### OECD SIDS UREA

UNEP PUBLICATIONS 

## FOREWORD INTRODUCTION



# UREA CAS N°: 57

-13-6Identifiers, Ph y

sical and Chemical properties 1

CAS Number : 57-13-6 End Point : IDENTIFIERS, PHYSICAL AND CHEMICAL PROPERTIES 

## Substance Chemical Name : Urea Common Name : Urea RTECS Number : YR6250000



## Properties & Definitions Molecular Formula : CH4N2O Molecular Weight : 60.06 Melting Point : 133C* Boiling Point : 135C decomposition** State : Crystal prismatic or powder Flamable Limit : Non-flammable Density : 1323 kg/m3 at 20-24C Vapour Pressure : 80 Pa (0.6 mmHg) at 20C CAL*** Octanol/Water Partition : Coefficient -1.59 at 20-25C experimental Water Solubility : 1080 g/L at 20C Solubility in other : Solvents 10 g/L in 95% alcohol, 167 g/L in methanol, 500 g/L in glycerol Colour : Colourless to white Taste : Cooling, saline Odour : Almost odourless Additives : Urea-formaldehyde binder can be used in some prilling processes. Impurities : Biuret 0.3 - 2 wt%; cyanates. Analysis of technical urea gave the followings: water (as moisture) 0.4 wt%; free ammonia 0.4 wt%; Fe 2+ <0.0002 wt%; ash content < 0.02 wt%. Degree of purity 98-99 wt%. General Comments : *On further heating decomposes to biuret, NH3 and cyanuric acid. On standing or on heating decomposes to NH3 and CO2. ** Urea decomposes before boiling.***VP of saturated water solution=2kPa at 20C. Hypochlorites can react with urea to form the explosive compound, nitrogen trichloride. Reacts violently with gallium perchlorate. Benural 70 B-I-K Carbamide Carbamimidic acid Carbonyl diamide Isourea Nimin Pseudourea UR Urea perhydrate Ureaphil Ureophil Urepearl Urevert Varioform II 

## Synonyms

log Pow =

CURRENTLY OF LOW PRIORITY FOR FURTHER WORK SIDS INITIAL ASSESSMENT Urea has generally low acute ecotoxicity to organisms. The aquatic effects assessment showed that calculated PECs were lower than the MTC. Urea is very soluble in water and degrades ultimately in the inherent biodegradability test. 

## Overall Evaluation

IRPTC Data ProfileIdentifiers, Physical and Chemical properties 2 Although urea has generally low ecotoxicity to organisms, its well documented indirect and longterm effects to the ecosystems, e.g. eutrophication, groundwater pollution, soil acidification and ammonia emissions to air should be considered. Urea is an important endogenous product of mammalian metabolism. This may partly explain why it has not been rigorously studied with toxicological tests. Nevertheless, urea appears to cause little or no toxicity to most mammalian species (ruminants are an exception) and humans at reasonable dose levels. The tentatively determined EHE is lower than the EDLC based on human observations. EXPOSURE TYPES OF USES AND EXPOSURE SOURCES: 1) Industry Urea is used in many industrial sectors for many functional uses e.g. as adhesives, binders, sealants, resins, fillers, analytical reagents, catalysts, intermediates, solvent, dyestuffs, fragrances, deodourisers, flavouring agents, humectants and dehydrating agents, formulation components, monomers, paint and coating additives, photosensitive agents, fertilizers, surface treatment agents. Urea is also the key synthetic ingredient in the manufacture of some medicines. Occupational and environmental exposure during production is possible due to accidental process breakdown and disorders in reactor operations, pumping cycles, evaporation and crystallization processes, in maintenance, loading and unloading operations. Potential occupational exposure occurs via inhalation of aerosols from urea melt and hot saturated solutions, splashed to skin or eyes or inhalation of dust. 2) Agriculture Urea is widely used as a nitrogenous fertilizer. As an animal feed supplement urea is used at approximately 3% of the grain ratio or 1% of the total ration. The use of highly concentrated fertilizers may cause human, livestock, especially ruminant and pet hazard. Sources of exposure may be accidental inclusions of highly concentrated fertilizers in rations, application of fertilizers to fields with livestock, washing of recently applied fertilizers by rain into water supplies of livestock, spilling accidentally fertilizers on land and into ponds or watering livestock with fertilizer containers without thorough cleaning and removal of residual fertilizers. Also various species of wild animals are exposed to urea when urea fertilizers are spread directly on the fields and in the forests. Aquatic organisms may be exposed to urea when recently applied fertilizers are washed by rain into rivers, lakes and seas. Livestock urine can cause environmental exposure when livestock graze in the grazing season or when manure of livestock is spread to the fields (reliable estimations of the emission levels from urine of naturally living mammalians can not be given). 3) Deicing agent Intensive use of urea as a deicing agent in many airports have lead to groundwater pollution. Urea is washed out from runways with the melting ice and leaches into the surface and groundwater. 4) Consumer products Urea is used in liquid soaps, detergents, household cleaning products and also in cosmetics products such as creams, shampoos, hair conditioners, hair dyes and dye removers, in ammoniated dentifrices etc. (Maximum urea concentration is commonly 1%.) ENVIRONMENTAL EXPOSURE Urea is "ultimately biodegradable". Degradation Urea is ultimately biodegradable in inherent biodegradability test (OECD 302 B). In semi-continuous activated sludge (SCAS) urea is biodegraded on the average of 93-98% in 24-hour cycle. The main mode of degradation is enzymatic mineralization. In soil and water urea is expected to biodegrade fairly rapidly to ammonia and bicarbonate if temperature is not too low. Ammonia is a volatile gas in alkaline solutions. In natural waters, most ammonia appear in the form of ammonium, from which nitrogen is oxidized IRPTC Data ProfileIdentifiers, Ph y

sical and Chemical properties 3 as the result of bacterial action, forming nitrite and nitrate. According to US-EPA PCGEMS-model hydrolysis of urea is expected to be extremely slow (T1/2 > 1 years). Bioaccumulation: Due to low log Pow value (- 1.59 at 20-25 C) urea is not likely to undergo bioaccumulation. DISTRIBUTION BETWEEN ENVIRONMENTAL COMPARTMENTS AND OCCURENCE IN THE ENVIRONMENT The model used for estimating the partitioning of urea in the environment was the Mackay level 1 model. According to the model there is 99.84% and 0.16% partitioning into water and air, respectively. (i) Air Urea is essentially non-volatile in solid form. Its high water solubility, low vapour pressure (solid pure urea 80 Pa at 20C; calculated) and consequently low Henry's law constant (4.4E-8 atm m3/mol) indicate that urea will not evaporate from water to atmosphere. Degradation of urea to ammonia causes NH3-emissions to air. Emissions are higher in alkaline soil (pH>7). (ii) Soil According to the worldwide use pattern of urea, when 85 - 90% of urea is used as a fertilizer, the highest environmental exposure is to soil. Urea is, however, relatively leachable from the soil into the surface and the groundwater because of its weak adsorption to the soil, high water solubility and low soil-water partition coefficient. This can happen especially if the soil surface is saturated with water, as might be the case after a rainfall. (iii) Water As earlier described, urea can be leached relatively easily into the surface water and the groundwater. The concentration of urea itself, however, is not generally detected, because of its high degradation rate. Therefore usually degradation products e.g. nitrate, nitrite and ammonium can be measured. Some monitoring data are, however, available: a) the concentration of urea in domestic sewage: 2 - 6 mg/L and in primary sewage plant effluent: 0.016 - 0.043 mg/L. b) the concentration of urea in sewage of Kemira's fertilizer factory (Finland): 0.34 mg/L. The monitoring data has been further used for calculation of the predicted environmental concentration (PEC). For calculation of PEC the dilution factors of 10 for domestic waste water effluents and 100 for industrial effluents are used. Thereby (a) PEC of 0.0016 - 0.0043 mg/L is obtained for primary sewage plant effluent and (b) PEC of 0.0034 mg/L for fertilizer factory. Environmental exposure by consumer use can be considered insignificant. CONSUMER EXPOSURE Because urea is an important endogenous product of protein catabolism in mammals and occurs in significant concentrations in blood and obviously in extracellular water, human food of animal origin contains some urea. If meat contained the same concentration of urea as human blood (about 30 mg/100 g), intake of urea from meat would amount to some tens of milligrams per day. Edible parts of plants may contain up to 4.5 per cent (oats) of their total nitrogen content as urea. The nitrogen content of grain seeds and grass is of the order 2-4%. If one per cent of the total nitrogen were urea (consequently 0.03% of the fresh weight of food of plant origin were urea), the human daily intake of urea from plants could amount up to several grams. However, due to the very limited data available concerning actual urea concentrations in e.g. root vegetables and potatoes, the uncertainties about the quantity are great. The possible food additive use of urea apparently adds litlle to the intake via food. The use of urea in skin preparations (soaps, cosmetics, medicines) may lead to highly variable cutaneous doses. The highest doses would concern patients treated extensively because of dry pruritic skin. About 1 per cent of the weight of the skin preparation could be absorbed as urea (preparation contains 10% urea, 10% is absorbed) resulting mostly in the dermal uptake of some tens of milligrams per day. Intake of urea from dental preparations cannot be estimated with any accuracy, but it probably amounts to relatively small quantities. IRPTC Data ProfileIdentifiers, Physical and Chemical properties 4 OCCUPATIONAL EXPOSURE Occupational exposure to urea can be envisaged from inhalation of aerosols and dust during production of urea, urea fertilizers and animal feed supplements, in chemical synthesis using urea as a starting material and whendispersing urea fertilizers/urea in the fields, roads and runways. In the context of airborne exposure, the nonrespirable fraction will be mostly ingested. A part of the airborne dust will deposit onto the skin and, additionally, heavier contamination of the hands will result from the handling of urea. Accidental splashes to the skin are possible too. No reports on actual measurements of urea concentration in the workplace or breathing zone air were located. The worst case scenario would assume that the exposure conforms to the permissible exposure levels of OSHA: 15 mg/m3 total dust and 5 mg/m3 respirable dust. Uptake of respirable urea at 5 mg/m3 (with a 10 m3 volume of total ventilation and 100% absorption) would amount to 50 mg (inhalation dose). The non-respirable part of urea at 10 mg/m3 and 10 m3 ventilation results in the airway deposition of 100 mg, most of which will be ingested. The amount of urea deposited on the skin may be significant, but the fraction absorbed is likely to be less than from skin preparations (the formulation affects the penetration of urea into the skin). Consequently, although no accurate estimates can be given, percutaneous uptake probably will not be higher than the respiratory uptake and ingestion, rather it is less. The tentative overall dose of urea resulting from the worst-case occupational exposure is thus of the order 200 mg per day. HUMAN TOXICITY a) Acute toxicity The acute toxicity by urea is well delineated by the oral route. Toxicity is low in mammals other than ruminants, especially cattle, and sheep, in which the rumen micro-organisms contain urease activity and metabolize urea to ammonia at a high rate. In mice and rats, urea is of low toxicity even by the subcutaneous and intravenous route. b) Repeated dose toxicity No well-conducted repeated dose toxicity studies on urea were located. Chronic toxicity and carcinogenicity screening studies in mice and rats fed with 4500, 9000 or 45000 ppm in diet (up to about 6750 mg/kg body weight/day for mice and about 2250 mg/kg body weight/day for rats) did not uncover any treatment-related toxic syndromes in the various organs studied. Neither was any weight depression noted at terminal necropsy for animals of either sex or species at any dose levels. Thus the NOAELs were about 6750 mg/kg body weight/day for mice and about 2250 mg/kg body weight/day for rats. Repeated dose toxicity studies with rats by skin application over 4 weeks and 25 weeks were conducted using urea ointment at 10%, 20% and 40% concentrations, and no consistent treatment-related toxic effects were found. The ointments were applied on a 20 cm2 area of the back skin but, unfortunately, the quantities of urea applied were not given. Therefore no value for NOAEL by dermal route can be determined. It can be concluded, however, that the repeated dose toxicity of urea by dermal route was low. c) Reproductive/developmental toxicity The studies cited under repeated dose toxicity did not indicate any toxic effects on the reproductive organs of mice and rats. No adequate teratogenicity/developmental toxicity studies of urea with mammals were located. According to one rat study, 50 g/kg body weight/day administered by gavage in two doses 12 hours apart for an average of 14 days did not cause outstanding (external) teratogenicity; the mean birthweight of the newborn was lower but the litter size greater. Injection of urea into the air sack of eggs shows that urea is toxic to the development of chick embryo. No NOAEL can be given for the reproductive/developmental toxicity of urea because appropriate studies are lacking. d) Genetic toxicity IRPTC Data ProfileIdentifiers, Ph y

sical and Chemical properties 5 Urea has been negative in several appropriately conducted bacterial mutagenicity tests. Urea caused DNA single strand breaks in mammalian cells in vitro and was clastogenic for mammalian cells in vitro and in vivo but only at concentrations much beyond the physiological range (about 50-100 higher concentrations than found in human blood). The mechanism of genotoxicity is probably non-specific (e.g. difference in osmotic pressure across the cell membrane). e) Any other human health related information that is available There is little data that relates urea to human health other than its use in dermatology and some more limited applications in clinical medicine. The use of urea (at 10% concentration or less) in ointments and creams totreat dry skin has been widespread, and long term follow-up studies have indicated that the substance is nonallergenic and virtually free from side effects. Among other clinical therapeutic uses, the treatment of inappropriate secretion of antidiuretic hormone (SIADH) should be noted, because its chronic form has involved long term oral administration of large amounts of urea. Most patients have tolerated urea well, although diarrhoea is sometimes reported after ingestion of 60-90 g/day. One patient who had received 30 g of urea (about 470 mg/kg body weight/day) by ingestion for 5 years did not exhibit any side effects. The possibility exists that infection of H. pylori in human stomach may aggravate local effects by urea because of ammonia generation. ENVIRONMENTAL ASSESSMENT In order to calculate the maximum tolerable concentration (MTC), assessment factor 100 is used, because NOEC-values were not available and acute L(E)C50-values were available for fish and crustaceans. Toxicity Threshold-value (TT) was available for algae representing more longterm than acute toxicity. It can be assumed, however, that acute L(E)C50 for algae can not be lower than the available toxicity treshold concentration. MTC is calculated for the most sensitive species, protozoa flagellata (Entosiphon sulcatum) where the lowest aquatic effect concentration, toxicity treshold (TT) (72 hours) of 29 mg/L, has been recorded: MTC: 29/100 = 0.29 mg/L According to the PEC calculated, MTC/PEC > 1: MTC/PEC => (a) 0.29/0.0043 = 67.4 (primary sewage plant effuent) (b) 0.29/0.0034 = 85.3 (sewage of Kemira's fertilizer factory) The degradation product of urea, ammonia, is known to be toxic to all vertebrates. In neutral and acidic conditions, however, ammonia exists in the form of ammonium. HUMAN HEALTH ASSESSMENT Urea is an endogenous product of protein and aminoacid catabolism, and consequently 20-35 g of urea is excreted daily in human urine. The blood concentration of urea is also relatively high, 3.3-6.7 mmol/L. Non-physiological, 50-100 times higher urea concentrations in the cultivating medium were shown to disrupt DNA and elicit genotoxicity in mammalian cells, apparently through non-specific osmotic mechanisms. It can be expected that the human organism is well adapted to urea within the physiological range of concentrations and even beyond. This is supported by clinical evidence from high dose administration orally and intravenously for therapeutic purposes. The bulk of human exposure to urea apparently results from urea ingestion through plant food and meat. Actual measurements concerning the urea content of food were not found, however, and therefore no certain or accurate amounts can be given. Among the consumers, patients using urea containing preparations for the treatment of dry skin may receive an additional but minor dose. Occupational exposure (via inhalation, ingestion and dermally) adds little to the amounts received from food. The estimated human exposure (EHE) level for urea can only be given very crudely, and it can probably vary widely depending on the food consumed. As a tentative value 3 g/day (about 40 mg/kg body weight/day) is proposed. Due to the fact that urea has not been rigorously examined with toxicity testing, meaningful NOAELs from animal studies are difficult to find. Especially it may be noted that the existing studies for reproductive and developmental toxicityare not adequate. However,chronic toxicityand carcinogenicityscreeningstudies of urea IRPTC Data ProfileIdentifiers, Physical and Chemical properties 6 in diet with mice and rats suggested that the NOAELs are of the order 2000-6000 mg/kg body weight/day. In a human female patient ingestion of 470 mg/kg body weight/day of urea over 5 years did not cause adverse effects. The estimated dose of low concern (EDLC) from animal data, using 100 as the uncertainty factor, would give 20- 60 mg/kg body weight/day but, as presented above, clinical experience shows that more than ten times higher dose levels in human patients have resulted in little or no adverse effects, even over relatively long periods of time. A further perspective to the EDLC assessment is the endogenous rate of urea formation (excretion), up to about 500 mg/kg body weight/day. Based on human observations, the EDLC appears to be about one order of magnitude higher than the proposed EHE. CONCLUSIONS Based upon the available information, the initial assessment gave no indication for concern for the human health and the environment. Based on the MTC/PEC-ratio urea is considered to possess low current concern. Urea has generally low acute ecotoxicity to organisms. The degradation product of urea, ammonia, is known to be toxic to all vertebrates. In neutral and acidic conditions, however, ammonia exists in the form of ammonium. Instead of toxic effects, more emphasis should be put on the indirect influence of urea to the environment via eutrophication and the pollution risk of urea to groundwater, when urea is used as a fertilizer and a deicer agent in airports. Also the longterm influence of urea use e.g. soil acidification after the longterm fertilization and ammonia emissions to air can have influence to the whole ecosystem and should be considered. Urea is an important endogenous product of mammalian metabolism. This may partly explain why it has not been rigorously studied with toxicological tests. Nevertheless, urea appears to cause little or no toxicity to most mammalian species (ruminants are more sensitive because of microbial ammonia production) and humans at reasonable dose levels. Based on the EHE/EDLC ratio, urea should be of low current concern to human health. RECOMMENDATIONS No further tests are needed. More accurate data concerning the daily intake of urea from diet are desirable.

IRPTC Data ProfileProduction-Trade 7

CAS Number : 57-13-6 

## Production-Trade Geographic Area : WORLD Chemical Name : Urea

1985-1989 

## Production 19062400-27963000 t/y - P 41440000-60789000 t/y - P 89800000-+134E+5 t/y - P Quantity Year 1985-1989 1989
General Comments : 1- The total production volume of urea in metric tons of N (urea N-46%)in the world. 2- World total production volume of urea. 3- Capacities in production or being commissioned in December 1989 (reported in: Information Chimie No. 315, March , pp. 179-201, (1990). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : USA Area Specifications : AMN Chemical Name : Urea

1985-1989 

## Production 1470000-2350000 t/y - P 13 % - EX Quantity Year

General Comments : The given values are the production volume tonnes per annum of nitrogen (urea N-46%). The data related to the export reported in the Altman, P. L., Dittmer, D. S. Biology Data Book, Vol III, 2nd ed., Federation of American Societies for Experimental Biology, 1974, pp. 1494 & 1501.

IRPTC Data ProfileProduction-Trade 8 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : AMN Chemical Name : Urea 

## Production 11599000-+630000 t/y - P Quantity Year

General Comments : Capacities in production or being commissioned in December 1989. 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) INFCAS Information Chimie, 315, 179-201, (1990)
CAS Number : 57-13-6 

## Production-Trade Chemical Name : Urea 

## Production 31635000-+3617000 t/y - P Quantity Year

General Comments : Capacities in production or being commissioned in December 1989 in Planned Economy Countries.

IRPTC Data ProfileProduction-Trade 9 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) INFCAS Information Chimie, 315, 179-201, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : EUR Area Specifications : W Chemical Name : Urea 

## Production 6215000-+250000 t/y - P Quantity Year

General Comments : Capacities in production or being commissioned in December 1989. 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) INFCAS Information Chimie, 315, 179-201, (1990)
CAS Number : 57-13-6 

## Production-Trade Chemical Name : Urea 

## Production 3419000-+1150000 t/y - P Quantity Year

General Comments : Capacities in production or being commissioned in December 1989 for Central and South America.

IRPTC Data ProfileProduction-Trade 10 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) INFCAS Information Chimie, 315, 179-201, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : AFRI Chemical Name : Urea 

## Production 2957000-+575000 t/y - P Quantity Year

General Comments : Capacities in production or being commissioned in December 1989. 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) INFCAS Information Chimie, 315, 179-201, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : ASIA Chemical Name : Urea 

## Production 5295000-+2550000 t/y - P 28728000-+4650000 t/y - P Quantity Year

General Comments : 1- Capacities in production or being commissioned in December 1989 in Middle East and Persian Gulf. 2- Capacities in production or being commissioned in December 1989 in Asia and Oceania. IRPTC Data ProfileProduction-Trade 11 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) INFCAS Information Chimie, 315, 179-201, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : EUR Chemical Name : Urea

1985-1989 

## Production 7144900-8321000 t/y - P Quantity Year

General Comments : The total production volume of urea In metric tons of N (urea N-46%) in Europe. 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : ASIA Chemical Name : Urea

1985-1989 

## Production 8063500-12185000 t/y - P Quantity Year

General Comments : The total production volume of urea in metric tons of N (urea N-46%) in Asia.
IRPTC Data ProfileProduction-Trade 12 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : NGA Area Specifications : AFRI Chemical Name : Urea

1987-1988 

## Production 70000-230000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : CAN Area Specifications : AMN Chemical Name : Urea

1985-1989 

## Production 1000000-3000000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). IRPTC Data ProfileProduction-Trade 13 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : CUB Chemical Name : Urea

1985-1989 

## Production 20000-38000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : MEX Chemical Name : Urea

1985-1988 

## Production 500000-640000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%).
IRPTC Data ProfileProduction-Trade 14 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : TTO Chemical Name : Urea

1985-1989 

## Production 150000-250000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : AFG Area Specifications : ASIA Chemical Name : Urea

1985-1989 

## Production 45000-60000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). IRPTC Data ProfileProduction-Trade 15 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : BDG Area Specifications : ASIA Chemical Name : Urea

1985-1989 

## Production 380000-680000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : IND Area Specifications : ASIA Chemical Name : Urea

1985-1989 

## Production 3400000-5750000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). IRPTC Data ProfileProduction-Trade 16 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : IDN Area Specifications : ASIA Chemical Name : Urea

1986-1989 

## Production 1800000-2240000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : IRN Area Specifications : ASIA Chemical Name : Urea

1986-1988 

## Production 50000-100000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). IRPTC Data ProfileProduction-Trade 17 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : JPN Area Specifications : ASIA Chemical Name : Urea

1985-1989 

## Production 300000-350000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metrictons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : KWT Area Specifications : ASIA Chemical Name : Urea

1985-1989 

## Production 260000-400000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). IRPTC Data ProfileProduction-Trade 18 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : PAK Area Specifications : ASIA Chemical Name : Urea

1985-1989 

## Production 835000-970000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : QAT Area Specifications : ASIA Chemical Name : Urea

1985-1989 

## Production 320000-360000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). IRPTC Data ProfileProduction-Trade 19 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : SAU Area Specifications : ASIA Chemical Name : Urea

1985-1989 

## Production 400000-450000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : SYR Area Specifications : ASIA Chemical Name : Urea

1985-1989 

## Production 50000-90000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). IRPTC Data ProfileProduction-Trade 20 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : TUR Area Specifications : ASIA Chemical Name : Urea

1985-1988 

## Production 70000-160000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : ARE Area Specifications : ASIA Chemical Name : Urea

1985-1989 

## Production 150000-260000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). IRPTC Data ProfileProduction-Trade 21 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : VNM Area Specifications : ASIA Chemical Name : Urea

1985-1988 

## Production 3500-15000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : BGR Area Specifications : EUR Chemical Name : Urea

1985-1989 

## Production 330000-370000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). IRPTC Data ProfileProduction-Trade 22 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : CSK Area Specifications : EUR Chemical Name : Urea

1987-1989 

## Production 70000-80000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : FRG Area Specifications : EUR Chemical Name : Urea

1987-1989 

## Production 500000-520000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). IRPTC Data ProfileProduction-Trade 23 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : HUN Area Specifications : EUR Chemical Name : Urea

1985-1989 

## Production 120000-200000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : IRL Area Specifications : EUR Chemical Name : Urea

1986-1988 

## Production 127000-147000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). IRPTC Data ProfileProduction-Trade 24 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : ITA Area Specifications : EUR Chemical Name : Urea

1985-1989 

## Production 460000-600000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : NLD Area Specifications : EUR Chemical Name : Urea

1985-1987 

## Production 380000-570000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). IRPTC Data ProfileProduction-Trade 25 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : POL Area Specifications : EUR Chemical Name : Urea

1985-1989 

## Production 240000-470000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : PRT Area Specifications : EUR Chemical Name : Urea

1985-1988 

## Production 4900-9000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). IRPTC Data ProfileProduction-Trade 26 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : ESP Area Specifications : EUR Chemical Name : Urea

1985-1989 

## Production 113000-165000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : YUG Area Specifications : EUR Chemical Name : Urea

1988 

## Production 0-240000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). IRPTC Data ProfileProduction-Trade 27 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : RUS Area Specifications : EUR Chemical Name : Urea

1987-1989 

## Production 4800000-4950000 t/y - P Quantity Year

General Comments : The given values are the production volume of urea in metric tons of N (urea N46%). 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : AMN Chemical Name : Urea

1985-1989 

## Production 3140000-6278000 t/y - P Quantity Year

General Comments : The total production volume of urea in metric tons of N (urea N-46%) in north and central America. IRPTC Data ProfileProduction-Trade 28 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 40, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : WORLD Chemical Name : Urea

1985-1989 

## Production 41440000-60789000 t - P Quantity Year

General Comments : The capacities of urea production have increased. By the year 1994-1995 the capacites should reach a level of the order of 60 million tonnes of nitrogen (or 130 million tonnes of urea), making the third chemical product together with ammonia and sulphuric acid, to cross the threshold of 100 million per year. The largest forcasted increase in capacity are in Saudi Arabia; Iraq and the Gulf States in general; Indonesia, India and China. 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAO Statistics Series. FAO Fertilizer Yearbook, 315, 179-201, (1990)
CAS Number : 57-13-6 

## Production-Trade Geographic Area : FIN Chemical Name : Urea

IRPTC Data ProfileProduction-Trade 29

1986 

## Production 13640 t/y - P 1550 t/y - P 8210 t/y - P 610 t/y - P 34010 t/y - P 40000-60000 t/y - IM Quantity Year 1986 1986 1986 1986
General Comments : Estimated urea production of livestock in Finland. (Estimation is based on statistical figures of year 1986). Animal species and total number of animals are as follows: 1) cattle 942300; 2) Swine 1030700; 3) poultry 7035600; 4) horses 38700. Total urea produced = 34010 tonnes/year, to be compared with total urea import to Finland. 

## References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) ENFAF* Keranen, S. and Niskanen, R. Effects of Nitrogen Fertilizer to Acidification in Finland : Litterature Survey, D/39, (1987)

IRPTC Data ProfileProcesses 30
CAS Number : 57-13-6 Chemical Name : Urea 

## Processes
Process comments : In modern synthetic processes, urea is made by reacting ammonia and carbon dioxide at high pressure and temperature to form ammonium carbonate and simultaneously dehydrating the ammonium carbonate to urea and water. Produced urea is purified by crystallization. Urea is also a natural end product of biochemical protein decomposition and the main solid component of mammalian urine (e.g. man produces urea in urine 20-35 g/24 hours, (200-500 mg/kg body weight-1 day-1). Urea is a natural constituent of many common foodstuffs. Up to 15 percent of the total nitrogen of young plants and about 5 percent of the nature plants is non-proteinaceous and much is in the form of urea. Urea is a normal constituent of animal tissues and fluids and is ingested in small amounts when meat is consumed. Oats may contain 4.5 percent of their total nitrogen content as urea and oil seed meals about 0.25 percent. 

## Process

References Secondar y

Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileUses 31
CAS Number : 57-13-6 

## Uses Chemical Name : Urea 

## Use

3 % 1 % Quantity Year Use in agriculture: Urea is widely manufactured and distributed as a nitrogenous fertilizer, particularly for fibrous-rooted crops such as rice. It is used extensively as one of the ingredients of nitrogen solutions widely used for direct field fertilizer application. Approximate quantity used as an animals feed supplement of the grain ration. Approximate quantity used as an animal feed supplement of the total ration. Comments



## References Primary References : GASTR* Secondary References : !SIDSP* Oehme, F. W. and Barrel, D. Veterinary Gastrointestinal Toxicology, 489-490, (1986) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)
CAS Number : 57-13-6 

## Uses Chemical Name : Urea 

## Use

wt 1 % 6.4-9.6 % Quantity Year Use in consumer products: Urea is used in liquid soaps, detergents and houshold cleaning products. It is also used in cosmetic products as creams, shampoos, hair conditioners, hair dyes and dye removers, in ammoniated dentifrices etc. Maximum urea concentration is commonly 1%. Urea (as 10-15% urea peroxide) in preparations for tooth bleaching yield. Following reference is also cited: management director Kaj Svenson, Suomen Teknokemian yhdistys (Cosmetics and Detergents Association in Finland). Comments



## References Primary References : COSDA* Secondary References : !SIDSP* Cosmetics and Detergent Association in Finland, (1992) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) IRPTC Data ProfileUses 32
CAS Number : 57-13-6 

## Uses Geographic Area : USA Chemical Name : Urea 

## Use42 % 31 % 5 % 9 % Quantity Year Fertilizer, solid Fertilizer solutions Urea-formaldehyde resins and adhesives Others, including animal feed and melamine Comments


## References Primary References : CMKRA5 Secondary References : !SIDSP* Karcher, AR. Chemical Profiles. Chemical Marketing Reporter, 234(13), 54, (1988) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)
CAS Number : 57-13-6 

## Uses Geographic Area : FIN Chemical Name : Urea 

## Use23 % 68 % 2 % 7 % Quantity Year Fertilizer, solid Urea-formaldehyde resins and adhesives Deicer on airport runways Other, including use as a nutrient in waste water treatment plant. Comments


## References Primary References : INFFI* Secondary References : !SIDSP* Information from Finnish Industry, (1990) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)
CAS Number : 57-13-6 

## Uses Geographic Area : WORLD Chemical Name : Urea

IRPTC Data ProfileUses 33 

## Use85-90 % 2-4 % 8-11 % Quantity Year Fertilizer Animal feed Industrial use Comments 

## References Primary References : CHWKA9 Secondary References : !SIDSP* Chemical Week, 112(4), 19, (1973) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)
CAS Number : 57-13-6 

## Uses Geographic Area : FIN Chemical Name : Urea 

## UseQuantity Year Types of uses are divided into three: industrial use (open system and closed system), public use and export. Urea is used in all three sectors. Industrial use concerns both open and closed systems. Use categories: urea is used by the following industrial sectors : -Adhesives and sealant production -Agriculture, field crops -Agriculture, other -Electrical or electronic products -Fertilizer -Food, feed and beverage -Metallurgical -Organic chemicals, industrial -Paint and coating -Pigment, dye and printing ink -Plastic and synthetic resins -Plating and publishing -Pulp and paper -Soap and cleaning products -Textile, primary manufacture -Textile, product Comments



## References Primary References : ECAPD* Secondary References : !SIDSP* Chenier,R. Environment Canada 1974. National Inventory of Sources and Emissions of Asbestos, Beryllium, Lead and Mercury. Summary of Emissions for 1970, (1991) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileUses 34
CAS Number : 57-13-6 

## Uses Geographic Area : FIN Chemical Name : Urea 

## UseQuantity Year Urea is used for the following functional uses: Adhesive/binder/sealant/filter Analytical reagent Catalyst/accelerator/inhibitor/activatorChemical intermediate-organic. Chemical intermediateinorganic, organometallic Colourant-pigment/stain/dye/ink. Paint/coating additive Fertilizer Formulation component Fragrance/perfume/deodouriser/flavouring agent Humectant/dewatering aid/dehumidifier/dehydrating agent Monomer Photosensitive agent-fluorecent agent/brightener/UV absorber . Comments



## References Primary References : ECAPD* Secondary References : !SIDSP* Chenier, R. Environment Canada 1974. National Inventory of Sources and Emissions of Asbestos, Beryllium, Lead and Mercury. Summary of Emissions for 1970, (1991) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)
CAS Number : 57-13-6 

## Uses Chemical Name : Urea 

## UseQuantity Year Urea is a key synthetic ingredient in the manufacture of resins, glues, solvents and some medecines. Urea is used as a formulating component in cosmetics, detergents, textile dyes and numerous other products. Comments

IRPTC Data ProfileUses 35 

## References Primary References : NHCUH* Secondary References : !SIDSP* National Health Council. Urea. Safe Use and Handling Data Sheet, I-691/Rev 90, 3 OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfilePathways into the Environment and Environmental Fate 36

CAS Number : 57-13-6 End Point : Pathway into the Environment and Environmental Fate. 

## Study Chemical Name : Urea
Test method : description Mackay level 1 model 

## Test Method and Conditions
Pathwa y

: LOAD 

## Pathway and Transport Quantity Transported to AQ to AIR to AIR 99.84 % 0.16 % NH3 emission, resulted from degradation of urea to ammonia. Emissions are higher in alkaline soil. Partitioning into air. Partitioning into water. Medium to Medium Quantity Time Year to Year



## References Secondar y

Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6 End Point : Pathway into the Environment and Environmental Fate. 

## Study Geographic Area : FIN Chemical Name : Urea
Pathwa y

: NATUR 

## Pathway and Transport APPLI
BIOTA AGRIC 

## Quantity Transported to SOIL to AIR to SOIL When 85-90% of urea is used as a fertilizer, the highest environmental exposure is to soil. Emission from urine of living animals. Reliable estimation of the emission levels cannot be given. Emission in agriculture from livestock urine when spread on the fields and in the grazing season. Medium to Medium Quantity Time Year to Year

IRPTC Data ProfilePathways into the Environment and Environmental Fate 37 

## References Secondar y

Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileConcentration 38

Species/strain/s y

stem : Waste water AQ SEW AQ GRND 

## Test Subject Organism Medium SpecificationLifestage Sex

Stud y

t

y

pe : LAB CAS Number : 57-13-6 Chemical Name : Urea

End Point : CONCENTRATION 

## Study
Geo g

raphic Area : FIN

Test method : description The monitoring data has been used for calculation of the predicted environmental concentration (PEC). For calculation of PEC the dilution factor of 10 for domestic waste water effluent is used. 

## Test Method and Conditions Test Results In domestic sewage In primary sewage plant effluent PEC for primary sewage plant effluent Concentration in groundwater in airport area as of 1980 General Comments : The information concerning the groundwater is reported in the following reference: National Board of Waters and the Environment, Finland (Unpublished data). 2-6 mg/L 0.016-0.043 mg/L 0.0016-0.0043 mg/L 20 ug/L 1980 Matrix Concentrations Spec. Date



## References Primar y

Reference : HBEDC* Secondar y

Reference : !SIDSP* Vershueren, K. Handbook of Environmental Data on Organic Chemicals, 2nd ed., 1178, (1983) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileConcentration 39

Species/strain/s y

stem : Sewage of Kemira's fertilizer factory, Finland AQ SEW 

## Test Subject Organism Medium SpecificationLifestage Sex

Stud y

t

y

pe : FIELD CAS Number : 57-13-6 Chemical Name : Urea

End Point : CONCENTRATION 

## Study
Geo g

raphic Area : FIN

Test method : description The monitoring data has been used for calculation of the predicted environment concentration (PEC). For calculation of PEC the dilution factor of 100 for industrial effluent is used. 

## Test Method and Conditions Test Results Concentration in fertilizer manufacturing plant waste water (highest monthly mean) as of 1993. PEC for fertilizer factory 0.34 mg/L 0.0034 mg/L Matrix Concentrations Spec. Date 1993


## References Primar y

Reference : TWEDO* Secondar y

Reference : !SIDSP* Anttalainen, M. Turku Water and Environment District Oral Communication, (1994) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileConcentration 40

Species/strain/s y

stem : Groundwater at the Helsinki-Vantaa Airport, Finland (1975-1990) AQ GRND 

## Test Subject Organism Medium SpecificationLifestage Sex

Stud y

t

y

pe : FIELD CAS Number : 57-13-6 Chemical Name : Urea

End Point : CONCENTRATION 

## Study
Geo g

raphic Area : FIN

Test method : description Analysis of groundwater nitrate, nitrite and ammonium concentrations 

## Test Method and Conditions Test Results Nitrate concentrations in the airport area groundwater increased up to 150 mg/L Due to diminished use amounts of urea in recent years, from 300 tonnes to less than 100 tonnes/year, nitrate concentrations slowly decreased to 80 mg/L. General Comments : It is not likely to detect urea itself in the groundwater, but only its degradation products. 150 mg/L 80 mg/L Matrix Concentrations Spec. Date 1975-1990



## References Primar y

Reference : #URNWE* Secondar y

Reference : !SIDSP* National Board of Waters and the Environment Unpublished Report OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileConcentration 41

HUMAN Species/strain/s y

stem : Physiological concentrations in man ADULT 

## Test Subject Organism Medium SpecificationLifestage Sex

Stud y

t

y

pe : LAB CAS Number : 57-13-6 Chemical Name : Urea

End Point : CONCENTRATION 

## Study
Geo g

raphic Area : FIN



## Test Results In urine (200-500 mg/kg body weight/day) In sweat In blood (200-500 mg/L) General Comments : The information related to concentration of urea in urine are reported in: Harper, H. A. and Rodwell, V. W. Review of Physiological Chemistry, 16th ed., Lange Medical Publications, Los Altos California, 1977, page 625. URINE 20-35 g/24h

BLOOD 120-570 mg/L 3.3-6.4 mmol/L Matrix Concentrations Spec. Date



## References Primar y

Reference : FASEB* Secondar y

Reference : !SIDSP* Altman, P. L. and Dittmer, D. S. Biology Data Book, III 2nd ed., 1494&01, (1974) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileConcentration 42

HUMAN PLANT FOOD SEED 

## Test Subject Organism Medium SpecificationLifestage Sex

Stud y

t

y

pe : LAB CAS Number : 57-13-6 Chemical Name : Urea

End Point : CONCENTRATION 

## Study
Geo g

raphic Area : FIN



## Test Results
In human blood Edible parts of plants may contain up to 4.5 per cent (oats) of their total nitrogen content as urea. The nitrogen content of grain seeds and grass General Comments : Due to the very limited data available concerning actual urea concentrations in e.g. root vegetables and potatoes, the uncertainties about the quantity are great. BLOOD 30-100 mg/L 4.5 % 2-4 % Matrix Concentrations Spec. Date



## References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* EPA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileHuman Intake and Exposure 43
CAS Number : 57-13-6 Chemical Name : Urea

End Point : HUMAN INTAKE AND EXPOSURE 

## Study

Evaluation text : Occupational and environmental exposure during production is possible due to accidental process breakdown and disorders in reactor operations, pumping cycles, evaporation and crystallization processes, in maintenance, loading and unloading operations. Potential occupational exposure occurs via inhalation of aerosols from urea melt and hot saturated solutions , or splashes to skin or eyes, or inhalation of dust. Occupational exposure can be also envisaged from inhalation of aerosols and dust during production of urea fertilizers and animal feed supplements in chemical syntheses using urea as a starting material and when dispesrsing urea fertilizers/urea in the fields, roads and runways. In the context of airborne exposure,the non-respirable fraction will be mostly ingested. A part of the airborne dust will deposit onto the skin and, additionally, heavier contamination of the hands will result from the handling of urea. 

## Evaluations

References Secondar y

Reference : !SIDSP* Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

HUMAN HUMAN Species/strain/s y

stem : Potential anthropogenic sources of exposure are manufacturing, industrial, agricultural and consumer uses. AIR 

## Test Subject Organism Medium Specification Lifestage Sex

CAS Number : 57-13-6 Chemical Name : Urea

End Point : HUMAN INTAKE AND EXPOSURE 

## Study Geo g

raphic Area : FIN

IHL SKN Route


## Test Results The tentative overall dose of urea resulting from the worst- case occupational exposure Uptake of respirable urea at 5 mg/m3 (with 10 m3 volume of total ventilation and 100% absorption). The airway deposition, most of which will be ingested, results from the non-respirable part of urea at 10 mg/m3 and 10 m3 ventilation. 200 mg/d 50 mg 100 mg Intake Spec. Date

IRPTC Data ProfileHuman Intake and Exposure 44 

## References Secondar y

Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

HUMAN

- Species/strain/s y

stem : Potential anthropogenic sources of exposure are manufacturing, industrial, agricultural and consumer uses. FOOD ANI HUMAN PLANT AGRIC AIR 

## Test Subject Organism Medium Specification Lifestage Sex

CAS Number : 57-13-6 Chemical Name : Urea

End Point : HUMAN INTAKE AND EXPOSURE 

## Study Geo g

raphic Area : FIN

ORL

- IHL Route



## Test Results Intake of urea from meat would amount to >10 mg/L per day. The human daily intake of urea from plants could amount up to several grams. The possible food additive use of urea apparently adds little to the intake via food. General Comments : Because urea is an important endogenous product of protein catabolism in mammals and occurs in significant concentrations in blood and obviously in extracellular water, human food of animal origin contains some urea. Intake Spec. Date



## References Secondar y

Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

HUMAN 

## Test Subject Organism Medium Specification Lifestage Sex

CAS Number : 57-13-6 Chemical Name : Urea

End Point : HUMAN INTAKE AND EXPOSURE 

## Study Geo g

raphic Area : USA Route
IRPTC Data ProfileHuman Intake and Exposure 45 Test method : description The National Occupational Hazard Survey conducted by NIOSH. 

## Test Method and Conditions Test Results General Comments : Probable human exposure: according to the survey in the USA 855894 workers may be exposed to urea; 7% from actual observed use, 31% from observed use of a tradename product known to contain this chemical, and 62% from observed use of a product in some type of general use which leads NIOSH to suspect that chemical may be contained in the product. Exposure in farming: the use of highly concentrated fertilizers in agricultural practice and in gardens can lead to human hazards. Most toxicities from fertilizers occur in ruminants. (Reported in: Oehme, F. W. and Barrel, D. S.: Veterinary Gastrointestinal Toxicology, Chapter 17 in Rozman, K. and Hanninen, O. (eds). 

## References Primar y

Reference : HSDBM* Secondar y

Reference : !SIDSP* Hazardous Substances Databank HSDB, 11, (1991) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileBiodegradation 46

AQ FRESH 

## Test Subject Organism Medium Specification

Stud y

t

y

pe : LAB CAS Number : 57-13-6 Chemical Name : Urea

End Point : BIODEGRADATION 

## Study
Geo g

raphic Area : FIN

Test method : description GLP: no Temperature : 

## Test Method and Conditions <8 C 

## Test Results Comments on result Time Quantity In river water at 1-15 mg/L degradation of urea is negligible below 8C for up to 14 days. 

## References Primar y

Reference : WATRAG Secondar y

Reference : !SIDSP* Evans, W. H. et al. Water Research, 7, 975-985, (1973) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

Species/strain/s y

stem : Semi-continuous activated sludge (SCAS) AQ SLUDG 

## Test Subject Organism Medium Specification

Stud y

t

y

pe : LAB CAS Number : 57-13-6 Chemical Name : Urea

End Point : BIODEGRADATION 

## Study
Geo g

raphic Area : FIN

IRPTC Data ProfileBiodegradation 47 Test method : description The diappearance of urea was determined by colorimetric analysis. 

## Test Method and Conditions Test Results Comments on result 24 h Time Quantity 93-98 % Mean disappearance of urea in 24-hour cycle General Comments : Urea is biodegradable in semi-continuous activated sludge (SCAS). (Job No. 1449006, as cited in the reference). 

## References Primar y

Reference : ANCHAM Secondar y

Reference : !SIDSP* EPA. Analytical Chemistry, 71-8, (1983) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

Species/strain/s y

stem : Activated sludge from a laboratory sewage treatment facility fed with domestic and synthetic sewage; adapted. AQ SLUDG 

## Test Subject Organism Medium Specification

Stud y

t

y

pe : LAB CAS Number : 57-13-6 Chemical Name : Urea

End Point : BIODEGRADATION 

## Study
Geo g

raphic Area : FIN

Test method : description Inherent Biodegradability: OECD Guideline 302 B (1981), Zahn-Wellens Test; GLP: no (An)aerobic : AEROB 

## Test Method and Conditions

Dose / Concentration : 

## Exposure 400 mg/L

IRPTC Data ProfileBiodegradation 48 

## Test Results
52 % 60 % 85 % 96 % Comments on result 7 h 10 d 14 d 16 d 3 h Time Quantity 3 % Decomposed urea Decomposed urea Decomposed urea Decomposed urea Decomposed urea General Comments : Urea is ultimately biodegradable according to this study. (Proj. No: 1/91/0452/10/1) as cited in the reference. 

## References Primar y

Reference : #URBSF* Secondar y

Reference : !SIDSP* BASF AG. BASF Unpublished Report, (1991) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

Species/strain/s y

stem : Flooded soil AQ SOIL 

## Test Subject Organism Medium Specification

Stud y

t

y

pe : LAB CAS Number : 57-13-6 Chemical Name : Urea

End Point : BIODEGRADATION 

## Study
Geo g

raphic Area : FIN

Exposure Period : 

## Exposure 30 h Exposure comments : 30 hours of incubation

IRPTC Data ProfileBiodegradation 49 

## Test Results

3 % 64 % Comments on result
30 h 30 h Time Quantity A laboratory study demonstrated that the main site of urea hydrolysis in flooded soil columns was in the soil and not the floodwater (ureolytic bacterial action). The added urea which was hydrolysed in the floodwater after 30 hours of incubation. The added urea which was hydrolysed in the soil after 30 hours of incubation. Additional studies also showed that soil water content had little effect on urease activity, but other researchers have found hydrolysis rates to increase with increasing soil water up to field capacity. General Comments : Report number: D/39/1978 

## References Primar y

Reference : SOSCAK Secondar y

Reference : !SIDSP* Vlek, P. L. G. and Carter, M. C. Soil Science, 136, 56-63, (1983) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

- BACT SOIL SOIL 

## Test Subject Organism Medium Specification

Stud y

t

y

pe : LAB CAS Number : 57-13-6 Chemical Name : Urea

End Point : BIODEGRADATION 

## Study
Geo g

raphic Area : FIN

Test method : description Transformation times of different nitrogen forms in soil Temperature : 

## Test Method and Conditions 2-20 C Exposure Period : 

## Exposure 1-4 d

IRPTC Data ProfileBiodegradation 50 

## Test Results

50 % 50 % 50 % 50 % Comments on result 2 d 1 d 6 wk 4 wk 2 wk 1 wk 4 d Time Quantity Transformation of urea-N to ammonium-N by urease at 2C Transformation of urea-N to ammonium-N by urease at 10C Transformation of urea-N to ammonium-N by urease at 20C Conversion (transformation of ammonium-N to nitrate-N by bacteria) at 5C Conversion (transformation of ammonium-N to nitrate-N by bacteria) at 8C Conversion (transformation of ammonium-N to nitrate-N by bacteria) at 10C Conversion (transformation of ammonium-N to nitrate-N by bacteria) at 20C 

## References Primar y

Reference : BUARE* Secondar y

Reference : !SIDSP* Bua. BUA Report on Chemicals of Environmental Relevance, 76 OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

BACT Species/strain/s y

stem : Psychrophilic bacteria AQ SEW 

## Test Subject Organism Medium Specification

Stud y

t

y

pe : LAB CAS Number : 57-13-6 Chemical Name : Urea

End Point : BIODEGRADATION 

## Study
Geo g

raphic Area : FIN

Temperature : Relative Humidity : 

## Test Method and Conditions 20 C 2 %

IRPTC Data ProfileBiodegradation 51 

## Test Results 10.9 mg/L 4.0 mg/L 3.2 mg/L Comments on result 1 h 1 h 1 h 1 h Time Quantity 11.6 mg/L Maximum degradation rate per hour at 20C Average degradation rate per hour at 20C Maximum degradation rate per hour at 2C Average degradation rate per hour at 2C 

## References Primar y

Reference : HBEDC* Secondar y

Reference : !SIDSP* Verschueren, K. Handbook of Environmental Data on Organic Chemicals, 2nd. ed., (1983) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

BACT SOIL AQ 

## Test Subject Organism Medium Specification

Stud y

t

y

pe : LAB CAS Number : 57-13-6 Chemical Name : Urea

End Point : BIODEGRADATION 

## Study
Geo g

raphic Area : FIN


## Exposure Exposure comments : Main factors affecting the rates of nitrogen metabolization are the initial concentration of the ureolytic bacteria, the physical state of the nitrifying micro-organisms and the concentration of toxic organics. 

## Test Results Comments on result Time Quantity Main mode of degradation is enzymatic mineralization. In soil and water urea is expected to biodegrade fairly rapidly to ammonia and bicarbonate if temperature is not too low. Main mode of degradation : 1) NH2CONH2 + 2H20 (Urease-enzyme) --- > NH3 + NH4 + HCO3- 2) NH4+ + 1.5 O2 Nitrosomonas ---> NO2- + H2O + 2H+ ---> NO2- + 0.5 O2 Nitrobacter ---> NO3-
IRPTC Data ProfileBiodegradation 52 

## References Primar y

Reference : AHCBAU Secondar y

Reference : !SIDSP* Gunkel, K. et al. Acta Hydrochimica et Hydrobiologica, 18(1), 3-20, (1990) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileHydrolysis 53
CAS Number : 57-13-6 Chemical Name : Urea

End Point : HYDROLYSIS 

## Study Geographic Area : FIN Test method : description Calculation by PCHYDRO-model. PCHYDRO, a hydrolysis rate estimation model, is a part of the US-EPA PCGEMS-modelling system (Personal Computer Version of the Graphical Exposure Modelling System); GLP: no 

## Test Method and Conditions
Test Results Comments on result >1 y Time Quantity 50 % Estimated half-life. PCHYDRO-model estimated the urea hydrolysis to be extremely slow. 

## References Primar y

Reference : #URNWE* Secondar y

Reference : !SIDSP* National Board of Waters and the Environment Unpublished Report, (1994) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileSorption 54

Stud y

t

y

pe : LAB CAS Number : 57-13-6 Chemical Name : Urea

End Point : SORPTION 

## Study

Geographic Area : FIN Medium : - Specifications : - SILT LOAM SOIL SOIL 

## Test Results Comments on result Time Quantity Urea is relatively leachable from the soil into the surface and the groundwater because of its weak adsorption to the soil, high water solubility and soil-water partition coefficient. This can happen especially if the soil surface is saturated with water, as might be the case after a rainfall. Urea adsorption coefficient in Crowly silt loam flooded soil column ranged from 0.037 (50 mg N/L) to 0.064 (1000 mg N/L) depending on the concentration of urea water. General Comments : Urea adsorption by the soil was low. The following reference is also cited: Sharply, A. N. et al. 1983. Water, Air and Soil Pollution 14(3): 425- 430 (1983); as cited in HSDB 1991. 

## References Primar y

Reference : SSSJD4 Secondar y

Reference : !SIDSP* Hongprayoon, C. et al. Soil Science Society of America Journal, 55, 1130-34, (1991) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileEvaporation 55

Stud y

t

y

pe : LAB CAS Number : 57-13-6 Chemical Name : Urea

End Point : EVAPORATION 

## Study

Geographic Area : FIN Medium : AQ Specifications : FRESH 

## Test Results General Comments : Urea is essentially non-volatile in solid form. Its high solubility and low vapour pressure and consequently low Henry's law constant (4.4E-8 atm m3/mol) indicate that urea itself will not evaporate from water to atmosphere. 

## References Secondar y

Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileEcosystems 56

Species/strain/system : Soil properties after long-term fertilization with urea 

## Test Subject CAS Number : 57-13-6 Chemical Name : Urea

End Point : ECOSYSTEMS 

## Study Geographic Area : FIN
Ecosystems : TERR Description of the test : substance Nitrogenous fertilizers 

## Test Substance

Test method : description Effects monitored: soil pH and micronutrients availabilities. 

## Test Method and Conditions Exposure Exposure comments Physical properties of soil: maximum bulk density 1.49-1.60 mg/m3; optimum water content for compaction 0.196-0.219 kg/kg; Clod density 1.46-1.68 mg/m3; water content at -1.5 MPa potential 0.125-0.192 kg/kg. Particle size distributiion at 0.06 to 0.14 m soil layer: sand (0.05-2 mm), coarse silt (0.02-0.05 mm), fine silt (0.002-0.02 mm), clay (<0.002 mm). 

## Test Results General Comments : 20 years of urea fertilization reduced soil pH significantly, compared with the control area. The soil acidification occurs due to nitrification of NH4+ which is decomposition product of urea. Urea fertilization caused also an increase in micronutrients (Fe, Cu, Mn) and a decrease in available P (phosphor) and exchangeable bases (Ca, Mg, Na). Soil acidification occurred also on areas treated with ammonia, NH4NO3 and urea-NH4NO3 mixture. 

## References Primary Reference : SSSJD4 Secondary Reference : !SIDSP* Darusman, L. R. et al. Soil Science Society of America Journal, 55, 1097-00, (1991) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileAbsorption 57

HUMAN SKN 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 Chemical Name : Urea End Point : ABSORPTION 

## Study

Test Results General Comments : Urea penetrates rapidly into the human stratum corneum; penetration is enhanced at higher urea concentrations and with time. However, transport to systemic circulation is slow and limited. About 5.9% of urea applied to human skin was recovered in the urine. 

## References Secondar y

Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileDistribution 58

HUMAN ORL 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 Chemical Name : Urea

End Point : DISTRIBUTION 

## Study

Test Results General Comments : Urea is extremely soluble in water and is adsorbed and distributed rapidly after oral doses. In man the peak concentration in blood is attained in 30 to 90 minutes after oral dose. The dose of 30 g urea (about 0.5 g/kg) doubles serum urea levels in 20 minutes and a maximum level of 94.6 mg/100 mL is achieved in 90 minutes (mean control 36 mg/ 100 mL). 

## References Secondar y

Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

RAT SKN 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 Chemical Name : Urea

End Point : DISTRIBUTION 

## Study

Test Results General Comments : Subcutaneous injection of urea to pregnant rats showed that the substance readily penetrated the placenta and raised fetal urea concentrations. 

## References Secondar y

Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)
IRPTC Data ProfileBioconcentration 59

Stud y

t

y

pe : LAB CAS Number : 57-13-6 Chemical Name : Urea

End Point : BIOCONCENTRATION 

## Study
Geo g

raphic Area : FIN 

## Test Results General Comments : Due to the low log Pow value urea is not likely to undergo bioaccumulation. 

## References Secondar y

Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileExcretion 60
CAS Number : 57-13-6 Chemical Name : Urea

End Point : EXCRETION 

## Study Geo g

raphic Area : FIN 

## Test Results General Comments : Ammonia is toxic to all vertebrates. It can be converted to the less toxic urea, but this is a metabolically expensive process found only in terrestrial vertebrates that cannot readily excrete ammonia, and marine fish that use urea as osmotic filter. Freshwater fish mostly excrete ammonia with only a small quantity of urea. Urea is the end product of biochemical protein decomposition and the main component of mammalian urine. 

## References Primar y

Reference : NATUAS Secondar y

Reference : !SIDSP* Randall, D. J. et al. Nature OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileMammalian Acute Toxicity 61

Species/strain/s y

stem : Strain not mentioned CAS Number : 57-13-6 End Point : MAMMALIAN ACUTE TOXICITY 

## Study Chemical Name : Urea Fre quenc y

: Dose / Concentration : 1 x 14300-15000 mg/kg BW Test method : description GLP: no 

## Test Method and Conditions

Oral LD50 for male rats was established as 14300 mg/kg and for female rats as 15000 mg/kg body weight. General Comments : The general symptoms consisted mainly of sedation, loss of righting reflex and staggering gait. RAT ORL M LD50 F 

## Test Results Organism Medium Spec. Route Lifestage Sex Effect Effect Comments


## References Primar y

Reference : OYYAA2 Secondar y

Reference : !SIDSP* Sato, N. et al. Oyo Yakuri (Pharmacometrics), 13, 749-772, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6 End Point : MAMMALIAN ACUTE TOXICITY 

## Study Chemical Name : Urea Fre quenc y

: Dose / Concentration : 1 x 8200-9400 mg/kg BW Test method : description GLP: no 

## Test Method and Conditions

Subcutaneous LD50 for male and female rats was established as 9400 mg/kg and 8200 mg/kg body weight, respectively. RAT SCU M LD50 F 

## Test Results Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

IRPTC Data ProfileMammalian Acute Toxicity 62 

## References Primar y

Reference : OYYAA2 Secondar y

Reference : !SIDSP* Sato, N. et al. Oyo Yakuri (Pharmacometrics), 13, 749-772, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

Species/strain/s y

stem : Strain not mentioned CAS Number : 57-13-6 End Point : MAMMALIAN ACUTE TOXICITY 

## Study Chemical Name : Urea Fre quenc y

: Dose / Concentration : 1 x 11500-13000 mg/kg BW Test method : description GLP: no 

## Test Method and Conditions

Oral LD50 for male and female mice was established as 11500 mg/kg and 13000 mg/kg, respectively. General Comments : The general symptoms consisted mainly of sedation, loss of righting reflex and staggening gait. MOUSE ORL M LD50 F 

## Test Results Organism Medium Spec. Route Lifestage Sex Effect Effect Comments


## References Primar y

Reference : OYYAA2 Secondar y

Reference : !SIDSP* Sato, N. et al. Oyo Yakuri (Pharmacometrics), 13, 749-772, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6 End Point : MAMMALIAN ACUTE TOXICITY 

## Study Chemical Name : Urea Fre quenc y

: Dose / Concentration : 1 x 9200-10700 mg/kg BW
IRPTC Data ProfileMammalian Acute Toxicity 63
Test method : description GLP: no 

## Test Method and Conditions

Subcutaneous LD50 for male and female mice was established as 9200 mg/kg and 10700 mg/kg body weight, respectively. MOUSE SCU M LD50 F 

## Test Results Organism Medium Spec. Route Lifestage Sex Effect Effect Comments


## References Primar y

Reference : OYYAA2 Secondar y

Reference : !SIDSP* Sato, N. et al. Oyo Yakuri (Pharmacometrics), 13, 749-772, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

Species/strain/s y

stem : Cow CAS Number : 57-13-6 End Point : MAMMALIAN ACUTE TOXICITY 

## Study Chemical Name : Urea Dose / Concentration : 510 mg/kg BW Test method : description GLP: no 

## Test Method and Conditions

Oral LD50 for cow was established as 510 mg/kg body weight. CATTL ORL LD50 

## Test Results Organism Medium Spec. Route Lifestage Sex Effect Effect Comments 

## References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)
IRPTC Data ProfileMammalian Acute Toxicity 64

CAS Number : 57-13-6 End Point : MAMMALIAN ACUTE TOXICITY 

## Study Chemical Name : Urea Dose / Concentration : 510 mg/kg BW Test method : description GLP: no 

## Test Method and Conditions

Oral LD50 for sheep was established as 510 mg/kg body weight . SHEEP ORL LD50 

## Test Results Organism Medium Spec. Route Lifestage Sex Effect Effect Comments 

## References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

Species/strain/s y

stem : Cow CAS Number : 57-13-6 End Point : MAMMALIAN ACUTE TOXICITY 

## Study Chemical Name : Urea Dose / Concentration : 600-1080 mg/kg BW Test method : description GLP: no 

## Test Method and Conditions

Oral LD50 for cows was established as 600 - 1080 mg/kg body weight. CATTL ORL LD50 

## Test Results Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

IRPTC Data ProfileMammalian Acute Toxicity 65 

## References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6 End Point : MAMMALIAN ACUTE TOXICITY 

## Study Chemical Name : Urea Fre quenc y

: Dose / Concentration : 1 x 5300-5400 mg/kg BW Test method : description GLP: no 

## Test Method and Conditions

Intravenous LD50 for male and female rats was established as 5400 mg/kg and 5300 mg/kg body weight, respectively. RAT IVN M LD50 F 

## Test Results Organism Medium Spec. Route Lifestage Sex Effect Effect Comments 

## References Primar y

Reference : OYYAA2 Secondar y

Reference : !SIDSP* Sato, N. et al. Oyo Yakuri (Pharmacometrics), 13, 749-772, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6 End Point : MAMMALIAN ACUTE TOXICITY 

## Study Chemical Name : Urea Fre quenc y

: Dose / Concentration : 1 x 4600-5200 mg/kg BW Test method : description GLP: no 

## Test Method and Conditions
IRPTC Data ProfileMammalian Acute Toxicity 66

Intravenous LD50 for male and female mice was established as 4600 mg/kg and 5200 mg/kg body weight, respectively. MOUSE IVN M LD50 F 

## Test Results Organism Medium Spec. Route Lifestage Sex Effect Effect Comments


## References Primar y

Reference : OYYAA2 Secondar y

Reference : !SIDSP* Sato, N. et al. Oyo Yakuri (Pharmacometrics), 13, 749-772, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6 End Point : MAMMALIAN ACUTE TOXICITY 

## Study Chemical Name : Urea Dose / Concentration : 10000 mg/kg BW Test method : description GLP: no 

## Test Method and Conditions

Intravenous LD50 for dogs was established as > 10000 mg/kg body weight. DOG IVN LD50 

## Test Results Organism Medium Spec. Route Lifestage Sex Effect Effect Comments 

## References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileMammalian Toxicity 67

MAMM Species/strain/s y

stem : Ruminants 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

Test method : description GLP: no 

## Test Method and Conditions General Comments : Urea is generally regarded a safe and efficient feed additive (substitute for natural proteins) for ruminants. The toxicity of urea depends on the formation of ammonia. Problems occur when ingested urea releases more ammonia than in the rumen microorganisms can fully utilize to synthetize amino acids and protein. Urea can cause clinical signs of toxicosis in ruminants at 300 - 500 mg/kg body weight and death at 1000 - 1500 mg/kg body weight. Horses are less susceptible, urea being lethal at approximately 4000 mg/kg body weight. Monogastric animals, such as swine and baby calves, are not affected by urea on biuret except for a mild diuretic action. 

## References Primar y

Reference : GASTR* Secondar y

Reference : !SIDSP* Veterinary Gastrointestinal Toxicology, 489-490, (1986) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileMammalian Toxicity 68

CATTL Species/strain/s y

stem : Cow ORL 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

Test method : description GLP: no 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 116 mg/kg BW

LDLO Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Oral LDLO for cows was established as 116 mg/kg body weight. 

## Test Results
References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

DOG SCU 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

Test method : description GLP: no 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 3000-9000 mg/kg BW IRPTC Data ProfileMammalian Toxicity 69

LDLO Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Subcutaneous LDLO for dogs was established at a dose level of 3000-9000 mg/kg body weight. 

## Test Results
References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

DOG Species/strain/s y

stem : Strain not specified SCU 12 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

Test method : description GLP: unknown 

## Test Method and Conditions Exposure Type : SHORT Exposure Period : Dose / Concentration : 

## Exposure 45 d 3000-4000 mg/kg Exposure comments : Urea was injected subcutaneously every 8 hours to 12 unilaterally nephrectomized dogs for 45 days.

IRPTC Data ProfileMammalian Toxicity 70

PLSMA BIOCH Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Plasma urea levels were 200 to 700 mg/100 mL BEHAV Mild drowsiness URINE INCR Increased diuresis NEF Treatment did not affect hematocrit, platelet counts nor EEg . 

## Test Results

References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

DOG IVN 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

Test method : description GLP: no 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 3000 mg/kg BW

LDLO Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Intravenous LDLO for dogs was 3000 mg/kg body weight. 

## Test Results

IRPTC Data ProfileMammalian Toxicity 71 

## References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

GPIG Species/strain/s y

stem : Guinea pig IVN 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

Test method : description GLP: no 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 4800 mg/kg BW

LDLO Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Intravenous LDLO for guinea pigs was established as 4800 mg/kg body weight. 

## Test Results
References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileMammalian Toxicity 72

HORSE Species/strain/s y

stem : Pony ORL 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

Test method : description GLP: no 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 3310-3610 mg/kg BW

LDLO Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Oral LDLO for pony was established at dose level of 3310- 3610 mg/kg body weight. 

## Test Results
References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

HUMAN SKN 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea 

## Exposure Exposure comments : Urea has been extensively used during the last two decades in the treatment of dry skin, both clinically and in cosmetic products.

IRPTC Data ProfileMammalian Toxicity 73

SKIN NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- No long-term side effects have been found. No reports of contact allergy were located and, in spite of common use for many years, no epidermal or dermal atrophy has been reported. 

## Test Results

References Primar y

Reference : HAUTAW Secondar y

Reference : !SIDSP* Stuttgen, G. Hautarzt, Suppl. 11, 9-12, (1992) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1995)

PIG Species/strain/s y

stem : Young pigs ORL JUV 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

Test method : description GLP: no 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 16000 mg/kg BW

LDLO Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Oral LDLO for pigs was established as >16000 mg/kg body weight. 

## Test Results

General Comments : Ten % (m/m) urea in pig food over a period of 5 days was without apparent deleterious effects. 

## References Primar y

Reference : JAVTAP Secondar y

Reference : !SIDSP* Button, J. P. et al. Journal of the South African Veterinary Association, 53(1), 67-68, (1982) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) IRPTC Data ProfileMammalian Toxicity 74

RAT Species/strain/s y

stem : Wistar rats SKN 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

Test method : description GLP: unknown 

## Test Method and Conditions Exposure Type : SHORT Exposure Period : 

## Exposure 4 wk Exposure comments : Urea in 10%, 20% or 40% ointment was applied to the back skin (20 cm2 area) for 4 weeks.

NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- No dose-dependent toxicity was observed. There were no consistent treatment-related effects on standard haematological parameters, clinical chemistry, organ weights or organ histopathology, including testicles, prostate, seminal vesicles, ovaries and uterus. 

## Test Results

References Primar y

Reference : OYYAA2 Secondar y

Reference : !SIDSP* Sato, N. et al. Oyo Yakuri (Pharmacometrics), 13, 749-772, (1977) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileMammalian Toxicity 75

RAT Species/strain/s y

stem : Strain not specified ORL 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

Description of the test : substance Purity not known 

## Test Substance

Test method : description GLP: unknown 

## Test Method and Conditions Exposure Type : LONG Exposure Period : Dose / Concentration : 

## Exposure 190 d 20000-250000 mg/kg DIET Exposure comments : Rats were fed a diet containing 20000-250000 ppm urea for 190 days (about 2000-25000 mg/kg/day).

DEATH Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- 250000 ppm and 20000 ppm were lethal in 12 days and 20-76 days, respectively. BW DECR BEHAV There was weight loss and suppression of sexual function at lower doses. 

## Test Results

General Comments : Author's comment: "the validity of the study is limited by the small number of animals used (often 1 to 3 per group) and failure to report actual food intake. Extreme weight loss of the rats suggested that inanition was likely". 

## References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileMammalian Toxicity 76

RAT Species/strain/s y

stem : Wistar rats SKN 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

Test method : description GLP: unknown 

## Test Method and Conditions Exposure Type : LONG Exposure Period : 

## Exposure 24 wk Exposure comments : Urea ointments of 10%, 20% or 40% concentrations were applied to the back skin on a 20 cm2 area for 24 weeks.

NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- There were no consistent treatment-related effects on standard heamatological parameters, clinical chemistry or different organs. 

## Test Results

References Primar y

Reference : OYYAA2 Secondar y

Reference : !SIDSP* Sato, N. et al. Oyo Yakuri (Pharmacometrics), 13, 749-772, (1977) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

RBT Species/strain/s y

stem : Rabbit ORL 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

IRPTC Data ProfileMammalian Toxicity 77 Test method : description GLP: no 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 5000 mg/kg BW

LDLO Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Oral LDLO for rabbits was established as 5000 mg/kg body weight. 

## Test Results
References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

RBT Species/strain/s y

stem : Rabbit SCU 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

Test method : description GLP: no 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 3000-9000 mg/kg BW

LDLO Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Subcutaneous LDLO for rabbits was established at dose level of 3000-9000 mg/kg body weight. 

## Test Results

IRPTC Data ProfileMammalian Toxicity 78 

## References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

RBT Species/strain/s y

stem : Rabbit IVN 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

Test method : description GLP: no 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 7320 mg/kg BW

LDLO Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Intravenous LDLO for rabbits was established as 7320 mg/kg body weight. 

## Test Results
References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileMammalian Toxicity 79

RBT Species/strain/s y

stem : Rabbit IVN 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

Test method : description GLP: no 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 6310 mg/kg BW

LDLO Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Intravenous LDLO for rabbits was established as 6310 mg/kg body weight. 

## Test Results
References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

SHEEP ORL 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 End Point : MAMMALIAN TOXICITY 

## Study Chemical Name : Urea

Test method : description GLP: no 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 160 mg/kg BW IRPTC Data ProfileMammalian Toxicity 80

LDLO Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Oral LDLO for sheep was established as 160 mg/kg body weight . 

## Test Results
References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileCarcinogenicity 81

MOUSE Species/strain/s y

stem : CB7B1/6 mice ORL M F 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : CARCINOGENICITY 

## Study Chemical Name : Urea

Test method : description Chronic toxicity and carcinogenicity screening study over 12 months; GLP: no data 

## Test Method and Conditions Exposure Type : LONG Dose / Concentration : 

## Exposure 0.45-4.5 g/kg DIET Exposure comments : Mice were fed a diet containing 0.45%, 0.9% or 4.5% of urea over 12 months.

NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- No carcinogenic effects were found. 

## Test Results

General Comments : OECD/SIDS Comment: 5 animals per sex from all dose groups were necropsied at the end of the treatment period, and the gonads were histologically examined. No pathology was reported. After further 4 months of follow up all survivors were killed, necropsied and the tissues were fixed. However, concerning the reproductive organs, histological tumor data on the ovary and the uterus only were given. Other sex organs may not have been histologically studied. 

## References Primar y

Reference : JEPTDQ Secondar y

Reference : !SIDSP* Fleischman, R. W. et al. Journal of Environmental Pathology and Toxicology, 3(5/6), 149-170, (1980) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileCarcinogenicity 82

RAT Species/strain/s y

stem : Fischer 344 rats ORL M F 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : CARCINOGENICITY 

## Study Chemical Name : Urea

Test method : description Chronic toxicity and carcinogenicity screening study over 12 months; GLP: no data 

## Test Method and Conditions Exposure Type : LONG Exposure Period : Dose / Concentration : 

## Exposure 12 mo 4.5-45 g/kg DIET Exposure comments : Rats were fed a diet containing 0.45%, 0.9% or 4.5% of urea over 12 months.

NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Not carcinogenic 

## Test Results

General Comments : OECD/SIDS Comment: 5 animals per sex from all dose groups were necropsied at the end of the treatment period, and the gonads were histologically examined. No pathology was reported. After further 4 months of follow up all survivors were killed, necropsied and the tissues were fixed. The testes, prostate and uterus were histologically examined for the occurrence of tumours. Although there was a statistically increased incidence of interstitial cell adenomas of the testis in the high dose group, its biological significance was deemed questionable, since the lesions may occur in 100% of controls. 

## References Primar y

Reference : JEPTDQ Secondar y

Reference : !SIDSP* Fleischman, R. W. et al. Journal of Environmental Pathology and Toxicology, 3(5/6), 149-170, (1980) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileMutagenicity 83

BACT Species/strain/s y

stem : Salmonella typhimurium TA98, TA100, TA1537 VTR 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : MUTAGENICITY 

## Study Chemical Name : Urea

Description of the test : substance Purity unknown 

## Test Substance

Test method : description Bacterial test, Ames test; GLP: no data 

## Test Method and Conditions Exposure Exposure comments : Test performed with and without metabolic activation.

NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Negative results with and without metabolic activation 

## Test Results
References Primar y

Reference : GMCRDC Secondar y

Reference : !SIDSP* Ishidate, M. et al. GANN Monograph on Cancer Research, 27, 95-108, (1981) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileMutagenicity 84

BACT Species/strain/s y

stem : Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538 Escherichia coli WP2uvrA VTR 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : MUTAGENICITY 

## Study Chemical Name : Urea

Purit y

Grade : 99% Vehicle - Solvent : Water 

## Test Substance

Test method : description Bacterial test (Ames test); GLP: not known 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 5-5000 ug/ PLATE Exposure comments : Tests were performed with and without metabolic activation.

NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Negative results with and without metabolic activation at a dose range of 5-5000 ug/plate. 

## Test Results
References Primar y

Reference : SAIGBL Secondar y

Reference : !SIDSP* Shimizu, H. et al. Japanese Journal of Industrial Health, 27, 400-419, (1985) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileMutagenicity 85

BACT Species/strain/s y

stem : Salmonella typhimurium TA98, TA100, TA1535, TA1537 VTR 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : MUTAGENICITY 

## Study Chemical Name : Urea

Purit y

Grade : 99% Vehicle - Solvent : DMSO 

## Test Substance

Test method : description Bacterial test (Ames test); GLP: not known 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 100-10000 ug/ PLATE Exposure comments : Tests were performed with and without metabolic activation with rat liver and hamster liver S9 mix.

NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Negative results at a dose range of 100-10000 ug/plate with and without metabolic activation. CELL Minimum concentration at which toxicity to bacteria was observed: 100-10000 ug/plate depending on strain. 

## Test Results

References Primar y

Reference : ENMUDM Secondar y

Reference : !SIDSP* Mortelmans, K. et al. Environmental Mutagenesis, 8 Suppl. 7, 1-119, (1986) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileMutagenicity 86

HAMST Species/strain/s y

stem : Chinese hamster fibroblast (CHL) VTR 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : MUTAGENICITY 

## Study Chemical Name : Urea

Vehicle - Solvent : Physiological saline Description of the test : substance Purity unknown 

## Test Substance

Test method : description Chromosomal aberration test; GLP: not known 

## Test Method and Conditions

CHROM STRUC Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Positive results without metabolic activation at 266 mmolar. Aberrations in 37% of metaphases at 24 hours (chromosomal gaps, chromatid or chromosomal breaks, translocations, fragmentation). NEF Negative result with metabolic activation 

## Test Results

General Comments : OECD/SIDS Comment: The maximally effective concentration was 266 mmolar, a very high concentration suggesting a low clastogenic potential. 

## References Primar y

Reference : MUREAV Secondar y

Reference : !SIDSP* Ishidate, M. and Odashima, S. Mutation Research, 48, 337-354, (1977) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileMutagenicity 87

HAMST Species/strain/s y

stem : Chinese hamster fibroblast (CHL) VTR 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : MUTAGENICITY 

## Study Chemical Name : Urea

Test method : description Chromosomal aberration test; GLP: not known 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 13 g/L Exposure comments : Urea concentration 216 mmolar

CHROM STRUC Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Positive results without metabolic activation. Chromosomal aberrations were detected in 20% of metaphases at 216 mmolar concentration. 

## Test Results

General Comments : OECD/SIDS Comment: chromosomal aberrations detected in 20% of metaphases at urea concentration of 13 g/L (216 mmolar) indicate a low clastogenic potential. 

## References Primar y

Reference : GMCRDC Secondar y

Reference : !SIDSP* Ishidate, M. et al. GANN Monograph on Cancer Research, 27, 95-108, (1981) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

MOUSE Species/strain/s y

stem : Mouse lymphoma heterozygous L5178Y TK+/- VTR 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : MUTAGENICITY 

## Study Chemical Name : Urea

IRPTC Data ProfileMutagenicity 88 Purit y

Grade : AG 

## Test Substance
Test method : description Mouse Lymphoma TK Locus Assay; GLP: no data 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 7.9-38 g/L Exposure comments : Concentrations of 132 - 662 mmolar of urea were used with and without metabolic activation.

NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Negative result with metabolic activation GENE MUT NEF INC Weakly positive at very high urea concentrations 530 - 662 mmolar negative at 132 mmolar, equivalent at 265 - 397 mmolar. CELL Lowest concentration producing cell toxicity: 265 mmolar 

## Test Results

General Comments : OECD/SIDS Comment: Authors discuss the possibility that the positive genotoxic findings may depend on secondary cellular effects (e.g. difference in osmotic pressure across the cell membrane) at high concentration which might not take place under in vivo conditions. 

## References Primar y

Reference : MUTAEX Secondar y

Reference : !SIDSP* Wangenhaim, J. and Bolcsfoldi, G. Mutagenesis, 3, 193-205, (1988) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

MOUSE Species/strain/s y

stem : Mouse lymphoma L5178Y TK+/- VTR 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : MUTAGENICITY 

## Study Chemical Name : Urea

IRPTC Data ProfileMutagenicity 89 Purit y

Grade : AG 

## Test Substance
Test method : description Analysis for DNA singlestrand breaks by alkaline unwinding and hydroxyapatite elution; GLP: no data 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 20.5-43.0 g/L Exposure comments : Concentrations of 339 - 718 mmolar of urea were used.

DNA STRUC Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Positive result at very high concentrations (628 and 718 mmolar) with relative fractions of ssDNA of 9.2 and 17.3%, respectively, without metabolic activation. NEF Although a dose response was found, lower urea concentrations (359 - 339 mmolar) did not yield responses classified as positive. 

## Test Results

References Primar y

Reference : MUREAV Secondar y

Reference : !SIDSP* Garberg, P. et al. Mutation Research, 203, 155-176, (1988) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

MOUSE Species/strain/s y

stem : Swiss albino mice ORL 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : MUTAGENICITY 

## Study Chemical Name : Urea

Description of the test : substance Purity unknown 

## Test Substance

Test method : description Bone marrow cytogenetic assay; GLP: no data 

## Test Method and Conditions IRPTC Data ProfileMutagenicity 90 Exposure Type : SHORT Exposure Period : Dose / Concentration : 

## Exposure 5 d 500 mg/ ANIMAL Exposure comments : Mice were fed with urea 500 mg per animal per day in food for 5 days (dosage approaching an acute lethal dose).

CHROM STRUC Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Bone marrow cell, metaphases exhibited chromosome breaks, acentric fragments, translocations, gaps and constrictions at a 7-fold rate compared to controls. 

## Test Results

General Comments : OECD/SIDS Comment: the interpretation of this clastogenic effect is limited by the usage of a single extremely high dose level. 

## References Primar y

Reference : CYTOAN Secondar y

Reference : !SIDSP* Chaurasia, O. P. and Sinha, S. P. Cytologia, 52, 877-882, (1987) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

RAT Species/strain/s y

stem : Rat hepatocytes VTR 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : MUTAGENICITY 

## Study Chemical Name : Urea

Purit y

Grade : AG Vehicle - Solvent : Water 

## Test Substance

Test method : description Analysis for DNA singlestrand breaks by alkaline elution; GLP: no data 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 18-180 mg/L Exposure comments : Concentrations of 0.3 - 3 mmolar were used.
IRPTC Data ProfileMutagenicity 91

NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Negative result 

## Test Results
References Primar y

Reference : MUREAV Secondar y

Reference : !SIDSP* Sina, J. F. et al. Mutation Research, 113, 357-391, (1984) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileSensitization 92

HUMAN SKN 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

CAS Number : 57-13-6 End Point : SENSITIZATION 

## Study Chemical Name : Urea

Vehicle - Solvent : Water 

## Test Substance
Test method : description GLP: unknown 

## Test Method and Conditions Exposure Exposure comments : 10% water solution

SKN NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- No skin sensitization 

## Test Results
References Primar y

Reference : VDVEAV Secondar y

Reference : !SIDSP* Alchangian, L. V. et al. Vestnik Dermatologii Venerologii, 9, 26-29, (1986) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileIrritation 93

HUMAN SKN 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : IRRITATION 

## Study Chemical Name : Urea

Vehicle - Solvent : Water 

## Test Substance
Test method : description Chamber-Scarification Test; GLP: unknown 

## Test Method and Conditions Exposure Type : ACUTE Dose / Concentration : 

## Exposure 75-300 g/L Exposure comments : 7.5% and 30% urea solutions in water were applied.

SKN IRRIT Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Slight irritation with 7.5% urea SKN IRRIT Marked irritation with 30% urea SKN IRRIT Comparison between hypo- and hyperactive individuals with 30% urea in water after 48 hours: hyporeactors score 0.8 (slight); hyperreactors score 2.4 (moderate) on the scale 0-4. 

## Test Results

References Primar y

Reference : 38FTAB Secondar y

Reference : !SIDSP* Frosch, P. J. et al. Cutaneous Toxicity: Proceedings of the Conference on Cutaneous Toxicity, 127-153, (1977) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileIrritation 94

HUMAN SKN 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : IRRITATION 

## Study Chemical Name : Urea

Vehicle - Solvent : Water 

## Test Substance
Test method : description Not specified; GLP: unknown 

## Test Method and Conditions Exposure Type : ACUTE Dose / Concentration : 

## Exposure 100 g/L Exposure comments : 10% water solution of urea

SKIN NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- No irritation after 24 hours 

## Test Results
References Primar y

Reference : VDVEAV Secondar y

Reference : !SIDSP* Alchangian, L. V. et al. Vestnik Dermatologii Venerologii, 9, 26-29, (1986) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

MOUSE Species/strain/s y

stem : Nude MF1h mice SKN M 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : IRRITATION 

## Study Chemical Name : Urea

IRPTC Data ProfileIrritation 95 Vehicle - Solvent : Water 

## Test Substance
Test method : description GLP: unknown 

## Test Method and Conditions Exposure Type : ACUTE Dose / Concentration : 

## Exposure 100-109 g/L Exposure comments : 10% solution

SKIN NEF NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- The skin of nude mice showed no irritation. 10% urea induced no discernible change in the histological appearance of the skin. 

## Test Results

References Primar y

Reference : JPPMAB Secondar y

Reference : !SIDSP* Lashmar, U. T. et al. Journal of Pharmacy & Pharmacology, 41, 118-121, (1981) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

RBT Species/strain/s y

stem : Rabbit SKN 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : IRRITATION 

## Study Chemical Name : Urea

Vehicle - Solvent : Water 

## Test Substance
Test method : description GLP: unknown 

## Test Method and Conditions

IRPTC Data ProfileIrritation 96 Exposure Period : Dose / Concentration : 

## Exposure 20 h 500 g/L Exposure comments : 20 hours semiocclusive application of 50% urea water solution on the back and ear skin of rabbit.

SKN NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- No irritation of the skin after 24 hours 

## Test Results
References Primar y

Reference : #URBSF* Secondar y

Reference : !SIDSP* BASF AG. BASF Unpublished Report OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

RBT Species/strain/s y

stem : Rabbit OCU 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : IRRITATION 

## Study Chemical Name : Urea

Test method : description OECD 405; GLP: yes 

## Test Method and Conditions

EYE NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Not irritating (no irritancy after 24 hours) 

## Test Results

IRPTC Data ProfileIrritation 97 

## References Primar y

Reference : #URBSF* Secondar y

Reference : !SIDSP* BASF AG. BASF Unpublished Report OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileReproduction 98
CAS Number : 57-13-6 End Point : REPRODUCTION 

## Study Chemical Name : Urea General Comments : OECD/SIDS Conclusion: Based on the carcinogenicity screening studies with mice and rats and repeated dose toxicity studies by dermal route with rats, where no toxic effects were observed in the gonads, even at the histopathological examination, and the lack of evidence for developmental toxicity in limited mouse and rat studies, urea would not be expected to display significant potential for reproductive toxicity. 

## References Secondar y

Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileTeratogenicity 99

BIRD Species/strain/s y

stem : Chick embryo INJ 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : TERATOGENICITY 

## Study Chemical Name : Urea

Test method : description GLP: no data 

## Test Method and Conditions Exposure Exposure comments : 50 to 900 mg of urea dissolved in egg albumin was injected into eggs between 7th and 20th hours of incubation.

EMBRY STRUC Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Among 132 embryos 78 showed neural, vascular or cardiac abnormalities. 

## Test Results

General Comments : "The results indicate that urea was teratogenic in chick embryo". 

## References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

BIRD Species/strain/s y

stem : Chick embryo INJ 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : TERATOGENICITY 

## Study Chemical Name : Urea

IRPTC Data ProfileTeratogenicity 100 Purit y

Grade : AG Vehicle - Solvent : Distilled water 

## Test Substance

Test method : description GLP: no data 

## Test Method and Conditions
Dose / Concentration : 

## Exposure 200-1200 mg/kg Exposure comments : 200, 400, 800 and 1200 mg/kg eggs was injected in a volume of 0.05 mL distilled water into the air sack of the eggs on day 16, 17 and 18 of incubation.

EMBRY DEATH Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Mortality of the embryos varied 8.8-38.9%, dose-dependently. The mortality in the control group was 6.1%. EMBRY BIOCH In the treated embryos, the plasma T3 level increased and T4 level decreased. EMBRY STRUC Electron microscopy revealed cytoplasmic oedema, mitochondrial swelling and membrane damage in thyroid cells. 

## Test Results

General Comments : The results indicate that urea was foetotoxic to the chicken. 

## References Primar y

Reference : AVSCA7 Secondar y

Reference : !SIDSP* Mora, S. et al. Acta Veterinaria Scandinavica, Suppl. 87, 197-198, (1991) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

MOUSE Species/strain/s y

stem : ICR miceORL F 10 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : TERATOGENICITY 

## Study Chemical Name : Urea

Test method : description A single oral dose study; GLP: no 

## Test Method and Conditions IRPTC Data ProfileTeratogenicity 101 Exposure Type : ACUTE Exposure Period : Fre quenc y

: Dose / Concentration : 

## Exposure 10 TDP 1 x 2000 mg/kg BW Exposure comments : A single dose of 2000 mg/kg was administered orally to 10 pregnant mice on day 10 of pregnancy.

NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- No effects on foetal data (live/dead, sex, external defects, soft tissue and skeletal defects). NEF No maternal toxicity 

## Test Results

General Comments : Not teratogenic. OECD/SIDS comment: "not an adequate teratogenicity study". 

## References Primar y

Reference : TJADAB Secondar y

Reference : !SIDSP* Teramoto et al. Teratology, Journal of Abnormal Development, 23, 335-342, (1981) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

RAT Species/strain/s y

stem : Wistar rats ORL F 4 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : TERATOGENICITY 

## Study Chemical Name : Urea

Test method : description A single oral dose study; GLP: no 

## Test Method and Conditions Exposure Type : ACUTE Exposure Period : Fre quenc y

: Dose / Concentration : 

## Exposure 12 TDP 1 x 2000 mg/kg BW Exposure comments : A single dose of 2000 mg/kg was administered to 4 pregnant rats on day 12 of pregnancy. IRPTC Data ProfileTeratogenicity 102

NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- No effects on foetal data (live/dead, sex, external defects, soft tissue and skeletal defects) NEF No maternal toxicity 

## Test Results

General Comments : Not teratogenic. OECD/SIDS comment: "not an adequate teratogenicity study". 

## References Primar y

Reference : TJADAB Secondar y

Reference : !SIDSP* Teramoto et al. Teratology, Journal of Abnormal Development, 23, 335-342, (1981) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

RAT Species/strain/s y

stem : Wistar rats ORL F 6 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : TERATOGENICITY 

## Study Chemical Name : Urea

Test method : description Within 48 hours after delivery the pups were killed and the kidneys examined; GLP: no data 

## Test Method and Conditions Exposure Type : SHORT Exposure Period : Dose / Concentration : 

## Exposure 14 d 50 g/kg BW/d Exposure comments : Urea was administered by gavage in 2 doses 12 hours apart to 6 rats during pregnancy for an average of 14 days and the dams were allowed to delivery.

NEF Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- No hypertrophy or other kidney changes were detected nor were any teratogenic effects noted. 

## Test Results

General Comments : OECD/SIDS Comment: "not a full-range teratogenicity study".
IRPTC Data ProfileTeratogenicity 103 

## References Primar y

Reference : ZEIUR* Secondar y

Reference : !SIDSP* Seipelt, H. et al. Zeitschrift Urologie, 62, 623-627, (1969) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileAquatic Acute Toxicity 104

Species/strain/s y

stem : Snail (Helisoma trivolvis) Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : AQUATIC ACUTE TOXICITY 

## Study
Geo g

raphic Area : FIN Chemical Name : Urea

Test method : description Static; GLP: not known 

## Test Method and Conditions

LC50 for 24 hours for egg = 14241 mg/L; LC50 for 24 hours for juveniles = 18255 mg/L; LC50 for 24 hours for adults = 30060 mg/L. MOLL AQ FRESH EGG LC50 JUV ADULT 

## Test Results Organism Medium Spec. Route Lifestage Sex Effect Effect Comments


## References Primar y

Reference : AECTCV Secondar y

Reference : !SIDSP* Tchounwou, P. B. et al. Archives of Environmental Contamination and Toxicology, 21, 359-364, (1991) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

Species/strain/s y

stem : Mosquito (Aedes aegypti) larvae Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : AQUATIC ACUTE TOXICITY 

## Study
Geo g

raphic Area : FIN Chemical Name : Urea

Test method : description Static; GLP: no 

## Test Method and Conditions

LC50 for 4 hours = 60000 mg/L. INSEC AQ FRESH LARVA LC50 

## Test Results Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

IRPTC Data ProfileAquatic Acute Toxicity 105 

## References Primar y

Reference : JIVPAZ Secondar y

Reference : !SIDSP* Kramer, V. C. et al. Journal of Invertebrate Pathology, 42, 285-287, (1983) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

Species/strain/s y

stem : Barilius barna Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : AQUATIC ACUTE TOXICITY 

## Study
Geo g

raphic Area : FIN Chemical Name : Urea

Test method : description Static 

## Test Method and Conditions

LC50 for 96 hours > 9100 mg/L. General Comments : Urea is not acutely toxic to fish. FISH AQ LC50 

## Test Results Organism Medium Spec. Route Lifestage Sex Effect Effect Comments 

## References Primar y

Reference : HCPBE5 Secondar y

Reference : !SIDSP* Dodriyal, A. K. and Bahuguna, A. K. Himalayan Chemical Pharma. Bulletin, 5, 15-16, (1988) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileAquatic Toxicity 106

ALGAE Species/strain/s y

stem : Green algae (Scenedesmus quadricauda) AQ FRESH 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : AQUATIC TOXICITY 

## Study
Geo g

raphic Area : FIN Chemical Name : Urea

Test method : description Cell multiplication inhibition test 

## Test Method and Conditions

BIOMA Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Toxicity threshold for 192 hours > 10000 mg/L 

## Test Results

General Comments : Urea is not toxic to algae. 

## References Primar y

Reference : VJWWAU Secondar y

Reference : !SIDSP* Bringmann, G. and Kuhn, R. Vom Wasser, 50, 45-60, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

PROTO Species/strain/s y

stem : Flagellate (Entosiphon sulcatum) AQ FRESH 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : AQUATIC TOXICITY 

## Study
Geo g

raphic Area : FIN Chemical Name : Urea

IRPTC Data ProfileAquatic Toxicity 107
Test method : description Cell multiplication inhibition test; static; GLP: no 

## Test Method and Conditions

BIOMA Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Toxicity threshold for 72 hours = 29 mg/L BIOMA UNS To some extent urea exhibited selective toxic action on Entosiphon sulcatum. For example toxicity threshold for chloroform was > 6560 mg/L. 

## Test Results

General Comments : Urea exhibits to some extent toxic action to Entosiphon sulcatum. 

## References Primar y

Reference : WATRAG Secondar y

Reference : !SIDSP* Bringmann, G. and Kuhn, R. Water Research, 14, 231-241, (1980) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileAquatic Toxicity 108

ALGAE Species/strain/s y

stem : Blue-green algae (Microcystis aeruginosa) AQ FRESH 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : AQUATIC TOXICITY 

## Study
Geo g

raphic Area : FIN Chemical Name : Urea

Test method : description Cell multiplication inhibition test. Single species tests such as "Microtox Photobacterium Luminescence Test" and tests on overall processes such as nitrification or soil respiration are included in this item. GLP: not known 

## Test Method and Conditions

BIOMA INHIB Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Toxicity threshold for 192 hours = 47 mg/L 

## Test Results

General Comments : Urea exhibits to some extent toxic action to Microcystis aeruginosa. 

## References Primar y

Reference : VJWWAU Secondar y

Reference : !SIDSP* Bringmann, G. and Kuhn, R. Vom Wasser, 50, 45-60, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

BACT Species/strain/s y

stem : Bioluminiscent bacteria (Photobacterium luminescence) AQ MARIN 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : AQUATIC TOXICITY 

## Study
Geo g

raphic Area : FIN Chemical Name : Urea

IRPTC Data ProfileAquatic Toxicity 109
Test method : description Microtox Photobacterium Luminescence Test. Single species tests such as "Microtox Photobacterium Luminescence Test: and tests on overall processes such as nitrification or soil respiration are included in this item. GLP: no known 

## Test Method and Conditions

EC50 Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- EC50 for 5 minutes = 24000 mg/L 

## Test Results
References Primar y

Reference : ASTTAB Secondar y

Reference : !SIDSP* Bulich, A. A. et al. ASTM Special Technical Publication Aquatic Toxicology and Hazard Assessment, ASTM STP 737, 338-347 OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

CRUS Species/strain/s y

stem : Water flea (Daphnia magna) AQ FRESH 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : AQUATIC TOXICITY 

## Study
Geo g

raphic Area : FIN Chemical Name : Urea

Test method : description DIN 38412 Teil 11 (modified) 

## Test Method and Conditions

EC50 Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- EC50 for 24 hours > 10000 mg/L. 

## Test Results

General Comments : Urea is not acutely toxic to daphnids.

IRPTC Data ProfileAquatic Toxicity 110 

## References Primar y

Reference : ZWABAQ Secondar y

Reference : !SIDSP* Bringmann, G. and Kuhn, R. Zeitschrift fuer Wasser und Abwasser Forschung, 15(1), 1-6, (1982) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

FISH Species/strain/s y

stem : Golden orfe (Leuciscus idus melanotous) AQ FRESH 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : AQUATIC TOXICITY 

## Study
Geo g

raphic Area : FIN Chemical Name : Urea

Test method : description Static; GLP: no 

## Test Method and Conditions Exposure Type : ACUTE 

## Exposure

LC0 Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- LC0 for 48 hours > 10000 mg/L 

## Test Results

General Comments : Urea is not acutely toxic to fish. 

## References Primar y

Reference : ZWABAQ Secondar y

Reference : !SIDSP* Juhnke, I. and Ludemann, D. Zeitschrift fuer Wasser und Abwasser Forschung, 11, 5, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileAquatic Toxicity 111

FISH Species/strain/s y

stem : Tilapia (Tilapia mossambica) AQ ESTUA FRESH 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : AQUATIC TOXICITY 

## Study
Geo g

raphic Area : FIN Chemical Name : Urea

Test method : description Test method not specified 

## Test Method and Conditions

LC0 Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- LC0 for 96 hours = 20000 mg/L.; LC50 LC50 for 96 hours = 22500 mg/L.; LC100 LC100 for 96 hours = 25000 mg/L BW DECR BW SIZE BEHAV When the fish was reared in different sublethal concentrations (5, 10, 15 and 20 g/L, test period 25 days) of urea, there was a decrease in feeding and growth rates. In addition to the realized energy from food consumption, the fish lost reserve energy at the highest concentration of 

## Test Results

urea. Conversion efficiency fell rapidly as the concentration increased. General Comments : Urea is not acutely toxic to fish. Tilapia mossambica lives under wide varity of environmental circumstances tolerating different osmotic conditions. This chemical fertilizer appeared to be metabolic stressor at high concentrations. 

## References Primar y

Reference : ENECEV Secondar y

Reference : !SIDSP* Palanichamy, S. et al. Environment and Ecology, 3(2), 157-161, (1985) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)
IRPTC Data ProfileTerrestrial Toxicity 112

WORM Species/strain/s y

stem : Grassland earthworms (Oligochaeta, Lumbricidae) TERR 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : TERRESTRIAL TOXICITY 

## Study
Geo g

raphic Area : FIN Chemical Name : Urea

Test method : description Effects monitored: earthworm numbers and biomass. Fertilizer was organic coated urea, the organic coating being based on soybean oil at annual rate of 60, 120 & 180 kg N/ha. Soil was treated annually for 20 years. Organic Matter : Content 

## Test Method and Conditions
6.2-6.7 % 

## Exposure Exposure comments : Sandy loam soil. The organisms relation to soil acidification was studied. Application of nitrogenous fertilizers to grassland for long period may have a deleterious effect on earthworms in the absence of liming. 

## Test Results References Primar y

Reference : AEENDO Secondar y

Reference : !SIDSP* Wei-Chum Ma, L. et al. Agriculture, Ecosystems and Environment, 30, 71-80, (1990) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileTerrestrial Toxicity 113

BACT Species/strain/s y

stem : Soil bacteria (Pseudomonas putida) TERR 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : TERRESTRIAL TOXICITY 

## Study
Geo g

raphic Area : FIN Chemical Name : Urea

Test method : description Cell multiplication inhibition test. Single species tests such as "Microtox Photobacterium Luminescence Test" and tests on overall processes such as nitrification or soil respiration, are included in this item. GLP: not knwon 

## Test Method and Conditions

BIOMA INHIB Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Toxicity threshold for 16 hours > 10000 mg/L 

## Test Results
References Primar y

Reference : WATRAG Secondar y

Reference : !SIDSP* Bringmann, G. and Kuhn, R. Water Research, 14, 231-241, (1980) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

BIRD Species/strain/s y

stem : Pigeon TERR 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : TERRESTRIAL TOXICITY 

## Study
Geo g

raphic Area : FIN Chemical Name : Urea

IRPTC Data ProfileTerrestrial Toxicity 114 Test method : description Test method not specified; GLP: no 

## Test Method and Conditions

LDLO SCU Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Lowest lethal dose found = 16000 mg/kg 

## Test Results

General Comments : Urea is not acutely toxic to pigeon. 

## References Primar y

Reference : D8REP4 Secondar y

Reference : !SIDSP* FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

PLANT Species/strain/s y

stem : Soybean (Glycine max. L.) Merr TERR 

## Test Subject Organism Medium Specification Route Lifestage Sex Number exposed Number controls

Stud y

t

y

pe : LAB CAS Number : 57-13-6 End Point : TERRESTRIAL TOXICITY 

## Study
Geo g

raphic Area : FIN Chemical Name : Urea

Test method : description Test method not specified; GLP: no 

## Test Method and Conditions

LEAF STRUC Affected in Organ Effect Rev. OnSet Sex Exposed - Controls --------- ----------- ------- ------------------- ------- ----------------------------- Leaf-tip necrosis observed after foliar fertilization of soybean with urea. NOEL Maximum concentration at which no effect was observed within the period of the test < 0.01 wt -% urea of dry weight of leaves (= 9 mg/leaf, a 7-day study). 

## Test Results

General Comments : It was concluded in this study that necrosis resulted from accumulation of toxic amounts of urea rather than from formation of toxic amounts of ammonia. IRPTC Data ProfileTerrestrial Toxicity 115 

## References Primar y

Reference : PNASA6 Secondar y

Reference : !SIDSP* Krogmeier, J. M. et al. Proceedings of the National Academy of Sciences of the United States of America, 86, 8189-91, (1989) OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data ProfileRecomendations/Legal mechanisms 116

CAS Number : 57-13-6 Chemical Name : 

## Substance Reported Name : Urea

GBR REG Permitted for use only as a home garden fungicide on cut stumps of trees and on apple and pear trees. Pesticides 1992: Pesticides approved under the Control of Pesticides Regulations 1986 Effective Date : Entry / Update : 01MCH1991 NOV1992 Title : Reference : Last Amendment : PESTI CONSM RSTR RSTR Area Type Subject Spec. Description Level / Summary Information : USE USE PACPR*, 500, xlv, 1992

CAS Number : 57-13-6 Chemical Name : UREA 

## Substance Reported Name : UREA

CSK REG COMPONENT OF RUBBER PRODUCTS PERMITTED FOR CO NTACT WITH FOOD AND THE HUMAN BODY. MAXIMUM L IMIT FOR THE FINAL PRODUCTS: 30MG/G. DIRECTIVE NO. 62 ON HYGIENIC REQUIREMENTS ON RUBBERS AND RUBBER GOODS COMING IN CONTACT WI TH FOODSTUFFS AND HUMAN ORGANISM Effective Date : Entry / Update : 1JAN1983 DEC1991 Title : Reference : Last Amendment : - PRMT MXL Area Type Subject Spec. Description Level / Summary Information : FOOD GOODS HPMZC*, 54, 1982 HYGIENICKE PREDPISY MINISTERSTVA ZDRAVOTNICTVI CSR (HYGIENIC REGULATIONS OF MINISTRY OF HEALTH OF CSR)

CAS Number : 57-13-6 Chemical Name : UREA 

## Substance Reported Name : UREA

CSK REG MAXIMUM LIMITS IN COSMETICS: 50MG/G DIRECTIVE NO. 34 ON HYGIENIC REQUIREMENTS ON COSMETICS, DETERGENTS, AND GOODS OF PERSONAL USE Effective Date : Entry / Update : 1JAN1971 DEC1991 Title : Reference : Last Amendment : - RSTR MXL Area Type Subject Spec. Description Level / Summary Information : GOODS HPMZC*, 32, 1970 HYGIENICKE PREDPISY MINISTERSTVA ZDRAVOTNICTVI CSR (HYGIENIC REGULATIONS OF MINISTRY OF HEALTH OF CSR)

IRPTC Data ProfileRecomendations/Legal mechanisms 117

CAS Number : 57-13-6 Chemical Name : UREA 

## Substance Reported Name : UREA

CSK REG SUBSTANCE IS APPROVED AS PESTICIDE. SPECIFIC USES, LIMITATIONS AND SAFETY PRECAUTIONS ARE GIVEN. LIST OF PERMITTED CHEMICALS FOR PLANT PROTECT ION Effective Date : Entry / Update : JAN1991 DEC1991 Title : Reference : Last Amendment : AGRIC PRMT Area Type Subject Spec. Description Level / Summary Information : USE SPPOR*, 290, 1990 SEZNAM POVOLENYCH PRIPRAVKU NA OCHRANU ROSTLIN (LIST OF PERMITTED CHEMICALS FOR PLANT PROTECTION)

CAS Number : 57-13-6 Chemical Name : UREA 

## Substance Reported Name : UREA

DEU REC THIS SUBSTANCE IS CLASSIFIED AS SLIGHTLY HAZA RDOUS TO WATER (WATERHAZARD CLASS: WGK 1). ( THE DIFFERENT CLASSES ARE: WGK 3 = VERY HAZAR DOUS; WGK 2 = HAZARDOUS; WGK 1 = SLIGHTLY HAZ ARDOUS; WGK 0 = IN GENERAL NOT HAZARDOUS.) TH E CLASSIFICATION FORMS THE BASIS FOR WATER-PROTECTION REQUIREMENTS FOR INDUSTRIAL PLANTS I N WHICH WATERHAZARDOUS SUBSTANCES ARE HANDLE D. ADMINISTRATIVE RULES CONCERNING WATER-HAZARDO US SUBSTANCES (VERWALTUNGSVORSCHRIFT WASSERGE FAEHRDENDE STOFFE) Effective Date : Entry / Update : DEC1991 Title : Reference : Last Amendment : - INDST CLASS RQR Area Type Subject Spec. Description Level / Summary Information : AQ USE

GMSMA6, 8, 114, 1990 Gemeinsames Ministerialblatt. Joint Ministerial Papers

CAS Number : 57-13-6 Chemical Name : UREA 

## Substance Reported Name : urea

GBR REG CATEGORY C SUBSTANCE: DISCHARGE INTO THE SEA IS PROHIBITED; DISCHARGE OF TANK WASHINGS AND RESIDUAL MIXTURES IS SUBJECT TO RESTRICTIONS . (APPLIES TO SOLUTION WITH AMMONIUM NITRATE CONTAINING AQUA AMMONIA). THE MERCHANT SHIPPING (CONTROL OF POLLUTION B Y NOXIOUS LIQUID SUBSTANCES IN BULK) REGULATI ONS 1987, SCHEDULE 1 Effective Date : Entry / Update : 06APR1987 1992 Title : Reference : Last Amendment : MARIN MARIN EMI RQR RSTR RSTR Area Type Subject Spec. Description Level / Summary Information : TRNSP AQ AQ GBRSI*, 551, 15, 1987 GBRSI*, 2604, 2, 1990 Statutory Instruments Statutory Instruments

IRPTC Data ProfileRecomendations/Legal mechanisms 118

CAS Number : 57-13-6 Chemical Name : UREA 

## Substance Reported Name : urea

GBR REG CATEGORY D SUBSTANCE: DISCHARGE INTO THE SEA IS PROHIBITED; DISCHARGE OF RESIDUAL MIXTURES IS SUBJECT TO RESTRICTIONS. (APPLIES TO UREASOLUTION WITH AMMONIUM MONO-HYDROGEN PHOSPHA TE, AMMONIUM DIHYDROGEN PHOSPHATE AND POTASS IUM CHLORIDE, APPLIES ALSO TO UREA SOLUTION W ITH AMMONIUM NITRATE, AND ALSO TO UREA SOLUTI ON WITH AMMONIUM PHOSPHATE). THE MERCHANT SHIPPING (CONTROL OF POLLUTION B Y NOXIOUS LIQUID SUBSTANCES IN BULK) REGULATI ONS 1987, SCHEDULE 1 Effective Date : Entry / Update : 06APR1987 1992 Title : Reference : Last Amendment : MARIN MARIN EMI RQR RSTR RSTR Area Type Subject Spec. Description Level / Summary Information : TRNSP AQ AQ
GBRSI*, 551, 15, 1987 GBRSI*, 2604, 2, 1990 Statutory Instruments Statutory Instruments

CAS Number : 57-13-6 Chemical Name : UREA 

## Substance Reported Name : urea

GBR REG CLASSIFIED AS A NON-POLLUTING LIQUID SUBSTANC E. DOCUMENTARY EVIDENCE OF ASSESSMENT AND APP ROVAL REQUIRED BY A CARRIER. DISCHARGE INTO T HE SEA IS NOT PROHIBITED. (APPLIES TO SOLUTIO N). THE MERCHANT SHIPPING (CONTROL OF POLLUTION B Y NOXIOUS LIQUID SUBSTANCES IN BULK) REGULATI ONS 1987, SCHEDULE 2 Effective Date : Entry / Update : 06APR1987 1992 Title : Reference : Last Amendment : MARIN MARIN EMI RQR RQR RQR Area Type Subject Spec. Description Level / Summary Information : TRNSP AQ AQ GBRSI*, 551, 15, 1987 GBRSI*, 2604, 2, 1990 Statutory Instruments Statutory Instruments

CAS Number : 57-13-6 Chemical Name : UREA 

## Substance Reported Name : UREA

KEN REG FOOD ADDITIVE PERMITTED AS YEAST FOOD. FOOD P RODUCTS IN OR UPON WHICH IT IS PERMITTED ANDM AXIMUM LEVELS OF USE ARE LISTED. THE FOOD, DRUGS AND CHEMICAL SUBSTANCES (FOOD LABELLING, ADDITIVES AND STANDARDS) REGULATI ONS, 1978 Effective Date : Entry / Update : SEP1982 Title : Reference : Last Amendment : ADDIT PRMT Area Type Subject Spec. Description Level / Summary Information : FOOD GSKEN*, 40, 406, 1978 KENYA GAZETTE SUPPLEMENT NO. 40, SPECIAL ISSUE (LEGISLATIVE SUPPLEMENT NO. 27)

IRPTC Data ProfileRecomendations/Legal mechanisms 119

CAS Number : 57-13-6 Chemical Name : UREA 

## Substance Reported Name : UREA

RUS REG 0.2 MG/M3 AV/D. Effective Date : Entry / Update : AUG1984 SEP1985 Title : Reference : Last Amendment : AMBI MAC Area Type Subject Spec. Description Level / Summary Information : AIR PDKAV*, 3086-84, 1984 PREDELNO DOPUSTIMYE KONTSENTRATSII (PDK) ZAGRYAZNYAYUSHCHIKH VESHCHESTV V ATMOSFERNOM VOZDUKHE NASELENNYKH MEST (MAXIMUM ALLOWABLE CONCENTRATIONS (MAC) OF CONTAMINANTS IN THEAMBIENT AIR OF RESIDENTIAL AREAS)

CAS Number : 57-13-6 Chemical Name : UREA 

## Substance Reported Name : UREA

RUS REG SURFACE WATER FOR FISHING : 80.0 MG/L Effective Date : Entry / Update : SEP1985 Title : Reference : Last Amendment : SURF MAC Area Type Subject Spec. Description Level / Summary Information : AQ PDKTV*, 1978 PREDELNO-DOPUSTIMYE KONTSENTRATSII I ORIENTIROVOCHNYE BEZOPASNYEUROVNI VOZDEISTVIA VREDNYKH VESHCHESTV V OBIEKTAKH VNESHNEI SREDY. NORMATIVNYE MATERIALY. (MAXIMUM ALLOWABLE CONCENTRATIONS AND PRELIMINARY SAFETY LEVELSOF TOXIC SUBSTANCES IN ENVIRONMENT. STANDARDS.)

CAS Number : 57-13-6 Chemical Name : UREA 

## Substance Reported Name : UREA

RUS REG CLV: 10MG/M3 (AEROSOL) HAZARD CLASS: II Effective Date : Entry / Update : 01JAN1989 MAY1990 Title : Reference : Last Amendment : OCC MAC CLASS Area Type Subject Spec. Description Level / Summary Information : AIR
GOSTS*, 12.1.005, 1988 GOSUDARSTVENNYI STANDART SSSR (STATE STANDARD OF USSR)
IRPTC Data ProfileRecomendations/Legal mechanisms 120

CAS Number : 57-13-6 Chemical Name : UREA 

## Substance Reported Name : UREA

RUS REG CLV: 25MG/M3 (VAPOUR, AEROSOL- APPLIES TO FER TILIZER MIXT. WITH AMMONIA); HAZ. CLASS: IV Effective Date : Entry / Update : 1JAN1989 MAY1990 Title : Reference : Last Amendment : OCC MAC CLASS Area Type Subject Spec. Description Level / Summary Information : AIR
GOSTS*, 12.1.005, 1988 GOSUDARSTVENNYI STANDART SSSR (STATE STANDARD OF USSR)

CAS Number : 57-13-6 Chemical Name : 

## Substance Reported Name : UREA

USA REG CASE NAME UREA; Summary - THIS SUBSTANCE IS I NCLUDED ON A LIST OF ACTIVE INGREDIENTS CONTA INED IN A PRODUCT FIRST REGISTERED BEFORE NOV EMBER 1, 1984, FOR WHICH A REGISTRATION STAND ARD HAS NOT BEEN ISSUED. PUBLICATION OF THIS LIST INITIATES AN ACCELERATED REREGISTRATION AND DATA C ALL-IN FOR PRODUCTS CONTAINING THE LISTED ACTIVE INGREDIENTS. FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICI DE ACT PESTICIDES REQUIRED TO BE REREGISTERED ; LIST D Effective Date : Entry / Update : 1989 JAN1992 Title : Reference : Last Amendment : PESTI PESTI ADDIT RQR PRMT RQR Area Type Subject Spec. Description Level / Summary Information : CLASS MANUF FOOD
FEREAC, 54, 204, 43388, 1989 FEREAC, 54, 204, 43388, 1989 Federal Register Federal Register

CAS Number : 57-13-6 Chemical Name : UREA 

## Substance Reported Name : UREA

EEC REG TECHNICALLY PURE UREA MAY BE MARKETED AS FEED INGSTUFF UNDER THE CONDITIONS LAID DOWN. COUNCIL DIRECTIVE OF 30 JUNE 1982 CONCERNING CERTAIN PRODUCTS USED IN ANIMAL NUTRITION (82 /471/EEC). Effective Date : Entry / Update : 01JUL1988 SEP1987 Title : Reference : Last Amendment : - PRMT Area Type Subject Spec. Description Level / Summary Information : FEED OJEC**, L213, 8, 1982 OJEC**, L239, 36, 1988 Official Journal of the European (Communities)/Union Official Journal of the European (Communities)/Union

IRPTC Data ProfileRecomendations/Legal mechanisms 121

CAS Number : 57-13-6 Chemical Name : UREA 

## Substance Reported Name : UREA

EEC REG THE SUBSTANCE MAY BE USED FOR THE MANUFACTURE OF REGENERATED CELLULOSE FILM WHICH IS INTEN DED TO OR DOES COME INTO CONTACT WITH FOODSTU FFS. IT MAY BE USED AS SOFTENER; MAXIMUM CONT ENT OF SOFTENERS IN TOTAL: 27%. COUNCIL DIRECTIVE OF 25 APRIL 1983 ON THE APP ROXIMATION OF THE LAWS OF THE MEMBER STATES R ELATING TO MATERIALS AND ARTICLES MADE OF REG ENERATED CELLULOSE FILM INTENDED TO COME INTO CONTACT WITH FOODSTUFFS. (83/229/EEC). Effective Date : Entry / Update : 01APR1987 OCT1987 Title : Reference : Last Amendment : - RQR MXL RSTR Area Type Subject Spec. Description Level / Summary Information : FOOD FOOD FOOD
OJEC**, L123, 31, 1983 OJEC**, L228, 32, 1986 Official Journal of the European (Communities)/Union Official Journal of the European (Communities)/Union

CAS Number : 57-13-6 Chemical Name : 

## Substance Reported Name : Urea

IMO REC Category C substance (substance which is slightly toxic to aquatic life): discharge into the sea of this substance, of ballast water, tank washings or other residues or mixtures containing such a substance shall be prohibited except where specified conditions are satisfied. Technological requirements prescribe equipments and designs that must be present on the tankers as well as port facilities for receiving residues or mixtures containing the regulated substance. Technical assistance for training of scientific and technical personnel shall be promoted where requested by the Parties of the Convention. (Applies to urea/ammonium nitrate solution containing aqua ammonia) International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 relating thereto (MARPOL 73/78). Effective Date : Entry / Update : SEP1994 Title : Reference : Last Amendment : EMI MARIN RSTR RSTR Area Type Subject Spec. Description Level / Summary Information : AQ AQ

IMODC*,

IRPTC Data Profile