OECD SIDS 

FOREWORD INTRODUCTION 

UIREA 

CAS N°: 57-13-6 

UREA 

rri 

CONTAINS NO CBI 

3a4393 

UNEP PUBLICATIONS 
Identifiers, 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 

U repearl U revert 

Varioform 11 

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) 0.4 wt°/a; free ammonia 0.4 wt°/a; Fe 

2+ <0 .0002 wt%; ash content < 0.02 wt°/a. Degree of purity 98-99 

wt%. 

General Comments . *On further heating decomposes to biuret, NH3 and cyanuric acid . On standing 

or on heating decomposes to NH3 and C02. ** Urea decomposes before 

boiling .***VP of saturated water solution=2kPa at 20C. Hypochlorites can react 

with urea to form the explosive compound, nitrogen trichloride . Reacts violently 

with gallium perchlorate . 

Overall Evaluation 

CURRENTLY OF LOW PRIORITY FOR FURTHER WORK 

SIDS INITIAL ASSESSMENT 

Urea has generally low acute ecotoxicity to organisms. The aquatic effects assessment showed that calculated 

PECs were lower than the MTC. Urea is very soluble in water and degrades ultimately in the inherent 

biodegradability test . 

IRPTC Data Profile 
2 identifiers, Physical and Chemical properties 

Although urea has generally low ecotoxicity to organisms, its well documented indirect and longterm effects to 

the ecosystems, e.g . eutrophication, groundwater pollution, soil acidification and ammonia emissions to air 

should be considered. 

Urea is an important endogenous product of mammalian metabolism. This may partly explain why it has not 

been rigorously studied with toxicological tests . Nevertheless, urea appears to cause little or no toxicity to most 

mammalian species (ruminants are an exception) and humans at reasonable dose levels . The tentatively 

determined EHE is lower than the EDLC based on human observations . 

EXPOSURE 

TYPES OF USES AND EXPOSURE SOURCES: 

1) Industry 

Urea is used in many industrial sectors for many functional uses e.g . as adhesives, binders, sealants, resins, 

fillers, analytical reagents, catalysts, intermediates, solvent, dyestuffs, fragrances, deodourisers, flavouring 

agents, humectants and dehydrating agents, formulation components, monomers, paint and coating additives, 

photosensitive agents, fertilizers, surface treatment agents. Urea is also the key synthetic ingredient in the 

manufacture of some medicines. 

Occupational and environmental exposure during production is possible due to accidental process breakdown 

and disorders in reactor operations, pumping cycles, evaporation and crystallization processes, in maintenance, 

loading and unloading operations . 

Potential occupational exposure occurs via inhalation of aerosols from urea melt and hot saturated solutions, 

splashed to skin or eyes or inhalation of dust. 

2) Agriculture 

Urea is widely used as a nitrogenous fertilizer. As an animal feed supplement urea is used at approximately 3% 

of the grain ratio or 1 % of the total ration . 

The use of highly concentrated fertilizers may cause human, livestock, especially ruminant and pet hazard . 

Sources of exposure may be accidental inclusions of highly concentrated fertilizers in rations, application of 

fertilizers to fields with livestock, washing of recently applied fertilizers by rain into water supplies of livestock, 

spilling accidentally fertilizers on land and into ponds or watering livestock with fertilizer containers without 

thorough cleaning and removal of residual fertilizers . 

Also various species of wild animals are exposed to urea when urea fertilizers are spread directly on the fields 

and in the forests . Aquatic organisms may be exposed to urea when recently applied fertilizers are washed by 

rain into rivers, lakes and seas. 

Livestock urine can cause environmental exposure when livestock graze in the grazing season or when manure 

of livestock is spread to the fields (reliable estimations of the emission levels from urine of naturally living 

mammalians can not be given) . 

3) Deicing agent 

Intensive use of urea as a deicing agent in many airports have lead to groundwater pollution . Urea is washed 

out from runways with the melting ice and leaches into the surface and groundwater. 

4) Consumer products 

Urea is used in liquid soaps, detergents, household cleaning products and also in cosmetics products such as 

creams, shampoos, hair conditioners, hair dyes and dye removers, in ammoniated dentifrices etc . (Maximum 

urea concentration is commonly 1%.) 

ENVIRONMENTAL EXPOSURE 

Urea is "ultimately biodegradable". 

Degradation 

Urea is ultimately biodegradable in inherent biodegradability test (OECD 302 B). In semi-continuous activated 

sludge (SCAS) urea is biodegraded on the average of 93-98% in 24-hour cycle. 

The main mode of degradation is enzymatic mineralization . In soil and water urea is expected to biodegrade 

fairly rapidly to ammonia and bicarbonate if temperature is not too low. Ammonia is a volatile gas in alkaline 

solutions . In natural waters, most ammonia appear in the form of ammonium, from which nitrogen is oxidized 

IRPTC Data Profile 
Identifiers, Physical and Chemical properties 3 

as the result of bacterial action, forming nitrite and nitrate. 

According to US-EPA PCGEMS-model hydrolysis of urea is expected to be extremely slow (T1/2 > 1 years) . 

Bioaccumulation : 

Due to low log Pow value (- 1 .59 at 20-25 C) urea is not likely to undergo bioaccumulation . 

DISTRIBUTION BETWEEN ENVIRONMENTAL COMPARTMENTS AND OCCURENCE IN THE ENVIRONMENT 

The model used for estimating the partitioning of urea in the environment was the Mackay level 1 model. 

According to the model there is 99.84% and 0.16% partitioning into water and air, respectively . (i) Air 

Urea is essentially non-volatile in solid form. Its high water solubility, low vapour pressure (solid pure urea 80 Pa at 20C; calculated) and consequently low Henry's law constant (4 .4E-8 atm m3/mol) indicate that urea will not evaporate from water to atmosphere . 

Degradation of urea to ammonia causes NH3-emissions to air . Emissions are higher in alkaline soil (pH>7). 

(ii) Soil 

According to the worldwide use pattern of urea, when 85 - 90%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 low soil-water partition 

coefficient. This can happen especially if the soil surface is saturated with water, as might be the case after a rainfall . 

(iii) Water 

As earlier described, urea can be leached relatively easily into the surface water and the groundwater. The 

concentration of urea itself, however, is not generally detected, because of its high degradation rate. Therefore usually degradation products e.g . nitrate, nitrite and ammonium can be measured . 

Some monitoring data are, however, available : 

a) the concentration of urea in domestic sewage: 2 - 6 mg/L and in primary sewage plant effluent: 0.016 - 0.043 mg/L. 

b) the concentration of urea in sewage of Kemira's fertilizer factory (Finland) : 0.34 mg/L. 

The monitoring data has been further used for calculation of the predicted environmental concentration (PEC). For calculation of PEC the dilution factors of 10 for domestic waste water effluents and 100 for industrial effluents are used. Thereby (a) PEC of 0.0016 - 0.0043 mg/L is obtained for primary sewage plant effluent and (b) PEC of 0.0034 mg/L for fertilizer factory. 

Environmental exposure by consumer use can be considered insignificant . 

CONSUMER EXPOSURE 

Because urea is an important endogenous product of protein catabolism in mammals and occurs in significant concentrations in blood and obviously in extracellular water, human food of animal origin contains some urea. If meat contained the same concentration of urea as human blood (about 30 mg/100 g), intake of urea from meat would amount to some tens of milligrams per day. Edible parts of plants may contain up to 4.5 per cent (oats) of their total nitrogen content as urea. The nitrogen content of grain seeds and grass is of the order 2-4%. If one per cent of the total nitrogen were urea (consequently 0 .03% of the fresh weight of food of plant origin were urea), the human daily intake of urea from plants could amount up to several grams. However, due to the very limited data available concerning actual urea concentrations in e.g . root vegetables and potatoes, the uncertainties about the quantity are great . The possible food additive use of urea apparently adds litlle to the intake via food . 

The use of urea in skin preparations (soaps, cosmetics, medicines) may lead to highly variable cutaneous doses. The highest doses would concern patients treated extensively because of dry pruritic skin . About 1 per cent of the weight of the skin preparation could be absorbed as urea (preparation contains 10% urea, 10% is absorbed) resulting mostly in the dermal uptake of some tens of milligrams per day. 

Intake of urea from dental preparations cannot be estimated with any accuracy, but it probably amounts to relatively small quantities . 

lRPTC Data Profile 
4 Identifiers, Physical and Chemical properties 

OCCUPATIONAL EXPOSURE 

Occupational exposure to urea can be envisaged from inhalation of aerosols and dust during production of urea, 

urea fertilizers and animal feed supplements, in chemical synthesis using urea as a starting material and 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 from the handling of urea. Accidental splashes to the skin are 

possible too . 

No reports on actual measurements of urea concentration in the workplace or breathing zone air were located . 

The worst case scenario would assume that the exposure conforms to the permissible exposure levels of OSHA: 

15 mg/m3 total dust and 5 mg/m3 respirable dust . 

Uptake of respirable urea at 5 mg/m3 (with a 10 m3 volume of total ventilation and 100% absorption) would 

amount to 50 mg (inhalation dose). 

The non-respirable part of urea at 10 mg/m3 and 10 m3 ventilation results in the airway deposition of 100 mg, 

most of which will be ingested . 

The amount of urea deposited on the skin may be significant, but the fraction absorbed is likely to be less than 

from skin preparations (the formulation affects the penetration of urea into the skin). Consequently, although no 

accurate estimates can be given, percutaneous uptake probably will not be higher than the respiratory uptake 

and ingestion, rather it is less . 

The tentative overall dose of urea resulting from the worst-case occupational exposure is thus of the order 200 

mg per day. 

HUMAN TOXICITY 

a) Acute toxicity 

The acute toxicity by urea is well delineated by the oral route . Toxicity is low in mammals other than ruminants, 

especially cattle, and sheep, in which the rumen micro-organisms contain urease activity and metabolize urea to 

ammonia at a high rate . In mice and rats, urea is of low toxicity even by the subcutaneous and intravenous 

route . 

b) Repeated dose toxicity 

No well-conducted repeated dose toxicity studies on urea were located . Chronic toxicity and carcinogenicity 

screening studies in mice and rats fed with 4500, 9000 or 45000 ppm in diet (up to about 6750 mg/kg body 

weight/day for mice and about 2250 mg/kg body weight/day for rats) did not uncover any treatment-related toxic 

syndromes in the various organs studied . 

Neither was any weight depression noted at terminal necropsy for animals of either sex or species at any dose 

levels . Thus the NOAELs were about 6750 mg/kg body weight/day for mice and about 2250 mg/kg body 

weight/day for rats . 

Repeated dose toxicity studies with rats by skin application over 4 weeks and 25 weeks were conducted using 

urea ointment at 10%, 20% and 40% concentrations, and no consistent treatment-related toxic effects were 

found. The ointments were applied on a 20 cm2 area of the back skin but, unfortunately, the quantities of urea 

applied were not given . Therefore no value for NOAEL by dermal route can be determined . It can be concluded, 

however, that the repeated dose toxicity of urea by dermal route was low. 

c) Reproductive/developmental toxicity 

The studies cited under repeated dose toxicity did not indicate any toxic effects on the reproductive organs of 

mice and rats . 

No adequate teratogenicity/developmental toxicity studies of urea with mammals were located . According to one rat study, 50 g/kg body weight/day administered by gavage in two doses 12 hours apart for an average of 14 days did not cause outstanding (external) teratogenicity ; the mean birthweight of the newborn was lower but the 

litter size greater . Injection of urea into the air sack of eggs shows that urea is toxic to the development of chick embryo. 

No NOAEL can be given for the reproductive/developmental toxicity of urea because appropriate studies are lacking . 

d) Genetic toxicity 

IRPTC Data Profile 
Identifiers, Physical and Chemical properties 

Urea has been negative in several appropriately conducted bacterial mutagenicity tests . Urea caused DNA single strand breaks in mammalian cells in vitro and was clastogenic for mammalian cells in vitro and in vivo but only at concentrations much beyond the physiological range (about 50-100 higher concentrations than found in human blood) . 

The mechanism of genotoxicity is probably non-specific (e .g . difference in osmotic pressure across the cell membrane) . 

e) Any other human health related information that is available 

There is little data that relates urea to human health other than its use in dermatology and some more limited applications in clinical medicine. The use of urea (at 10% concentration or less) in ointments and creams to treat dry skin has been widespread, and long term follow-up studies have indicated that the substance is non- allergenic and virtually free from side effects . Among other clinical therapeutic uses, the treatment of inappropriate secretion of antidiuretic hormone (SIADH) should be noted, because its chronic form has involved long term oral administration of large amounts of urea. Most patients have tolerated urea well, although diarrhoea is sometimes reported after ingestion of 60-90 g/day. One patient who had received 30 g of urea (about 470 mg/kg body weight/day) by ingestion for 5 years did not exhibit any side effects . 

The possibility exists that infection of H. pylori in human stomach may aggravate local effects by urea because of ammonia generation . 

ENVIRONMENTAL ASSESSMENT 

In order to calculate the maximum tolerable concentration (MTC), assessment factor 100 is used, because NOEC-values were not available and acute L(E)C50-values were available for fish and crustaceans. Toxicity Threshold-value (TT) was available for algae representing more longterm than acute toxicity. It can be assumed, however, that acute L(E)C50 for algae can not be lower than the available toxicity treshold concentration . 

MTC is calculated for the most sensitive species, protozoa flagellata (Entosiphon sulcatum) where the lowest aquatic effect concentration, toxicity treshold (TT) (72 hours) of 29 mg/L, has been recorded : 

MTC: 29/100 = 0.29 mg/L 

According to the PEC calculated, MTC/PEC > 1 : 

MTC/PEC => (a) 0.29/0 .0043 = 67.4 (primary sewage plant effuent) 

(b) 0.29/0.0034 = 85 .3 (sewage of Kemira's fertilizer factory) 

The degradation product of urea, ammonia, is known to be toxic to all vertebrates . In neutral and acidic conditions, however, ammonia exists in the form of ammonium. 

HUMAN HEALTH ASSESSMENT 

Urea is an endogenous product of protein and aminoacid catabolism, and consequently 20-35 g of urea is excreted daily in human urine. The blood concentration of urea is also relatively high, 3.3-6 .7 mmol/L. Non-physiological, 50-100 times higher urea concentrations in the cultivating medium were shown to disrupt DNA and elicit genotoxicity in mammalian cells, apparently through non-specific osmotic mechanisms. It can be expected that the human organism is well adapted to urea within the physiological range of concentrations and even beyond. This is supported by clinical evidence from high dose administration orally and intravenously for therapeutic purposes . 

The bulk of human exposure to urea apparently results from urea ingestion through plant food and meat. Actual measurements concerning the urea content of food were not found, however, and therefore no certain or accurate amounts can be given . Among the consumers, patients using urea containing preparations for the treatment of dry skin may receive an additional but minor dose. Occupational exposure (via inhalation, ingestion and dermally) adds little to the amounts received from food. 

The estimated human exposure (EHE) level for urea can only be given very crudely, and it can probably vary widely depending on the food consumed . As a tentative value 3 g/day (about 40 mg/kg body weight/day) is proposed . 

animal 

Due to the fact that urea has not been rigorously examined with toxicity testing, meaningful NOAELs from studies are difficult to find . 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 

IRPTC Data 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 470 mglkg body weight/day of urea over 5 years did not cause adverse effects . 

The estimated dose of low concern (EDLC) from animal data, using 100 as the uncertainty factor, would give 20- 60 mg/kg body weight/day but, as presented above, clinical experience shows that more than ten times higher dose levels in human patients have resulted in little or no adverse effects, even over relatively long periods of time. A further perspective to the EDLC assessment is the endogenous rate of urea formation (excretion), up to about 500 mg/kg body weight/day. 

Based on human observations, the EDLC appears to be about one order of magnitude higher than the proposed EHE. 

CONCLUSIONS 

Based upon the available information, the initial assessment gave no indication for concern for the human 

health and the environment . 

Based on the MTC/PEC-ratio urea is considered to possess low current concern . Urea has generally low acute ecotoxicity to organisms . The degradation product of urea, ammonia, is known to be toxic to all vertebrates . In neutral and acidic conditions, however, ammonia exists in the form of ammonium. 

Instead of toxic effects, more emphasis should be put on the indirect influence of urea to the environment via eutrophication and the pollution risk of urea to groundwater, when urea is used as a fertilizer and a deicer agent in airports. Also the longterm influence of urea use e.g . soil acidification after the longterm fertilization and 

ammonia emissions to air can have influence to the whole ecosystem and should be considered. 

Urea is an important endogenous product of mammalian metabolism. This may partly explain why it has not been rigorously studied with toxicological tests . Nevertheless, urea appears to cause little or no toxicity to most mammalian species (ruminants are more sensitive because of microbial ammonia production) and humans at reasonable dose levels. Based on the EHE/EDLC ratio, urea should be of low current concern to human health . 

RECOMMENDATIONS 

No further tests are needed. 

More accurate data concerning the daily intake of urea from diet are desirable . 

IRPTC Data 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* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name : Urea 

CAS Number . 57-13-6 

Geographic Area : 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 . 

1RPTC Data Profile 
Production-Trade 

References 

!SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

FAOSS* 

FAO Statistics Series . FAD Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name : Urea 

CAS Number ; 57-13-6 

Geographic Area : 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 . 

IRPTC Data 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 . 

IRPTC Data Profile 
10 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 

Geographic Area . 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 

Geographic Area . ASIA 

Production 

uantit Year 

5295000-+2550000 tly - P 

28728000-+4650000 Uy-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. 

IRPTC Data 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 

Geographic Area : EUR 

Production 

uantit Year 

7144900-8321000 tly - 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* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name : Urea 

CAS Number : 57-13-6 

Geographic Area . 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. 

1RPTC Data Profile 
p. 13 

12 Production-Trade 

References 

!SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

FAOSS* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name . Urea 

CAS Number . 57-13-6 

Geographic Area . NGA 

Area Specifications . AFRI 

Production 

uantit Year 

70000-230000 t/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* 

FAO Statistics Series. FAO Fertilizer 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* 

FAO Statistics Series. FAO Fertilizer 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* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name . Urea 

CAS Number . 57-13-6 

Geographic Area MEX 

Production 

uantit Year 

500000-640000 Uy - P 1985-1988 

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

IRPTC Data Profile 
p. 15 

14 Production-Trade 

References 

!SIDSP* 

OECD/SIDS . Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

FAOSS* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name : Urea 

CAS Number . 57-13-6 

Geographic Area : TTO 

Production 

uantit Year 

150000-250000 tly - 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* 

FAO Statistics Series . FAO Fertilizer 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%). 

IRPTC Data Prorrle 
p. 16 

Production-Trade 

References 

!SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

FAOSS* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name : Urea 

CAS Number : 57-13-6 

Geographic Area . BDG 

Area Specifications : ASIA 

Production 

uanti Y Year 

380000-680000 tly - 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* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name . Urea 

CAS Number : 57-13-6 

Geographic Area : 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%). 

IRPTC Data Profile 
p. 17 

6 Production-Trade 

References 

!SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

FAOSS* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

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* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name . Urea 

CAS Number : 57-13-6 

Geographic Area . IRN 

Area Specifications . ASIA 

Production 

uantit Year 

50000-100000 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. 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* 

FAO Statistics Series . FAO Fertilizer 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 

Geographic Area : 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* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

IRPTC Data Profile 
p. 19 

18 Production-Trade 

References 

!SIDSP* 

OECD/SIDS . Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

FAOSS* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name : Urea 

CAS Number : 57-13-6 

Geographic Area . PAK 

Area Specifications : ASIA 

Production 

uantit Year 

835000-970000 tly - 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* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name : Urea 

CAS Number ; 57-13-6 

Geographic Area . 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%). 

IRPTC Data Profile 
p. 20 

Production-Trade 19 

References 

!SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

FAOSS* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

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* 

FAO Statistics Series . FAO Fertilizer 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%). 

IRPTC Data Profile 
p. 21 

20 Production-Trade 

References 

!SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

FAOSS* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name : Urea 

CAS Number : 57-13-6 

Geographic Area : TUR 

Area Specifications : ASIA 

Production 

uantit Year 

70000-160000 Uy - 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* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name : Urea 

CAS Number ; 57-13-6 

Geographic Area . 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* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

!SIDSP* 

OECDISIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

FAOSS* 

FAO Statistics Series . FAO Fertilizer 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%). 

IRPTC Data Profile 
p. 23 

22 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* 

FAO Statistics Series . FAO Fertilizer 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 

Geographic Area 

Area Specifications 

Production 

!SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

FAOSS* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

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%). 

IRPTC Data Profile 
p. 24 

Production-Trade 23 

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* 

FAO Statistics Series . FAO Fertilizer 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* 

FAO Statistics Series . FAO Fertilizer 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* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Urea 

57-13-6 

ITA 

EUR 

uantit Year 

460000-600000 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 

!SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

FAOSS* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Urea 

57-13-6 

NLD 

EUR 

uantit Year 

380000-570000 tJy - P 1985-1987 

. 

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

IRPTC Data 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* 

FAO Statistics Series. FAO Fertilizer 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 

Geographic Area 

Area Specifications 

Production 

!SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

FAOSS* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

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%). 

IRPTC Data 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* 

FAO Statistics Series . FAO Fertilizer 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* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Urea 

57-13-6 

YUG 

EUR 

IRPTC Data Profile 
p. 28 

Production-Trade 

References 

!SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

FAOSS* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name . Urea 

CAS Number : 57-13-6 

Geographic Area : RUS 

Area Specifications . EUR 

Production 

Quantitv Year 

4800000-4950000 t/y - P 1987-1989 

27 

" 

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

References 

!SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

FAOSS* 

FAO Statistics Series . FAO Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name : Urea 

CAS Number . 57-13-6 

Geographic Area . AMN 

Production 

uantit Year 

3140000-6278000 t/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. 

lRPTC Data 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 . FAO Fertilizer Yearbook, 40, (1990) 

Production-Trade 

Chemical Name : Urea 

CAS Number : 57-13-6 

Geographic Area . WORLD 

Production 

uantit Year 

41440000-60789000 t - P 1985-1989 

General Comments : The capacities of urea production have increased . By the year 1994-1995 the 

capacites should reach a level of the order of 60 million tonnes of nitrogen (or 

130 million tonnes of urea), making the third chemical product together with 

ammonia and sulphuric acid, to cross the threshold of 100 million per year. 

The largest forcasted increase in capacity are in Saudi Arabia ; Iraq and the 

Gulf States in general ; Indonesia, India and China . References 

!SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

FAOSS* 

FAO Statistics Series . FAO Fertilizer Yearbook, 315, 179-201, (1990) 

Production-Trade 

Chemical Name : Urea 

CAS Number : 57-13-6 

Geographic Area : FIN 

1RPTC Data Profile 
Production-Trade 29 

Production 

uantit Year 

13640 Uy - P 1986 

1550 tly - P 1986 

8210 tly - P 1986 

610 Uy - 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 = 34010 tonnes/year, to be compared with 

total urea import to Finland . 

References 

!SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

ENFAF* 

Keranen, S. and Niskanen, R. Effects of Nitrogen Fertilizer to Acidification in 

Finland : Litterature Survey, D139, (1987) 

IRPTC Data 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 form ammonium 

carbonate and simultaneously dehydrating the ammonium carbonate to 

urea and water. Produced urea is purified by crystallization . Urea is also 

a natural end product of biochemical protein decomposition and the 

main solid component of mammalian urine (e .g . man produces urea in 

urine 20-35 g/24 hours, (200-500 mg/kg body weight-1 day-1). Urea is a 

natural constituent of many common foodstuffs . Up to 15 percent of the 

total nitrogen of young plants and about 5 percent of the nature plants is 

non-proteinaceous and much is in the form of urea. Urea is a normal 

constituent of animal tissues and fluids and is ingested in small amounts 

when meat is consumed . Oats may contain 4.5 percent of their total 

nitrogen content as urea and oil seed meals about 0.25 percent . 

References 

Secondary Reference : !SIDSP " 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

IRPTC Data 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) 

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 

" 

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 % Maximum urea 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) 

Secondary References . !SIDSP* 

OECDISIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

IRPTC Data 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) 

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 . WORLD 

IRPTC Data 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 system and closed system), public use and 

export . Urea is used in all three sectors . 

Industrial use concerns both open and closed systems. 

Use categories : urea is used by the following industrial 

sectors : -Adhesives and sealant production 

-Agriculture, field crops -Agriculture, other 

-Electrical or electronic products 

-Fertilizer-Food, feed and beverage 

-Metallurgical 

-Organic chemicals, industrial 

-Paint and coating -Pigment, dye and printing ink 

-Plastic and synthetic resins 

-Plating and publishing -Pulp and paper 

-Soap and cleaning products 

-Textile, primary manufacture -Textile, product 

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) 

Secondary References . !SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

IRPTC Data 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 . 

1RPTC Data Profile 
Uses 35 

References 

Primary References : NHCUH" 

National Health Council . Urea. Safe Use and Handling Data Sheet, I-691/Rev 

90,3 

Secondary References : !SIDSP"' 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

lRPTC Data Profile 
p. 37 

36 Pathways into the Environment and Environmental Fate 

Study 

End Point . Pathway into the Environment and 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 from degradation 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 

End Point : Pathway into the Environment and Environmental Fate. 

Chemical Name . Urea 

CAS Number ; 57-13-6 

Geographic Area : 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 from livestock urine when spread on the fields and in the grazing season. 

to AIR 

Emission from urine 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 to soil . 

IRPTC Data 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) 

1RPTC Data Profile 
p. 39 

38 Concentration 

Study 

End Point 

Chemical Name 

CAS Number 

Study type 

Geographic Area 

Test Subject 

CONCENTRATION 

Urea 

57-13-6 

LAB 

FIN 

" 

Organism Medium 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 PEC the dilution 

factor of 10 for 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) 

1RPTC Data Profile 
p. 40 

Concentration 39 

Study 

End Point . CONCENTRATION 

Chemical Name . Urea 

CAS Number . 57-13-6 

Study type . FIELD 

Geographic Area : FIN 

Test Subject 

Or aq 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 PEC the 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) 

fRPTC Data 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 

Organism Medium -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 ammonium concentrations 

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, from 300 tonnes 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 and the Environment Unpublished Report 

Secondary Reference : !SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

lRPTC Data Profile 
Concentration 41 

Study 

End Point 

Chemical Name 

CAS Number 

Study type 

Geographic Area 

Test Subject 

CONCENTRATION 

Urea 

57-13-6 

LAB 

FIN 

" 

Or an nism Medium S.Lecification Lifestage Sex 

HUMAN ADULT 

Species/strain/system : Physiological concentrations in man 

Test Results 

Matrix Concentrations -Sp e c. 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) 

1RPTC Data 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 

Organism Medium 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 and Exposure 43 

Study 

End Point : HUMAN INTAKE AND EXPOSURE 

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 from inhalation of 

aerosols and dust during production of urea fertilizers and animal feed 

supplements in chemical syntheses using urea as a starting material and 

when dispesrsing urea fertilizers/urea in the fields, roads and runways . In 

the context of airborne exposure,the non-respirable fraction will be 

mostly ingested . A part of the airborne dust will deposit onto the skin 

and, additionally, heavier contamination of the hands will result from the 

handling of urea . 

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 from the 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 from the non-respirable part of urea at 10 mg/m3 and 10 m3 ventilation . 

IRPTC Data 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 AND EXPOSURE 

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 from meat would amount to >10 mglL per day. 

The human daily intake of urea from plants could amount up to several grams. 

The possible food additive use of urea apparently adds little to the intake via food. 

General Comments 

References 

Because urea is an important endogenous product of protein catabolism in 

mammals and occurs in significant concentrations in blood and obviously in 

extracellular water, human food of animal origin contains some urea . Secondary Reference : !SIDSP* 

OECD/SIDS. 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 : USA 

Test Subject 

Organism Medium Specification Route Lifestage Sex 

HUMAN 

IRPTC Data 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% from actual observed use, 31 % from 

observed use of a tradename product known to contain this chemical, and 

62% from observed use of a product in some type of general use which 

leads NIOSH to suspect that chemical may be contained in the product . 

Exposure in farming : the use of highly concentrated fertilizers in agricultural 

practice and in gardens can lead to human hazards . Most toxicities from 

fertilizers occur in ruminants. (Reported in : Oehme, F. W. and Barrel, D. S. : 

Veterinary Gastrointestinal Toxicology, Chapter 17 in Rozman, K. and 

Hanninen, O. (eds) . 

Primary Reference : HSDBM" 

Hazardous Substances Databank HSDB, 11, (1991) 

Secondary Reference . !SIDSP " 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

IRPTC Data Profile 
p. 47 

46 Biodegradation 

Study 

End Point 

Chemical Name 

CAS Number 

Study type 

Geographic Area 

Test Subject 

r anism Medium ,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 Time Comments on result 

References 

In river water at 1-15 mg/L degradation of urea is negligible below 8C for 

up to 14 days. 

Primary Reference : WATRAG 

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

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 . Semi-continuous activated sludge (SCAS) 

IRPTC Data 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 from a laboratory sewage treatment facility fed with 

domestic and synthetic sewage; adapted. 

Test Method and Conditions 

Test method : Inherent Biodegradability : OECD Guideline 302 B (1981), Zahn-Wellens 

description Test; GLP: no 

(An)aerobic : AEROB 

Exposure 

Dose / Concentration : 400 mg/L 

IRPTC Data 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 % 16 d 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 . Flooded soil 

Exposure 

Exposure Period : 30 h 

Exposure comments . 30 hours of incubation 

IRPTC Data 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 

End Point . 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 forms in soil 

description 

Temperature . 2-20 C 

Exposure 

Exposure Period . 1-4 d 

" 

tRPTC Data Profile 
p. 51 

50 Biodegradation 

Test Results 

uantit Time Comments on result 

4 d 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 % 6 wk 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 

End Point 

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 % 

IRPTC Data Profile 
p. 52 

Biodegradation 51 

Test Results 

uantit Time Comments on result 

11 .6 mglL 1 h Maximum degradation rate per hour at 20C 

10.9 mg/L 1 h Average degradation rate per hour at 20C 

4.0 mglL 1 h Maximum degradation 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) 

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 

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 of the 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- 

IRPTC Data Profile 
52 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) 

IRPTC Data Profile 
Hydrolysis 53 

Study 

End Point . HYDROLYSIS 

Chemical Name . Urea 

CAS Number : 57-13-6 

Geographic Area : 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 and the Environment Unpublished Report, 

(1994) 

Secondary Reference . !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 from the soil into the surface and the 

groundwater because of its weak adsorption to the soil, high water 

solubility and soil-water partition coefficient. This can happen especially 

if the soil surface is saturated with water, as might be the case after a 

rainfall . 

Urea adsorption coefficient in Crowly silt loam flooded soil column 

ranged from 0.037 (50 mg N/L) to 0.064 (1000 mg N/L) depending on 

the concentration of urea water. 

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 Society of America Journal, 55, 

1130-34,(1991) 

Secondary Reference : !SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

IRPTC Data Profile 
p. 56 

Evaporation 55 

Study 

End Point . EVAPORATION 

Chemical Name : Urea 

CAS Number . 57-13-6 

Study type : LAB 

Medium . A4 

Specifications : FRESH 

Geographic Area : Fix 

Test Results 

General Comments 

References 

Secondary Reference 

" 

Urea is essentially non-volatile in solid form. Its high solubility and low 

vapour pressure and consequently low Henry's law constant (4.4E-8 atm 

m3lmol) indicate that urea itself will not evaporate from water to 

atmosphere. 

!SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

IRPTC Data Profile 
p. 57 

56 Ecosystems 

Study 

End Point 

Chemical Name 

CAS Number 

Geographic Area 

Test Subject 

ECOSYSTEMS 

Urea 

57-13-6 

FIN 

Species/strain/system . Soil properties after long-term fertilization 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 : maximum bulk density 1 .49-1 .60 mg/m3; 

optimum water content for compaction 0.196-0 .219 kg/kg ; Clod density 

1 .46-1 .68 mg/m3; water content at -1 .5 MPa potential 0.125-0 .192 

kg/kg . Particle size distributiion at 0.06 to 0.14 m soil layer : sand (0 .05-2 

mm), coarse silt (0 .02-0 .05 mm), fine silt (0 .002-0 .02 mm), clay (<0 .002 

mm). 

Test Results 

General Comments 

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) 

Secondary Reference : !SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

IRPTC Data 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 slow and 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) 

IRPTC Data Profile 
p. 59 

5$ Distnbution 

Study 

End Point 

Chemical Name 

CAS Number 

Test Subject 

DISTRIBUTION 

Urea 

57-13-6 

Or, anism Medium Specitication Route Lifestaae Sex 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 0.5 g/kg) doubles serum urea levels in 20 minutes and a 

maximum level of 94.6 mg/100 mL is achieved in 90 minutes (mean 

control 36 mg/ 100 mL). 

References 

Secondary Reference . !SIDSP' 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

Study 

End Point . 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 Profile 
8ioconcentration 59 

Study 

End Point . BIOCONCENTRATION 

Chemical Name : Urea 

CAS Number . 57-13-6 

Study type : LAB 

Geographic Area FIN 

Test Results 

General Comments 

References 

Due to the low log 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) 

" 

IRPTC Data Profile 
p. 61 

60 Excretion 

Study 

End Point : 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) 

IRPTC Data Profile 
Mammalian Acute Toxicity 61 

Study 

End Point . MAMMALIAN ACUTE 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 LD50 for male rats was established 

as 14300 mg/kg and for female rats as 

15000 mg/kg body weight. 

General Comments : The general symptoms consisted mainly of sedation, loss of righting reflex and 

staggering gait . 

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 : MAMMALIAN ACUTE 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 anism Medium Spec. Route Lifestaae Sex Effect Effect Comments 

" 

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. 

IRPTC Data 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 

End Point . MAMMALIAN ACUTE 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 LD50 for 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 . 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 : MAMMALIAN ACUTE TOXICITY 

Chemical Name . Urea 

CAS Number . 57-13-6 

Frequency : 1 x 

Dose / Concentration . 9200-10700 mg/kg BW 

" 

IRPTC Data Profile 
Mammalian Acute Toxicity 63 

Test Method and Conditions 

Test method . GLP: no 

description 

Test Results 

Organism Medium 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 : MAMMALIAN ACUTE TOXICITY 

Chemical Name : Urea 

CAS Number : 57-13-6 

Species/straln/system : Cow 

Dose / Concentration . 510 mg/kg BW 

Test Method and Conditions 

Test method . GLP: no 

description 

Test Results 

Organism Medium Spec. Route Lifestaoe Sex Effect Effect Comments 

" 

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) 

Secondary Reference . !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) 

IRPTC Data Profile 
64 Mammalian Acute Toxicity 

Study 

End Point . MAMMALIAN ACUTE 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_qanism Medium Spec. Route Lifestaae Sex Effect Effect Comments 

SHEEP ORL LD50 Oral LD50 for sheep 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) 

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 

Species/strain/system : Cow 

Dose / Concentration . 600-1080 mg/kg BW 

Test Method and Conditions 

Test method . GLP: no 

description 

Test Results 

Organism Medium ec. Route Lifestaoe Sex Effect Effect Comments 

CATTL ORL LD50 Oral LD50 for cows was established as 

600 - 1080 mg/kg body weight. 

1RPTC Data Profile 
Mammalian 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 LD50 for 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 

End Point . MAMMALIAN ACUTE 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 

" 

lRPTC Data Profile 
66 Mammalian Acute Toxicity 

Test Results 

r anism Medium 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 . MAMMALIAN ACUTE TOXICITY 

Chemical Name . Urea 

CAS Number : 57-13-6 

Dose / Concentration : 10000 mg/kg BW 

Test Method and Conditions 

Test method : GLP: no 

description 

Test Results 

Organism Medium Spec. Route Lifestaoe Sex Effect Effect Comments 

DOG IVN LD50 Intravenous LD50 for 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) 

IRPTC Data Profile 
p. 68 

Mammalian Toxicity 67 

Study 

End Point : MAMMALIAN TOXICITY 

Chemical Name . Urea 

CAS Number . 57-13-6 

Test Subject 

" 

Organism Medium 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 Profile 
68 Mammalian Toxicity 

Study 

End Point . MAMMALIAN TOXICITY 

Chemical Name . Urea 

CAS Number : 57-13-6 

Test Subject 

Organism Medium S12ecification Route Lifestaae Sex 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 LDLO for 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 Medium S, .gecification Route Lifestage Sex Number epx o sed Number controls 

DOG SCU 

Test Method and Conditions 

Test method . GLP: no 

description 

Exposure 

Dose / Concentration . 3000-9000 mglkg BW 

IRPTC Data Profile 
p. 70 

Mammalian Toxicity 69 

Test Results 

Affected in 

Organ Effect Rev. OnSet Sex Exposed - Controls 

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

LDLO 

Subcutaneous LDLO for 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 

End Point . MAMMALIAN TOXICITY 

Chemical Name . Urea 

CAS Number : 57-13-6 

Study type . LAB 

Test Subject 

" 

Or, anism Medium Specification Route Lifestage Sex 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. 

IRPTC Data 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 LDLO for dogs was 3000 mg/kg body weight. 

IRPTC Data Profile 
p. 72 

Mammalian Toxicity 7 

References 

Primary Reference : D8REP4 

FDA (US-Food and Drug Admin.) . Health Hazard Evaluation Determination 

Report, PB-288673, (1978) 

Secondary Reference . 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 Route Lifestaoe Sex 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 LDLO for guinea pigs was established as 4800 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) 

tRPTC Data Profile 
p. 73 

72 Mammalian Toxicity 

Study 

End Point : MAMMALIAN TOXICITY 

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 LDLO for 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 . 

IRPTC Data Profile 
p. 74 

Test Results 

Mammalian Toxicity 73 

Affected in 

Organ Effect Rev. OnSet Sex Exposed - Controls 

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

SRIN NBF 

No long-term side effects have been found. No reports of contact allergy were located and, in spite of common 

use for many years, no epidermal or dermal atrophy has been reported . 

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 : 16000 mg/kg BW 

Test Results 

Organ Effect Rev. OnSet Sex Exposed - Controls 

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

LDLO 

Oral LDLO for pigs was established as >16000 mg/kg body weight. 

General Comments . Ten % (m/m) urea in pig food over a period of 5 days 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) 

Secondary Reference . !SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

Affected in 

IRPTC Data Profile 
p. 75 

74 Mammalian Toxicity 

Study 

End Point 

Chemical Name 

CAS Number 

Study type 

Test Subject 

MAMMALIAN TOXICITY 

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 . 4 wk 

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 . 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) 

IRPTC Data Profile 
p. 76 

Mammalian Toxicity 75 

Study 

End Point 

Chemical Name 

CAS Number 

Study type 

Test Subject 

MAMMALIAN TOXICITY 

Urea 

57-13-6 

LAB 

. 

Oroanism Medium 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 . 190 d 

Dose / Concentration : 20000-250000 mg/kg DIET 

Exposure comments : Rats were fed a diet containing 20000-250000 ppm urea for 190 days (about 

Test Results 

2000-25000 mg/kg/day) . 

Affected in 

Organ Effect Rev. OnSet Sex Exposed - Controls 

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

DEATH 

250000 ppm and 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) 

Secondary Reference : !SIDSP' 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

IRPTC Data Profile 
p. 77 

76 Mammalian Toxicity 

Study 

End Point : MAMMALIAN TOXICITY 

Chemical Name : Urea 

CAS Number : 57-13-6 

Study type : LAB 

Test Subject 

Or, ag' nism Medium Specification Route 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 . 24 wk 

Exposure comments . Urea ointments of 10%, 20% or 40% concentrations were applied to the back 

skin on a 20 cm2 area for 24 weeks. 

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 

End Point : MAMMALIAN TOXICITY 

Chemical Name : Urea 

CAS Number . 57-13-6 

Test Subject 

. 

Or anism Medi 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 : 5000 mg/kg BW 

Test Results 

Mammalian Toxicity 

Affected in 

Organ Effect Rev. OnSet Sex Exposed - Controls 

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

LDLO 

Oral LDLO for rabbits was established 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 

End Point : MAMMALIAN TOXICITY 

Chemical Name . Urea 

CAS Number . 57-13-6 

Test Subject 

" 

Oraanism Medium 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 LDLO for rabbits was established at dose level of 3000-9000 mg/kg body weight. 

Affected in 

IRPTC Data 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 LDLO for 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 

1RPTC Data Profile 
p. 80 

Mammalian Toxicity 79 

Study 

End Point : MAMMALIAN TOXICITY 

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 LDLO for 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 

End Point : MAMMALIAN TOXICITY 

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 

IRPTC Data Profile 
$o Mammalian Toxicity 

Test Results 

Affected in 

Organ Effect Rev. OnSet Sex Exposed - Controls 

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

LDLO 

Oral LDLO for 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) 

IRPTC Data Profile 
p. 82 

Carcinogenicity 81 

Study 

End Point : CARCINOGENICITY 

Chemical Name : Urea 

CAS Number . 57-13-6 

Study type : LAB 

Test Subject 

" 

Organism Medium 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 from all dose groups were 

necropsied at the end of the treatment period, and the gonads were 

histologically examined . No pathology was reported . After further 4 months of 

follow up all survivors were killed, necropsied and the tissues were fixed . 

However, concerning the reproductive organs, histological tumor data on the 

ovary and the uterus only were given . Other sex organs may not have been 

histologica!ly studied . 

References 

Primary Reference : JEPTDCd 

Fleischman, R. W. et al . 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) 

IRPTC Data 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 344 rats 

Test Method and Conditions 

Test method : Chronic toxicity and carcinogenicity screening study 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 from all dose groups were 

necropsied at the end of the treatment period, and the gonads were 

histologically examined . No pathology was reported . After further 4 months of 

follow up all survivors were killed, necropsied and the tissues were fixed . The 

testes, prostate and uterus were histologically examined for the occurrence of 

tumours. Although there was a statistically increased incidence of interstitial 

cell adenomas of the testis in the high dose group, its biological significance 

was deemed questionable, since the lesions may occur in 100% of controls . 

References 

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) 

IRPTC Data 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 typhimurium TA98, 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) 

IRPTC Data 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 typhimurium TA98, 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 . Japanese Journal 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) 

IRPTC Data 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 typhimurium TA98, 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 

Minimum concentration 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) 

IRPTC Data 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) 

Secondary Reference : !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 m Medium 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 216 mmolar 

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 

Study type . LAB 

Test Subject 

" 

Organism Medium Specification Route Lifestaae Sex Number exposed Number controls 

MOUSE VTR 

Species/strain/system : Mouse lymphoma heterozygous L5178Y TK+/- 

IRPTC Data 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) 

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 

" 

r nism Medium SAecification Route L'fes e Sex Number exposed Number controls 

MOUSE VTR 

Species/strain/system : Mouse lymphoma L5178Y TK+/- 

IRPTC Data Profile 
p. 90 

Mutagenicity as 

Test Substance 

Purity Grade . AG 

Test Method and Conditions 

Test method . Analysis for DNA singlestrand 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 

IRPTC Data Profile 
p. 91 

90 Mutagenicity 

Exposure 

Exposure Type . SHORT 

Exposure Period . 5 d 

Dose / Concentration : 500 mg/ ANIMAL 

Exposure comments : Mice were fed with urea 500 mg per animal per day in food for 5 days (dosage 

approaching an acute lethal dose). 

Test Results 

Affected in 

Organ Effect Rev. OnSet Sex Exposed - Controls 

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

CHROM STRIIC 

Bone marrow cell, 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 

End Point 

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 DNA singlestrand 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. 

IRPTC Data 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) 

lRPTC Data Profile 
92 Sensitization 

Study 

End Point . SENSITIZATION 

Chemical Name : Urea 

CAS Number . 57-13-6 

Test Subject 

Organism Medium Specification Route Lifestaoe Sex 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) 

IRPTC Data 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) 

Secondary Reference : !SIDSP" 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

IRPTC Data Profile 
94 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 . 100 gIL 

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 

IRPTC Data 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 

IRPTC Data Profile 
p. 97 

9s Irritation 

Exposure 

Exposure Period . 20 h 

Dose / Concentration : 500 gIL 

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 

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 

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) 

IRPTC Data Profile 
Irritation 97 

References 

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) 

IRPTC Data Profile 
p. 99 

9$ Reproduction 

Study 

End Point . 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) 

IRPTC Data Profile 
p. 100 

Teratogenicity 99 

Study 

End Point . TERATOGENICITY 

Chemical Name : Urea 

CAS Number : 57-13-6 

Study type : LAB 

Test Subject 

" 

Organism Medium 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 

IRPTC Data Profile 
p. 101 

100 Teratogenicity 

Test Substance 

Purity Grade : AG 

Vehicle - Solvent . Distilled water 

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 group was 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 

End Point . TERATOGENICITY 

Chemical Name : Urea 

CAS Number . 57-13-6 

Study type . LAB 

Test Subject 

" 

Or, anism Medium Specification Route Lifestaoe Sex 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 

1RPTC Data 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 

A single dose of 2000 mg/kg was administered orally to 10 pregnant mice on 

day 10 of pregnancy. 

Affected in 

Rev. OnSet Sex Exposed - Controls 

No effects 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 Medium 

RAT 

TERATOGENICITY 

Urea 

57-13-6 

LAB 

" 

Specification Route 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 

A single dose of 2000 mg/kg was administered to 4 pregnant rats on day 12 of 

pregnancy . 

IRPTC Data 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 . Not teratogenic. OECD/SIDS comment: "not an adequate teratogenicity study" . 

References 

Primary Reference : TJADAB 

Teramoto et al . Teratology, Journal of Abnormal Development, 23, 335-342, 

(1981) 

Secondary Reference 

Study 

End Point 

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) 

IRPTC Data Profile 
p. 105 

104 Aquatic Acute Toxicity 

Study 

End Point 

Chemical Name 

CAS Number 

Study type 

Geographic Area 

AQUATIC ACUTE 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 Medium SDec. Route Lifestaae Sex Effect Effect Comments 

" 

MOLL AQ FRESH EGG LC50 LC50 for 24 hours for egg = 14241 

JUV mg/L; LC50 for 24 hours for juveniles = 

18255 mg/L; LC50 for 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 . AQUATIC ACUTE TOXICITY 

Chemical Name . Urea 

CAS Number : 57-13-6 

Study type : LAB 

Geographic Area 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 LC50 for 4 hours = 60000 mg/L. 

" 

IRPTC Data Profile 
Aquatic Acute Toxicity 105 

References 

Primary Reference . JIVPAZ 

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

Secondary Reference : !SIDSP* 

OECD/SIDS. Screening Information Data Set (SIDS) of OECD High 

Production Volume Chemicals Programme, (1994) 

Study 

End Point . AQUATIC ACUTE TOXICITY 

Chemical Name . Urea 

CAS Number . 57-13-6 

Study type : LAB 

Geographic Area . FIN 

Species/strain/system : Barilius barna 

Test Method and Conditions 

Test method : Static 

description 

Test Results 

Oroanism Medium ,Spec. Route Lifestag_e Sex Effect Effect Comments 

FISH AQ LC50 LC50 for 96 hours > 9100 mg/L. 

General Comments . Urea is not acutely toxic to fish . 

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) 

IRPTC Data Profile 
p. 107 

106 Aquatic Toxicity 

Study 

End Point : AQUATIC TOXICITY 

Chemical Name . Urea 

CAS Number . 57-13-6 

Study type : LAB 

Geographic Area . 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 toxic to 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 

Geographic Area : FIN 

Test Subject 

" 

r nism Medium Specification Route Lifestaae Sex Number exposed Number controls 

PROTO AQ FRESH 

Species/strain/system : Flagellate (Entosiphon sulcatum) 

IRPTC Data 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 

chloroform was > 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) 

1RPTC Data Profile 
p. 109 

108 Aquatic Toxicity 

Study 

End Point 

Chemical Name 

CAS Number 

Study type 

Geographic Area 

Test Subject 

AQUATIC TOXICITY 

Urea 

57-13-6 

LAB 

FIN 

" 

Organism Medium &ecification Route Lifestage Sex 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 

Photobacterium Luminescence 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 toxic action 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 : AQUATIC TOXICITY 

Chemical Name : Urea 

CAS Number . 57-13-6 

Study type . LAB 

Geographic Area . FIN 

Test Subject 

" 

Organism Medium Specification Route Lifestaae Sex Number exposed Number controls 

BACT AQ MARIN 

Species/strain/system . Bioluminiscent bacteria (Photobacterium luminescence) 

IRPTC Data Profile 
p. 110 

Aquatic Toxicity ' 

Test Method and Conditions 

Test method 

description 

Test Results 

Microtox Photobacterium Luminescence Test. Single species tests such as 

"Microtox Photobacterium Luminescence Test: and tests on overall processes 

such as nitrification or soil respiration are included in this item . GLP: no 

known 

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 . ASTM Special Technical Publication Aquatic Toxicology and 

Hazard Assessment, ASTM STP 737, 338-347 

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 

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 

EC50 for 24 hours > 10000 mg/L. 

General Comments : Urea is not acutely toxic to daphnids . 

IRPTC Data Profile 
110 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 . AQUATIC TOXICITY 

Chemical Name : Urea 

CAS Number : 57-13-6 

Study type : LAB 

Geographic Area . FIN 

Test Subject 

r anism Medium SRecification Route 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 

LCO for 48 hours > 10000 mg/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) 

IRPTC Data Profile 
p. 112 

Aquatic Toxicity 1 

Study 

End Point . AQUATIC TOXICITY 

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 not specified 

description 

Test Results 

Affected in 

Organ Effect Rev. OnSet Sex Exposed - Controls 

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

LCO 

LCO for 96 hours = 20000 mg/L. ; 

LC50 

LC50 for 96 hours = 22500 mg/L. ; 

LC100 

LC100 for 96 hours = 25000 mg/L 

BW DECR 

BW SIZE 

BBHAV 

When the fish was reared in different sublethal concentrations (5, 10, 15 and 20 g/L, test period 25 days) of 

urea, there was a decrease in feeding and growth rates . In addition to the realized energy from food 

consumption, the fish lost reserve energy at the highest concentration of 

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) 

tRPTC Data Profile 
p. 113 

112 Terrestrial Toxicity 

Study 

End Point : TERRESTRIAL TOXICITY 

Chemical Name . Urea 

CAS Number . 57-13-6 

Study type : LAB 

Geographic Area . 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 : earthworm numbers 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 loam soil . 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) 

IRPTC Data Profile 
p. 114 

Study 

End Point : TERRESTRIAL TOXICITY 

Chemical Name . Urea 

CAS Number : 57-13-6 

Study type : LAB 

Geographic Area . FIN 

Test Subject 

" 

r anism Medium 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 

Photobacterium Luminescence 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 

Geographic Area : FIN 

Test Subject 

" 

Or aa nism Medium SDecification Route Lifestaae Sex Number exoosed Number controls 

BIRD TERR 

Species/strain/system . Pigeon 

IRPTC Data 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 Sex 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 

Maximum concentration at which no effect was observed within the period of the test < 0.01 wt % urea of dry 

weight of leaves (= 9 mg/leaf, a 7-day study) . 

General Comments : It was concluded in this study that necrosis resulted from accumulation of toxic 

amounts of urea rather than from formation of toxic amounts of ammonia. 

1RPTC Data Profile 
Terrestrial 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) 

IRPTC Data 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 to ion Level / Summary Information 

Last Amendment : 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 PERMITTED FOR CO NTACT WITH FOOD AND GOODS MXL THE HUMAN BODY. MAXIMUM L IMIT FOR THE FINAL PRODUCTS: 30MG/G . 

rtte : DIRECTIVE NO. 62 ON HYGIENIC REQUIREMENTS ON RUBBERS AND 

RUBBER GOODS COMING IN CONTACT WI TH FOODSTUFFS AND HUMAN 

ORGANISM 

HYGIENICKE PREDPISY MINISTERSTVA ZDRAVOTNICl1/l CSR 

(HYGIENIC REGULATIONS OF MINISTRY OF 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 IN COSMETICS: 50MG/C 

MXL Title : DIRECTIVE NO. 34 ON HYGIENIC REQUIREMENTS ON COSMETICS, 

Last Amendment : Entry / Update : DEC 1991 

DETERGENTS, AND GOODS OF PERSONAL USE 

" 

" 

" 

Reference HPMZC" , 32, 1970 Effective Date : 1JAN1971 

HYGIENICKE PREDPISY MINISTERSTVA ZDRAVOTNICTVI CSR 

(HYGIENIC REGULATIONS OF MINISTRY OF HEALTH OF CSR) 

Last Amendment : 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, LIMITATIONS AND SAFETY 

PRECAUTIONS ARE GIVEN. 

Title : LIST OF PERMITTED CHEMICALS FOR PLANT PROTECT ION 

SEZNAM POVOLENYCH 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 : 

ast Amendment : Entry / Update DEC1991 

DEU REC AQ - CLASS THIS SUBSTANCE IS CLASSIFIED AS SLIGHTLY HAZA RDOUS TO WATER (WATER- USE INDST RQR HAZARD CLASS: WGK 1) . (THE DIFFERENT CLASSES ARE: WGK 3 = VERY HAZAR 

DOUS; WGK 2 = HAZARDOUS; WGK 1 = SLIGHTLY HAZ ARDOUS; WGK 0 = IN GENERAL 

NOT HAZARDOUS.) TH E CLASSIFICATION FORMS THE BASIS FOR WATER-PR 

OTECTION REQUIREMENTS FOR INDUSTRIAL PLANTS I N WHICH WATERHAZARDOUS SUBSTANCES ARE HANDLE D. 

Title : ADMINISTRATIVE RULES CONCERNING WATER-HAZARDO US 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 C SUBSTANCE: DISCHARGE INTO THE SEA IS PROHIBITED; DISCHARGE OF TANK WASHINGS AND RESIDUAL MIXTURES IS SUBJECT TO RESTRICTIONS . (APPLIES TO SOLUTION WITH AMMONIUM NITRATE CONTAINING AQUA AMMONIA). 

Title : THE MERCHANT SHIPPING (CONTROL OF POLLUTION B Y NOXIOUS LIQUID 

SUBSTANCES IN BULK) REGULATI ONS 1987, SCHEDULE 1 

Reference GBRSI" , 551, 15, 1987 Effective Date : O6APR1987 

Statutory Instruments 

Last Amendment : GBRSI', 2604, 2, 1990 Entry / Update : 1992 

Statutory Instruments 

IRPTC Data 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 (CONTROL OF POLLUTION B Y NOXIOUS LIQUID 

SUBSTANCES IN BULK) REGULATI ONS 1987, SCHEDULE 1 

GBR REG TRNSP MARIN RQR CATEGORY D SUBSTANCE: DISCHARGE INTO THE SEA IS PROHIBITED; DISCHARGE AQ MARIN RSTR OF RESIDUAL MIXTURES IS SUBJECT TO RESTRICTIONS. (APPLIES TO UREA AQ EMI RSTR SOLUTION WITH AMMONIUM MONO-HYDROGEN PHOSPHATE, AMMONIUM DIHYDROGEN PHOSPHATE AND POTASS iUM CHLORIDE, APPLIES ALSO TO UREA 

SOLUTION W ITH AMMONIUM NITRATE, AND ALSO TO UREA SOLUTI ON WITH 

AMMONIUM PHOSPHATE). 

Substance 

Chemical Name : UREA 

Reported Name . urea 

CAS Number . 57-13-6 

T= Subiec ec. Descri tp ion Level /Summary Information : 

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 tv ion Level / Summarv Infomiation 

" 

KEN REG FOOD ADDIT PRMT FOOD ADDITIVE PERMITTED AS YEAST FOOD. FOOD P RODUCTS IN OR UPON WHICH 

IT IS PERMITTED ANDM AXIMUM LEVELS OF USE ARE LISTED. 

Title : THE FOOD, DRUGS AND CHEMICAL SUBSTANCES (FOOD LABELLING, 

ADDITIVES AND STANDARDS) 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 

Last Amendment : GBRSI`, 2604, 2, 1990 Entry / U d~: 1992 

Statutory Instruments 

" 

" 

CLASSIFIED AS A NON-POLLUTING LIQUID SUBSTANC E. DOCUMENTARY EVIDENCE OF ASSESSMENT AND APP ROVAL REQUIRED BY A CARRIER. DISCHARGE INTO T HE SEA IS NOT PROHIBITED. (APPLIES TO SOLUTIO N). 

Title : THE MERCHANT SHIPPING (CONTROL OF POLLUTION B Y NOXIOUS 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 

Last Amendment : 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 / Summa/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) 

ZAGRYAZNYAYUSHCHIKH VESHCHESTV V ATMOSFERNOM 

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 WATER FOR FISHING : 80.0 MG/L 

Title : 

Reference Effective Date : 

Last Amendment : PDKTV-, 1978 Entrv / Update : 

" 

SEP1985 

PREDELNO-DOPUSTIMYE KONTSENTRATSII I 

ORIENTIROVOCHNYE BEZOPASNYEUROVNI VOZDEISTVIA 

VREDNYKH VESHCHESTV V OBIEKTAKH VNESHNE1 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) HAZARD CLASS: II 

CLASS T)tfe : 

" 

Reference Effective Date : 01JAN1989 

Last Amendment : GOSTS-, 12 .1 .005, 1988 Entry / Update MAY1990 

GOSUDARSTVENNYI STANDART SSSR 

(STATE STANDARD OF USSR) 

IRPTC Data 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 : 

Last Amendment : GOSTS-, 12.1 .005, 1988 Entry / Update MAY1990 

RUS REG AIR OCC MAC CLV: 25MG/M3 (VAPOUR, AEROSOL APPLIES TO FERTILIZER MD(T . WITH AMMONIA); 

CLASS HpZ, CLASS: IV 

Title : 

Reference Effective Date : 1 JAN 7 989 

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 NCLUDED ON A LIST OF ACTIVE 

INGREDIENTS CONTA INED IN A PRODUCT FIRST REGISTERED BEFORE NOV EMBER 

1, 1984, FOR WHICH A REGISTRATION STAND ARD HAS NOT BEEN ISSUED . 

PUBLICATION OF THIS LIST INITIATES AN ACCELERATED REREGISTRATION AND 

DATA C ALL-IN FOR PRODUCTS CONTAINING THE LISTED ACTIVE INGREDIENTS. 

Title : FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICI DE ACT PESTICIDES 

REQUIRED TO BE REREGISTERED ; LIST D 

Reference FEREAC, 54, 204, 43388, 1989 Effective Date , 1989 

Federal Register 

Last Amendment : 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 MAY BE MARKETED AS FEED INGSTUFF UNDER THE 

CONDITIONS LAID DOWN. 

Title : COUNCIL DIRECTIVE OF 30 JUNE 1982 CONCERNING CERTAIN PRODUCTS 

USED IN ANIMAL NUTRITION (82 /471/EEC) . 

Reference OJEC°, L213, 8, 1982 ENective Date : 01JUL1988 

Official Journal of the European (Communities)/Union 

Last Amendment : OJEC"-, L239, 36, 1988 Entrv / Update SEP1987 

Official Journal of the European (Communities)/Union 

1RPTC Data Profile 
Recomendations/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 FOR THE MANUFACTURE OF REGENERATED 

FOOD MXL CELLULOSE FILM WHICH IS INTEN DED TO OR DOES COME INTO CONTACT WITH 

FOOD RSTR FOODSTU FFS . IT MAY BE USED AS SOFTENER; MAXIMUM CONT ENT OF SOFTENERS 

IN TOTAL : 27% . Title : COUNCIL DIRECTIVE OF 25 APRIL 1983 ON THE APP ROXIMATION OF THE 

LAWS OF THE MEMBER STATES R ELATING TO MATERIALS AND ARTICLES 

MADE OF REG ENERATED CELLULOSE FILM INTENDED TO COME INTO 

CONTACT WITH FOODSTUFFS. (83/229/EEC) . 

_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 C substance (substance which is slightly toxic to aquatic life) : discharge into the sea of 

AQ MARIN RSTR this substance, of ballast water, tank washings or other residues or mixtures containing such a 

substance shall be prohibited except where specified conditions are satisfied. 

Technological requirements prescribe equipments and designs that must be present on the 

tankers as well as port facilities for receiving residues or mixtures containing the regulated 

substance . Technical assistance for training of scientific and technical personnel shall be 

promoted where requested by the Parties of the Convention . (Applies to urea/ammonium 

nitrate solution containing aqua ammonia) 

Title : International Convention for the Prevention of Pollution from Ships, 1973 . as modified 

by the Protocol of 1978 relating thereto (MARPOL 73178) . 

Reference Effective Date : 

LastAmendment : IMODC', EntN/U dp ate : SEP1994 

IRPTC Data Prorile