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Chemwatch:4650.17 Page 8 of 12 Issue Date:06/27/2017 Version No:6.1.1.1 Phosphate Test Solution#2 Print Date:06121/2019 trioctanoin as reproductive toxicant. Phosphate Test Solution TOXICITY IRRITATION #2 Not Available Not Available TOXICITY IRRITATION GLYCERINE 96% Oral(rat)LD50:>10000 mg/kg[21 Not Available STANNOUS CHLORIDE TOXICITY IRRITATION SOLUTION Oral(rat)LD50:700 mg/kg[21 Not Available Legend: 1.Value obtained from Europe ECHA Registered Substances-Acute toxicity 2.*Value obtained from manufacturer's SDS. Unless otherwise specified data extracted from RTECS-Register of Toxic Effect of chemical Substances For glycerol: Acute toxicity:Glycerol is of a low order of acute oral and dermal toxicity with LD50 values in excess of 4000 mg/kg bw. At very high dose levels,the signs of toxicity include tremor and hyperaemia of the gastro-intestinal-tract.Skin and eye irritation studies indicate that glycerol has low potential to irritate the skin and the eye.The available human and animal data,together with the very widespread potential for exposure and the absence of case reports of sensitisation,indicate that glycerol is not a skin sensitiser. Repeat dose toxicity:Repeated oral exposure to glycerol does not induce adverse effects other than local irritation of the gastro-intestinal tract.The overall NOEL after prolonged treatment with glycerol is 10,000 mg/kg bw/day(20%in diet). At this dose level no systemic or local effects were observed.For inhalation exposure to aerosols,the NOAEC for local irritant effects to the upper respiratory tract is 165 mg/m3 and 662 mg/m3 for systemic effects. Genotoxicity:Glycerol is free from structural alerts,which raise concern for mutagenicity.Glycerol does not induce gene GLYCERINE 96% mutations in bacterial strains,chromosomal effects in mammalian cells or primary DNA damage in vitro.Results of a limited gene mutation test in mammalian cells were of uncertain biological relevance.In vivo,glycerol produced no statistically significant effect in a chromosome aberrations and dominant lethal study.However,the limited details provided and the absence of a positive control,prevent any reliable conclusions to be drawn from the in vivo data. Overall,glycerol is not considered to possess genotoxic potential. Carcinogenicity:The experimental data from a limited 2 year dietary study in the rat does not provide any basis for concerns in relation to carcinogenicity.Data from non-guideline studies designed to investigate tumour promotion activity in male mice suggest that oral administration of glycerol up to 20 weeks had a weak promotion effect on the incidence of tumour formation. Reproductive and developmental toxicity: No effects on fertility and reproductive performance were observed in a two generation study with glycerol administered by gavage(NOAEL 2000 mg/kg bw/day).No maternal toxicity or teratogenic effects were seen in the rat,mouse or rabbit at the highest dose levels tested in a guideline comparable teratogenicity study(NOEL 1180 mg/kg bw/day). 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 respiratory disease,in a non-atopic individual,with abrupt onset of persistent asthma-like symptoms within minutes to GLYCERINE & hours of a documented exposure to the irritant.A reversible airflow pattern,on spirometry,with the presence of moderate STANNOUS CHLORIDE to severe bronchial hyperreactivity on methacholine challenge testing and the lack of minimal lymphocytic inflammation, SOLUTION 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 X Reproductivity X Serious Eye 01 STOT-Single Exposure X Damage/Irritation Respiratory or Skin X STOT-Repeated X sensitisation Exposure Mutagenicity X Aspiration Hazard X Legend: X —Data either not available or does not fill the criteria for classification .I—Data available to make classification SECTION 12 ECOLOGICAL INFORMATION Toxicity Continued...