### OECD SIDS



# FOREWORD INTRODUCTION



# UIREA CAS N° : 57-13-6 UREA

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# CONTAINS NOCBI

3a4393 UNEP PUBLICATIONSIdentifiers, Physical and Chemical properties



# Substance End Point . IDENTIFIERS, PHYSICAL AND CHEMICAL PROPERTIES Chemical Name . Urea Common Name : Urea CAS Number : 57-13-6 RTECS Number : YR6250000 

# Synonyms Benural 70 B-I-K Carbamide Carbamimidic acid Carbonyl diamide Isourea Nimin Pseudourea UR Urea perhydrate Ureaphil Ureophil Urepearl Urevert Varioform11 

# Properties & Definitions Molecular Formula . CH4N20 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 : log Pow= -1 .59 at 20-25C experimental Coefficient Water Solubility : 1080 g/L at 20C Solubility in other : 10 g/L in 95% alcohol, 167 gIL in methanol, 500 gIL in glycerol "

Solvents 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 .4wt°/a ; free ammonia 0

.4 wt°/a; Fe 2+ <0.0002 wt%

; ash content < 0

.02wt°/a. Degree of purity 98-99 wt% . General Comments . *On further heating decomposes to biuret, NH3and cyanuric acid. On standing or on heating decomposes to NH3and C02. ** Urea decomposes before boiling.***VPof saturated water solution=2kPa at 20C . Hypochlorites can react with urea to form

the explosive compound, nitrogen trichloride. Reacts violently with galliumperchlorate. 

# Overall Evaluation CURRENTLY OF LOW PRIORITY FOR FURTHERWORK 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 . IRPTCData Profile

### 2 identifiers, Physical and Chemical properties Although urea has generally lowecotoxicity to organisms, its well documented indirect and longtermeffects 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 fromurea 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 intowater 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 ofwild 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 fromurine 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 formof ammonium, fromwhich nitrogen is oxidized IRPTCData ProfileIdentifiers, Physicaland 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 lowlog 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 intowater and air, respectively. (i) Air Urea is essentially non-volatile in solid form . Its high water solubility, lowvapour pressure (solid pure urea 80 Pa at 20C ; calculated) and consequently lowHenry's law constant (4.4E-8 atmm3/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%a 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 lowsoil-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 ammoniumcan 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 10for 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 catabolismin 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 frommeat 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%ofthe fresh weight of food of plant origin were urea), the human daily intake of urea fromplants 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 fromdental preparations cannot be estimated with any accuracy, but it probably amounts to relatively small quantities. lRPTCData Profile4 Identifiers, Physical and Chemical properties 

### OCCUPATIONAL EXPOSURE Occupational exposure to urea can be envisaged frominhalation of aerosols and dust during production of urea, urea fertilizers and animal feed supplements, in chemical synthesis using urea as a starting material and when dispersing 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 fromthe 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 m3ventilation 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 fromskin 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 fromthe 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 lowin 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 lowtoxicity even by the subcutaneous and intravenous route. b) Repeated dose toxicity Nowell-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 ppmin 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 25weeks 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 novalue 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, Physical and Chemicalproperties 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 mechanismof 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 to treat dry skin has been widespread, and long termfollow-up studies have indicated that the substance is non- allergenic and virtually free fromside effects. Among other clinical therapeutic uses, the treatment of inappropriate secretion of antidiuretic hormone (SIADH) should be noted, because its chronic formhas involved long termoral 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 30g of urea (about 470 mg/kg body weight/day) by ingestion for 5years 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 maximumtolerable 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 longtermthan 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 (sewageof Kemira's fertilizer factory) The degradation product of urea, ammonia, is known to be toxic toall vertebrates. In neutral and acidic conditions, however, ammonia exists in the formof 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, 50-100times higher urea concentrations in the cultivating mediumwere shown to disrupt DNAand elicit genotoxicity in mammalian cells, apparently through non-specific osmotic mechanisms. It can be expected that the human organismis well adapted to urea within the physiological range of concentrations and even beyond. This is supported by clinical evidence fromhigh dose administration orally and intravenously for therapeutic purposes. The bulk of human exposure to urea apparently results fromurea 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 fromfood. 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 tofind. Especially it may be noted that the existing studies for reproductive and developmental toxicity are not adequate. However, chronic toxicity and carcinogenicity screening studies of urea IRPTCData Profile

### Identifiers, Physical and Chemical properties 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 470mglkg body weight/day of urea over 5 years did not cause adverse effects. The estimated dose of lowconcern (EDLC) fromanimal 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 lowcurrent concern. Urea has generally lowacute 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 formof 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 longterminfluence of urea use e.g. soil acidification after the longtermfertilization and ammonia emissions to air can have influence to the whole ecosystemand 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 lowcurrent concern to human health . RECOMMENDATIONS No further tests are needed. More accurate data concerning the daily intake of urea fromdiet are desirable.

IRPTCData Profile

### Production-Trade 7



# Production-Trade Chemical Name : Urea CAS Number . 57-13-6 Geographic Area : WORLD 

# Production uantit Year 19062400-27963000 Uy-P 1985-1989 41440000-60789000 Uy - P 1985-1989 89800000-+134E+5 Uy - P 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* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name : Urea CAS Number . 57-13-6 GeographicArea : USA Area Specifications : AMN 

# Production uantit Year 1470000-2350000 tly - P 1985-1989 13 %-EX

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 .

1RPTCData Profile

### Production-Trade



# References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAD Fertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name : Urea CAS Number ; 57-13-6 GeographicArea : AMN 

# Production uantit Year 11599000-+630000 tly - P

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) 

# Production-Trade Chemical Name . Urea CAS Number , 57-13-6 

# Production uantit Year 31635000-+3617000 Uy-P

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

IRPTCData Profile

### p. 10

Production-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) 

# Production-Trade Chemical Name . Urea CAS Number ; 57-13-6 Geographic Area . EUR Area Specifications : W 

# Production antit Year 6215000-+250000 Uy-P

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) 

# Production-Trade Chemical Name . Urea CAS Number , 57-13-6 

# Production uantit Year 3419000-+1150000 Uy - P

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

IRPTCData Profile10 Production-Trade



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

# Production-Trade Chemical Name : Urea CAS Number : 57-13-6 GeographicArea . AFRI 

# Production uantit Year 2957000-+575000 tly - P

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) 

# Production-Trade Chemical Name . Urea CAS Number . 57-13-6 GeographicArea . ASIA 

# Production uantit Year 5295000-+2550000 tly - P 28728000-+4650000Uy-P

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. IRPTCData Profile

### p. 12

Production-Trade 71 

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

# Production-Trade Chemical Name . Urea CAS Number . 57-13-6 GeographicArea : EUR 

# Production uantit Year 7144900-8321000tly - P 1985-1989

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* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name : Urea CAS Number : 57-13-6 GeographicArea . ASIA 

# Production uantit Year 8063500-12185000 tly - P 1985-1989 "

"

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

1RPTCData Profile

### p. 13

12 Production-Trade 

# References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name . Urea CAS Number . 57-13-6 Geographic Area . NGA Area Specifications . AFRI 

# Production uantit Year 70000-230000t/y - P 1987-1988

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* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name . Urea CAS Number : 57-13-6 Geographic Area . CAN Area Specifications : AMN 

# Production uantit Year 1000000-3000000 t/y - P 1985-1989

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

### p. 14

Production-Trade 

# References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name : Urea CAS Number : 57-13-6 Geographic Area . CUB 

# Production u ntit Year 20000-38000 Uy - P 1985-1989 13



### "

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* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name . Urea CAS Number . 57-13-6 GeographicArea MEX 

# Production uantit Year 500000-640000Uy - P 1985-1988

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

IRPTCData Profile

### p. 15

14 Production-Trade 

# References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name : Urea CAS Number . 57-13-6 GeographicArea : TTO 

# Production uantit Year 150000-250000 tly - P 1985-1989 "

General Comments . The given values arethe 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* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name : Urea CAS Number : 57-13-6 Geographic Area . AFG Area Specifications . ASIA 

# Production uantitY Year 45000-60000 tly - P 1985-1989

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

### p. 16

Production-Trade 

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

### FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name : Urea CAS Number : 57-13-6 Geographic Area . BDG Area Specifications : ASIA 

# Production uanti Y Year 380000-680000tly - P 1985-1989 15



### "

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* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name . Urea CAS Number : 57-13-6 GeographicArea : IND Area Specifications : ASIA 

# Production an It Year 3400000-5750000 Uy - P 1985-1989

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

### p. 17

6 Production-Trade 

# References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name . Urea CAS Number . 57-13-6 Geographic Area . IDN Area Specifications : ASIA 

# Production uantit Year 1800000-2240000 Uy-P 1986-1989

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

# References !SIDSP* OECDISIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name . Urea CAS Number : 57-13-6 GeographicArea . IRN Area Specifications . ASIA 

# Production uantit Year 50000-100000tly - P 1986-1988 

### "

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

. IRPTC Data Profile

### p. 18

Production-Trade 17 

# References

Production-Trade Chemical Name : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990)



### Urea CAS Number : 57-13-6 Geographic Area : JPN Area Specifications : ASIA 

# Production antit Year 300000-350000 Uy - P 1985-1989 "

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

# References

Production-Trade Chemical Name . Urea CAS Number . 57-13-6 GeographicArea : KWT Area Specifications . ASIA 

# Production uantit Year 260000-400000 tly - P 1985-1989 "

General Comments . The given values are the production volume of urea in metric tons of N (urea N46%) . !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990)

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### p. 19

18 Production-Trade 

# References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name : Urea CAS Number : 57-13-6 GeographicArea . PAK Area Specifications : ASIA 

# Production uantit Year 835000-970000tly - P 1985-1989

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* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name : Urea CAS Number ; 57-13-6 GeographicArea . QAT Area Specifications : ASIA 

# Production uantit Year 320000-360000 Uy - P 1985-1989 "

General Comments . The given values are the production volume of urea in metric tons of N (urea N- 46%) . IRPTCData Profile

### p. 20

Production-Trade 19 

# References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name : Urea CAS Number , 57-13-6 Geographic Area : SAU Area Specifications : ASIA 

# Production u ntit Year 400000-450000 t/y - P 1985-1989 "

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* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name . Urea CAS Number : 57-13-6 Geographic Area : SYR Area Specifications : ASIA 

# Production uantit Year 50000-90000 tly - P 1985-1989 "

General Comments : The given values are the production volume of urea in metric tons of N (urea N- 46%) . IRPTCData Profile

### p. 21

20 Production-Trade 

# References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name : Urea CAS Number : 57-13-6 Geographic Area : TUR Area Specifications : ASIA 

# Production uantit Year 70000-160000Uy - P 1985-1988

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* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name : Urea CAS Number ; 57-13-6 GeographicArea . ARE Area Specifications . ASIA 

# Production uantit Year 150000-260000 t/y - P 1985-1989

General Comments : The given values are the production volume of urea in metric tons of N (urea N- 46%) . 1RPTC Data Profile

### p. 22

Production-Trade 21 

# References

Production-Trade Chemical Name CAS Number Geographic Area Area Specifications 

# Production u ntit Year 3500-15000 tly - P 1985-1988

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* 

### FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990)

!SIDSP* OECDISIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

### Urea 57-13-6 VNM ASIA



# Production-Trade Chemical Name CAS Number Geographic Area Area Specifications Urea 57-13-6 BGR EUR 

# Production

antit Year 330000-370000 tly - P 1985-1989

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

### p. 23

22 Production-Trade 

# References

Production-Trade Chemical Name CAS Number GeographicArea Area Specifications 

# Production !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990)



### Urea 57-13-6 CSK EUR uantit Year 70000-80000 t/y - P 1987-1989

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

# References



# Production-Trade Chemical Name CAS Number GeographicArea Area Specifications 

# Production !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990)



### Urea 57-13-6 FRG EUR

uantit Year 500000-520000 Uy-P 1987-1989 "

General Comments : The given values are the production volume of urea'in metric tons of N (urea N- 46%) . IRPTCData Profile

### p. 24

Production-Trade 23 

# References

Production-Trade Chemical Name CAS Number GeographicArea Area Specifications 

# Production !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990)



### Urea 57-13-6 HUN EUR Qu_a_ntitv Year 120000-200000 Uy - P 1985-1989 "

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

# References

Production-Trade Chemical Name CAS Number Geographic Area Area Specifications 

# Production !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990)



### Urea 57-13-6 IRL EUR uantit Year 127000-147000 tly - P 1986-1988 "

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

### p. 25

24 Production-Trade 

# References

Production-Trade Chemical Name CAS Number Geographic Area Area Specifications 

# Production !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990)



### Urea 57-13-6 ITA EUR uantit Year 460000-600000tly - P 1985-1989 "

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

# References

Production-Trade Chemical Name CAS Number GeographicArea Area Specifications 

# Production !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAO Fertilizer Yearbook, 40, (1990)



### Urea 57-13-6 NLD EUR uantit Year 380000-570000tJy - P 1985-1987 .

General Comments . The given values are the production volume of urea in metric tons of N (urea N- 46%) . IRPTCData Profile

### p. 26

Production-Trade 25 

# References

Production-Trade Chemical Name CAS Number Geographic Area Area Specifications 

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

### FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990)

Urea 57-13-6 POL EUR uantit Year 240000-470000 tly - P 1985-1989 

### "

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

# References

Production-Trade Chemical Name CAS Number GeographicArea Area Specifications 

# Production !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990)



### Urea 57-13-6 PRT EUR

uantit Year 4900-9000 Uy - P 1985-1988 "

Genera! Comments . The given values are the production volume of urea in metric tons of N (urea N46%) . IRPTCData Profile

### p. 27

26 Production-Trade 

# References



# Production-Trade Chemical Name CAS Number Geographic Area Area Specifications 

# Production !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990)



### Urea 57-13-6 ESP EUR uantit Year 113000-165000 tly - P 1985-1989

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

# References

Production-Trade Chemical Name CAS Number Geographic Area Area Specifications 

# Production uantit Year 0-240000 Uy - P 1988 "

General Comments . The given values are the production volume of urea in metric tons of N (urea N46%) . !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990)



### Urea 57-13-6 YUG EUR

IRPTCData Profile

### p. 28

Production-Trade 

# References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name . Urea CAS Number : 57-13-6 Geographic Area : RUS Area Specifications . EUR 

# Production Quantitv Year 4800000-4950000t/y - P 1987-1989 27

"



### General Comments . The givenvalues arethe 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* FAOStatistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name : Urea CAS Number . 57-13-6 Geographic Area . AMN 

# Production uantit Year 3140000-6278000t/y - P 1985-1989

General Comments . The total production volume of urea in metric tons of N (urea N-46%) in north and central America. lRPTCData Profile

### p. 29

28 Production-Trade 

# References !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) FAOSS* FAD Statistics Series. FAOFertilizer Yearbook, 40, (1990) 

# Production-Trade Chemical Name : Urea CAS Number : 57-13-6 GeographicArea . WORLD 

# Production uantit Year 41440000-60789000 t - P 1985-1989

General Comments : The capacities of urea production have increased. By the year 1994-1995the 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* FAOStatistics Series. FAOFertilizer Yearbook, 315, 179-201, (1990) 

# Production-Trade Chemical Name : Urea CAS Number : 57-13-6 Geographic Area : FIN

1RPTCData ProfileProduction-Trade 29



# Production uantit Year 13640 Uy - P 1986 1550 tly - P 1986 8210 tly - P 1986 610Uy - P 1986 34010 tly - P 1986 40000-60000 tly - IM

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 = 34010tonnes/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 toAcidification in Finland : Litterature Survey, D139, (1987)

IRPTCData Profile

### p. 31

30 Processes 

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

# Process Process comments : In modern synthetic processes, urea is made by reacting ammonia and carbon dioxide at high pressure and temperature to formammonium carbonate and simultaneously dehydrating the ammoniumcarbonate 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 ofthe 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 . 

# References Secondary Reference : !SIDSP" OECD/SIDS

. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTCData Profile

### p. 32

Uses 31 

# Uses Chemical Name . Urea CAS Number 

# Use 57-13-6 uantit Year Comments "

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. 

### 3 % Approximate quantity used as an animals feed supplement of the grain ration. 1 % Approximate quantity used as an animal feed supplement of the total ration. 

# References Primary References : GASTR* Oehme, F. W

. and Barrel, D

. Veterinary Gastrointestinal Toxicology, 489-490, (1986) 

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

# Uses Chemical Name . Urea CAS Number 

# Use 57-13-6 uantit Year Comments "

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. 1 % Maximumurea concentration is commonly 1% . 6.4-9.6 % wt 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) . 

# References Primary References . COSDA* Cosmetics and Detergent Association in Finland, (1992) 

### SecondaryReferences . !SIDSP* OECDISIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) IRPTCData Profile

### p. 33

32 Uses 

# Uses Chemical Name : Urea CAS Number ; 57-13-6 Geographic Area : USA 

# Use uantit Year Comments 42 % 31 % 5 % 9 % Fertilizer, solid Fertilizer solutions Urea-formaldehyde resins and adhesives Others, including anima! feed and melamine 

# References "

Primary References : CMKRA5 Karcher, AR

. Chemical Profiles. Chemical Marketing Reporter, 234(13), 54, (1988) Secondary References : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) 

# Uses Chemical Name . Urea CAS Number ; 57-13-6 Geographic Area : FIN 

# Use uantit Year Comments 23 % 68 % 2 % 7 % Fertilizer, solid Urea-formaldehyde resins and adhesives Deicer on airport runways 

### Other, including use as a nutrient in waste water treatment plant. 

# References Primary References . INFFI* Information from Finnish Industry, (1990) 

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

# Uses Chemical Name . Urea CAS Number . 57-13-6 GeographicArea . WORLD IRPTCData Profile

### p. 34

Uses 33 

# Use uantit Year Comments 85-90 % 2-4 % 8-11 % Fertilizer Animal feed Industrial use 

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

# Uses Chemical Name : Urea CAS Number ; 57-13-6 Geographic Area . FIN 

# Use uantit Year Comments



# References "

Types of uses are divided into three: industrial use (open systemand 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 Primary References . ECAPD* Chenier,R. Environment Canada 1974. National Inventory of Sources and Emissions of Asbestos, Beryllium, Lead and Mercury. Summary of Emissions for1970,(1991) 

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

IRPTCData Profile

### p. 35

34 Uses 

### Uses Chemical Name : Urea CAS Number , 57-13-6 Geographic Area : FIN 

# Use uan it Year Comments "

Urea is used for the following functional uses: Adhesive/binder/sealanUfifter Analytical reagent CatalysUacceleratorlinhibitor/activator Chemical intermediate-organic. Chemical intermediateinorganic, organometallic Colourant-pigment/stain/dye/ink. Paint/coating additive Fertilizer Formulation component Fragrancelperfume/deodouriser/flavouring agent HumectanUdewatering aid/dehumidifier/dehydrating agent Monomer Photosensitive agent-fluorecent agent/brightener/UV absorber . 

# References Primary References . ECAPD* Chenier, R

. Environment Canada 1974. National Inventory of Sources and Emissions of Asbestos, Beryllium, Lead and Mercury. Summary of Emissions for 1970, (1991) 

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

# Uses Chemical Name : Urea CAS Number 

# Use 57-13-6 uantit Year Comments 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.

1RPTCData Profile

### Uses 35



# References Primary References : NHCUH" National Health Council . Urea. Safe Use and Handling Data Sheet, I-691/Rev 90,3 

### SecondaryReferences : !SIDSP"' OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

lRPTCData Profile

### p. 37

36 Pathways into the Environment andEnvironmental Fate 

# Study End Point . Pathway into the Environmentand Environmental Fate. Chemical Name : Urea CAS Number : 57-13-6 

# Test Method and Conditions Test method : Mackay level 1 model description 

# Pathway and Transport Pathway . LOAD 

# Quantity Transported "

Medium to Medium u ntit Time Year to Year to AQ 99.84 % Partitioning into water. 

### Partitioning into air. to AIR 0.16 % to AIR NH3 emission, resulted fromdegradation of urea to ammonia. Emissions are higher in alkaline soil . 

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

# Study EndPoint : Pathway into the Environment and Environmental Fate. Chemical Name . Urea CAS Number ; 57-13-6 GeographicArea : FIN 

# Pathway and Transport Pathway : NATUR APPLI 

# Quantity Transported Medium to Medium u nti Time Year to Year BIOTA AGRIC to SOIL Emission in agriculture fromlivestock urine when spread on the fields and in the grazing season. to AIR Emission fromurine of living animals. Reliable estimation of the emission levels cannot be given. to SOIL When 85-90% of urea is used as a fertilizer, the highest environmental exposure is tosoil . IRPTCData Profrfe

### p. 38

Pathways into the Environment and Environmental Fate 37 

# References Secondary Reference . !S!DSP" OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

1RPTCData Profile

### p. 39

38 Concentration 

# Study End Point Chemical Name CAS Number Study type GeographicArea 

# Test Subject CONCENTRATION Urea 57-13-6 LAB FIN "



### OrganismMedium Speciffcation Lifestape Sex

AQ SEW AQ GRND 

### Species/strain/system . Waste water 

# Test Method and Conditions Test method description 

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

### Matrix Concentrations Spec. Date

2-6 mg/L In domestic sewage

0.016-0.043 mg/L In primary sewage plant effluent

0.0016-0.0043 mg1L PEC for primary sewage plant effluent

20 ug/L 1980 Concentration in groundwater in airport area as of 1980 

### Genera! Comments 

# References Primary Reference The information concerning the groundwater is reported in the following reference: National Board of Waters and the Environment, Finland (Unpublished data) . HBEDC* Vershueren, K. Handbook of Environmental Data on Organic Chemicals, 2nd ed., 1178, (1983) 

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

1RPTCData Profile

### p. 40

Concentration 39 

# Study End Point . CONCENTRATION Chemical Name . Urea CAS Number . 57-13-6 Study type . FIELD GeographicArea : FIN 

# Test Subject Oraq nism Medium Specification Lifestage Sex

AQ SEW Species/strain/system : Sewage of Kemira's fertilizer factory, Finland 

# Test Method and Conditions "

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

# Test Results Matrix Concentrations Spec. Date

0.34 mg/L 1993 Concentration in fertilizer manufacturing plant waste water (highest monthly mean) as of 1993.

0 .0034 mg/L PEC for fertilizer factory 

# References Primary Reference : TWEDO" Anttalainen, M

. Turku Water and Environment District Oral Communication, (1994) 

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

fRPTCData Profile

### p. 41

40 Concentration 

# Study End Point Chemical Name CAS Number Study type Geographic Area 

# Test Subject CONCENTRATION Urea 57-13-6 FIELD FIN 

### OrganismMedium -Speciffcation Lifestape Sex

AQ GRND Species/strain/system : Groundwater at the Helsinki-Vantaa Airport, Finland (1975-1990) 

# Test Method and Conditions Test method description 

# Test Results Analysis of groundwater nitrate, nitrite and ammoniumconcentrations



### Matrix Concentrations Spec. Date

150 mg/L 1975-1990 Nitrate concentrations in the airport area groundwater increased up to 150 mg/L

80 mglL Due to diminished use amounts of urea in recent years, from300tonnes to less than 100 tonnes/year, nitrate concentrations slowly decreased to 80 mg/L. 

### General Comments 

# References It is not likely to detect urea itself in the groundwater, but only its degradation products. 

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

lRPTCData Profile

### Concentration 41



# Study End Point Chemical Name CAS Number Study type GeographicArea 

# Test Subject CONCENTRATION Urea 57-13-6 LAB FIN 

### "

Or an nismMedium S.Lecification Lifestage Sex HUMAN ADULT Species/strain/system : Physiological concentrations in man 

# Test Results Matrix Concentrations -Sp ec . Date URINE 20-35 g/24h In urine (200-500 mg/kg body weight/day) In sweat 120-570 mglL BLOOD 3.3-6.4 mmollL In blood (200-500 mg/L) 

### General Comments 

# References 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. 

### Primary Reference : FASEB* A!tman, P. L. and Dittmer, D . S. Biology Data Book, III 2nd ed., 1494&01,(1974) 

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

1RPTCData Prorrle

### p. 43

42 Concentration 

# Study End Point . CONCENTRATION Chemical Name . Urea CAS Number : 57-13-e Study type : LAB Geographic Area : FIN 

# Test Subject OrganismMedium Specification Lifestaae Sex HUMAN FOOD PLANT SEED 

# Test Results Matrix Concentrations Spec. Date BLOOD 30-100 mglL In human blood

4.5 % Edible parts of plants may contain up to 4.5 per cent (oats) of their total nitrogen content as urea.

2-4 % The nitrogen content of grain seeds and grass 

### General Comments 

# References 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 . 

### Primary Reference : D8REP4 EPA (US-Food and Drug Admin.) . Health Hazard Evaluation Determination Report, PB-288673, (1978) 

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

IRPTC Data Profile

### p. 44

Human Intake andExposure 43 

# Study End Point : HUMANINTAKE ANDEXPOSURE Chemical Name . Urea CAS Number . 57-13-6 

# Evaluations "

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 frominhalation 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 fromthe handling of urea. 

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

# Study End Point : HUMAN INTAKE AND EXPOSURE Chemical Name . Urea CAS Number . 57-13-6 Geographic Area FIN 

# Test Subject Organism Medium Specification Route Lif s e Sex HUMAN AIR IHL HUMAN SKN Species/strain/system : Potential anthropogenic sources of exposure are manufacturing, industrial, agricultural and consumer uses. 

# Test Results Intake Sg,c. Date 200 mgld The tentative overall dose of urea resulting fromthe worst- case occupational exposure 50 mg Uptake of respirable urea at 5 mg/m3 (with 10 m3 volume of total ventilation and 100%absorption) . "

100 mg The airway deposition, most of which will be ingested, results fromthe non-respirable part of urea at 10 mg/m3 and 10 m3 ventilation. IRPTCData Profile

### p. 45

44 Human Intake and Exposure 

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

# Study End Point : HUMAN INTAKE ANDEXPOSURE Chemical Name : Urea CAS Number : 57-13-6 Geographic Area : FIN 

# Test Subject Orpanism Medium Specification Route Lifes a e Sex HUMAN FOOD - PLANT HUMAN AIR ANI ORL AGRIC IHL Species/strain/system : Potential anthropogenic sources of exposure are manufacturing, industrial, agricultural and consumer uses. 

# Test Results Intake Snec . Date Intake of urea frommeat would amount to >10 mglL per day. The human daily intake of urea fromplants could amount up to several grams. The possible food additive use of urea apparently adds little to the intake via food. 

### General Comments 

# References Because urea is an important endogenous product of protein catabolismin mammals and occurs in significant concentrations in blood and obviously in extracellular water, human food of animal origin contains some urea . 

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

# Study End Point : HUMANINTAKE ANDEXPOSURE Chemical Name : Urea CAS Number : 57-13-6 Geographic Area : USA 

# Test Subject Organism Medium Specification Route Lifestage Sex HUMAN IRPTCData Profile

### p. 46

Human Intake and Exposure 45 

# Test Method and Conditions Test method : The National Occupational Hazard Survey conducted by NIOSH . description 

# Test Results General Comments



# References Probable human exposure: according to the survey in the USA 855894 workers may be exposed to urea; 7% fromactual observed use, 31 % from observed use of a tradename product known to contain this chemical, and 62%fromobserved use of a product in some type of general use which leads NIOSHto 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) . 

### Primary Reference : HSDBM " Hazardous Substances Databank HSDB, 11, (1991) 

### SecondaryReference . !SIDSP" OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTCData Profile

### p. 47

46 Biodegradation 

# Study End Point Chemical Name CAS Number Study type GeographicArea 

# Test Subject r anism M

edium ,Specification AQ FRESH 

### BIODEGRADATION Urea 57-13-6 LAB FIN



# Test Method and Conditions Test method : GLP : no description Temperature : <8 C 

# Test Results u ntitY T

im e Comments on result 

# References In river water at 1-15 mg/L degradation of urea is negligible below8C for up to 14 days. Primary Reference : WATRAG Evans, W

. H. et al . Water Research, 7, 975-985, (1973) 

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

# Study EndPoint . BIODEGRADATION Chemical Name : Urea CAS Number : 57-13-6 Study type : LAB Geographic Area FIN 

# Test Subject Organism Medium Specification

AQ SLUDG Species/strain/system . Semi-continuous activated sludge (SCAS)

IRPTCData Profile

### p. 48

Biodegradation 47 

# Test Method and Conditions Test method : The diappearance of urea was determined by colorimetric analysis. description 

# Test Results uantit Time Comments on result 93-98 %a 24 h 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 Primary Reference . ANCHAM EPA. Analytical Chemistry, 71-8, (1983) 

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

# Study End Point : BIODEGRADATION Chemical Name . Urea CAS Number : 57-13-6 Study type : LAB Geographic Area . FIN 

# Test Subject Organism Medium Specification

AQ SLUDG Species/strain/system : Activated sludge froma laboratory sewage treatment facility fed with domestic and synthetic sewage; adapted. 

# Test Method and Conditions Test method : Inherent Biodegradability: OECDGuideline 302 B (1981), Zahn-Wellens description Test ; GLP: no 

### (An)aerobic : AEROB 

# Exposure Dose / Concentration : 400 mg/L

IRPTCData Profile

### p. 49

48 Biodegradation 

# Test Results uantit Time Comments on result 3 % 3 h Decomposed urea 52 % 7 h Decomposed urea 60 %a 10d Decomposed urea 85 % 14d Decomposed urea 96 % 16d Decomposed urea General Comments : Urea is ultimately biodegradable according to this study. (Proj . No: 119110452/10/1) as cited in the reference. 

# References Primary Reference . #URBSF" BASF AG

. BASF Unpublished Report, (1991) 

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

# Study End Point . BIODEGRADATION Chemical Name : Urea CAS Number . 57-13-6 Study type : LAB Geographic Area : FIN 

# Test Subject Or, aq nism Medium Specification

AQ SOIL 

### Species/strain/system . Floodedsoil 

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

IRPTCData Profile

### p. 50 Biodegradation 49 

# Test Results uantit Time Comments on result 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) . 3 % 30 h The added urea which was hydrolysed in the floodwater after 30 hours of incubation. 64 % 30 h 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/3911978 

# References Primary Reference : SOSCAK V!ek, P. L. G. and Carter, M . C . Soil Science, 136, 56-63, (1983) Secondary Reference . !SIDSP* 

### OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) 

# Study EndPoint . BIODEGRADATION Chemical Name : Urea CAS Number : 57-13-6 

### Study type . LAB Geographic Area : FIN 

# Test Subject Organism Medium Specification BACT SOIL

SOIL 

# Test Method and Conditions Test method : Transformation times of different nitrogen formsin soil description Temperature . 2-20C 

# Exposure Exposure Period . 1-4 d "

tRPTCData Profile

### p. 51

50 Biodegradation 

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

# References Primary Reference : BUARE' Bua. BUA Report on Chemicals of Environmental Relevance, 76 

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

# Study EndPoint Chemical Name CAS Number Study type Geographic Area 

# Test Subject BIODEGRADATION Urea 57-13-6 LAB FIN Organism Medium Specification BACT AQ SEW Specieslstrainlsystem : Psychrophilic bacteria 

# Test Method and Conditions Temperature . 20 C Relative Humidity : 2 %

IRPTCData Profile

### p. 52 Biodegradation 51 

# Test Results uantit Time Comments on result 11 .6 mglL 1 h Maximumdegradation rate per hour at 20C 10.9 mg/L 1 h Average degradation rate per hour at 20C 4 .0 mglL 1 h Maximumdegradation rate per hour at 2C 3.2 mglL 1 h Average degradation rate per hour at 2C 

# References Primary Reference . HBEDC* Verschueren, K

. Handbook of Environmental Data on Organic Chemicals, 2nd. ed., (1983) 

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

# Study EndPoint . BIODEGRADATION Chemical Name : Urea CAS Number . 57-13-6 Study type . LAB Geographic Area . FIN 

# Test Subject OrganismMedium Specification BACT SOIL

AQ 

# Exposure "

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

# Test Results uantit Time Comments on result 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 + HC03- 2) NH4+ + 1 .5 02 Nitrosomonas -> N02- + H20 + 2H+ -_-> N02- + 0.5 02 Nitrobacter -> N03-

IRPTCData Profile52 Biodegrada6on



# References Primary Reference : AHCBAU Gunkel, K. et al . Acta Hydrochimica et Hydrobiologica, 18(1), 3-20, (1990) 

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

IRPTCData ProfileHydrolysis 53



# Study EndPoint . HYDROLYSIS Chemical Name . Urea CAS Number : 57-13-6 GeographicArea : FIN 

# Test Method and Conditions "

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

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

. 

# References Primary Reference . #URNWE* 

### National Board of Waters andthe Environment Unpublished Report, (1994) SecondaryReference . !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data Profile

### p. 55

54 Sorption 

# Study End Point : SORPTION Chemical Name : Urea CAS Number : 57-13-6 Study type . LAB Medium : - SILT LOAM Specifications : - SOIL SOIL Geographic Area . FIN 

# Test Results uantit Time Comments on result

General Comments 

# References "

Urea is relatively leachable fromthe 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 loamflooded soil column ranged from0.037 (50 mg N/L) to 0.064 (1000 mg N/L) depending on the concentration of urea water. 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 . 

### Primary Reference : SSSJD4 Hongprayoon, C

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

IRPTCData Profile

### p. 56 Evaporation 55 

# Study EndPoint . EVAPORATION Chemical Name : Urea CAS Number . 57-13-6 Study type : LAB Medium . A4 Specifications : FRESH Geographic Area : Fix 

# Test Results General Comments 

# References SecondaryReference "

Urea is essentially non-volatile in solid form . Its high solubility and low vapour pressure and consequently lowHenry's law constant (4

.4E-8 atm m3lmol) indicate that urea itself will not evaporate fromwater to atmosphere.

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

IRPTCData Profile

### p. 57

56 Ecosystems 

# Study EndPoint Chemical Name CAS Number GeographicArea 

# Test Subject ECOSYSTEMS Urea 57-13-6 FIN Species/strain/system . Soil properties after long-termfertilization with urea Ecosystems : TERR 

# Test Substance Description of the test . Nitrogenous fertilizers substance 

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

# Exposure Exposure comments Physical properties of soil : maximumbulk density 1 .49-1 .60 mg/m3; optimumwater 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



# References 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, NH4N03 and urea-NH4N03 mixture. 

### Primary Reference : SSSJD4 Darusman, L. R. et al . Soil Science Society of America Journal, 55, 1097-00,(1991) 

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

IRPTCData Profile

### p. 58

Absorption 5' 

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

# Test Subject .

Organism Medium Specification Route Lifestaae Sex Number ex o Number controls HUMAN SKN 

# Test Results General Comments 

# References Urea penetrates rapidly into the human stratum corneum

; penetration is enhanced at higher urea concentrations and with time. However, transport to systemic circulation is slowand limited. About 5.9%of urea applied to human skin was recovered in the urine. 

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

IRPTCData Profile

### p. 59

5$ Distnbution 

# Study End Point Chemical Name CAS Number 

# Test Subject DISTRIBUTION Urea 57-13-6 Or, anism M

edium Specitication Route Lifestaae S ex Number ex osed Number controls HUMAN ORL 

# 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 0.5g/kg) doubles serum urea levels in 20 minutes and a maximumlevel of 94.6 mg/100 mL is achieved in 90 minutes (mean control 36 mg/ 100 mL) . 

# References Secondary Reference . !SIDSP' OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) 

# Study EndPoint . DISTRIBUTION Chemical Name . Urea CAS Number : 57-13-6 

# Test Subject Organism Medium Specification Route Lifestaae Sex Number ex o~d_ Number controls RAT SKN 

# Test Results General Comments 

# References Subcutaneous injection of urea to pregnant rats showed that the substance readily penetrated the placenta and raised fetal urea concentrations. 

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

IRPTC Data Profile8ioconcentration 59



# Study End Point . BIOCONCENTRATION Chemical Name : Urea CAS Number . 57-13-6 Study type : LAB GeographicArea FIN 

# Test Results General Comments 

# References Due to the lowlog Pow value urea is not likely to undergo bioaccumulation . 

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

IRPTCData Profile

### p. 61

60 Excretion 

# Study EndPoint : EXCRETION Chemical Name : Urea CAS Number . 57-13-6 Geographic Area : FIN 

# Test Results General Comments



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

IRPTCData ProfileMammalian Acute Toxicity 61



# Study End Point . MAMMALIANACUTE TOXICITY Chemical Name . Urea CAS Number : 57-13-6 Species/strain/system : Strain not mentioned Frequency : 1 x Dose / Concentration : 14300-15000 mg/kg BW 

# Test Method and Conditions Test method : GLP : no description 

# Test Results Organism Medium Spec" Route Lifestage Sex Effect Effect Comments RAT ORL M LD50 Oral LD50for 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 . 

# References Primary Reference . OYYAA2 Sato, N. et al . Oyo Yakuri (Pharmacometrics), 13, 749-772, (1978) 

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

# Study End Point : MAMMALIANACUTE TOXICITY Chemical Name : Urea CAS Number : 57-13-6 Frequency . 1 x Dose / Concentration . 8200-9400 mg/kg BW 

# Test Method and Conditions Test method . GLP : no description 

# Test Results Or anismMedium Spec. Route Lifestaae Sex Effect Effect Comme nts "

RAT SCU M LD50 Subcutaneous LD50 for male and F female rats was established as 9400

mg/kg and 8200 mg/kg body weight, respectively. IRPTCData Profile

### p. 63

62 Mammalian Acute Toxicity 

# References Primary Reference . OYYAA2 Sato, N. et al . Oyo Yakuri (Pharmacometrics), 13, 749-772, (1978) 

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

# Study EndPoint . MAMMALIANACUTE TOXICITY Chemical Name : Urea CAS Number . 57-13-6 Species/strain/system . Strain not mentioned Frequency : 1 x Dose / Concentration . 11500-13000 mg/kg BW 

# Test Method and Conditions Test method : GLP : no description 

# Test Results Oroanism Medium Spec. Route if st e ex Effect Effect Comments MOUSE ORL M LD50 Oral LD50for male and female mice p was established as 11500 mg/kg and

13000 mg/kg, respectively. Genera! Comments . The general symptoms consisted mainly of sedation, loss of righting reflex and staggening gait . 

# References Primary Reference . OYYAAZ Sato, N. et al . OyoYakuri (Pharmacometrics), 13, 749-772, (1978) 

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

# Study End Point : MAMMALIANACUTE TOXICITY Chemical Name . Urea CAS Number . 57-13-6 Frequency : 1 x Dose / Concentration . 9200-10700 mg/kg BW "

IRPTCData ProfileMammalian Acute Toxicity 63



# Test Method and Conditions Test method . GLP : no description 

# Test Results OrganismMedium Spec. Route Lifestaoe Sex Effect Effect Comments MOUSE SCU M LD50 Subcutaneous LD50 for male and F female mice was established as 9200

mg/kg and 10700 mg/kg body weight, respectively. 

# References Primary Reference . OYYAA2 Sato, N. et al . Oyo Yakuri 

### Secondary Reference 

# Study End Point : MAMMALIANACUTE TOXICITY Chemical Name : Urea CAS Number : 57-13-6 Species/straln/system : Cow Dose / Concentration . 510mg/kg BW 

# Test Method and Conditions Test method . GLP: no description 

# Test Results Organism Med

ium Spec. Route Lifestaoe S ex Effect Effect Com ments "

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

# References Primary Reference . D8REP4 FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) 

### SecondaryReference . !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) (Pharmacometrics), 13, 749-772, (1978) !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTCData Profile64 Mammalian Acute Toxicity



# Study End Point . MAMMALIANACUTE TOXICITY Chemical Name . Urea CAS Number : 57-13-6 Dose / Concentration : 510 mglkg BW 

# Test Method and Conditions Test method : GLP : no description 

# Test Results Or_qanismMed

ium S p ec . Route Lifestaae Sex Effec t Effect Comments SHEEP ORL LD50 Oral LD50for sheepwas established as 510 mg/kg body weight . 

# References Primary Reference : D8REP4 FDA (US-Food and Drug Admin .) . Health Hazard Evaluation Determination Report, PB-288673, (1978) 

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

# Study EndPoint : MAMMALIANACUTE TOXICITY Chemical Name . Urea CAS Number : 57-13-6 Species/strain/system : Cow Dose / Concentration . 600-1080 mg/kg BW 

# Test Method and Conditions Test method . GLP : no description 

# Test Results OrganismMedium ec. Route Lifestaoe Sex Effect Effect Comments CATTL ORL LD50 Oral LD50 for cows was established as 600 - 1080 mg/kg body weight .

1RPTCData ProfileMammalian Acute Toxicity 65



# References Primary Reference : D8REP4 FDA (US-Food and Drug Admin.) . Health Hazard Evaluation Determination Report, PB-288673, (1978) 

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

# Study End Point : MAMMALIAN ACUTE TOXICITY Chemical Name : Urea CAS Number : 57-13-6 Frequency . 1 x Dose / Concentration : 5300-5400 mg/kg BW 

# Test Method and Conditions Test method : GLP : no description 

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

RAT IVN M LD50 Intravenous LD50for male and female F rats was established as 5400 mg/kg and



### 5300 mg/kg body weight, respectively. 

# References Primary Reference : OYYAA2 Sato, N. et al . Oyo Yakuri (Pharmacometrics), 13, 749-772, (1978) Secondary Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) 

# Study EndPoint . MAMMALIANACUTE TOXICITY Chemical Name . Urea CAS Number . 57-13-6 Frequency . 1 x Dose / Concentration : 4600-5200 mg/kg BW 

# Test Method and Conditions Test method : GLP: no description "

lRPTCData Profile66 Mammalian Acute Toxicity



# Test Results r anismMedium SDec. Route Lif e Sex Effect Effect Comments MOUSE IVN M LD50 Intravenous LD50 for male and female mice was established as 4600 mg/kg and 5200 mg/kg body weight, respectively. 

# References Primary Reference : OYYAA2 Sato, N. et al . Oyo Yakuri (Pharmacometrics), 13, 749-772, (1978) 

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

# Study End Point . MAMMALIANACUTE TOXICITY Chemical Name . Urea CAS Number : 57-13-6 Dose /Concentration : 10000mg/kg BW 

# Test Method and Conditions Test method : GLP : no description 

# Test Results Organism Med

ium Spec. Route Lifestaoe S ex Effect Effect Comments DOG IVN LD50 Intravenous LD50for dogs was established as > 10000 mg/kg body weight . 

# References Primary Reference . D8REP4 FDA (US-Food and Drug Admin.) . Health Hazard Evaluation Determination Report, PB-288673, (1978) 

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

IRPTCData Profile

### p. 68

Mammalian Toxicity 67 

# Study End Point : MAMMALIAN TOXICITY Chemical Name . Urea CAS Number . 57-13-6 

# Test Subject "

Organism M

edium Specification Route Lifestaae Sex Number ex osed Number controls MAMM 

### Species/strain/system : Ruminants 

# Test Method and Conditions Test method : GLP : no description 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 Primary Reference : GASTR* Veterinary Gastrointestinal Toxicology, 489-490, (1986) 

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

IRPTC Data Profile68 Mammalian Toxicity



# Study End Point . MAMMALIANTOXICITY Chemical Name . Urea CAS Number : 57-13-6 

# Test Subject Organism M

ed i um S12ecification Route Lifestaae S ex Number exposed Number controls CATTL ORL 

### Species/strain/system . Cow 

# Test Method and Conditions Test method : GLP : no description 

# Exposure Dose / Concentration . 116 mglkg BW 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed- Controls --------- ----------- ------- ---------------- ------------- --------------

LDLO Oral LDLOfor cows was established as 116 mg/kg body weight. 

# References Primary Reference . D8REP4 FDA (US-Food and Drug Admin.) . Health Hazard Evaluation Determination Report, PB-288673, (1978) Secondary Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) 

# Study End Point : MAMMALIAN TOXICITY Chemical Name : Urea CAS Number : 57-13-6 

# Test Subject Organism M

edium S, .gecification Route Lifestage S ex Number epx o

sed Number controls DOG SCU 

# Test Method and Conditions Test method . GLP : no description 

# Exposure Dose / Concentration . 3000-9000 mglkg BW IRPTCData Profile

### p. 70

Mammalian Toxicity 69 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed- Controls -------- ---------- ----------- ------

LDLO Subcutaneous LDLOfor dogs was established at a dose level of 3000-9000 mg/kg body weight . 

# References Primary Reference : D8REP4 FDA (US-Food and Drug Admin.) . Health Hazard Evaluation Determination Report, PB-288673, (1978) 

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

# Study EndPoint . MAMMALIAN TOXICITY Chemical Name . Urea CAS Number : 57-13-6 Study type . LAB 

# Test Subject "



### Or, anism Medium Specification Route Lifestage S ex Number Mosed Number controls DOG SCU 12 Species/strain/system : Strain not specified 

# Test Method and Conditions Test method . GLP: unknown description 

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

IRPTCData Profile

### p. 71

70 Mammalian Toxicity 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls --------- ---------- ---------------- -------------------------- PLSNA BIOCH Plasma urea levels were 200 to 700 mg/100 mL

BsHAv Mild drowsiness URINE INCR Increased diuresis

NEF Treatment did not affect hematocrit, platelet counts nor EEg . 

# References Primary Reference : D8REP4 FDA (US-Food and Drug Admin.) . Health Hazard Evaluation Determination Report, PB288673, (1978) 

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

# Study End Point : MAMMALIAN TOXICITY Chemical Name . Urea CAS Number : 57-13-6 

# Test Subject Oraanism Medium Snecification Route Lifestage Sex Number eDx o sed Number controls DOG IVN 

# Test Method and Conditions Test method : GLP : no description 

# Exposure Dose / Concentration . 3000 mglkg BW 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls --------- ----------- ------- --------- -------- -----

- LDLO Intravenous LDLOfor dogs was 3000 mg/kg body weight .

IRPTCData Profile

### p. 72

Mammalian Toxicity 7 

# References Primary Reference : D8REP4 FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) SecondaryReference . lSIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) 

# Study End Point . MAMMALIAN TOXICITY Chemical Name : Urea CAS Number . 57-13-6 

# Test Subject "

Organism Medium Specification R oute Lifestaoe S ex Number ex on sed Number controls GPIG IVN 

### Species/strain/system : Guinea pig 

# Test Method ond Conditions Test method . GLP : no description 

# Exposure Dose / Concentration . 4800 mg/kg BW 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls 

# --------- ----------- ------- ---------------

LDLO 

### Intravenous LDLOforguinea pigs was established as 4800 mg/kg bodyweight. 

# References Primary Reference : D8REP4 FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination Report, PB-288673, (1978) 

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

tRPTCData Profile

### p. 73

72 Mammalian Toxicity 

# Study End Point : MAMMALIANTOXICITY Chemical Name . Urea CAS Number : 57-13-6 

# Test Subject "

Organism Medium Specification Route Lifestaae Sex Number ex o R sed Number controls HORSE ORL 

### Species/strain/system : Pony 

# Test Method and Conditions Test method : GLP : no description 

# Exposure Dose / Concentration . 3310-3610 mg/kg BW 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls --------- -------

-- ------- ------ ---------------------- LDLO Oral LDLOfor pony was established at dose level of 3310- 3610 mg/kg body weight . 

# References Primary Reference . D8REP4 FDA (US-Food and Drug Admin.) . Health Hazard Evaluation Determination Report, PB-288673, (1978) 

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

# Study End Point : MAMMALIAN TOXICITY Chemical Name : Urea CAS Number : 57-13-6 

# Test Subject Oraanism Medium Specification Route Lifestage Sex Number"osed Number controls HUMAN SKN 

# 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.

IRPTCData Profile

### p. 74



# Test Results Mammalian Toxicity 73 

### Affected in Organ Effect Rev . OnSet Sex Exposed - Controls 

### ------- ---------------- ------ --------------- SRIN NBF No long-termside 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. 

# References Primary Reference : HAUTAW Stuttgen, G

. Hautarzt, Supp! . 11, 9-12, (1992) 

### Secondary Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1995) 

# Study End Point . MAMMALIAN TOXICITY Chemical Name . Urea CAS Number . 57-13-6 

# Test Subject "

Organism Medium Specification Route Lifestaae Sex Number exposed Number controls PIG ORL JUV 

### Species/strain/system : Young pigs 

# Test Method and Conditions Test method : GLP : no description 

# Exposure Dose/Concentration : 16000mg/kg BW 

# Test Results Organ Effect Rev . OnSet Sex Exposed - Controls --------- ------ - - ----- LDLO Oral LDLOfor pigs was established as >16000 mg/kg body weight . General Comments . Ten %(m/m) urea in pig food over a period of 5days was without apparent deleterious effects. 

# References Primary Reference . JAVTAP Button, J . P. et al . Journal of the South African Veterinary Association, 53(1), 67-68,(1982) 

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

### Affected in

IRPTCData Profile

### p. 75

74 Mammalian Toxicity 

# Study End Point Chemical Name CAS Number Study type 

# Test Subject MAMMALIANTOXICITY Urea 57-13-6 LAB Organism Medium Specification Route Lifestaae Sex Number ex o~ Number controls RAT SKN 

### Species/strain/system . Wistar rats 

# Test Method and Conditions Test method : GLP: unknown 

### description 

# Exposure Exposure Type : SHORT Exposure Period . 4wk Exposure comments : Urea in 10%, 20%or 40%ointment was applied to the back skin (20 cm2 

# Test Results area) for 4 weeks. 

### Affected in Organ Effect Rev . OnSet Sex Exposed- Controls NSF 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. 

# References Primary Reference : OYYAA2 Sato, N. et al . OyoYakuri (Pharmacometrics), 13, 749-772, (1977) Secondary Reference . !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTC Data Profile

### p. 76

Mammalian Toxicity 75 

# Study End Point Chemical Name CAS Number Study type 

# Test Subject MAMMALIANTOXICITY Urea 57-13-6 LAB .

Oroanism Medi um Specification Route if t Sex Number ex osed _Number controls RAT ORL Species/strain/system . Strain not specified 

# Test Substance Description of the test : Purity not known substance 

# Test Method and Conditions Test method : GLP : unknown description 

# Exposure Exposure Type . LONG Exposure Period . 190d Dose / Concentration : 20000-250000 mg/kg DIET Exposure comments : Rats were fed a diet containing 20000-250000 ppmurea for 190 days (about 

# Test Results 2000-25000 mg/kg/day) . 

### Affected in Organ Effect Rev . OnSet Sex Exposed - Controls --------- ---------- ------ ------ --- - - ----- DEATH 250000 ppmand 20000 ppm were lethal in 12 days and 20-76 days, respectively. BW DBCR

BBHAV There was weight loss and suppression of sexual function at lower doses. 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 Primary Reference . D8REP4 FDA (US-Food and Drug Admin.) . Health Hazard Evaluation Determination Report, PB-288673, (1978) 

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

IRPTCData Profile

### p. 77

76 Mammalian Toxicity 

# Study End Point : MAMMALIANTOXICITY Chemical Name : Urea CAS Number : 57-13-6 Study type : LAB 

# Test Subject Or, ag' nism Medium Specification R oute Lifestaae Sex Number ex o

~ sed Number controls RAT SKN 

### Species/strain/system . Wistar rats 

# Test Method and Conditions Test method . GLP : unknown description 

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

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls ------ - - ---

------- ------------ ----- -

---------------- NSF There were no consistent treatment-related effects on standard heamatologica! parameters, clinical chemistry or different organs. 

# References Primary Reference : OYYAA2 Sato, N. et a! . Oyo Yakuri (Pharmacometrics), 13, 749-772, (1977) 

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

# Study EndPoint : MAMMALIANTOXICITY Chemical Name : Urea CAS Number . 57-13-6 

# Test Subject .

Or anism M

edi um SQecification Route Lifestage Sex Number"osed Number controls RBT ORL Species/strain/system . Rabbit IRPTC Data Prorile

### p. 78



# Test Method and Conditions Test method : GLP : no description 

# Exposure Dose / Concentration : 5000mg/kg BW 

# Test Results Mammalian Toxicity

Affected in Organ Effect Rev . OnSet Sex Exposed- Controls --------- ---------- ---------- ----- - LDLO 

### Oral LDLOfor rabbits wasestablished as 5000 mg/kg body weight . 

# References Primary Reference : D8REP4 FDA (US-Food and Drug Admin .) . Health Hazard Evaluation Determination Report, PB-288673, (1978) 

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

# Study EndPoint : MAMMALIANTOXICITY Chemical Name . Urea CAS Number . 57-13-6 

# Test Subject "

Oraanism Medi um Specification Route Lifestaae Sex Number exposed Number controls RBT SCU 

### Species/strain/system . Rabbit 

# Test Method and Conditions Test method : GLP : no description 

# Exposure Dose / Concentration : 3000-9000 mg/kg BW 

# Test Results Organ Effect Rev . OnSet Sex Exposed- Controls --------- ---------- ------- ------- ------ --- --------- -------- LDLO Subcutaneous LDLOfor rabbits was established at dose level of 3000-9000 mg/kg body weight . 

### Affected in

IRPTCData Profile

### p. 79

T$ Mammalian Toxicity 

# References Primary Reference . D8REP4 FDA (US-Food and Drug Admin.) . Health Hazard Evaluation Determination Report, PB-288673, (1978) 

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

# Study End Point : MAMMALIAN TOXICITY Chemical Name : Urea CAS Number : 57-13-6 

# Test Subject 

# /

Organism Medium Specitrcation Route Lifes Sex Number exposed Number controls RBT IVN 

### Species/strain/system . Rabbit 

# Test Method and Conditions Test method . GLP : no description 

# Exposure Dose / Concentration . 7320 mg/kg BW 

# Test Results Organ Effect Rev . OnSet Sex Exposed - Controls --------- ----------- -----------------

LDLO Intravenous LDLOfor rabbits was established as 7320 mg/kg body weight. 

# References Primary Reference : D8REP4 FDA (US-Food and Drug Admin.) . Health Hazard Evaluation Determination Report, PB-288673, (1978) Secondary Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) 

### Affected in

1RPTCData Profile

### p. 80

Mammalian Toxicity 79 

# Study End Point : MAMMALIANTOXICITY Chemical Name . Urea CAS Number . 57-13-6 

# Test Subject "

r anism Medium Speciftcation Route Lifes a e ex Number"osed Number controls RBT IVN 

### Species/strain/system : Rabbit 

# Test Method and Conditions Test method : GLP : no description 

# Exposure Dose /Concentration . 6310 mg/kg BW 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls --------- ----------- ------- --- -- ---------- - ------ -

--------- ------ --------- LDLO Intravenous LDLOfor rabbits was established as 6310 mg/kg body weight . 

# References Primary Reference . D8REP4 FDA (US-Food and Drug Admin.) . Health Hazard Evaluation Determination Report, PB-288673, (1978) 

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

# Study EndPoint : MAMMALIANTOXICITY Chemical Name : Urea CAS Number . 57-13-6 

# Test Subject "

r nism Medium SDecification Route Lifestaae Sex Number ex oD sed Number controls SHEEP ORL 

# Test Method and Conditions Test method : GLP : no description 

# Exposure Dose / Concentration . 160 mg/kg BW IRPTCData Profile$o Mammalian Toxicity



# Test Results Affected in 

### Organ Effect Rev. OnSet Sex Exposed - Controls --------- -------

-- ------- -------------- LDLO Oral LDLOfor sheep was established as 160 mg/kg body weight . 

# References Primary Reference : D8REP4 FDA (US-Food and Drug Admin.) . Health Hazard Evaluation Determination Report, PB-288673, (1978) 

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

IRPTCData Profile

### p. 82

Carcinogenicity 81 

# Study End Point : CARCINOGENICITY Chemical Name : Urea CAS Number . 57-13-6 Study type : LAB 

# Test Subject "

OrganismMedium SAeciftcation Route Lifestage Sex Number ex osed Number controls MOUSE ORL M F 

### Species/strain/system : CB7B1/6 mice 

# Test Method and Conditions Test method : Chronic toxicity and carcinogenicity screening study over 12 months; GLP : no 

### description 

# Exposure data 

### Exposure Type : LONG Dose / Concentration . 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. 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls 

# --------- -------

--- ------- NSF No carcinogenic effects were found. General Comments : OECD/SIDS Comment : 5 animals per sex fromall 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 followup 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 histologica!ly studied. 

# References Primary Reference : JEPTDCd Fleischman, R. W

. et al . Journal of Environmental Pathology and Toxicology, 3(5/6), 149-170, (1980) 

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

IRPTCData Profile

### p. 83

82 Carcinogenicity 

# Study End Point Chemical Name CAS Number Study type 

# Test Subject CARCINOGENICITY Urea 57-13-6 LAB "

Or ac~nism Medium Specification Route Lifestaoe Sex, Number exposed Number controls RAT ORL M F 

### Species/strain/system : Fischer 344rats 

# Test Method and Conditions Test method : Chronic toxicity and carcinogenicity screeningstudy over 12 months; GLP : no description 

# Exposure data Exposure Type . LONG Exposure Period . 12 mo Dose / Concentration : 4.5-45 glkg DIET Exposure comments : Rats were fed a diet containing 0.45%, 0.9%or 4.5%of urea over 12 months. 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed- Controls --------- -------

--- ----------- NSF Not carcinogenic General Comments : OECD/SIDS Comment : 5 animals per sex fromall 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 followup 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 Primary Reference : JEPTDQ Fleischman, R

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

IRPTCData Profile

### p. 84

Mutagenicity 83 

# Study End Point : MUTAGENICITY Chemical Name : Urea CAS Number . 57-13-6 Study type : LAB 

# Test Subject "

Organism Medium Specification Route Lifesta,ae Sex Number exposed Number controls BACT VTR Species/strain/system : Salmonella typhimuriumTA98, TA100, TA1537 

# Test Substance Description of the test : Purity unknown substance 

# Test Method and Conditions Test method : Bacterial test, Ames test ; GLP: no data description 

# Exposure Exposure comments . Test performed with and without metabolic activation. 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed- Controls --------- ----------- ----------

N8F Negative results with and without metabolic activation 

# References Primary Reference . GMCRDC Ishidate, M

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

IRPTCData Profile

### p. 85

84 Mutagenicity 

# Study End Point . MUTAGENICITY Chemical Name : Urea CAS Number : 57-13-6 Study type : LAB 

# Test Subject "



### r anism Medium Specification Route Lifestaae Sex Number exposed Number controls BACT VTR Species/strain/system . Salmonella typhimuriumTA98, TAI 00, TA1535, TAI 537, TA1538 Escherichia coli WP2uvrA 

# Test Substance Purity Grade : 99% Vehicle - Solvent : Water 

# Test Method and Conditions Test method . Bacterial test (Ames test) ; GLP: not known 

### description 

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

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls NEF Negative results with and without metabolic activation at a dose range of 5-5000 uglplate. 

# References Primary Reference : SAIGBL Shimizu, H

. et al . JapaneseJournal of Industrial Health, 27, 400-419, (1985) 

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

IRPTCData Profile

### p. 86 Mutagenicity 85 

# Study End Point Chemical Name CAS Number Study type 

# Test Subject MUTAGENICITY Urea 57-13-6 LAB .

Or ag nism Medium SDeciftcation Route Lifestaae Sex Number exposed Number controls BACT VTR Species/strain/system : Salmonella typhimuriumTA98, TA100, TA1535, TA1537 

# Test Substance Purity Grade : 99% Vehicle -Solvent : DMSO 

# Test Method and Conditions Test method : Bacterial test (Ames test); GLP: not known description 

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

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls 

### --------- --------- ------ ----------------- ------ ------------------------

NEF Negative results at a dose range of 100-10000 uglplate with and without metabolic activation.

CELL Minimumconcentration at which toxicity to bacteria was observed: 100-10000 ug/plate depending on strain. 

# References Primary Reference : ENMUDM Mortelmans, K. et al . Environmental Mutagenesis, 8 Suppl . 7, 1-119, (1986) 

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

IRPTCData Profile

### p. 87

86 Mutagenicity 

# Study End Point : MUTAGENICITY Chemical Name . Urea CAS Number . 57-13-6 Study type : LAB 

# Test Subject "

Oraanism Medium Specification Route Lifestaqe_ Sex Number ex osed Number controls HAMST VTR Species/strain/system . Chinese hamster fibroblast (CHL) 

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

# Test Method and Conditions Test method . Chromosomal aberration test ; GLP: not known description 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls ------- - ---------- ---- -- -------------------- CHROM STRIIC Positive results without metabolic activation at 266 mmolar . Aberrations in 37%of metaphases at 24 hours (chromosomal gaps, chromatid or chromosomal breaks, trans!ocations, fragmentation) .

NSF Negative result with metabolic activation General Comments : OECD/SIDS Comment: The maximally effective concentration was 266 mmolar, a very high concentration suggesting a low clastogenic potential . 

# References Primary Reference : MUREAV Ishidate, M

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

IRPTC Data Profile

### p. 88 Mutagenicity 87 

# Study End Point . MUTAGENICITY Chemical Name : Urea CAS Number : 57-13-6 Study type : LAB 

# Test Subject "

r ani mM

edium S,ceciftcation Route Lifestaae Sex Number exposed Number controls HAMST VTR Species/strain/system : Chinese hamster fibrob!ast (CHL) 

# Test Method and Conditions Test method : Chromosomal aberration test ; GLP: not known description 

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

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls -------- ----------- ---- - ------------- ----- --- CHROM STRIIC Positive results without metabolic activation. Chromosomal aberrations were detected in 20%of metaphases at 216 mmolar concentration. 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 Primary Reference : GMCRDC Ishidate, M

. et al . GANN Monograph on Cancer Research, 27, 95-108, (1981) 

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

# Study End Point : MUTAGENICITY Chemical Name : Urea CAS Number . 57-13-6 Studytype . LAB 

# Test Subject "

Organism Medium Specification Route Lifestaae Sex Number exposed Number controls MOUSE VTR Species/strain/system : Mouse lymphoma heterozygous L5178Y TK+/- IRPTCData Prorile

### p. 89

88 Mutagenicity 

# Test Substance Purity Grade : AG 

# Test Method and Conditions Test method : Mouse Lymphoma TK Locus Assay; GLP: no data description 

# Exposure Dose / Concentration : 7.9-38 gIL Exposure comments : Concentrations of 132 - 662 mmo!ar of urea were used with and without metabolic activation. 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls NBF Negative result with metabolic activation GENE NUT

N8F 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 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 Primary Reference : MUTAEX Wangenhaim, J . and Bolcsfoldi, G. Mutagenesis, 3, 193-205, (1988) 

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

# Study End Point : MUTAGENICITY Chemical Name . Urea CAS Number . 57-13-6 Study type : LAB 

# Test Subject "

r nism Medium SAecification Route L'fes e Sex Number exposed Number controls MOUSE VTR Species/strain/system : Mouse lymphoma L5178Y TK+/- IRPTCData Profile

### p. 90

Mutagenicity as 

# Test Substance Purity Grade . AG 

# Test Method and Conditions Test method . Analysis for DNAsinglestrand breaks by alkaline unwinding and 

### description 

# Exposure hydroxyapatite elution; GLP: no data Dose / Concentration . 20.5-43.0 gIL Exposure comments : Concentrations of 339 - 718 mmolar of urea were used . 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls --------- ---------- ------- --- ------------- DNA STRIIC 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. 

# References Primary Reference . MUREAV Garberg, P. et al . Mutation Research, 203, 155-176, (1988) 

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

# Study End Point : MUTAGENICITY Chemical Name : Urea CAS Number : 57-13-6 Study type : LAB 

# Test Subject "

Organism Medium Specifrcation Route Lifestape Sex Number exposed Number controls MOUSE ORL Species/strain/system . Swiss albino mice 

# Test Substance Description of the test : Purity unknown substance 

# Test Method and Conditions Test method : Bone marrow cytogenetic assay; GLP : no data description IRPTCData Profile

### p. 91

90 Mutagenicity 

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

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls --------- --------- - ----- ------------- ---------- -- CHROM STRIIC Bone marrowcell, metaphases exhibited chromosome breaks, acentric fragments, translocations, gaps and constrictions at a 7-fold rate compared to controls. General Comments : OECD/SIDS Comment : the interpretation of this clastogenic effect is limited by the usage of a single extremely high dose level . 

# References Primary Reference : CYTOAN Chaurasia, O

. P. and Sinha, S. P. Cytologia, 52, 877-882, (1987) 

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

# Study EndPoint Chemical Name CAS Number Study type 

# Test Subject MUTAGENICITY Urea 57-13-6 LAB Organism Medium Specification Route Lifestage Sex Number ex o~ Number controls RAT VTR 

### Species/strain/system . Rat hepatocytes 

# Test Substance Purity Grade . AG Vehicle - Solvent : Water 

# Test Method and Conditions Test method . Analysis for DNAsinglestrand breaks by alkaline elution; GLP: no data 

### description 

# Exposure Dose /Concentration : 18-180 mg/L Exposure comments . Concentrations of 0.3 - 3 mmolar were used.

IRPTCData Profile

### Mutagenicity 91



# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed- Controls Negative result 

# References NEF 

### Primary Reference : MUREAV Sina, J . F. et al . Mutation Research, 113, 357-391, (1984) 

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

lRPTCData Profile

### 92 Sensitization



# Study End Point . SENSITIZATION Chemical Name : Urea CAS Number . 57-13-6 

# Test Subject Organism Medium Specification Route Lifestaoe S ex Number exposed Number controls HUMAN SKN 

# Test Substance Vehicle - Solvent : Water 

# Test Method and Conditions Test method . GLP: unknown 

### description 

# Exposure Exposure comments : 10% water solution 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed- Controls --------- ------ -

-- ----

-- --------------- ------------------ SRN NSF No skin sensitization 

# References Primary Reference : VDVEAV Alchangian, L. V. et a! . Vestnik Dermatologii Venerologii, 9, 26-29, (1986) 

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

IRPTCData Profile

### p. 94

Irritation 93 

# Study End Point : IRRITATION Chemical Name : Urea CAS Number : 57-13-6 Study type : LAB 

# Test Subject "

Organism Medium Specification Route Lifestaae Sex Number exposed Number controls HUMAN SKN 

# Test Substance Vehicle - Solvent : Water 

# Test Method and Conditions Test method : Chamber-Scarification Test ; GLP : unknown description 

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

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls SRN IRRIT Slight irritation with 7.5%urea SRN 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. 

# References Primary Reference : 38FTAB Frosch, P

. J . et a! . Cutaneous Toxicity: Proceedings of the Conference on Cutaneous Toxicity, 127-153, (1977) 

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

IRPTC Data Profile94 Irritation



# Study End Point : IRRITATION Chemical Name : Urea CAS Number . 57-13-6 Study type . LAB 

# Test Subject

anism Medium Specification Route Lifestaae Sex Number e=sed Number controls HUMAN SKN 

# Test Substance Vehicle - Solvent : Water 

# Test Method and Conditions Test method : Not specified; GLP: unknown description 

# Exposure Exposure Type : ACUTE Dose /Concentration . 100gIL Exposure comments : 10%water solution of urea 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed- Controls 

# --------- ---------- ------ ------ --- -- ----- SKIN NE F No irritation after 24 hours 

# References Primary Reference : VDVEAV Alchangian, L. V. et al . Vestnik Dermatologii Venerologii, 9, 26-29, (1986) 

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

# Study End Point Chemical Name CAS Number Study type 

# Test Subject IRRITATION Urea 57-13-6 LAB Or,aanism Medium Specification Route Lifestage Sex Number ex osed Number controls MOUSE SKN M Species/strain/system . Nude MF1h mice IRPTCData Profile

### p. 96

Irritation 95 

# Test Substance Vehicle - Solvent : Water 

# Test Method and Conditions Test method . GLP: unknown 

### description 

# Exposure Exposure Type : ACUTE Dose / Concentration . 100-109 gIL Exposure comments : 10%solution 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed- Controls--- 

### --------- ---------- ------- ---------------- --- - ----------------------- SKIN NEF

NHF The skin of nude mice showed no irritation. 10%urea induced no discernible change in the histological appearance of the skin. 

# References Primary Reference : JPPMAB Lashmar, U. T. et al . Journal of Pharmacy & Pharmacology, 41, 118-121, 

### (1981) Secondary Reference 

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

End Point : IRRITATION Chemical Name . Urea CAS Number : 57-13-6 Study type : LAB 

# Test Subject Oraanism Medium S12ecifrcation Route Lifestage Sex Number exposed Number controls RBT SKIN! 

### Species/strain/system . Rabbit 

# Test Substance Vehicle - Solvent . Water 

# Test Method and Conditions Test method . GLP: unknown 

### description IRPTCData Profile

### p. 97

9s Irritation 

# Exposure Exposure Period . 20 h Dose /Concentration : 500gIL Exposure comments : 20 hours semiocclusive application of 50%urea water solution on the back 

# Test Results and ear skin of rabbit . 

### Organ Effect Rev . --------- ---------- ------- S1CN N$F No irritation of the skin after 24 hours 

# References Affected in OnSet Sex Exposed - Controls

Primary Reference . #URBSF* BASF AG

. BASF Unpublished Report 

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

# Study EndPoint : IRRITATION Chemical Name : Urea CAS Number : 57-13-6 Study type . LAB 

# Test Subject Organism Medium Specification Route Lifestaae Sex Number exposed Number controls RBT OCU 

### Species/strain/system . Rabbit 

# Test Method and Conditions Test method : OECD 405 ; GLP: yes description 

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

IRPTCData ProfileIrritation 97



# References Primary Reference : #URBSF" BASF AG . BASF Unpublished Report SecondaryReference . !SIDSP' OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTCData Profile

### p. 99

9$ Reproduction 

# Study EndPoint . REPRODUCTION Chemical Name : Urea CAS Number : 57-13-6 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 Secondary Reference : !SIDSP* OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994)

IRPTCData Profile

### p. 100

Teratogenicity 99 

# Study EndPoint . TERATOGENICITY Chemical Name : Urea CAS Number : 57-13-6 Studytype : LAB 

# Test Subject "

Organism M

edium Specification Route Lifestaae Sex Number e,~x o sed Number controls BIRD INJ Species/strain/system . Chick embryo 

# Test Method and Conditions Test method : GLP: no data 

### description 

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

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed- Controls -------- ----------- ------- --- --------- ----- ------ ----

--- ----- ------------- BMBRY STRIIC Among 132 embryos 78 showed neural, vascular or cardiac abnormalities. General Comments : "The results indicate that urea was teratogenic in chick embryo" . 

# References Primary Reference . D8REP4 FDA (US-Food and Drug Admin.) . Health Hazard Evaluation Determination Report, PB-288673,(1978) Secondary Reference : !SIDSP' OECD/SIDS. Screening Information Data Set (SIDS) of OECD High Production Volume Chemicals Programme, (1994) 

# Study End Point . TERATOGENICITY Chemical Name : Urea CAS Number : 57-13-6 Study type : LAB 

# Test Subject "

Organism Medium Specification Route Lifestage Sex _Number exposed Number controls BIRD INJ Species/strain/system . Chick embryo IRPTCData Profile

### p. 101

100 Teratogenicity 

# Test Substance Purity Grade : AG Vehicle - Solvent . Distilledwater 

# Test Method and Conditions Test method . GLP : no data description 

# Exposure Dose /Concentration : 200-1200 mglkg 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 . 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed- Controls ------- -------

-- ------- ------------ ----- ------------

------------ EMERY DEATH - Mortality of the embryos varied 8 .8-38.9%a, dose-dependently. The mortality in the control groupwas 6.1% . EMBRY BIOCH In the treated embryos, the plasma T3 level increased and T4 !eve! decreased . BMBRY STRIIC Electron microscopy revealed cytoplasmic oedema, mitochondrial swelling and membrane damage in thyroid cells. General Comments : The results indicate that urea was foetotoxic to the chicken. 

# References Primary Reference : AVSCA7 Mora, S. et al . Acta Veterinaria Scandinavica, Supp! . 87, 197-198, (1991) 

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

# Study EndPoint . TERATOGENICITY Chemical Name : Urea CAS Number . 57-13-6 Study type . LAB 

# Test Subject "

Or, anism Medium Specification R oute Lifestaoe S

ex Number exposed Number controls MOUSE ORL F 10 Species/strain/system . ICR mice 

# Test Method and Conditions Test method : A single oral dose study; GLP: no description 1RPTCData Profile

### p. 102

Teratogenicity 101 

# Exposure Exposure Type Exposure Period Frequency Dose / Concentration Exposure comments 

# Test Results Organ Effect

NEF ACUTE

10 TDP 1x 2000 mg/kg BW Asingle dose of 2000 mg/kg was administered orally to 10 pregnant mice on day 10 of pregnancy. 

### Affected in Rev . OnSet Sex Exposed- Controls Noeffects on foetal data (live/dead, sex, external defects, soft tissue and skeletal defects) .

NSF No maternal toxicity General Comments 

# References Primary Reference Secondary Reference : Not teratogenic . OECD/SIDS comment: "not an adequate teratogenicity study" .

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

# Study End Point Chemical Name CAS Number Study type 

# Test Subject Organism M

edium RAT 

### TERATOGENICITY Urea 57-13-6 LAB "



### Specification R

o u te Lif s Sex, Number ex oD sed Number controls ORL F 4 

### Species/strain/system : Wistar rats 

# Test Method and Conditions Test method description 

# Exposure Exposure Type Exposure Period Frequency Dose / Concentration Exposure comments A single oral dose study; GLP: no ACUTE 12 TDP 1x 2000 mg/kg BW Asingle dose of 2000 mg/kg was administered to 4 pregnant rats on day 12 of pregnancy. IRPTCData Profile

### p. 103

102 Teratogenicity 

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

NEF No maternal toxicity 

### General Comments . Notteratogenic. OECD/SIDS comment: "not an adequate teratogenicity study" . 

# References Primary Reference : TJADAB Teramoto et al . Teratology, Journal of Abnormal Development, 23, 335-342, (1981) 

### SecondaryReference 

# Study EndPoint Chemical Name CAS Number Study type 

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



### TERATOGENICITY Urea 57-13-6 LAB .

Organism Medium Speciflcation Route Lifestagg Sex Number ex o~ Number controls RAT ORL F 6 Species/strain/system : Wistar rats 

# Test Method and Conditions Test method description 

# Exposure Exposure Type Exposure Period Dose / Concentration Exposure comments 

# Test Results Within 48 hours after delivery the pups were killed and the kidneys examined ; GLP: no data SHORT 14d 50 g/kg BW/d 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. 

### Affected in Organ Effect Rev . OnSet Sex Exposed- Controls --------- --------- ------- ------ ------------ - ---------------- NEF No hypertrophy or other kidney changes were detected nor were any teratogenic effects noted. General Comments . OECD/SIDS Comment : "not a full-range teratogenicity study" . IRPTC Data Profile

### Teratogenicity 103



# References Primary Reference : ZEIUR* Seipelt, H

. et al . Zeitschrift Urologie, 62, 623-627, (1969) 

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

IRPTCData Profile

### p. 105

104 Aquatic Acute Toxicity 

# Study End Point Chemical Name CAS Number Study type Geographic Area AQUATICACUTE TOXICITY Urea 57-13-6 LAB FIN Species/strain/system : Snail (Helisoma trivolvis) 

# Test Method and Conditions Test method : Static; GLP: not known 

### description 

# Test Results Oraanism Med

ium SDec. Route Lifestaae Sex Effect Effect Comments "

MOLL AQ FRESH EGG LC50 LC50 for 24 hours for egg = 14241 JUV mg/L; LC50for 24 hours forjuveniles = 18255 mg/L; LC50for 24 hours for adults = 30060 mg/L. ADULT 

# References Primary Reference : AECTCV Tchounwou, P. B. et al . Archives of Environmental Contamination and Toxicology, 21, 359-364, (1991) 

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

# Study End Point . AQUATICACUTE TOXICITY Chemical Name . Urea CAS Number : 57-13-6 Study type : LAB GeographicArea FIN Species/strain/system . Mosquito (Aedes aegypti) larvae 

# Test Method and Conditions Test method . Static; GLP : no 

### description 

# Test Results Organism Medium Spec. Route Lifesta,oe Sex Effect Effect Comments INSEC AQ FRESH LARVA LC50 LC50for 4 hours = 60000 mg/L. "

IRPTCData Profile

### AquaticAcute Toxicity 105



# References Primary Reference . JIVPAZ Kramer, V

. C . et a! . Journal of Invertebrate Pathology, 42, 285-287, (1983) 

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

# Study End Point . AQUATICACUTE TOXICITY Chemical Name . Urea CAS Number . 57-13-6 Study type : LAB GeographicArea . FIN Species/strain/system : Barilius barna 

# Test Method and Conditions Test method : Static description 

# Test Results OroanismMedium ,Spec. Route Lifestag_e Sex Effect Effect Comments FISH AQ LC50 LC50for 96 hours > 9100 mg/L. General Comments . Urea is not acutely toxic tofish. 

# References "



### Primary Reference : HCPBE5 Dodriyal, A. K. and Bahuguna, A . K. Himalayan Chemical Pharma. Bulletin, 5, 15-16, (1988) 

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

IRPTCData Profile

### p. 107

106 Aquatic Toxicity 

# Study End Point : AQUATICTOXICITY Chemical Name . Urea CAS Number . 57-13-6 Study type : LAB GeographicArea . FIN 

# Test Subject "



### r anism Medium Specification Route Lifestaae Sex Number exnosed Number controls ALGAE AQ FRESH Species/strain/system : Green algae (Scenedesmus quadricauda) 

# Test Method and Conditions Test method . Cell multiplication inhibition test 

### description 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls --------- --------- ------ ------- --------------------- B=oarA Toxicity threshold for 192 hours > 10000 mg/L 

### General Comments . Urea is not toxicto algae. 

# References Primary Reference : VJWWAU Bringmann, G

. and Kuhn, R. Vom

Wasser, 50, 45-60, (1978) 

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

# Study End Point : AQUATIC TOXICITY Chemical Name : Urea CAS Number : 57-13-6 Study type : LAB GeographicArea : FIN 

# Test Subject "

r nism Medium Specification Route Lifestaae S ex Number exposed Number controls PROTO AQ FRESH Species/strain/system : Flagellate (Entosiphon sulcatum) IRPTCData Profile

### Aquatic Toxicity 107



# Test Method and Conditions Test method . Cell multiplication inhibition test ; static; GLP: no description 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed- Controls --------- ------ -

--- ------- ---

------------

- B=ONA Toxicity threshold for 72 hours = 29 mg/L 

### s=or4A urrs To some extent urea exhibited selective toxic action on Entosiphon sulcatum . For example toxicity threshold for chloroformwas > 6560 mg/L. General Comments : Urea exhibits to some extent toxic action to Entosiphon sulcatum . 

# References Primary Reference . WATRAG Bringmann, G. and Kuhn, R . Water Research, 14, 231-241, (1980) 

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

1RPTCData Profile

### p. 109

108 Aquatic Toxicity 

# Study End Point Chemical Name CAS Number Study type GeographicArea 

# Test Subject AQUATICTOXICITY Urea 57-13-6 LAB FIN "



### Organism Med

ium &ecification Route Lifestage S ex Number exposed Number controls ALGAE AQ FRESH Species/strain/system : Blue-green algae (Microcystis aeruginosa) 

# Test Method and Conditions Test method description 

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

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

### General Comments : Urea exhibits to some extent toxicaction to Microcystis aeruginosa. 

# References Primary Reference . VJWWAU Bringmann, G. and Kuhn, R. Vom Wasser, 50, 45-60, (1978) 

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

# Study End Point : AQUATICTOXICITY Chemical Name : Urea CAS Number . 57-13-6 Study type . LAB Geographic Area . FIN 

# Test Subject "

Organism M

edi um Specification Route Lifestaae Sex Number exposed Number controls BACT AQ MARIN Species/strain/system . Bioluminiscent bacteria (Photobacteriumluminescence) IRPTCData Profile

### p. 110

AquaticToxicity ' 

# Test Method and Conditions Test method description 

# Test Results Microtox PhotobacteriumLuminescence Test . Single species tests such as "Microtox PhotobacteriumLuminescence Test: and tests on overall processes such as nitrification or soil respiration are included in this item . GLP: no known 

### Affected in Organ Effect Rev . OnSet Sex Exposed- Controls --------- ---------- ------- ------ ------ ----- -------------------- BC50 EC50 for 5 minutes = 24000 mglL 

# References Primary Reference . ASTTAB Bulich, A. A

. et al . ASTMSpecial Technical Publication Aquatic Toxicology and Hazard Assessment, ASTM STP737, 338-347 

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

# Study End Point : AQUATICTOXICITY Chemical Name : Urea CAS Number : 57-13-6 Study type : LAB Geographic Area . FIN 

# Test Subject "

Organism Medium Specification Route Lifestage Sex Number exposed Number controls CRUS AQ FRESH Species/strain/system : Water flea (Daphnia magna) 

# Test Method and Conditions Test method . DIN 38412 Teil 11 (modified) description 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls sc50 EC50for 24 hours > 10000 mg/L. General Comments : Urea is not acutely toxic to daphnids.

IRPTCData Profile110 Aquatic Toxicity



# References Primary Reference . ZWABAQ Bringmann, G

. and Kuhn, R. Zeitschrift fuer Wasser und Abwasser Forschung, 15(l),1-6, (1982) 

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

# Study End Point . AQUATICTOXICITY Chemical Name : Urea CAS Number : 57-13-6 Study type : LAB GeographicArea . FIN 

# Test Subject r anism Medium SRecification R oute Lifestaoe ,Sex Number exposed Number controls FISH AQ FRESH Species/strain/system . Golden orfe (Leuciscus idus melanotous) 

# Test Method and Conditions Test method : Static; GLP: no 

### description 

# Exposure Exposure Type : ACUTE 

# Test Results Organ Effect Rev. OnSet

--------------- LCO 

### LCOfor 48 hours > 10000mg/L Genera! Comments . Urea is not acutely toxic to fish. 

# References Affected in Sex Exposed- Controls

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

IRPTCData Profile

### p. 112 Aquatic Toxicity 1 

# Study End Point . AQUATICTOXICITY Chemical Name : Urea CAS Number . 57-13-6 Study type : LAB Geographic Area . FIN 

# Test Subject "

Organism Medium Speciflcation Route Lifestaae Sex Number" osed Number controls FISH AQ ESTUA FRESH Species/strain/system . Tilapia (Tilapia mossambica) 

# Test Method and Conditions Test method : Test method notspecified description 

# Test Results Affected in Organ Effect Rev . OnSet Sex Exposed - Controls --------- ----------- ------------------- ------- - ------ -- ------ --------- LCO LCOfor 96 hours = 20000 mg/L. ;

LC50 LC50for 96 hours = 22500 mg/L. ;

LC100 LC100 for 96 hours = 25000 mg/L BW DECR BW SIZE BBHAV When the fish was reared in different sublethal concentrations (5, 10, 15 and 20g/L, test period 25 days) of urea, there was a decrease in feeding and growth rates. In addition to the realized energy fromfood consumption, the fish lost reserve energy at the highest concentration of 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 Primary Reference . ENECEV Palanichamy, S. et al . Environment and Ecology, 3(2), 157-161, (1985) 

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

tRPTCData Profile

### p. 113

112 Terrestrial Toxicity 

# Study EndPoint : TERRESTRIAL TOXICITY Chemical Name . Urea CAS Number . 57-13-6 Study type : LAB GeographicArea . FIN 

# Test Subject "

Organism Medium $_pecification Route Lifestage Sex Number exposed Number controls WORM TERR 

### Species/strain/system : Grassland earthworms (Oligochaeta, Lumbricidae) 

# Test Method and Conditions Test method . Effects monitored : earthwormnumbers and biomass. Fertilizer was organic description 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 . 6.2-6.7 % Content 

# Exposure Exposure comments . Sandy loamsoil . The organisms relation to soil acidification was studied. 

# Test Results Application of nitrogenous fertilizers to grassland for long period may have a deleterious effect on earthworms in the absence of liming. 

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

IRPTCData Profile

### p. 114



# Study End Point : TERRESTRIAL TOXICITY Chemical Name . Urea CAS Number : 57-13-6 Study type : LAB GeographicArea . FIN 

# Test Subject "

r anismMedium sSpecification Route Lif a e Sex Number exposed Number controls BACT TERR Species/strain/system : Soil bacteria (Pseudomonas putida) 

# Test Method and Conditions Test method description 

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

### Organ Effect Rev . OnSet Sex -------- ---

------- ---------- ------- sioriA xxsis Toxicity threshold for 16 hours > 10000 mg/L 

# References Terrestrial Toxicity 113

Affected in Exposed - Controls - ------------

Primary Reference : WATRAG Bringmann, G

. and Kuhn, R. Water Research, 14, 231-241, (1980) 

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

# Study End Point : TERRESTRIAL TOXICITY Chemical Name : Urea CAS Number : 57-13-6 Study type : LAB GeographicArea : FIN 

# Test Subject "

Or aa nism M

edium SDecification Route Lifestaae Sex Number exoosed Number controls BIRD TERR 

### Species/strain/system . Pigeon

IRPTCData Profile

### p. 115

114 Terrestrial Toxicity 

# Test Method and Conditions Test method : Test method not specified; GLP : no 

### description 

# Test Results Affected in 

### Organ Effect Rev . OnSet Sex Exposed - Controls -------------- LDLO SCII Lowest lethal dose found = 16000 mg/kg General Comments . Urea is not acutely toxic to pigeon. 

# References Primary Reference . D8REP4 FDA (US-Food and Drug Admin.) . Health Hazard Evaluation Determination Report, PB-288673, (1978) 

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

# Study End Point Chemical Name CAS Number Study type Geographic Area 

# Test Subject TERRESTRIAL TOXICITY Urea 57-13-6 LAB FIN "

Oroanism Medium Specifrcation Route Life S ex Number exposed Number controls PLANT TERR 

### Species/strain/system : Soybean (Glycine max. L.) Merr 

# Test Method and Conditions Test method : Test method not specified ; GLP: no 

### description 

# Test Results Organ Effect Rev . Onset Sex LEAP STRUC Leaf-tip necrosis observed after foliar fertilization of soybean with urea.

NOEL 

### Affected in Exposed - Controls

Maximumconcentration at which noeffect was observed within the period of the test < 0.01 wt % urea of dry weight of leaves (= 9 mg/leaf, a 7-day study) . General Comments : It was concluded in this study that necrosis resulted from accumulation of toxic amounts of urea rather than fromformation of toxic amounts of ammonia. 1RPTCData ProfileTerrestrial Toxicity 715



# References Primary Reference : PNASA6 Krogmeier, J . M

. et al . Proceedings of the National Academy of Sciences of the United States of America, 86, 8189-91, (1989) 

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

IRPTCData Profile

### p. 117

116 Recomendations/Legal mechanisms 

# Substance Chemical Name . Reported Name . Urea CAS Number : 57-13-6 Area Tvve u ie t ,gg~p . Descrl toion Level /SummaryInformation

LastAmendment : Entry/ UDdate : NOV1992 GBR REG USE PESTI RSTR Permitted for use only as a home garden fungicide on cut stumps of trees and on apple and

USE CONSM RSTR pear trees. Title : Pesticides 1992: Pesticides approved under the Control of Pesticides Regulations 1986 Reference PACPR ", 500, xlv, 1992 Effective Date : 01 MCH1991 

# Substance Chemical Name Reported Name CAS Number UREA UREA 57-13-6 Area Tvoe Subiect Sec . Description Level / Summaty Information :

Reference HPMZC', 54, 1982 Effective Date : 1JAN7983 CSK REG FOOD - PRMT COMPONENT OF RUBBER PRODUCTS PERMITTEDFORCO NTACTWITH FOODAND

GOODS MXL THE HUMAN BODY. MAXIMUM L IMIT FORTHE FINALPRODUCTS : 30MG/G. rtte : DIRECTIVE NO . 62 ON HYGIENIC REQUIREMENTS ON RUBBERSAND RUBBERGOODSCOMINGIN CONTACTWI TH FOODSTUFFS ANDHUMAN ORGANISM HYGIENICKE PREDPISY MINISTERSTVAZDRAVOTNICl1/l CSR

(HYGIENIC REGULATIONS OF MINISTRYOF HEALTH OF CSR) 

# Substance Chemical Name : UREA Reported Name : UREA CAS Number . 57-13-6 Area Type Sublect 3" .p . f2escriotion Level /Summarv 1Lifonnation : CSK REG GOODS - RSTR MAXIMUM LIMITS INCOSMETICS : 50MG/C MXL Title : DIRECTIVE NO . 34 ON HYGIENIC REQUIREMENTS ONCOSMETICS, Last Amendment : Entry/ Update : DEC1991

DETERGENTS,ANDGOODSOF PERSONAL USE 

### "

"

"

Reference HPMZC " , 32, 1970 Effective Date : 1JAN1971 HYGIENICKE PREDPISY MINISTERSTVA ZDRAVOTNICTVI CSR (HYGIENIC REGULATIONS OF MINISTRY OF HEALTH OF CSR) LastAmendment : EntN/UDdate : DEC1991

IRPTC Data Profile

### p. 118 Recomendations/Legal mechanisms 117 

# Substance Chemical Name : UREA Reported Name : UREA CAS Number : 57-13-6 Area TvDe SubJect Spec. Descri t~ Level / Summarv Information :

Reference SPPOR " , 290, 1990 Effective Date : JAN1991 CSK REG USE AGRIC PRMT SUBSTANCE IS APPROVED AS PESTICIDE

. SPECIFIC USES, LIMITATIONSANDSAFETY PRECAUTIONSARE GIVEN . Title : LIST OF PERMITTEDCHEMICALS FORPLANT PROTECT ION SEZNAMPOVOLENYCH PRIPRAVKU NA OCHRANU ROSTLIN (LIST OF PERMITTED CHEMICALS FOR PLANT PROTECTION) 

# Substance Chemical Name : UREA Reported Name : UREA CAS Number . 57-13-6 Area lym Su

.blec t &-Qc Description Level /Summary Inforrnation : astAmendment : Entry / Update DEC1991

DEU REC AQ - CLASS THIS SUBSTANCE IS CLASSIFIEDAS SLIGHTLY HAZA RDOUSTOWATER(WATER-

USE INDST RQR HAZARDCLASS: WGK1) . (THE DIFFERENT CLASSESARE: WGK3 =VERY HAZAR DOUS; WGK2 = HAZARDOUS ;WGK1 =SLIGHTLYHAZARDOUS; WGK0=IN GENERAL NOT HAZARDOUS.) TH E CLASSIFICATION FORMSTHE BASIS FORWATER-PR OTECTIONREQUIREMENTS FORINDUSTRIAL PLANTS I NWHICHWATERHAZARDOUSSUBSTANCES ARE HANDLE D . Title : ADMINISTRATIVE RULESCONCERNINGWATER-HAZARDOUS SUBSTANCES (VERWALTUNGSVORSCHRIFT WASSERGE FAEHRDENDE STOFFE)



# Substance Chemical Name . UREA Reported Name : Urea CAS Number : 57-13-6 r~ IyRe Subiect S°ec. Descrivtion Level / Summary Information : GBR REG TRNSP MARIN RQR

AQ MARIN RSTR AQ EMI RSTR Reference GMSMA6, 8, 114, 1990 Effective Date : Gemeinsames Ministerialblatt. Joint Ministerial Papers Last Amendment: Entry / Update DEC1991 

### "

"

"

CATEGORY CSUBSTANCE : DISCHARGE INTOTHE SEA IS PROHIBITED; DISCHARGE OF TANKWASHINGS AND RESIDUAL MIXTURES IS SUBJECTTORESTRICTIONS . (APPLIES TOSOLUTION WITH AMMONIUM NITRATE CONTAININGAQUAAMMONIA) . Title : THE MERCHANT SHIPPING (CONTROL OF POLLUTION BYNOXIOUS LIQUID SUBSTANCES IN BULK) REGULATI ONS 1987, SCHEDULE 1 Reference GBRSI " , 551, 15, 1987 Effective Date : O6APR1987 Statutory Instruments LastAmendment : GBRSI', 2604, 2, 1990 Entry/ Update : 1992 Statutory Instruments

IRPTCData Profile

### p. 119

118 Recomendations/Legal mechanisms 

# Substance Chemical Name Reported Name CAS Number UREA urea 57-13-6 Area Tvoe Subject ec. Descriotion Level /Summary nfQrrnation :

TWO : THE MERCHANT SHIPPING (CONTROLOF POLLUTIONBYNOXIOUS LIQUID SUBSTANCES IN BULK) REGULATI ONS 1987, SCHEDULE 1 GBR REG TRNSP MARIN RQR CATEGORY DSUBSTANCE : DISCHARGE INTOTHE SEAIS PROHIBITED ; DISCHARGE AQ MARIN RSTR OF RESIDUAL MIXTURES IS SUBJECTTORESTRICTIONS . (APPLIES TOUREA AQ EMI RSTR SOLUTION WITHAMMONIUM MONO-HYDROGEN PHOSPHATE, AMMONIUMDIHYDROGEN PHOSPHATE AND POTASS iUM CHLORIDE, APPLIES ALSOTOUREA SOLUTION W

ITHAMMONIUM

NITRATE, ANDALSOTO UREA SOLUTI ONWITH AMMONIUMPHOSPHATE) .



# Substance Chemical Name : UREA Reported Name . urea CAS Number . 57-13-6 T= Subie

c ec. Descri tp ion Level /Summary Informati on : GBR REG TRNSP MARIN RQR

AQ MARIN RQR AQ EMI RQR



# Substance Chemical Name . UREA Reported Name . UREA CAS Number . 57-13-6 Area Type Subiect Spec. Descri tvion Level /Summarv Infomiation "

KEN REG FOOD ADDIT PRMT FOODADDITIVE PERMITTEDAS YEAST FOOD . FOOD P RODUCTS IN OR UPONWHICH IT IS PERMITTEDANDM AXIMUMLEVELS OF USE ARE LISTED . Title : THE FOOD, DRUGSANDCHEMICAL SUBSTANCES (FOOD LABELLING, ADDITIVESANDSTANDARDS) REGULATI ONS, 1978 Reference GSKEN-, 40, 406, 1978 Effective Date : KENYA GAZETTE SUPPLEMENT NO . 40, SPECIAL ISSUE (LEGISLATIVE SUPPLEMENT NO . 27) Reference GBRSI', 551, 15, 1987 Effective Date : 06APR1987 Statutory Instruments LastAmendment : GBRSI`, 2604, 2, 1990 Entry/ U d~: 1992 Statutory Instruments "

"

CLASSIFIEDAS ANON-POLLUTINGLIQUIDSUBSTANC E . DOCUMENTARY EVIDENCE OF ASSESSMENT ANDAPPROVAL REQUIRED BY ACARRIER . DISCHARGE INTOT HE SEA IS NOT PROHIBITED . (APPLIES TO SOLUTIO N) . Title : THE MERCHANT SHIPPING (CONTROL OF POLLUTIONBYNOXIOUS LIQUID SUBSTANCES IN BULK) REGULATI ONS 1987, SCHEDULE 2 Reference GBRSI', 551, 15, 1987 Effective Date : O6APR1987 Statutory Instruments Last Amendment : GBRSr, 2604, 2, 1990 Entry/ Update : 1992 Statutory Instruments

LastAmendment : Entrv/ Update SEP1982

IRPTC Data Profile

### p. 120 Recomendations/Legal mechanisms 

# Substance Chemical Name : UREA Reported Name : UREA CAS Number . 57-13-6 Area Type SukieE Spec. Des=tion Level / Summ a/v Information : RUS REG AIR AMBI MAC 0.2 MG/M3 AV/D. Title : 119

"

Reference Effective Date : AUG1984 Last Amendment : PDKAV', 3086-84,1984 Entry/ Update SEP1985 PREDELNO DOPUSTIMYE KONTSENTRATSII (PDK) ZAGRYAZNYAYUSHCHIKHVESHCHESTV VATMOSFERNOM VOZDUKHE NASELENNYKH MEST (MAXIMUM

ALLOWABLE CONCENTRATIONS (MAC) OF CONTAMINANTS IN THEAMBIENT AIR OF RESIDENTIAL AREAS) 

# Substance Chemical Name . UREA Reported Name : UREA CAS Number . 57-13-6 Area 1'yqg SuqJect Spec. Descri tion Level /Summary Information : RUS REG AO SURF MAC SURFACE WATERFORFISHING : 80 .0 MG/L Title : Reference Effective Date : LastAmendment : PDKTV-, 1978 Entrv/ Update : "

SEP1985 PREDELNO-DOPUSTIMYE KONTSENTRATSII I ORIENTIROVOCHNYE BEZOPASNYEUROVNI VOZDEISTVIA VREDNYKHVESHCHESTV V OBIEKTAKHVNESHNE1 SREDY. NORMATIVNYE MATERIALY. (MAXIMUM

ALLOWABLE CONCENTRATIONS AND PRELIMINARY SAFETY LEVELSOF TOXIC SUBSTANCES IN ENVIRONMENT. STANDARDS.) 

# Substance Chemical Name : UREA Reported Name : UREA CAS Number : 57-13-6 Area Tvne Subject S . DBE Descriotion Level /Summary Information : RUS REG AIR OCC MAC CLV : lOMG/M3 (AEROSOL) HAZARDCLASS: II CLASS T)tfe : "

Reference Effective Date : 01JAN1989 LastAmendment : GOSTS-, 12.1 .005, 1988 Entry/ Update MAY1990 GOSUDARSTVENNYI STANDART SSSR (STATE STANDARD OF USSR)

IRPTCData Profile

### p. 121

120 Recomendations/Legal mechanisms 

# Substance Chemical Name : UREA Reported Name : UREA CAS Number . 57-13-6 Area Tvve Subject Spec . Descri tion Level /Summary Information :

LastAmendment : GOSTS-, 12 .1 .005, 1988 Entry / Update MAY1990 RUS REG AIR OCC MAC CLV : 25MG/M3 (VAPOUR, AEROSOLAPPLIESTO FERTILIZER MD(T. WITHAMMONIA) ; CLASS HpZ, CLASS: IV

Title : Reference Effective Date : 1JAN

7989 GOSUDARSTVENNYI STANDART SSSR (STATE STANDARD OF USSR) 

# Substance Chemical Name Reported Name CAS Number UREA 57-13-6 "

"

Area Iype- Subi~ct SPec. Descri tv ion Level / Summary Information USA REG CLASS PEST[ RQR

MANUF PESTI PRMT FOOD ADDR RQR



# Substance Chemical Name Reported Name CAS Number CASE NAME UREA; Summary - THIS SUBSTANCE IS I NCLUDEDONALIST OF ACTIVE INGREDIENTS CONTA INEDINAPRODUCT FIRST REGISTERED BEFORE NOVEMBER 1, 1984, FORWHICHA REGISTRATIONSTANDARDHAS NOT BEEN ISSUED. PUBLICATION OFTHIS LISTINITIATESANACCELERATED REREGISTRATIONAND DATA CALL-IN FORPRODUCTS CONTAININGTHE LISTEDACTIVE INGREDIENTS. Title : FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICI DE ACT PESTICIDES

REQUIREDTO BE REREGISTERED; LIST D Reference FEREAC, 54, 204, 43388, 1989 Effective Date , 1989 Federal Register LastAmendment : FEREAC, 54, 204, 43388, 1989 Enfty / Update JAN1992 Federal Register

UREA UREA 57-13-6 "

Area jyPg 'ect &~- Descrfotion Level /Summary Information : EEC REG FEED - PRMT TECHNICALLY PURE UREA MAYBE MARKETEDAS FEED INGSTUFF UNDERTHE CONDITIONS LAID DOWN. Title : COUNCIL DIRECTIVE OF 30JUNE 1982 CONCERNING CERTAIN PRODUCTS

USED INANIMAL NUTRITION (82 /471/EEC) . Reference OJEC°, L213, 8, 1982 ENective Date : 01JUL1988 Official Journal of the European (Communities)/Union LastAmendment : OJEC"-, L239, 36, 1988 Entrv/ Update SEP1987 Official Journal of the European (Communities)/Union

1RPTCData ProfileRecomendations/Legal mechanisms 121



# Substance Chemical Name : UREA Reported Name : UREA CAS Number . 57-13-6 Area Type Subiect 3ggq. QescriDtion Level /SummarJl Information: "

EEC REG FOOD - ROR THE SUBSTANCE MAY BE USED FORTHE MANUFACTURE OF REGENERATED

FOOD MXL CELLULOSE FILM WHICH IS INTEN DEDTOOR DOES COME INTOCONTACT WITH FOOD RSTR FOODSTU FFS. IT MAY BE USEDAS SOFTENER; MAXIMUM CONT ENT OF SOFTENERS IN TOTAL: 27%

. Title : COUNCIL DIRECTIVE OF 25 APRIL 1983 ONTHEAPPROXIMATION OF THE LAWS OFTHE MEMBERSTATES RELATINGTOMATERIALSAND ARTICLES MADE OF REGENERATEDCELLULOSE FILM INTENDEDTOCOME INTO CONTACTWITH FOODSTUFFS . (83/229/EEC) . _Reference OJEC", 1-123,311,1983 F-ffective Date : 01APR1987 Official Journal of the European (Communities)/Union Last Amendment : OJEC", L228, 32, 1986 Enta/ Update : OCT1987 Official Journal of the European (Communities)/Union 

# Substance Chemical Name : Reported Name . Urea CAS Number . 57-13-6 Area Tyo Subiect Spec. Description Level / Summarv Information : "

IMO REC AO EMI RSTR Category Csubstance (substance which isslightly toxic to aquatic life) : discharge into the sea of

AQ MARIN RSTR this substance, ofballast 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) Title : International Convention for the Prevention of Pollution fromShips, 1973. as modified

by the Protocol of 1978 relating thereto (MARPOL 73178) . Reference Effective Date : LastAmendment : IMODC', EntN/U dp ate : SEP1994

IRPTCData Prorile