine-treated groups of rats and mice were similar to those of the controls after two groups.There was no evidence for non-neoplastic lesions to be associated with the consumption of chlorinated drinking water[NTP,1992].Based on these findings,a NOAEL(chronic)can be calculated to be approximately 14 mg available chlorine/kg bw/day for rats and 22.5 mg available chlorine/kg bw/day for mice. Reproductive toxicity:No reproductive toxic effects were shown up to 5 mg/kg(highest dose tested)of sodium salt (equivalent to 4.8 mg/kg of calcium salt)in a one generation oral study in rats.No evidence of adverse developmental effects were reported in animals.Moreover,epidemiological studies in humans did not show any evidence of toxic effects on reproduction and development. Genotoxicity:There are data from in vitro studies to suggest that solutions of chlorine/hypochlorite have some mutagenic potential,but it can be concluded that they are not mutagenic in vivo. No carcinogenicity was observed in mice or rats exposed by inhalation to chlorine and orally to sodium hypochlorite, except some equivocal results were reported for female rats by oral route.For human carcinogenicity,no causal relationship between hypochlorite exposure and tumour incidence was observed.The observation is applicable to calcium hypochlorite. A number of fibrosarcomas and squamous cell carcinomas were observed in mice treated dermally with repeated subcarcinogenic doses of 4-nitroquinoline-1-oxide,followed by dermal treatment with sodium hypochlorite. as sodium hypochlorite pentahydrate Asthma-like symptoms may continue for months or even years after exposure to the material ceases.This may be due to a non-allergenic condition known as reactive airways dysfunction syndrome(RADS)which can occur following exposure to high levels of highly irritating compound.Key criteria for the diagnosis of RADS include the absence of preceding SODIUM HYDROXIDE g, respiratory disease,in a non-atopic individual,with abrupt onset of persistent asthma-like symptoms within minutes to SODIUM HYPOCHLORITE hours of a documented exposure to the irritant.A reversible airflow pattern,on spirometry,with the presence of moderate to severe bronchial hyperreactivity on methacholine challenge testing and the lack of minimal lymphocytic inflammation, SOL. without eosinophilia,have also been included in the criteria for diagnosis of RADS.RADS(or asthma)following an irritating inhalation is an infrequent disorder with rates related to the concentration of and duration of exposure to the irritating substance.Industrial bronchitis,on the other hand,is a disorder that occurs as result of exposure due to high concentrations of irritating substance(often particulate in nature)and is completely reversible after exposure ceases.The disorder is characterised by dyspnea,cough and mucus production. Acute Toxicity X Carcinogenicity X Skin Irritation/Corrosion 01 Reproductivity X Continued...