OECD SIDS UREA

UNEP PUBLICATIONS

FOREWORD INTRODUCTION

UREA

CAS N°: 57-13-6
Identifiers, Physical and Chemical properties 1

CAS Number : 57-13-6

End Point : IDENTIFIERS, PHYSICAL AND CHEMICAL PROPERTIES

Substance

Chemical Name : Urea

Common Name : Urea

RTECS Number : YR6250000

Properties & Definitions

Molecular Formula : CH4N2O

Molecular Weight : 60.06

Melting Point : 133C*

Boiling Point : 135C decomposition**

State : Crystal prismatic or powder

Flamable Limit : Non-flammable

Density : 1323 kg/m3 at 20-24C

Vapour Pressure : 80 Pa (0.6 mmHg) at 20C CAL***

Octanol/Water Partition : 

Coefficient 

-1.59 at 20-25C experimental

Water Solubility : 1080 g/L at 20C

Solubility in other : 

Solvents 

10 g/L in 95% alcohol, 167 g/L in methanol, 500 g/L in glycerol

Colour : Colourless to white

Taste : Cooling, saline

Odour : Almost odourless

Additives : Urea-formaldehyde binder can be used in some prilling processes.

Impurities : Biuret 0.3 - 2 wt%; cyanates. Analysis of technical urea gave the

followings: water (as moisture) 0.4 wt%; free ammonia 0.4 wt%; Fe

2+ <0.0002 wt%; ash content < 0.02 wt%. Degree of purity 98-99

wt%.

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

or on heating decomposes to NH3 and CO2. ** Urea decomposes before 

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

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

with gallium perchlorate.

Benural 70 B-I-K

Carbamide Carbamimidic acid

Carbonyl diamide Isourea

Nimin Pseudourea

UR Urea perhydrate

Ureaphil Ureophil

Urepearl Urevert

Varioform II

Synonyms

log Pow = 

CURRENTLY OF LOW PRIORITY FOR FURTHER WORK

SIDS INITIAL ASSESSMENT

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

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

biodegradability test.

Overall Evaluation

IRPTC Data 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% of urea is used as a fertilizer, the highest 

environmental exposure is to soil. Urea is, however, relatively leachable from the soil into the surface and the 

groundwater because of its weak adsorption to the soil, high water solubility and low soil-water partition 

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

rainfall. 

(iii) Water

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

concentration of urea itself, however, is not generally detected, because of its high degradation rate. Therefore 

usually degradation products e.g. nitrate, nitrite and ammonium can be measured.

Some monitoring data are, however, available: 

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

mg/L.

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

The monitoring data has been further used for calculation of the predicted environmental concentration (PEC). 

For calculation of PEC the dilution factors of 10 for domestic waste water effluents and 100 for industrial 

effluents are used. Thereby (a) PEC of 0.0016 - 0.0043 mg/L is obtained for primary sewage plant effluent and 

(b) PEC of 0.0034 mg/L for fertilizer factory.

Environmental exposure by consumer use can be considered insignificant.

CONSUMER EXPOSURE

Because urea is an important endogenous product of protein catabolism in mammals and occurs in significant 

concentrations in blood and obviously in extracellular water, human food of animal origin contains some urea. If 

meat contained the same concentration of urea as human blood (about 30 mg/100 g), intake of urea from meat 

would amount to some tens of milligrams per day. Edible parts of plants may contain up to 4.5 per cent (oats) 

of their total nitrogen content as urea. The nitrogen content of grain seeds and grass is of the order 2-4%. If one 

per cent of the total nitrogen were urea (consequently 0.03% of the fresh weight of food of plant origin were 

urea), the human daily intake of urea from plants could amount up to several grams. However, due to the very 

limited data available concerning actual urea concentrations in e.g. root vegetables and potatoes, the 

uncertainties about the quantity are great. The possible food additive use of urea apparently adds litlle to the 

intake via food.

The use of urea in skin preparations (soaps, cosmetics, medicines) may lead to highly variable cutaneous 

doses. The highest doses would concern patients treated extensively because of dry pruritic skin. About 1 per 

cent of the weight of the skin preparation could be absorbed as urea (preparation contains 10% urea, 10% is 

absorbed) resulting mostly in the dermal uptake of some tens of milligrams per day.

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

relatively small quantities.

IRPTC Data 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 5

Urea has been negative in several appropriately conducted bacterial mutagenicity tests. Urea caused DNA 

single strand breaks in mammalian cells in vitro and was clastogenic for mammalian cells in vitro and in vivo 

but only at concentrations much beyond the physiological range (about 50-100 higher concentrations than found 

in human blood).

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

membrane).

e) Any other human health related information that is available

There is little data that relates urea to human health other than its use in dermatology and some more limited 

applications in clinical medicine. The use of urea (at 10% concentration or less) in ointments and creams to 

treat dry skin has been widespread, and long term follow-up studies have indicated that the substance is nonallergenic and virtually free from side effects. Among other clinical therapeutic uses, the treatment of 

inappropriate secretion of antidiuretic hormone (SIADH) should be noted, because its chronic form has involved 

long term oral administration of large amounts of urea. Most patients have tolerated urea well, although 

diarrhoea is sometimes reported after ingestion of 60-90 g/day. One patient who had received 30 g of urea 

(about 470 mg/kg body weight/day) by ingestion for 5 years did not exhibit any side effects.

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

of ammonia generation.

ENVIRONMENTAL ASSESSMENT

In order to calculate the maximum tolerable concentration (MTC), assessment factor 100 is used, because 

NOEC-values were not available and acute L(E)C50-values were available for fish and crustaceans. Toxicity 

Threshold-value (TT) was available for algae representing more longterm than acute toxicity. It can be assumed, 

however, that acute L(E)C50 for algae can not be lower than the available toxicity treshold concentration.

MTC is calculated for the most sensitive species, protozoa flagellata (Entosiphon sulcatum) where the lowest 

aquatic effect concentration, toxicity treshold (TT) (72 hours) of 29 mg/L, has been recorded:

 MTC: 29/100 = 0.29 mg/L

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

 MTC/PEC => (a) 0.29/0.0043 = 67.4 (primary sewage plant effuent)

 (b) 0.29/0.0034 = 85.3 (sewage of Kemira's fertilizer factory)

The degradation product of urea, ammonia, is known to be toxic to all vertebrates. In neutral and acidic 

conditions, however, ammonia exists in the form of ammonium.

HUMAN HEALTH ASSESSMENT

Urea is an endogenous product of protein and aminoacid catabolism, and consequently

20-35 g of urea is excreted daily in human urine. The blood concentration of urea is also relatively high, 3.3-6.7 

mmol/L. Non-physiological, 50-100 times higher urea concentrations in the cultivating medium were shown to 

disrupt DNA and elicit genotoxicity in mammalian cells, apparently through non-specific osmotic mechanisms. It 

can be expected that the human organism is well adapted to urea within the physiological range of 

concentrations and even beyond. This is supported by clinical evidence from high dose administration orally and 

intravenously for therapeutic purposes.

The bulk of human exposure to urea apparently results from urea ingestion through plant food and meat. Actual 

measurements concerning the urea content of food were not found, however, and therefore no certain or 

accurate amounts can be given. Among the consumers, patients using urea containing preparations for the 

treatment of dry skin may receive an additional but minor dose. Occupational exposure (via inhalation, ingestion 

and dermally) adds little to the amounts received from food.

The estimated human exposure (EHE) level for urea can only be given very crudely, and it can probably vary 

widely depending on the food consumed. As a tentative value 3 g/day (about 40 mg/kg body weight/day) is 

proposed.

Due to the fact that urea has not been rigorously examined with toxicity testing, meaningful NOAELs from 

animal studies are difficult to find. Especially it may be noted that the existing studies for reproductive and 

developmental toxicity are not adequate. However, chronic toxicity and carcinogenicity screening studies of urea 

IRPTC Data Profile 
6 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 mg/kg body weight/day of urea over 5 years did not cause adverse 

effects.

The estimated dose of low concern (EDLC) from animal data, using 100 as the uncertainty factor, would give 20-

60 mg/kg body weight/day but, as presented above, clinical experience shows that more than ten times higher 

dose levels in human patients have resulted in little or no adverse effects, even over relatively long periods of 

time. A further perspective to the EDLC assessment is the endogenous rate of urea formation (excretion), up to 

about 500 mg/kg body weight/day.

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

EHE. 

CONCLUSIONS

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

health and the environment.

Based on the MTC/PEC-ratio urea is considered to possess low current concern. Urea has generally low acute 

ecotoxicity to organisms. The degradation product of urea, ammonia, is known to be toxic to all vertebrates. In 

neutral and acidic conditions, however, ammonia exists in the form of ammonium.

Instead of toxic effects, more emphasis should be put on the indirect influence of urea to the environment via 

eutrophication and the pollution risk of urea to groundwater, when urea is used as a fertilizer and a deicer agent 

in airports. Also the longterm influence of urea use e.g. soil acidification after the longterm fertilization and 

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

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

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

mammalian species (ruminants are more sensitive because of microbial ammonia production) and humans at 

reasonable dose levels. Based on the EHE/EDLC ratio, urea should be of low current concern to human health.

RECOMMENDATIONS

No further tests are needed.

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

IRPTC Data Profile 
Production-Trade 7

CAS Number : 57-13-6

Production-Trade

Geographic Area : WORLD

Chemical Name : Urea

1985-1989

Production

19062400-27963000 t/y - P

41440000-60789000 t/y - P

89800000-+134E+5 t/y - P

Quantity Year

1985-1989

1989

General Comments : 1- The total production volume of urea in metric tons of N (urea N-46%)in the 

world. 2- World total production volume of urea. 3- Capacities in production or 

being commissioned in December 1989 (reported in: Information Chimie No. 

315, March , pp. 179-201, (1990).

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : USA

Area Specifications : AMN

Chemical Name : Urea

1985-1989

Production

1470000-2350000 t/y - P

13 % - EX

Quantity Year

General Comments : The given values are the production volume tonnes per annum of nitrogen 

(urea N-46%). The data related to the export reported in the Altman, P. L., 

Dittmer, D. S. Biology Data Book, Vol III, 2nd ed., Federation of American 

Societies for Experimental Biology, 1974, pp. 1494 & 1501.

IRPTC Data Profile 
8 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)

CAS Number : 57-13-6

Production-Trade

Geographic Area : AMN

Chemical Name : Urea

Production

11599000-+630000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

INFCAS

Information Chimie, 315, 179-201, (1990)

CAS Number : 57-13-6

Production-Trade

Chemical Name : Urea

Production

31635000-+3617000 t/y - P

Quantity Year

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

Economy Countries.

IRPTC Data Profile 
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)

CAS Number : 57-13-6

Production-Trade

Geographic Area : EUR

Area Specifications : W

Chemical Name : Urea

Production

6215000-+250000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

INFCAS

Information Chimie, 315, 179-201, (1990)

CAS Number : 57-13-6

Production-Trade

Chemical Name : Urea

Production

3419000-+1150000 t/y - P

Quantity Year

General Comments : Capacities in production or being commissioned in December 1989 for Central 

and South America.

IRPTC Data 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)

CAS Number : 57-13-6

Production-Trade

Geographic Area : AFRI

Chemical Name : Urea

Production

2957000-+575000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

INFCAS

Information Chimie, 315, 179-201, (1990)

CAS Number : 57-13-6

Production-Trade

Geographic Area : ASIA

Chemical Name : Urea

Production

5295000-+2550000 t/y - P

28728000-+4650000 t/y - P

Quantity Year

General Comments : 1- Capacities in production or being commissioned in December 1989 in 

Middle East and Persian Gulf. 2- Capacities in production or being 

commissioned in December 1989 in Asia and Oceania.

IRPTC Data Profile 
Production-Trade 11

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

INFCAS

Information Chimie, 315, 179-201, (1990)

CAS Number : 57-13-6

Production-Trade

Geographic Area : EUR

Chemical Name : Urea

1985-1989

Production

7144900-8321000 t/y - P

Quantity Year

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

Europe.

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : ASIA

Chemical Name : Urea

1985-1989

Production

8063500-12185000 t/y - P

Quantity Year

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

IRPTC Data Profile 
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)

CAS Number : 57-13-6

Production-Trade

Geographic Area : NGA

Area Specifications : AFRI

Chemical Name : Urea

1987-1988

Production

70000-230000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : CAN

Area Specifications : AMN

Chemical Name : Urea

1985-1989

Production

1000000-3000000 t/y - P

Quantity Year

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

IRPTC Data Profile 
Production-Trade 13

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : CUB

Chemical Name : Urea

1985-1989

Production

20000-38000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : MEX

Chemical Name : Urea

1985-1988

Production

500000-640000 t/y - P

Quantity Year

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

IRPTC Data Profile 
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)

CAS Number : 57-13-6

Production-Trade

Geographic Area : TTO

Chemical Name : Urea

1985-1989

Production

150000-250000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : AFG

Area Specifications : ASIA

Chemical Name : Urea

1985-1989

Production

45000-60000 t/y - P

Quantity Year

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

IRPTC Data Profile 
Production-Trade 15

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : BDG

Area Specifications : ASIA

Chemical Name : Urea

1985-1989

Production

380000-680000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : IND

Area Specifications : ASIA

Chemical Name : Urea

1985-1989

Production

3400000-5750000 t/y - P

Quantity Year

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

IRPTC Data Profile 
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)

CAS Number : 57-13-6

Production-Trade

Geographic Area : IDN

Area Specifications : ASIA

Chemical Name : Urea

1986-1989

Production

1800000-2240000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : IRN

Area Specifications : ASIA

Chemical Name : Urea

1986-1988

Production

50000-100000 t/y - P

Quantity Year

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

IRPTC Data Profile 
Production-Trade 17

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : JPN

Area Specifications : ASIA

Chemical Name : Urea

1985-1989

Production

300000-350000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : KWT

Area Specifications : ASIA

Chemical Name : Urea

1985-1989

Production

260000-400000 t/y - P

Quantity Year

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

IRPTC Data Profile 
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)

CAS Number : 57-13-6

Production-Trade

Geographic Area : PAK

Area Specifications : ASIA

Chemical Name : Urea

1985-1989

Production

835000-970000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : QAT

Area Specifications : ASIA

Chemical Name : Urea

1985-1989

Production

320000-360000 t/y - P

Quantity Year

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

IRPTC Data Profile 
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)

CAS Number : 57-13-6

Production-Trade

Geographic Area : SAU

Area Specifications : ASIA

Chemical Name : Urea

1985-1989

Production

400000-450000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : SYR

Area Specifications : ASIA

Chemical Name : Urea

1985-1989

Production

50000-90000 t/y - P

Quantity Year

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

IRPTC Data Profile 
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)

CAS Number : 57-13-6

Production-Trade

Geographic Area : TUR

Area Specifications : ASIA

Chemical Name : Urea

1985-1988

Production

70000-160000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : ARE

Area Specifications : ASIA

Chemical Name : Urea

1985-1989

Production

150000-260000 t/y - P

Quantity Year

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

IRPTC Data Profile 
Production-Trade 21

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : VNM

Area Specifications : ASIA

Chemical Name : Urea

1985-1988

Production

3500-15000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : BGR

Area Specifications : EUR

Chemical Name : Urea

1985-1989

Production

330000-370000 t/y - P

Quantity Year

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

IRPTC Data Profile 
22 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)

CAS Number : 57-13-6

Production-Trade

Geographic Area : CSK

Area Specifications : EUR

Chemical Name : Urea

1987-1989

Production

70000-80000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : FRG

Area Specifications : EUR

Chemical Name : Urea

1987-1989

Production

500000-520000 t/y - P

Quantity Year

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

IRPTC Data Profile 
Production-Trade 23

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : HUN

Area Specifications : EUR

Chemical Name : Urea

1985-1989

Production

120000-200000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : IRL

Area Specifications : EUR

Chemical Name : Urea

1986-1988

Production

127000-147000 t/y - P

Quantity Year

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

IRPTC Data Profile 
24 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)

CAS Number : 57-13-6

Production-Trade

Geographic Area : ITA

Area Specifications : EUR

Chemical Name : Urea

1985-1989

Production

460000-600000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : NLD

Area Specifications : EUR

Chemical Name : Urea

1985-1987

Production

380000-570000 t/y - P

Quantity Year

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

IRPTC Data Profile 
Production-Trade 25

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : POL

Area Specifications : EUR

Chemical Name : Urea

1985-1989

Production

240000-470000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : PRT

Area Specifications : EUR

Chemical Name : Urea

1985-1988

Production

4900-9000 t/y - P

Quantity Year

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

IRPTC Data Profile 
26 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)

CAS Number : 57-13-6

Production-Trade

Geographic Area : ESP

Area Specifications : EUR

Chemical Name : Urea

1985-1989

Production

113000-165000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : YUG

Area Specifications : EUR

Chemical Name : Urea

1988

Production

0-240000 t/y - P

Quantity Year

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

IRPTC Data Profile 
Production-Trade 27

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : RUS

Area Specifications : EUR

Chemical Name : Urea

1987-1989

Production

4800000-4950000 t/y - P

Quantity Year

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

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : AMN

Chemical Name : Urea

1985-1989

Production

3140000-6278000 t/y - P

Quantity Year

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

and central America.

IRPTC Data Profile 
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)

CAS Number : 57-13-6

Production-Trade

Geographic Area : WORLD

Chemical Name : Urea

1985-1989

Production

41440000-60789000 t - P

Quantity Year

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

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

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

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

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

Gulf States in general; Indonesia, India and China.

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

FAOSS*

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

CAS Number : 57-13-6

Production-Trade

Geographic Area : FIN

Chemical Name : Urea

IRPTC Data Profile 
Production-Trade 29

1986

Production

13640 t/y - P

1550 t/y - P

8210 t/y - P

610 t/y - P

34010 t/y - P

40000-60000 t/y - IM

Quantity Year

1986

1986

1986

1986

General Comments : Estimated urea production of livestock in Finland. (Estimation is based on 

statistical figures of year 1986). Animal species and total number of animals 

are as follows: 1) cattle 942300; 2) Swine 1030700; 3) poultry 7035600; 4) 

horses 38700. Total urea produced = 34010 tonnes/year, to be compared with 

total urea import to Finland.

References

!SIDSP*

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

Production Volume Chemicals Programme, (1994)

ENFAF*

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

Finland : Litterature Survey, D/39, (1987)

IRPTC Data Profile 
30 Processes

CAS Number : 57-13-6

Chemical Name : Urea

Processes

Process comments : In modern synthetic processes, urea is made by reacting ammonia and 

carbon dioxide at high pressure and temperature to form ammonium 

carbonate and simultaneously dehydrating the ammonium carbonate to 

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

a natural end product of biochemical protein decomposition and the 

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

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

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

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

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

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

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

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

Process

References

Secondary Reference : !SIDSP*

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Uses 31

CAS Number : 57-13-6

Uses

Chemical Name : Urea

Use

3 %

1 %

Quantity Year

Use in agriculture: Urea is widely manufactured and 

distributed as a nitrogenous fertilizer, particularly for 

fibrous-rooted crops such as

rice. It is used extensively as one of the ingredients of 

nitrogen solutions widely used for direct field fertilizer 

application.

Approximate quantity used as an animals feed 

supplement of the grain ration.

Approximate quantity used as an animal feed 

supplement of the total ration.

Comments

References

Primary References : GASTR*

Secondary References : !SIDSP*

Oehme, F. W. and Barrel, D. Veterinary Gastrointestinal Toxicology, 489-490, 

(1986)

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

Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6

Uses

Chemical Name : Urea

Use

wt

1 %

6.4-9.6 %

Quantity Year

Use in consumer products: Urea is used in liquid 

soaps, detergents and houshold cleaning products. It 

is also used in cosmetic products as

creams, shampoos, hair conditioners, hair dyes and 

dye removers, in ammoniated dentifrices etc.

Maximum urea concentration is commonly 1%.

Urea (as 10-15% urea peroxide) in preparations for 

tooth bleaching yield. Following reference is also cited: 

management director Kaj

Svenson, Suomen Teknokemian yhdistys (Cosmetics 

and Detergents Association in Finland).

Comments

References

Primary References : COSDA*

Secondary References : !SIDSP*

Cosmetics and Detergent Association in Finland, (1992)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
32 Uses

CAS Number : 57-13-6

Uses

Geographic Area : USA

Chemical Name : Urea

Use

42 %

31 %

5 %

9 %

Quantity Year

Fertilizer, solid

Fertilizer solutions

Urea-formaldehyde resins and adhesives

Others, including animal feed and melamine

Comments

References

Primary References : CMKRA5

Secondary References : !SIDSP*

Karcher, AR. Chemical Profiles. Chemical Marketing Reporter, 234(13), 54, 

(1988)

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

Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6

Uses

Geographic Area : FIN

Chemical Name : Urea

Use

23 %

68 %

2 %

7 %

Quantity Year

Fertilizer, solid

Urea-formaldehyde resins and adhesives

Deicer on airport runways

Other, including use as a nutrient in waste water 

treatment plant.

Comments

References

Primary References : INFFI*

Secondary References : !SIDSP*

Information from Finnish Industry, (1990)

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

Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6

Uses

Geographic Area : WORLD

Chemical Name : Urea

IRPTC Data Profile 
Uses 33

Use

85-90 %

2-4 %

8-11 %

Quantity Year

Fertilizer

Animal feed

Industrial use

Comments

References

Primary References : CHWKA9

Secondary References : !SIDSP*

Chemical Week, 112(4), 19, (1973)

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

Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6

Uses

Geographic Area : FIN

Chemical Name : Urea

Use

Quantity Year

Types of uses are divided into three: industrial use 

(open system and closed system), public use and 

export. Urea is used in all three sectors.

Industrial use concerns both open and closed systems. 

Use categories: urea is used by the following industrial 

sectors : -Adhesives and sealant production

-Agriculture, field crops -Agriculture, other

-Electrical or electronic products

-Fertilizer -Food, feed and beverage

-Metallurgical

-Organic chemicals, industrial

-Paint and coating -Pigment, dye and printing ink

-Plastic and synthetic resins

-Plating and publishing -Pulp and paper

-Soap and cleaning products

-Textile, primary manufacture -Textile, product

Comments

References

Primary References : ECAPD*

Secondary References : !SIDSP*

Chenier,R. Environment Canada 1974. National Inventory of Sources and 

Emissions of Asbestos, Beryllium, Lead and Mercury. Summary of Emissions 

for 1970, (1991)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
34 Uses

CAS Number : 57-13-6

Uses

Geographic Area : FIN

Chemical Name : Urea

Use

Quantity Year

Urea is used for the following functional uses:

Adhesive/binder/sealant/filter

Analytical reagent

Catalyst/accelerator/inhibitor/activator

Chemical intermediate-organic. Chemical intermediateinorganic, organometallic

Colourant-pigment/stain/dye/ink. Paint/coating additive

Fertilizer

Formulation component

Fragrance/perfume/deodouriser/flavouring agent

Humectant/dewatering aid/dehumidifier/dehydrating 

agent

Monomer

Photosensitive agent-fluorecent agent/brightener/UV 

absorber .

Comments

References

Primary References : ECAPD*

Secondary References : !SIDSP*

Chenier, R. Environment Canada 1974. National Inventory of Sources and 

Emissions of Asbestos, Beryllium, Lead and Mercury. Summary of Emissions 

for 1970, (1991)

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

Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6

Uses

Chemical Name : Urea

Use

Quantity Year

Urea is a key synthetic ingredient in the manufacture of 

resins, glues, solvents and some medecines.

Urea is used as a formulating component in cosmetics, 

detergents, textile dyes and numerous other products.

Comments

IRPTC Data Profile 
Uses 35

References

Primary References : NHCUH*

Secondary References : !SIDSP*

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

90, 3

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
36 Pathways into the Environment and Environmental Fate

CAS Number : 57-13-6

End Point : Pathway into the Environment and Environmental Fate.

Study

Chemical Name : Urea

Test method : 

description 

Mackay level 1 model

Test Method and Conditions

Pathway : LOAD

Pathway and Transport

Quantity Transported

to AQ

to AIR

to AIR

99.84 %

0.16 %

NH3 emission, resulted from degradation of urea to ammonia. Emissions are higher in alkaline soil.

Partitioning into air.

Partitioning into water.

Medium to Medium Quantity Time Year to Year

References

Secondary Reference : !SIDSP*

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

Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6

End Point : Pathway into the Environment and Environmental Fate.

Study

Geographic Area : FIN

Chemical Name : Urea

Pathway : NATUR

Pathway and Transport

APPLI

BIOTA AGRIC

Quantity Transported

to SOIL

to AIR

to SOIL

When 85-90% of urea is used as a fertilizer, the highest environmental exposure is to soil.

Emission from urine of living animals. Reliable estimation of the emission levels cannot be given.

Emission in agriculture from livestock urine when spread on the fields and in the grazing season.

Medium to Medium Quantity Time Year to Year

IRPTC Data Profile 
Pathways into the Environment and Environmental Fate 37

References

Secondary Reference : !SIDSP*

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
38 Concentration

Species/strain/system : Waste water

AQ SEW

AQ GRND

Test Subject

 

Organism Medium Specification Lifestage Sex 

Study type : LAB

CAS Number : 57-13-6

Chemical Name : Urea

End Point : CONCENTRATION

Study

Geographic Area : FIN

Test method : 

description 

The monitoring data has been used for calculation of the predicted 

environmental concentration (PEC). For calculation of PEC the dilution 

factor of 10 for domestic waste water effluent is used.

Test Method and Conditions

Test Results

In domestic sewage

In primary sewage plant effluent

PEC for primary sewage plant effluent

Concentration in groundwater in airport area as of 1980

General Comments : The information concerning the groundwater is reported in the following 

reference: National Board of Waters and the Environment, Finland 

(Unpublished data).

2-6 mg/L

0.016-0.043 mg/L

0.0016-0.0043 mg/L

20 ug/L 1980

Matrix Concentrations Spec. Date

References

Primary Reference : HBEDC*

Secondary Reference : !SIDSP*

Vershueren, K. Handbook of Environmental Data on Organic Chemicals, 

2nd ed., 1178, (1983)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Concentration 39

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

AQ SEW

Test Subject

 

Organism Medium Specification Lifestage Sex 

Study type : FIELD

CAS Number : 57-13-6

Chemical Name : Urea

End Point : CONCENTRATION

Study

Geographic Area : FIN

Test method : 

description 

The monitoring data has been used for calculation of the predicted 

environment concentration (PEC). For calculation of PEC the dilution 

factor of 100 for industrial effluent is used.

Test Method and Conditions

Test Results

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

PEC for fertilizer factory

0.34 mg/L

0.0034 mg/L

Matrix Concentrations Spec. Date

1993

References

Primary Reference : TWEDO*

Secondary Reference : !SIDSP*

Anttalainen, M. Turku Water and Environment District Oral 

Communication, (1994)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
40 Concentration

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

AQ GRND

Test Subject

 

Organism Medium Specification Lifestage Sex 

Study type : FIELD

CAS Number : 57-13-6

Chemical Name : Urea

End Point : CONCENTRATION

Study

Geographic Area : FIN

Test method : 

description 

Analysis of groundwater nitrate, nitrite and ammonium concentrations

Test Method and Conditions

Test Results

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

Due to diminished use amounts of urea in recent years, from 300 tonnes to less than 100 tonnes/year, nitrate 

concentrations slowly decreased to 80 mg/L.

General Comments : It is not likely to detect urea itself in the groundwater, but only its 

degradation products.

150 mg/L

80 mg/L

Matrix Concentrations Spec. Date

1975-1990

References

Primary Reference : #URNWE*

Secondary Reference : !SIDSP*

National Board of Waters and the Environment Unpublished Report

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Concentration 41

HUMAN

Species/strain/system : Physiological concentrations in man

ADULT

Test Subject

 

Organism Medium Specification Lifestage Sex 

Study type : LAB

CAS Number : 57-13-6

Chemical Name : Urea

End Point : CONCENTRATION

Study

Geographic Area : FIN

Test Results

In urine (200-500 mg/kg body weight/day)

In sweat

In blood (200-500 mg/L)

General Comments : The information related to concentration of urea in urine are reported in: 

Harper, H. A. and Rodwell, V. W. Review of Physiological Chemistry, 16th 

ed., Lange Medical Publications, Los Altos California, 1977, page 625.

URINE 20-35 g/24h

BLOOD

120-570 mg/L

3.3-6.4 mmol/L

Matrix Concentrations Spec. Date

References

Primary Reference : FASEB*

Secondary Reference : !SIDSP*

Altman, P. L. and Dittmer, D. S. Biology Data Book, III 2nd ed., 

1494&01, (1974)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
42 Concentration

HUMAN

PLANT

FOOD

SEED

Test Subject

Organism Medium Specification Lifestage Sex 

Study type : LAB

CAS Number : 57-13-6

Chemical Name : Urea

End Point : CONCENTRATION

Study

Geographic Area : FIN

Test Results

In human blood

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

The nitrogen content of grain seeds and grass

General Comments : Due to the very limited data available concerning actual urea concentrations 

in e.g. root vegetables and potatoes, the uncertainties about the quantity 

are great.

BLOOD 30-100 mg/L

4.5 %

2-4 %

Matrix Concentrations Spec. Date

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Determination Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Human Intake and Exposure 43

CAS Number : 57-13-6

Chemical Name : Urea

End Point : HUMAN INTAKE AND EXPOSURE

Study

Evaluation text : Occupational and environmental exposure during production is possible 

due to accidental process breakdown and disorders in reactor 

operations, pumping cycles, evaporation and crystallization processes, in 

maintenance, loading and unloading operations. Potential occupational 

exposure occurs via inhalation of aerosols from urea melt and hot 

saturated solutions , or splashes to skin or eyes, or inhalation of dust. 

Occupational exposure can be also envisaged from inhalation of 

aerosols and dust during production of urea fertilizers and animal feed 

supplements in chemical syntheses using urea as a starting material and 

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

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

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

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

handling of urea.

Evaluations

References

Secondary Reference : !SIDSP*

Screening Information Data Set (SIDS) of OECD High Production 

Volume Chemicals Programme, (1994)

HUMAN

HUMAN

Species/strain/system : Potential anthropogenic sources of exposure are manufacturing, 

industrial, agricultural and consumer uses.

AIR

Test Subject

 

Organism Medium Specification Lifestage Sex 

CAS Number : 57-13-6

Chemical Name : Urea

End Point : HUMAN INTAKE AND EXPOSURE

Study

Geographic Area : FIN

IHL

SKN

Route 

Test Results

The tentative overall dose of urea resulting from the worst- case occupational exposure

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

The airway deposition, most of which will be ingested, results from the non-respirable part of urea at 10 mg/m3 

and 10 m3 ventilation.

200 mg/d

50 mg

100 mg

Intake Spec. Date

IRPTC Data Profile 
44 Human Intake and Exposure

References

Secondary Reference : !SIDSP*

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

Production Volume Chemicals Programme, (1994)

HUMAN

-

Species/strain/system : Potential anthropogenic sources of exposure are manufacturing, 

industrial, agricultural and consumer uses.

FOOD ANI

HUMAN

PLANT AGRIC

AIR

Test Subject

 

Organism Medium Specification Lifestage Sex 

CAS Number : 57-13-6

Chemical Name : Urea

End Point : HUMAN INTAKE AND EXPOSURE

Study

Geographic Area : FIN

ORL

-

IHL

Route 

Test Results

Intake of urea from meat would amount to >10 mg/L per day.

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

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

General Comments : Because urea is an important endogenous product of protein catabolism in 

mammals and occurs in significant concentrations in blood and obviously in 

extracellular water, human food of animal origin contains some urea.

Intake Spec. Date

References

Secondary Reference : !SIDSP*

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

Production Volume Chemicals Programme, (1994)

HUMAN

Test Subject

Organism Medium Specification Lifestage Sex 

CAS Number : 57-13-6

Chemical Name : Urea

End Point : HUMAN INTAKE AND EXPOSURE

Study

Geographic Area : USA

Route 

IRPTC Data Profile 
Human Intake and Exposure 45

Test method : 

description 

The National Occupational Hazard Survey conducted by NIOSH.

Test Method and Conditions

Test Results

General Comments : Probable human exposure: according to the survey in the USA 855894 

workers may be exposed to urea; 7% from actual observed use, 31% from 

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

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

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

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

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

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

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

Hanninen, O. (eds).

References

Primary Reference : HSDBM*

Secondary Reference : !SIDSP*

Hazardous Substances Databank HSDB, 11, (1991)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
46 Biodegradation 

AQ FRESH

Test Subject

Organism Medium Specification

Study type : LAB

CAS Number : 57-13-6

Chemical Name : Urea

End Point : BIODEGRADATION

Study

Geographic Area : FIN

Test method : 

description 

GLP: no

Temperature : 

Test Method and Conditions

<8 C

Test Results

Quantity Time Comments on result

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

up to 14 days.

References

Primary Reference : WATRAG

Secondary Reference : !SIDSP*

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

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

Production Volume Chemicals Programme, (1994)

Species/strain/system : Semi-continuous activated sludge (SCAS)

AQ SLUDG

Test Subject

 

Organism Medium Specification

Study type : LAB

CAS Number : 57-13-6

Chemical Name : Urea

End Point : BIODEGRADATION

Study

Geographic Area : FIN

IRPTC Data Profile 
Biodegradation 47

Test method : 

description 

The diappearance of urea was determined by colorimetric analysis.

Test Method and Conditions

Test Results

Comments on result

24 h

Quantity Time

93-98 % Mean disappearance of urea in 24-hour cycle

General Comments : Urea is biodegradable in semi-continuous activated sludge (SCAS). (Job 

No. 1449006, as cited in the reference).

References

Primary Reference : ANCHAM

Secondary Reference : !SIDSP*

EPA. Analytical Chemistry, 71-8, (1983)

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

Production Volume Chemicals Programme, (1994)

Species/strain/system : Activated sludge from a laboratory sewage treatment facility fed with 

domestic and synthetic sewage; adapted.

AQ SLUDG

Test Subject

 

Organism Medium Specification

Study type : LAB

CAS Number : 57-13-6

Chemical Name : Urea

End Point : BIODEGRADATION

Study

Geographic Area : FIN

Test method : 

description 

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

Test; GLP: no

(An)aerobic : AEROB

Test Method and Conditions

Dose / Concentration :

Exposure

400 mg/L 

IRPTC Data Profile 
48 Biodegradation 

Test Results

52 %

60 %

85 %

96 %

Comments on result

7 h

10 d

14 d

16 d

3 h

Quantity Time

3 % Decomposed urea

Decomposed urea

Decomposed urea

Decomposed urea

Decomposed urea

General Comments : Urea is ultimately biodegradable according to this study. (Proj. No: 

1/91/0452/10/1) as cited in the reference.

References

Primary Reference : #URBSF*

Secondary Reference : !SIDSP*

BASF AG. BASF Unpublished Report, (1991)

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

Production Volume Chemicals Programme, (1994)

Species/strain/system : Flooded soil

AQ

SOIL

Test Subject

 

Organism Medium Specification

Study type : LAB

CAS Number : 57-13-6

Chemical Name : Urea

End Point : BIODEGRADATION

Study

Geographic Area : FIN

Exposure Period : 

Exposure

30 h

Exposure comments : 30 hours of incubation

IRPTC Data Profile 
Biodegradation 49

Test Results

3 %

64 %

Comments on result

30 h

30 h

Quantity Time

A laboratory study demonstrated that the main site of urea hydrolysis in 

flooded soil columns was in the soil and not the floodwater (ureolytic 

bacterial action).

The added urea which was hydrolysed in the floodwater after 30 hours of 

incubation.

The added urea which was hydrolysed in the soil after 30 hours of 

incubation.

Additional studies also showed that soil water content had little effect on 

urease activity, but other researchers have found hydrolysis rates to 

increase with increasing soil water up to field capacity.

General Comments : Report number: D/39/1978

References

Primary Reference : SOSCAK

Secondary Reference : !SIDSP*

Vlek, P. L. G. and Carter, M. C. Soil Science, 136, 56-63, (1983)

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

Production Volume Chemicals Programme, (1994)

-

BACT

SOIL

SOIL

Test Subject

Organism Medium Specification

Study type : LAB

CAS Number : 57-13-6

Chemical Name : Urea

End Point : BIODEGRADATION

Study

Geographic Area : FIN

Test method : 

description 

Transformation times of different nitrogen forms in soil

Temperature : 

Test Method and Conditions

2-20 C

Exposure Period : 

Exposure

1-4 d

IRPTC Data Profile 
50 Biodegradation 

Test Results

50 %

50 %

50 %

50 %

Comments on result

2 d

1 d

6 wk

4 wk

2 wk

1 wk

4 d

Quantity Time

Transformation of urea-N to ammonium-N by urease at 2C

Transformation of urea-N to ammonium-N by urease at 10C

Transformation of urea-N to ammonium-N by urease at 20C

Conversion (transformation of ammonium-N to nitrate-N by bacteria) at 

5C

Conversion (transformation of ammonium-N to nitrate-N by bacteria) at 

8C

Conversion (transformation of ammonium-N to nitrate-N by bacteria) at 

10C

Conversion (transformation of ammonium-N to nitrate-N by bacteria) at 

20C

References

Primary Reference : BUARE*

Secondary Reference : !SIDSP*

Bua. BUA Report on Chemicals of Environmental Relevance, 76

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

Production Volume Chemicals Programme, (1994)

BACT

Species/strain/system : Psychrophilic bacteria

AQ SEW

Test Subject

 

Organism Medium Specification

Study type : LAB

CAS Number : 57-13-6

Chemical Name : Urea

End Point : BIODEGRADATION

Study

Geographic Area : FIN

Temperature : 

Relative Humidity : 

Test Method and Conditions

20 C

2 %

IRPTC Data Profile 
Biodegradation 51

Test Results

10.9 mg/L

4.0 mg/L

3.2 mg/L

Comments on result

1 h

1 h

1 h

1 h

Quantity Time

11.6 mg/L Maximum degradation rate per hour at 20C

Average degradation rate per hour at 20C

Maximum degradation rate per hour at 2C

Average degradation rate per hour at 2C

References

Primary Reference : HBEDC*

Secondary Reference : !SIDSP*

Verschueren, K. Handbook of Environmental Data on Organic 

Chemicals, 2nd. ed., (1983)

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

Production Volume Chemicals Programme, (1994)

BACT SOIL

AQ

Test Subject

Organism Medium Specification

Study type : LAB

CAS Number : 57-13-6

Chemical Name : Urea

End Point : BIODEGRADATION

Study

Geographic Area : FIN

Exposure

Exposure comments : Main factors affecting the rates of nitrogen metabolization are the initial 

concentration of the ureolytic bacteria, the physical state of the nitrifying 

micro-organisms and the concentration of toxic organics.

Test Results

Quantity 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 + HCO3- 2) NH4+ + 1.5 O2 Nitrosomonas ---> NO2- + 

H2O + 2H+ ---> NO2- + 0.5 O2 Nitrobacter ---> NO3-

IRPTC Data Profile 
52 Biodegradation 

References

Primary Reference : AHCBAU

Secondary Reference : !SIDSP*

Gunkel, K. et al. Acta Hydrochimica et Hydrobiologica, 18(1), 3-20, 

(1990)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Hydrolysis 53

CAS Number : 57-13-6

Chemical Name : Urea

End Point : HYDROLYSIS

Study

Geographic Area : FIN

Test method : 

description 

Calculation by PCHYDRO-model. PCHYDRO, a hydrolysis rate 

estimation model, is a part of the US-EPA PCGEMS-modelling system 

(Personal Computer Version of the Graphical Exposure Modelling 

System); GLP: no

Test Method and Conditions

Test Results

Comments on result

>1 y

Quantity Time

50 % Estimated half-life. PCHYDRO-model estimated the urea hydrolysis to 

be extremely slow.

References

Primary Reference : #URNWE*

Secondary Reference : !SIDSP*

National Board of Waters and the Environment Unpublished Report, 

(1994)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
54 Sorption 

Study type : LAB

CAS Number : 57-13-6

Chemical Name : Urea

End Point : SORPTION

Study

Geographic Area : FIN

Medium : -

Specifications : -

SILT LOAM

SOIL SOIL

Test Results

Quantity Time Comments on result

Urea is relatively leachable from the soil into the surface and the 

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

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

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

rainfall.

Urea adsorption coefficient in Crowly silt loam flooded soil column 

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

the concentration of urea water.

General Comments : Urea adsorption by the soil was low. The following reference is also 

cited: Sharply, A. N. et al. 1983. Water, Air and Soil Pollution 14(3): 425-

430 (1983); as cited in HSDB 1991.

References

Primary Reference : SSSJD4

Secondary Reference : !SIDSP*

Hongprayoon, C. et al. Soil Science Society of America Journal, 55, 

1130-34, (1991)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Evaporation 55

Study type : LAB

CAS Number : 57-13-6

Chemical Name : Urea

End Point : EVAPORATION

Study

Geographic Area : FIN

Medium : AQ

Specifications : FRESH

Test Results

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

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

m3/mol) indicate that urea itself will not evaporate from water to 

atmosphere.

References

Secondary Reference : !SIDSP*

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
56 Ecosystems 

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

Test Subject

 

CAS Number : 57-13-6

Chemical Name : Urea

End Point : ECOSYSTEMS

Study

Geographic Area : FIN

Ecosystems : TERR

Description of the test : 

substance 

Nitrogenous fertilizers

Test Substance

Test method : 

description 

Effects monitored: soil pH and micronutrients availabilities.

Test Method and Conditions

Exposure

Exposure comments Physical properties of soil: maximum bulk density 1.49-1.60 mg/m3; 

optimum water content for compaction 0.196-0.219 kg/kg; Clod density 

1.46-1.68 mg/m3; water content at -1.5 MPa potential 0.125-0.192 

kg/kg. Particle size distributiion at 0.06 to 0.14 m soil layer: sand (0.05-2 

mm), coarse silt (0.02-0.05 mm), fine silt (0.002-0.02 mm), clay (<0.002 

mm).

Test Results

General Comments : 20 years of urea fertilization reduced soil pH significantly, compared 

with the control area. The soil acidification occurs due to nitrification of 

NH4+ which is decomposition product of urea. Urea fertilization caused 

also an increase in micronutrients (Fe, Cu, Mn) and a decrease in 

available P (phosphor) and exchangeable bases (Ca, Mg, Na). Soil 

acidification occurred also on areas treated with ammonia, NH4NO3 

and urea-NH4NO3 mixture.

References

Primary Reference : SSSJD4

Secondary Reference : !SIDSP*

Darusman, L. R. et al. Soil Science Society of America Journal, 55, 

1097-00, (1991)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Absorption 57

HUMAN SKN

Test Subject

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

Chemical Name : Urea

End Point : ABSORPTION

Study

Test Results

General Comments : Urea penetrates rapidly into the human stratum corneum; penetration is 

enhanced at higher urea concentrations and with time. However, 

transport to systemic circulation is slow and limited. About 5.9% of urea 

applied to human skin was recovered in the urine.

References

Secondary Reference : !SIDSP*

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
58 Distribution

HUMAN ORL

Test Subject

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

 Chemical Name : Urea

End Point : DISTRIBUTION

Study

Test Results

General Comments : Urea is extremely soluble in water and is adsorbed and distributed 

rapidly after oral doses. In man the peak concentration in blood is 

attained in 30 to 90 minutes after oral dose. The dose of 30 g urea 

(about 0.5 g/kg) doubles serum urea levels in 20 minutes and a 

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

control 36 mg/ 100 mL).

References

Secondary Reference : !SIDSP*

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

Production Volume Chemicals Programme, (1994)

RAT SKN

Test Subject

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

 Chemical Name : Urea

End Point : DISTRIBUTION

Study

Test Results

General Comments : Subcutaneous injection of urea to pregnant rats showed that the 

substance readily penetrated the placenta and raised fetal urea 

concentrations.

References

Secondary Reference : !SIDSP*

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Bioconcentration 59

Study type : LAB

CAS Number : 57-13-6

 Chemical Name : Urea

End Point : BIOCONCENTRATION

Study

Geographic Area : FIN

Test Results

General Comments : Due to the low log Pow value urea is not likely to undergo 

bioaccumulation.

References

Secondary Reference : !SIDSP*

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
60 Excretion 

CAS Number : 57-13-6

Chemical Name : Urea

End Point : EXCRETION

Study

Geographic Area : FIN

Test Results

General Comments : Ammonia is toxic to all vertebrates. It can be converted to the less toxic 

urea, but this is a metabolically expensive process found only in 

terrestrial vertebrates that cannot readily excrete ammonia, and marine 

fish that use urea as osmotic filter. Freshwater fish mostly excrete 

ammonia with only a small quantity of urea. Urea is the end product of 

biochemical protein decomposition and the main component of 

mammalian urine.

References

Primary Reference : NATUAS

Secondary Reference : !SIDSP*

Randall, D. J. et al. Nature

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Mammalian Acute Toxicity 61

Species/strain/system : Strain not mentioned

CAS Number : 57-13-6

End Point : MAMMALIAN ACUTE TOXICITY

Study

Chemical Name : Urea

Frequency : 

Dose / Concentration :

1 x

14300-15000 mg/kg BW

Test method : 

description 

GLP: no

Test Method and Conditions

Oral LD50 for male rats was established 

as 14300 mg/kg and for female rats as 

15000 mg/kg body weight.

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

staggering gait.

RAT ORL M LD50

F

Test Results

Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

References

Primary Reference : OYYAA2

Secondary Reference : !SIDSP*

Sato, N. et al. Oyo Yakuri

(Pharmacometrics), 13, 749-772, (1978)

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

Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6

End Point : MAMMALIAN ACUTE TOXICITY

Study

Chemical Name : Urea

Frequency : 

Dose / Concentration :

1 x

8200-9400 mg/kg BW

Test method : 

description 

GLP: no

Test Method and Conditions

Subcutaneous LD50 for male and 

female rats was established as 9400 

mg/kg and 8200 mg/kg body weight, 

respectively.

RAT SCU M LD50

F

Test Results

Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

IRPTC Data Profile 
62 Mammalian Acute Toxicity 

References

Primary Reference : OYYAA2

Secondary Reference : !SIDSP*

Sato, N. et al. Oyo Yakuri

(Pharmacometrics), 13, 749-772, (1978)

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

Production Volume Chemicals Programme, (1994)

Species/strain/system : Strain not mentioned

CAS Number : 57-13-6

End Point : MAMMALIAN ACUTE TOXICITY

Study

Chemical Name : Urea

Frequency : 

Dose / Concentration :

1 x

11500-13000 mg/kg BW

Test method : 

description 

GLP: no

Test Method and Conditions

Oral LD50 for male and female mice 

was established as 11500 mg/kg and 

13000 mg/kg, respectively.

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

staggening gait.

MOUSE ORL M LD50

F

Test Results

Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

References

Primary Reference : OYYAA2

Secondary Reference : !SIDSP*

Sato, N. et al. Oyo Yakuri

(Pharmacometrics), 13, 749-772, (1978)

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

Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6

End Point : MAMMALIAN ACUTE TOXICITY

Study

Chemical Name : Urea

Frequency : 

Dose / Concentration :

1 x

9200-10700 mg/kg BW

IRPTC Data Profile 
Mammalian Acute Toxicity 63

Test method : 

description 

GLP: no

Test Method and Conditions

Subcutaneous LD50 for male and 

female mice was established as 9200 

mg/kg and 10700 mg/kg body weight, 

respectively.

MOUSE SCU M LD50

F

Test Results

Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

References

Primary Reference : OYYAA2

Secondary Reference : !SIDSP*

Sato, N. et al. Oyo Yakuri

(Pharmacometrics), 13, 749-772, (1978)

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

Production Volume Chemicals Programme, (1994)

Species/strain/system : Cow

CAS Number : 57-13-6

End Point : MAMMALIAN ACUTE TOXICITY

Study

Chemical Name : Urea

Dose / Concentration : 510 mg/kg BW

Test method : 

description 

GLP: no

Test Method and Conditions

Oral LD50 for cow was established as 

510 mg/kg body weight.

CATTL ORL LD50

Test Results

Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
64 Mammalian Acute Toxicity 

CAS Number : 57-13-6

End Point : MAMMALIAN ACUTE TOXICITY

Study

Chemical Name : Urea

Dose / Concentration : 510 mg/kg BW

Test method : 

description 

GLP: no

Test Method and Conditions

Oral LD50 for sheep was established as 

510 mg/kg body weight .

SHEEP ORL LD50

Test Results

Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

Species/strain/system : Cow

CAS Number : 57-13-6

End Point : MAMMALIAN ACUTE TOXICITY

Study

Chemical Name : Urea

Dose / Concentration : 600-1080 mg/kg BW

Test method : 

description 

GLP: no

Test Method and Conditions

Oral LD50 for cows was established as 

600 - 1080 mg/kg body weight.

CATTL ORL LD50

Test Results

Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

IRPTC Data Profile 
Mammalian Acute Toxicity 65

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6

End Point : MAMMALIAN ACUTE TOXICITY

Study

Chemical Name : Urea

Frequency : 

Dose / Concentration :

1 x

5300-5400 mg/kg BW

Test method : 

description 

GLP: no

Test Method and Conditions

Intravenous LD50 for male and female 

rats was established as 5400 mg/kg and 

5300 mg/kg body weight, respectively.

RAT IVN M LD50

F

Test Results

Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

References

Primary Reference : OYYAA2

Secondary Reference : !SIDSP*

Sato, N. et al. Oyo Yakuri

(Pharmacometrics), 13, 749-772, (1978)

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

Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6

End Point : MAMMALIAN ACUTE TOXICITY

Study

Chemical Name : Urea

Frequency : 

Dose / Concentration :

1 x

4600-5200 mg/kg BW

Test method : 

description 

GLP: no

Test Method and Conditions

IRPTC Data Profile 
66 Mammalian Acute Toxicity 

Intravenous LD50 for male and female 

mice was established as 4600 mg/kg 

and 5200 mg/kg body weight, 

respectively.

MOUSE IVN M LD50

F

Test Results

Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

References

Primary Reference : OYYAA2

Secondary Reference : !SIDSP*

Sato, N. et al. Oyo Yakuri

(Pharmacometrics), 13, 749-772, (1978)

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

Production Volume Chemicals Programme, (1994)

CAS Number : 57-13-6

End Point : MAMMALIAN ACUTE TOXICITY

Study

Chemical Name : Urea

Dose / Concentration : 10000 mg/kg BW

Test method : 

description 

GLP: no

Test Method and Conditions

Intravenous LD50 for dogs was 

established as > 10000 mg/kg body 

weight.

DOG IVN LD50

Test Results

Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Mammalian Toxicity 67

MAMM

Species/strain/system : Ruminants

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Test method : 

description 

GLP: no

Test Method and Conditions

General Comments : Urea is generally regarded a safe and efficient feed additive (substitute for 

natural proteins) for ruminants. The toxicity of urea depends on the formation 

of ammonia. Problems occur when ingested urea releases more ammonia 

than in the rumen microorganisms can fully utilize to synthetize amino acids 

and protein. Urea can cause clinical signs of toxicosis in ruminants at 300 - 

500 mg/kg body weight and death at 1000 - 1500 mg/kg body weight. Horses 

are less susceptible, urea being lethal at approximately 4000 mg/kg body 

weight. Monogastric animals, such as swine and baby calves, are not affected 

by urea on biuret except for a mild diuretic action.

References

Primary Reference : GASTR*

Secondary Reference : !SIDSP*

Veterinary Gastrointestinal Toxicology, 489-490, (1986)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
68 Mammalian Toxicity 

CATTL

Species/strain/system : Cow

ORL

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Test method : 

description 

GLP: no

Test Method and Conditions

Dose / Concentration :

Exposure

116 mg/kg BW

 LDLO 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

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

Test Results

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

DOG SCU

Test Subject

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Test method : 

description 

GLP: no

Test Method and Conditions

Dose / Concentration :

Exposure

3000-9000 mg/kg BW

IRPTC Data Profile 
Mammalian Toxicity 69

 LDLO 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

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

Test Results

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

DOG

Species/strain/system : Strain not specified

SCU 12

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Test method : 

description 

GLP: unknown

Test Method and Conditions

Exposure Type : SHORT

Exposure Period : 

Dose / Concentration :

Exposure

45 d

3000-4000 mg/kg 

Exposure comments : Urea was injected subcutaneously every 8 hours to 12 unilaterally 

nephrectomized dogs for 45 days.

IRPTC Data Profile 
70 Mammalian Toxicity 

PLSMA BIOCH 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Plasma urea levels were 200 to 700 mg/100 mL

 BEHAV 

Mild drowsiness

URINE INCR 

Increased diuresis

 NEF 

Treatment did not affect hematocrit, platelet counts nor EEg .

Test Results

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB288673, (1978)

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

Production Volume Chemicals Programme, (1994)

DOG IVN

Test Subject

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Test method : 

description 

GLP: no

Test Method and Conditions

Dose / Concentration :

Exposure

3000 mg/kg BW

 LDLO 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Intravenous LDLO for dogs was 3000 mg/kg body weight.

Test Results

IRPTC Data Profile 
Mammalian Toxicity 71

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

GPIG

Species/strain/system : Guinea pig

IVN

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Test method : 

description 

GLP: no

Test Method and Conditions

Dose / Concentration :

Exposure

4800 mg/kg BW

 LDLO 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Intravenous LDLO for guinea pigs was established as 4800 mg/kg body weight.

Test Results

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
72 Mammalian Toxicity 

HORSE

Species/strain/system : Pony

ORL

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Test method : 

description 

GLP: no

Test Method and Conditions

Dose / Concentration :

Exposure

3310-3610 mg/kg BW

 LDLO 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

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

Test Results

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

HUMAN SKN

Test Subject

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Exposure

Exposure comments : Urea has been extensively used during the last two decades in the treatment of 

dry skin, both clinically and in cosmetic products.

IRPTC Data Profile 
Mammalian Toxicity 73

SKIN NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

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

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

Test Results

References

Primary Reference : HAUTAW

Secondary Reference : !SIDSP*

Stuttgen, G. Hautarzt, Suppl. 11, 9-12, (1992)

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

Production Volume Chemicals Programme, (1995)

PIG

Species/strain/system : Young pigs

ORL JUV

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Test method : 

description 

GLP: no

Test Method and Conditions

Dose / Concentration :

Exposure

16000 mg/kg BW

 LDLO 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

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

Test Results

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

deleterious effects.

References

Primary Reference : JAVTAP

Secondary Reference : !SIDSP*

Button, J. P. et al. Journal of the South African Veterinary Association, 53(1), 

67-68, (1982)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
74 Mammalian Toxicity 

RAT

Species/strain/system : Wistar rats

SKN

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Test method : 

description 

GLP: unknown

Test Method and Conditions

Exposure Type : SHORT

Exposure Period : 

Exposure

4 wk

Exposure comments : Urea in 10%, 20% or 40% ointment was applied to the back skin (20 cm2 

area) for 4 weeks.

 NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

No dose-dependent toxicity was observed. There were no consistent treatment-related effects on standard 

haematological parameters, clinical chemistry, organ weights or organ histopathology, including testicles, 

prostate, seminal vesicles, ovaries and uterus.

Test Results

References

Primary Reference : OYYAA2

Secondary Reference : !SIDSP*

Sato, N. et al. Oyo Yakuri

(Pharmacometrics), 13, 749-772, (1977)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Mammalian Toxicity 75

RAT

Species/strain/system : Strain not specified

ORL

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Description of the test : 

substance 

Purity not known

Test Substance

Test method : 

description 

GLP: unknown

Test Method and Conditions

Exposure Type : LONG

Exposure Period : 

Dose / Concentration :

Exposure

190 d

20000-250000 mg/kg DIET

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

2000-25000 mg/kg/day).

 DEATH 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

250000 ppm and 20000 ppm were lethal in 12 days and 20-76 days, respectively.

BW DECR 

 BEHAV

There was weight loss and suppression of sexual function at lower doses.

Test Results

General Comments : Author's comment: "the validity of the study is limited by the small number of 

animals used (often 1 to 3 per group) and failure to report actual food intake. 

Extreme weight loss of the rats suggested that inanition was likely".

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
76 Mammalian Toxicity 

RAT

Species/strain/system : Wistar rats

SKN

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Test method : 

description 

GLP: unknown

Test Method and Conditions

Exposure Type : LONG

Exposure Period : 

Exposure

24 wk

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

skin on a 20 cm2 area for 24 weeks.

 NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

There were no consistent treatment-related effects on standard heamatological parameters, clinical chemistry 

or different organs.

Test Results

References

Primary Reference : OYYAA2

Secondary Reference : !SIDSP*

Sato, N. et al. Oyo Yakuri

(Pharmacometrics), 13, 749-772, (1977)

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

Production Volume Chemicals Programme, (1994)

RBT

Species/strain/system : Rabbit

ORL

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

IRPTC Data Profile 
Mammalian Toxicity 77

Test method : 

description 

GLP: no

Test Method and Conditions

Dose / Concentration :

Exposure

5000 mg/kg BW

 LDLO 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Oral LDLO for rabbits was established as 5000 mg/kg body weight.

Test Results

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

RBT

Species/strain/system : Rabbit

SCU

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Test method : 

description 

GLP: no

Test Method and Conditions

Dose / Concentration :

Exposure

3000-9000 mg/kg BW

 LDLO 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

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

Test Results

IRPTC Data Profile 
78 Mammalian Toxicity 

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

RBT

Species/strain/system : Rabbit

IVN

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Test method : 

description 

GLP: no

Test Method and Conditions

Dose / Concentration :

Exposure

7320 mg/kg BW

 LDLO 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

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

Test Results

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Mammalian Toxicity 79

RBT

Species/strain/system : Rabbit

IVN

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Test method : 

description 

GLP: no

Test Method and Conditions

Dose / Concentration :

Exposure

6310 mg/kg BW

 LDLO 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

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

Test Results

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

SHEEP ORL

Test Subject

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

End Point : MAMMALIAN TOXICITY

Study

Chemical Name : Urea

Test method : 

description 

GLP: no

Test Method and Conditions

Dose / Concentration :

Exposure

160 mg/kg BW

IRPTC Data Profile 
80 Mammalian Toxicity 

 LDLO 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

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

Test Results

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Carcinogenicity 81

MOUSE

Species/strain/system : CB7B1/6 mice

ORL M

F

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : CARCINOGENICITY

Study

Chemical Name : Urea

Test method : 

description 

Chronic toxicity and carcinogenicity screening study over 12 months; GLP: no 

data

Test Method and Conditions

Exposure Type : LONG

Dose / Concentration :

Exposure

0.45-4.5 g/kg DIET

Exposure comments : Mice were fed a diet containing 0.45%, 0.9% or 4.5% of urea over 12 months.

 NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

No carcinogenic effects were found.

Test Results

General Comments : OECD/SIDS Comment: 5 animals per sex from all dose groups were 

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

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

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

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

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

histologically studied.

References

Primary Reference : JEPTDQ

Secondary Reference : !SIDSP*

Fleischman, R. W. et al. Journal of Environmental Pathology and Toxicology, 

3(5/6), 149-170, (1980)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
82 Carcinogenicity

RAT

Species/strain/system : Fischer 344 rats

ORL M

F

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : CARCINOGENICITY

Study

Chemical Name : Urea

Test method : 

description 

Chronic toxicity and carcinogenicity screening study over 12 months; GLP: no 

data

Test Method and Conditions

Exposure Type : LONG

Exposure Period : 

Dose / Concentration :

Exposure

12 mo

4.5-45 g/kg DIET

Exposure comments : Rats were fed a diet containing 0.45%, 0.9% or 4.5% of urea over 12 months.

 NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Not carcinogenic

Test Results

General Comments : OECD/SIDS Comment: 5 animals per sex from all dose groups were 

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

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

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

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

tumours. Although there was a statistically increased incidence of interstitial 

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

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

References

Primary Reference : JEPTDQ

Secondary Reference : !SIDSP*

Fleischman, R. W. et al. Journal of Environmental Pathology and Toxicology, 

3(5/6), 149-170, (1980)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Mutagenicity 83

BACT

Species/strain/system : Salmonella typhimurium TA98, TA100, TA1537

VTR

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : MUTAGENICITY

Study

Chemical Name : Urea

Description of the test : 

substance 

Purity unknown

Test Substance

Test method : 

description 

Bacterial test, Ames test; GLP: no data

Test Method and Conditions

Exposure

Exposure comments : Test performed with and without metabolic activation.

 NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Negative results with and without metabolic activation

Test Results

References

Primary Reference : GMCRDC

Secondary Reference : !SIDSP*

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

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
84 Mutagenicity

BACT

Species/strain/system : Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538 

Escherichia coli WP2uvrA

VTR

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : MUTAGENICITY

Study

Chemical Name : Urea

Purity Grade : 99%

Vehicle - Solvent : Water

Test Substance

Test method : 

description 

Bacterial test (Ames test); GLP: not known

Test Method and Conditions

Dose / Concentration :

Exposure

5-5000 ug/ PLATE

Exposure comments : Tests were performed with and without metabolic activation.

 NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Negative results with and without metabolic activation at a dose range of 5-5000 ug/plate.

Test Results

References

Primary Reference : SAIGBL

Secondary Reference : !SIDSP*

Shimizu, H. et al. Japanese Journal of Industrial Health, 27, 400-419, (1985)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Mutagenicity 85

BACT

Species/strain/system : Salmonella typhimurium TA98, TA100, TA1535, TA1537

VTR

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : MUTAGENICITY

Study

Chemical Name : Urea

Purity Grade : 99%

Vehicle - Solvent : DMSO

Test Substance

Test method : 

description 

Bacterial test (Ames test); GLP: not known

Test Method and Conditions

Dose / Concentration :

Exposure

100-10000 ug/ PLATE

Exposure comments : Tests were performed with and without metabolic activation with rat liver and 

hamster liver S9 mix.

 NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Negative results at a dose range of 100-10000 ug/plate with and without metabolic activation.

 CELL 

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

Test Results

References

Primary Reference : ENMUDM

Secondary Reference : !SIDSP*

Mortelmans, K. et al. Environmental Mutagenesis, 8 Suppl. 7, 1-119, (1986)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
86 Mutagenicity

HAMST

Species/strain/system : Chinese hamster fibroblast (CHL)

VTR

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : MUTAGENICITY

Study

Chemical Name : Urea

Vehicle - Solvent : Physiological saline

Description of the test : 

substance 

Purity unknown

Test Substance

Test method : 

description 

Chromosomal aberration test; GLP: not known

Test Method and Conditions

CHROM STRUC 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Positive results without metabolic activation at 266 mmolar. Aberrations in 37% of metaphases at 24 hours 

(chromosomal gaps, chromatid or chromosomal breaks, translocations, fragmentation).

 NEF 

Negative result with metabolic activation

Test Results

General Comments : OECD/SIDS Comment: The maximally effective concentration was 266 

mmolar, a very high concentration suggesting a low clastogenic potential.

References

Primary Reference : MUREAV

Secondary Reference : !SIDSP*

Ishidate, M. and Odashima, S. Mutation Research, 48, 337-354, (1977)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Mutagenicity 87

HAMST

Species/strain/system : Chinese hamster fibroblast (CHL)

VTR

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : MUTAGENICITY

Study

Chemical Name : Urea

Test method : 

description 

Chromosomal aberration test; GLP: not known

Test Method and Conditions

Dose / Concentration :

Exposure

13 g/L 

Exposure comments : Urea concentration 216 mmolar

CHROM STRUC 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Positive results without metabolic activation. Chromosomal aberrations were detected in 20% of metaphases at 

216 mmolar concentration.

Test Results

General Comments : OECD/SIDS Comment: chromosomal aberrations detected in 20% of 

metaphases at urea concentration of 13 g/L (216 mmolar) indicate a low 

clastogenic potential.

References

Primary Reference : GMCRDC

Secondary Reference : !SIDSP*

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

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

Production Volume Chemicals Programme, (1994)

MOUSE

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

VTR

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : MUTAGENICITY

Study

Chemical Name : Urea

IRPTC Data Profile 
88 Mutagenicity

Purity Grade : AG 

Test Substance

Test method : 

description 

Mouse Lymphoma TK Locus Assay; GLP: no data

Test Method and Conditions

Dose / Concentration :

Exposure

7.9-38 g/L 

Exposure comments : Concentrations of 132 - 662 mmolar of urea were used with and without 

metabolic activation.

 NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Negative result with metabolic activation

GENE MUT 

 NEF 

 INC 

Weakly positive at very high urea concentrations 530 - 662 mmolar negative at 132 mmolar, equivalent at 265 - 

397 mmolar.

 CELL 

Lowest concentration producing cell toxicity: 265 mmolar

Test Results

General Comments : OECD/SIDS Comment: Authors discuss the possibility that the positive 

genotoxic findings may depend on secondary cellular effects (e.g. difference in 

osmotic pressure across the cell membrane) at high concentration which might 

not take place under in vivo conditions.

References

Primary Reference : MUTAEX

Secondary Reference : !SIDSP*

Wangenhaim, J. and Bolcsfoldi, G. Mutagenesis, 3, 193-205, (1988)

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

Production Volume Chemicals Programme, (1994)

MOUSE

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

VTR

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : MUTAGENICITY

Study

Chemical Name : Urea

IRPTC Data Profile 
Mutagenicity 89

Purity Grade : AG 

Test Substance

Test method : 

description 

Analysis for DNA singlestrand breaks by alkaline unwinding and 

hydroxyapatite elution; GLP: no data

Test Method and Conditions

Dose / Concentration :

Exposure

20.5-43.0 g/L 

Exposure comments : Concentrations of 339 - 718 mmolar of urea were used.

DNA STRUC 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Positive result at very high concentrations (628 and 718 mmolar) with relative fractions of ssDNA of 9.2 and 

17.3%, respectively, without metabolic activation.

 NEF 

Although a dose response was found, lower urea concentrations (359 - 339 mmolar) did not yield responses 

classified as positive.

Test Results

References

Primary Reference : MUREAV

Secondary Reference : !SIDSP*

Garberg, P. et al. Mutation Research, 203, 155-176, (1988)

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

Production Volume Chemicals Programme, (1994)

MOUSE

Species/strain/system : Swiss albino mice

ORL

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : MUTAGENICITY

Study

Chemical Name : Urea

Description of the test : 

substance 

Purity unknown

Test Substance

Test method : 

description 

Bone marrow cytogenetic assay; GLP: no data

Test Method and Conditions

IRPTC Data Profile 
90 Mutagenicity

Exposure Type : SHORT

Exposure Period : 

Dose / Concentration :

Exposure

5 d

500 mg/ ANIMAL

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

approaching an acute lethal dose).

CHROM STRUC 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Bone marrow cell, metaphases exhibited chromosome breaks, acentric fragments, translocations, gaps and 

constrictions at a 7-fold rate compared to controls.

Test Results

General Comments : OECD/SIDS Comment: the interpretation of this clastogenic effect is limited by 

the usage of a single extremely high dose level.

References

Primary Reference : CYTOAN

Secondary Reference : !SIDSP*

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

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

Production Volume Chemicals Programme, (1994)

RAT

Species/strain/system : Rat hepatocytes

VTR

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : MUTAGENICITY

Study

Chemical Name : Urea

Purity Grade : AG 

Vehicle - Solvent : Water

Test Substance

Test method : 

description 

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

Test Method and Conditions

Dose / Concentration :

Exposure

18-180 mg/L 

Exposure comments : Concentrations of 0.3 - 3 mmolar were used.

IRPTC Data Profile 
Mutagenicity 91

 NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Negative result

Test Results

References

Primary Reference : MUREAV

Secondary Reference : !SIDSP*

Sina, J. F. et al. Mutation Research, 113, 357-391, (1984)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
92 Sensitization

HUMAN SKN

Test Subject

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

CAS Number : 57-13-6

End Point : SENSITIZATION

Study

Chemical Name : Urea

Vehicle - Solvent : Water

Test Substance

Test method : 

description 

GLP: unknown

Test Method and Conditions

Exposure

Exposure comments : 10% water solution

SKN NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

No skin sensitization

Test Results

References

Primary Reference : VDVEAV

Secondary Reference : !SIDSP*

Alchangian, L. V. et al. Vestnik Dermatologii Venerologii, 9, 26-29, (1986)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Irritation 93

HUMAN SKN

Test Subject

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : IRRITATION

Study

Chemical Name : Urea

Vehicle - Solvent : Water

Test Substance

Test method : 

description 

Chamber-Scarification Test; GLP: unknown

Test Method and Conditions

Exposure Type : ACUTE

Dose / Concentration :

Exposure

75-300 g/L 

Exposure comments : 7.5% and 30% urea solutions in water were applied.

SKN IRRIT 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Slight irritation with 7.5% urea

SKN IRRIT 

Marked irritation with 30% urea

SKN IRRIT 

Comparison between hypo- and hyperactive individuals with 30% urea in water after 48 hours: hyporeactors 

score 0.8 (slight); hyperreactors score 2.4 (moderate) on the scale 0-4.

Test Results

References

Primary Reference : 38FTAB

Secondary Reference : !SIDSP*

Frosch, P. J. et al. Cutaneous Toxicity: Proceedings of the Conference on 

Cutaneous Toxicity, 127-153, (1977)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
94 Irritation

HUMAN SKN

Test Subject

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : IRRITATION

Study

Chemical Name : Urea

Vehicle - Solvent : Water

Test Substance

Test method : 

description 

Not specified; GLP: unknown

Test Method and Conditions

Exposure Type : ACUTE

Dose / Concentration :

Exposure

100 g/L 

Exposure comments : 10% water solution of urea

SKIN NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

No irritation after 24 hours

Test Results

References

Primary Reference : VDVEAV

Secondary Reference : !SIDSP*

Alchangian, L. V. et al. Vestnik Dermatologii Venerologii, 9, 26-29, (1986)

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

Production Volume Chemicals Programme, (1994)

MOUSE

Species/strain/system : Nude MF1h mice

SKN M

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : IRRITATION

Study

Chemical Name : Urea

IRPTC Data Profile 
Irritation 95

Vehicle - Solvent : Water

Test Substance

Test method : 

description 

GLP: unknown

Test Method and Conditions

Exposure Type : ACUTE

Dose / Concentration :

Exposure

100-109 g/L 

Exposure comments : 10% solution

SKIN NEF 

 NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

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

appearance of the skin.

Test Results

References

Primary Reference : JPPMAB

Secondary Reference : !SIDSP*

Lashmar, U. T. et al. Journal of Pharmacy & Pharmacology, 41, 118-121, 

(1981)

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

Production Volume Chemicals Programme, (1994)

RBT

Species/strain/system : Rabbit

SKN

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : IRRITATION

Study

Chemical Name : Urea

Vehicle - Solvent : Water

Test Substance

Test method : 

description 

GLP: unknown

Test Method and Conditions

IRPTC Data Profile 
96 Irritation

Exposure Period : 

Dose / Concentration :

Exposure

20 h

500 g/L 

Exposure comments : 20 hours semiocclusive application of 50% urea water solution on the back 

and ear skin of rabbit.

SKN NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

No irritation of the skin after 24 hours

Test Results

References

Primary Reference : #URBSF*

Secondary Reference : !SIDSP*

BASF AG. BASF Unpublished Report

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

Production Volume Chemicals Programme, (1994)

RBT

Species/strain/system : Rabbit

OCU

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : IRRITATION

Study

Chemical Name : Urea

Test method : 

description 

OECD 405; GLP: yes

Test Method and Conditions

EYE NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Not irritating (no irritancy after 24 hours)

Test Results

IRPTC Data Profile 
Irritation 97

References

Primary Reference : #URBSF*

Secondary Reference : !SIDSP*

BASF AG. BASF Unpublished Report

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
98 Reproduction

CAS Number : 57-13-6

End Point : REPRODUCTION

Study

Chemical Name : Urea

General Comments : OECD/SIDS Conclusion: Based on the carcinogenicity screening studies with 

mice and rats and repeated dose toxicity studies by dermal route with rats, 

where no toxic effects were observed in the gonads, even at the 

histopathological examination, and the lack of evidence for developmental 

toxicity in limited mouse and rat studies, urea would not be expected to display 

significant potential for reproductive toxicity.

References

Secondary Reference : !SIDSP*

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Teratogenicity 99

BIRD

Species/strain/system : Chick embryo

INJ

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : TERATOGENICITY

Study

Chemical Name : Urea

Test method : 

description 

GLP: no data

Test Method and Conditions

Exposure

Exposure comments : 50 to 900 mg of urea dissolved in egg albumin was injected into eggs between 

7th and 20th hours of incubation.

EMBRY STRUC 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Among 132 embryos 78 showed neural, vascular or cardiac abnormalities.

Test Results

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

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

BIRD

Species/strain/system : Chick embryo

INJ

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : TERATOGENICITY

Study

Chemical Name : Urea

IRPTC Data Profile 
100 Teratogenicity

Purity Grade : AG 

Vehicle - Solvent : Distilled water

Test Substance

Test method : 

description 

GLP: no data

Test Method and Conditions

Dose / Concentration :

Exposure

200-1200 mg/kg 

Exposure comments : 200, 400, 800 and 1200 mg/kg eggs was injected in a volume of 0.05 mL 

distilled water into the air sack of the eggs on day 16, 17 and 18 of incubation.

EMBRY DEATH 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Mortality of the embryos varied 8.8-38.9%, dose-dependently. The mortality in the control group was 6.1%.

EMBRY BIOCH 

In the treated embryos, the plasma T3 level increased and T4 level decreased.

EMBRY STRUC 

Electron microscopy revealed cytoplasmic oedema, mitochondrial swelling and membrane damage in thyroid 

cells.

Test Results

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

References

Primary Reference : AVSCA7

Secondary Reference : !SIDSP*

Mora, S. et al. Acta Veterinaria Scandinavica, Suppl. 87, 197-198, (1991)

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

Production Volume Chemicals Programme, (1994)

MOUSE

Species/strain/system : ICR mice

ORL F 10

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : TERATOGENICITY

Study

Chemical Name : Urea

Test method : 

description 

A single oral dose study; GLP: no

Test Method and Conditions

IRPTC Data Profile 
Teratogenicity 101

Exposure Type : ACUTE

Exposure Period : 

Frequency : 

Dose / Concentration :

Exposure

10 TDP

1 x

2000 mg/kg BW

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

day 10 of pregnancy.

 NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

No effects on foetal data (live/dead, sex, external defects, soft tissue and skeletal defects).

 NEF 

No maternal toxicity

Test Results

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

References

Primary Reference : TJADAB

Secondary Reference : !SIDSP*

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

(1981)

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

Production Volume Chemicals Programme, (1994)

RAT

Species/strain/system : Wistar rats

ORL F 4

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : TERATOGENICITY

Study

Chemical Name : Urea

Test method : 

description 

A single oral dose study; GLP: no

Test Method and Conditions

Exposure Type : ACUTE

Exposure Period : 

Frequency : 

Dose / Concentration :

Exposure

12 TDP

1 x

2000 mg/kg BW

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

pregnancy.

IRPTC Data Profile 
102 Teratogenicity

 NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

No effects on foetal data (live/dead, sex, external defects, soft tissue and skeletal defects)

 NEF 

No maternal toxicity

Test Results

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

References

Primary Reference : TJADAB

Secondary Reference : !SIDSP*

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

(1981)

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

Production Volume Chemicals Programme, (1994)

RAT

Species/strain/system : Wistar rats

ORL F 6

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : TERATOGENICITY

Study

Chemical Name : Urea

Test method : 

description 

Within 48 hours after delivery the pups were killed and the kidneys examined; 

GLP: no data

Test Method and Conditions

Exposure Type : SHORT

Exposure Period : 

Dose / Concentration :

Exposure

14 d

50 g/kg BW/d

Exposure comments : Urea was administered by gavage in 2 doses 12 hours apart to 6 rats during 

pregnancy for an average of 14 days and the dams were allowed to delivery.

 NEF 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

No hypertrophy or other kidney changes were detected nor were any teratogenic effects noted.

Test Results

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

IRPTC Data Profile 
Teratogenicity 103

References

Primary Reference : ZEIUR*

Secondary Reference : !SIDSP*

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

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
104 Aquatic Acute Toxicity 

Species/strain/system : Snail (Helisoma trivolvis)

Study type : LAB

CAS Number : 57-13-6

End Point : AQUATIC ACUTE TOXICITY

Study

Geographic Area : FIN

Chemical Name : Urea

Test method : 

description 

Static; GLP: not known

Test Method and Conditions

LC50 for 24 hours for egg = 14241 

mg/L; LC50 for 24 hours for juveniles = 

18255 mg/L; LC50 for 24 hours for 

adults = 30060 mg/L.

MOLL AQ FRESH EGG LC50

JUV

ADULT

Test Results

Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

References

Primary Reference : AECTCV

Secondary Reference : !SIDSP*

Tchounwou, P. B. et al. Archives of Environmental Contamination and 

Toxicology, 21, 359-364, (1991)

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

Production Volume Chemicals Programme, (1994)

Species/strain/system : Mosquito (Aedes aegypti) larvae

Study type : LAB

CAS Number : 57-13-6

End Point : AQUATIC ACUTE TOXICITY

Study

Geographic Area : FIN

Chemical Name : Urea

Test method : 

description 

Static; GLP: no

Test Method and Conditions

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

Test Results

Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

IRPTC Data Profile 
Aquatic Acute Toxicity 105

References

Primary Reference : JIVPAZ

Secondary Reference : !SIDSP*

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

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

Production Volume Chemicals Programme, (1994)

Species/strain/system : Barilius barna

Study type : LAB

CAS Number : 57-13-6

End Point : AQUATIC ACUTE TOXICITY

Study

Geographic Area : FIN

Chemical Name : Urea

Test method : 

description 

Static

Test Method and Conditions

LC50 for 96 hours > 9100 mg/L.

General Comments : Urea is not acutely toxic to fish.

FISH AQ LC50

Test Results

Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

References

Primary Reference : HCPBE5

Secondary Reference : !SIDSP*

Dodriyal, A. K. and Bahuguna, A. K. Himalayan Chemical Pharma. Bulletin, 5, 

15-16, (1988)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
106 Aquatic Toxicity

ALGAE

Species/strain/system : Green algae (Scenedesmus quadricauda)

AQ FRESH

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : AQUATIC TOXICITY

Study

Geographic Area : FIN

Chemical Name : Urea

Test method : 

description 

Cell multiplication inhibition test

Test Method and Conditions

BIOMA 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Toxicity threshold for 192 hours > 10000 mg/L

Test Results

General Comments : Urea is not toxic to algae.

References

Primary Reference : VJWWAU

Secondary Reference : !SIDSP*

Bringmann, G. and Kuhn, R. Vom Wasser, 50, 45-60, (1978)

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

Production Volume Chemicals Programme, (1994)

PROTO

Species/strain/system : Flagellate (Entosiphon sulcatum)

AQ FRESH

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : AQUATIC TOXICITY

Study

Geographic Area : FIN

Chemical Name : Urea

IRPTC Data Profile 
Aquatic Toxicity 107

Test method : 

description 

Cell multiplication inhibition test; static; GLP: no

Test Method and Conditions

BIOMA 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Toxicity threshold for 72 hours = 29 mg/L

BIOMA UNS 

To some extent urea exhibited selective toxic action on Entosiphon sulcatum. For example toxicity threshold for 

chloroform was > 6560 mg/L.

Test Results

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

References

Primary Reference : WATRAG

Secondary Reference : !SIDSP*

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

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
108 Aquatic Toxicity

ALGAE

Species/strain/system : Blue-green algae (Microcystis aeruginosa)

AQ FRESH

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : AQUATIC TOXICITY

Study

Geographic Area : FIN

Chemical Name : Urea

Test method : 

description 

Cell multiplication inhibition test. Single species tests such as "Microtox 

Photobacterium Luminescence Test" and tests on overall processes such as 

nitrification or soil respiration are included in this item. GLP: not known

Test Method and Conditions

BIOMA INHIB 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Toxicity threshold for 192 hours = 47 mg/L

Test Results

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

References

Primary Reference : VJWWAU

Secondary Reference : !SIDSP*

Bringmann, G. and Kuhn, R. Vom Wasser, 50, 45-60, (1978)

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

Production Volume Chemicals Programme, (1994)

BACT

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

AQ MARIN

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : AQUATIC TOXICITY

Study

Geographic Area : FIN

Chemical Name : Urea

IRPTC Data Profile 
Aquatic Toxicity 109

Test method : 

description 

Microtox Photobacterium Luminescence Test. Single species tests such as 

"Microtox Photobacterium Luminescence Test: and tests on overall processes 

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

known

Test Method and Conditions

 EC50 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

EC50 for 5 minutes = 24000 mg/L

Test Results

References

Primary Reference : ASTTAB

Secondary Reference : !SIDSP*

Bulich, A. A. et al. ASTM Special Technical Publication Aquatic Toxicology and 

Hazard Assessment, ASTM STP 737, 338-347

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

Production Volume Chemicals Programme, (1994)

CRUS

Species/strain/system : Water flea (Daphnia magna)

AQ FRESH

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : AQUATIC TOXICITY

Study

Geographic Area : FIN

Chemical Name : Urea

Test method : 

description 

DIN 38412 Teil 11 (modified)

Test Method and Conditions

 EC50 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

EC50 for 24 hours > 10000 mg/L.

Test Results

General Comments : Urea is not acutely toxic to daphnids.

IRPTC Data Profile 
110 Aquatic Toxicity

References

Primary Reference : ZWABAQ

Secondary Reference : !SIDSP*

Bringmann, G. and Kuhn, R. Zeitschrift fuer Wasser und Abwasser Forschung, 

15(1), 1-6, (1982)

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

Production Volume Chemicals Programme, (1994)

FISH

Species/strain/system : Golden orfe (Leuciscus idus melanotous)

AQ FRESH

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : AQUATIC TOXICITY

Study

Geographic Area : FIN

Chemical Name : Urea

Test method : 

description 

Static; GLP: no

Test Method and Conditions

Exposure Type : ACUTE

Exposure

 LC0 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

LC0 for 48 hours > 10000 mg/L

Test Results

General Comments : Urea is not acutely toxic to fish.

References

Primary Reference : ZWABAQ

Secondary Reference : !SIDSP*

Juhnke, I. and Ludemann, D. Zeitschrift fuer Wasser und Abwasser 

Forschung, 11, 5, (1978)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Aquatic Toxicity 111

FISH

Species/strain/system : Tilapia (Tilapia mossambica)

AQ ESTUA

FRESH

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : AQUATIC TOXICITY

Study

Geographic Area : FIN

Chemical Name : Urea

Test method : 

description 

Test method not specified

Test Method and Conditions

 LC0 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

LC0 for 96 hours = 20000 mg/L.;

 LC50 

LC50 for 96 hours = 22500 mg/L.;

 LC100 

LC100 for 96 hours = 25000 mg/L

BW DECR 

BW SIZE 

BEHAV 

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

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

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

Test Results

urea. Conversion efficiency fell rapidly as the concentration increased.

General Comments : Urea is not acutely toxic to fish. Tilapia mossambica lives under wide varity of 

environmental circumstances tolerating different osmotic conditions. This 

chemical fertilizer appeared to be metabolic stressor at high concentrations.

References

Primary Reference : ENECEV

Secondary Reference : !SIDSP*

Palanichamy, S. et al. Environment and Ecology, 3(2), 157-161, (1985)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
112 Terrestrial Toxicity

WORM

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

TERR

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : TERRESTRIAL TOXICITY

Study

Geographic Area : FIN

Chemical Name : Urea

Test method : 

description 

Effects monitored: earthworm numbers and biomass. Fertilizer was organic 

coated urea, the organic coating being based on soybean oil at annual rate of 

60, 120 & 180 kg N/ha. Soil was treated annually for 20 years.

Organic Matter : 

Content 

Test Method and Conditions

6.2-6.7 %

Exposure

Exposure comments : Sandy loam soil. The organisms relation to soil acidification was studied.

Application of nitrogenous fertilizers to grassland for long period may have a deleterious effect on earthworms 

in the absence of liming.

Test Results

References

Primary Reference : AEENDO

Secondary Reference : !SIDSP*

Wei-Chum Ma, L. et al. Agriculture, Ecosystems and Environment, 30, 71-80, 

(1990)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
Terrestrial Toxicity 113

BACT

Species/strain/system : Soil bacteria (Pseudomonas putida)

TERR

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : TERRESTRIAL TOXICITY

Study

Geographic Area : FIN

Chemical Name : Urea

Test method : 

description 

Cell multiplication inhibition test. Single species tests such as "Microtox 

Photobacterium Luminescence Test" and tests on overall processes such as 

nitrification or soil respiration, are included in this item. GLP: not knwon

Test Method and Conditions

BIOMA INHIB 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Toxicity threshold for 16 hours > 10000 mg/L

Test Results

References

Primary Reference : WATRAG

Secondary Reference : !SIDSP*

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

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

Production Volume Chemicals Programme, (1994)

BIRD

Species/strain/system : Pigeon

TERR

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : TERRESTRIAL TOXICITY

Study

Geographic Area : FIN

Chemical Name : Urea

IRPTC Data Profile 
114 Terrestrial Toxicity

Test method : 

description 

Test method not specified; GLP: no

Test Method and Conditions

 LDLO 

 SCU 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Lowest lethal dose found = 16000 mg/kg

Test Results

General Comments : Urea is not acutely toxic to pigeon.

References

Primary Reference : D8REP4

Secondary Reference : !SIDSP*

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

Report, PB-288673, (1978)

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

Production Volume Chemicals Programme, (1994)

PLANT

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

TERR

Test Subject

 

Organism Medium Specification Route Lifestage Sex Number exposed Number controls 

Study type : LAB

CAS Number : 57-13-6

End Point : TERRESTRIAL TOXICITY

Study

Geographic Area : FIN

Chemical Name : Urea

Test method : 

description 

Test method not specified; GLP: no

Test Method and Conditions

LEAF STRUC 

 Affected in

Organ Effect Rev. OnSet Sex Exposed - Controls

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

Leaf-tip necrosis observed after foliar fertilization of soybean with urea.

 NOEL 

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

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

Test Results

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

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

IRPTC Data Profile 
Terrestrial Toxicity 115

References

Primary Reference : PNASA6

Secondary Reference : !SIDSP*

Krogmeier, J. M. et al. Proceedings of the National Academy of Sciences of 

the United States of America, 86, 8189-91, (1989)

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

Production Volume Chemicals Programme, (1994)

IRPTC Data Profile 
116 Recomendations/Legal mechanisms 

CAS Number : 57-13-6

Chemical Name : 

Substance

Reported Name : Urea

GBR REG Permitted for use only as a home garden fungicide on cut stumps of trees and on apple and 

pear trees.

Pesticides 1992: Pesticides approved under the Control of Pesticides Regulations 1986

Effective Date : 

Entry / Update :

01MCH1991

NOV1992

Title :

Reference :

Last Amendment :

PESTI

CONSM

RSTR

RSTR

Area Type Subject Spec. Description Level / Summary Information :

USE

USE

PACPR*, 500, xlv, 1992

CAS Number : 57-13-6

Chemical Name : UREA

Substance

Reported Name : UREA

CSK REG COMPONENT OF RUBBER PRODUCTS PERMITTED FOR CO NTACT WITH FOOD AND 

THE HUMAN BODY. MAXIMUM L IMIT FOR THE FINAL PRODUCTS: 30MG/G.

DIRECTIVE NO. 62 ON HYGIENIC REQUIREMENTS ON RUBBERS AND 

RUBBER GOODS COMING IN CONTACT WI TH FOODSTUFFS AND HUMAN 

ORGANISM

Effective Date : 

Entry / Update :

 1JAN1983

DEC1991

Title :

Reference :

Last Amendment :

- PRMT

MXL

Area Type Subject Spec. Description Level / Summary Information :

FOOD

GOODS

HPMZC*, 54, 1982

HYGIENICKE PREDPISY MINISTERSTVA ZDRAVOTNICTVI CSR

(HYGIENIC REGULATIONS OF MINISTRY OF HEALTH OF CSR)

CAS Number : 57-13-6

Chemical Name : UREA

Substance

Reported Name : UREA

CSK REG MAXIMUM LIMITS IN COSMETICS: 50MG/G

DIRECTIVE NO. 34 ON HYGIENIC REQUIREMENTS ON COSMETICS, 

DETERGENTS, AND GOODS OF PERSONAL USE

Effective Date : 

Entry / Update :

 1JAN1971

DEC1991

Title :

Reference :

Last Amendment :

- RSTR

MXL

Area Type Subject Spec. Description Level / Summary Information :

GOODS

HPMZC*, 32, 1970

HYGIENICKE PREDPISY MINISTERSTVA ZDRAVOTNICTVI CSR

(HYGIENIC REGULATIONS OF MINISTRY OF HEALTH OF CSR)

IRPTC Data Profile 
Recomendations/Legal mechanisms 117

CAS Number : 57-13-6

Chemical Name : UREA

Substance

Reported Name : UREA

CSK REG SUBSTANCE IS APPROVED AS PESTICIDE. SPECIFIC USES, LIMITATIONS AND SAFETY 

PRECAUTIONS ARE GIVEN.

LIST OF PERMITTED CHEMICALS FOR PLANT PROTECT ION

Effective Date : 

Entry / Update :

 JAN1991

DEC1991

Title :

Reference :

Last Amendment :

AGRIC PRMT

Area Type Subject Spec. Description Level / Summary Information :

USE

SPPOR*, 290, 1990

SEZNAM POVOLENYCH PRIPRAVKU NA OCHRANU ROSTLIN

(LIST OF PERMITTED CHEMICALS FOR PLANT PROTECTION)

CAS Number : 57-13-6

Chemical Name : UREA

Substance

Reported Name : UREA

DEU REC THIS SUBSTANCE IS CLASSIFIED AS SLIGHTLY HAZA RDOUS TO WATER (WATERHAZARD CLASS: WGK 1). ( THE DIFFERENT CLASSES ARE: WGK 3 = VERY HAZAR 

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

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

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

ADMINISTRATIVE RULES CONCERNING WATER-HAZARDO US SUBSTANCES 

(VERWALTUNGSVORSCHRIFT WASSERGE FAEHRDENDE STOFFE)

Effective Date : 

Entry / Update : DEC1991

Title :

Reference :

Last Amendment :

-

INDST

CLASS

RQR

Area Type Subject Spec. Description Level / Summary Information :

AQ

USE

GMSMA6, 8, 114, 1990

Gemeinsames Ministerialblatt. Joint Ministerial Papers

CAS Number : 57-13-6

Chemical Name : UREA

Substance

Reported Name : urea

GBR REG CATEGORY C SUBSTANCE: DISCHARGE INTO THE SEA IS PROHIBITED; DISCHARGE 

OF TANK WASHINGS AND RESIDUAL MIXTURES IS SUBJECT TO RESTRICTIONS . 

(APPLIES TO SOLUTION WITH AMMONIUM NITRATE CONTAINING AQUA AMMONIA).

THE MERCHANT SHIPPING (CONTROL OF POLLUTION B Y NOXIOUS LIQUID 

SUBSTANCES IN BULK) REGULATI ONS 1987, SCHEDULE 1

Effective Date : 

Entry / Update :

06APR1987

 1992

Title :

Reference :

Last Amendment :

MARIN

MARIN

EMI

RQR

RSTR

RSTR

Area Type Subject Spec. Description Level / Summary Information :

TRNSP

AQ

AQ

GBRSI*, 551, 15, 1987

GBRSI*, 2604, 2, 1990

Statutory Instruments

Statutory Instruments

IRPTC Data Profile 
118 Recomendations/Legal mechanisms 

CAS Number : 57-13-6

Chemical Name : UREA

Substance

Reported Name : urea

GBR REG CATEGORY D SUBSTANCE: DISCHARGE INTO THE SEA IS PROHIBITED; DISCHARGE 

OF RESIDUAL MIXTURES IS SUBJECT TO RESTRICTIONS. (APPLIES TO UREA 

SOLUTION WITH AMMONIUM MONO-HYDROGEN PHOSPHA TE, AMMONIUM DIHYDROGEN PHOSPHATE AND POTASS IUM CHLORIDE, APPLIES ALSO TO UREA 

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

AMMONIUM PHOSPHATE).

THE MERCHANT SHIPPING (CONTROL OF POLLUTION B Y NOXIOUS LIQUID 

SUBSTANCES IN BULK) REGULATI ONS 1987, SCHEDULE 1

Effective Date : 

Entry / Update :

06APR1987

 1992

Title :

Reference :

Last Amendment :

MARIN

MARIN

EMI

RQR

RSTR

RSTR

Area Type Subject Spec. Description Level / Summary Information :

TRNSP

AQ

AQ

GBRSI*, 551, 15, 1987

GBRSI*, 2604, 2, 1990

Statutory Instruments

Statutory Instruments

CAS Number : 57-13-6

Chemical Name : UREA

Substance

Reported Name : urea

GBR REG CLASSIFIED AS A NON-POLLUTING LIQUID SUBSTANC E. DOCUMENTARY EVIDENCE 

OF ASSESSMENT AND APP ROVAL REQUIRED BY A CARRIER. DISCHARGE INTO T HE 

SEA IS NOT PROHIBITED. (APPLIES TO SOLUTIO N).

THE MERCHANT SHIPPING (CONTROL OF POLLUTION B Y NOXIOUS LIQUID 

SUBSTANCES IN BULK) REGULATI ONS 1987, SCHEDULE 2

Effective Date : 

Entry / Update :

06APR1987

 1992

Title :

Reference :

Last Amendment :

MARIN

MARIN

EMI

RQR

RQR

RQR

Area Type Subject Spec. Description Level / Summary Information :

TRNSP

AQ

AQ

GBRSI*, 551, 15, 1987

GBRSI*, 2604, 2, 1990

Statutory Instruments

Statutory Instruments

CAS Number : 57-13-6

Chemical Name : UREA

Substance

Reported Name : UREA

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

IT IS PERMITTED ANDM AXIMUM LEVELS OF USE ARE LISTED.

THE FOOD, DRUGS AND CHEMICAL SUBSTANCES (FOOD LABELLING, 

ADDITIVES AND STANDARDS) REGULATI ONS, 1978

Effective Date : 

Entry / Update : SEP1982

Title :

Reference :

Last Amendment :

ADDIT PRMT

Area Type Subject Spec. Description Level / Summary Information :

FOOD

GSKEN*, 40, 406, 1978

KENYA GAZETTE SUPPLEMENT NO. 40, SPECIAL ISSUE 

(LEGISLATIVE SUPPLEMENT NO. 27)

IRPTC Data Profile 
Recomendations/Legal mechanisms 119

CAS Number : 57-13-6

Chemical Name : UREA

Substance

Reported Name : UREA

RUS REG 0.2 MG/M3 AV/D.

Effective Date : 

Entry / Update :

AUG1984

SEP1985

Title :

Reference :

Last Amendment :

AMBI MAC

Area Type Subject Spec. Description Level / Summary Information :

AIR

PDKAV*, 3086-84, 1984

PREDELNO DOPUSTIMYE KONTSENTRATSII (PDK) 

ZAGRYAZNYAYUSHCHIKH VESHCHESTV V ATMOSFERNOM 

VOZDUKHE NASELENNYKH MEST

(MAXIMUM ALLOWABLE CONCENTRATIONS (MAC) OF 

CONTAMINANTS IN THEAMBIENT AIR OF RESIDENTIAL AREAS)

CAS Number : 57-13-6

Chemical Name : UREA

Substance

Reported Name : UREA

RUS REG SURFACE WATER FOR FISHING : 80.0 MG/L

Effective Date : 

Entry / Update : SEP1985

Title :

Reference :

Last Amendment :

SURF MAC

Area Type Subject Spec. Description Level / Summary Information :

AQ

PDKTV*, 1978

PREDELNO-DOPUSTIMYE KONTSENTRATSII I 

ORIENTIROVOCHNYE BEZOPASNYEUROVNI VOZDEISTVIA 

VREDNYKH VESHCHESTV V OBIEKTAKH VNESHNEI SREDY. 

NORMATIVNYE MATERIALY.

(MAXIMUM ALLOWABLE CONCENTRATIONS AND PRELIMINARY 

SAFETY LEVELSOF TOXIC SUBSTANCES IN ENVIRONMENT. 

STANDARDS.)

CAS Number : 57-13-6

Chemical Name : UREA

Substance

Reported Name : UREA

RUS REG CLV: 10MG/M3 (AEROSOL) HAZARD CLASS: II

Effective Date : 

Entry / Update :

01JAN1989

MAY1990

Title :

Reference :

Last Amendment :

OCC MAC

CLASS

Area Type Subject Spec. Description Level / Summary Information :

AIR

GOSTS*, 12.1.005, 1988

GOSUDARSTVENNYI STANDART SSSR

(STATE STANDARD OF USSR)

IRPTC Data Profile 
120 Recomendations/Legal mechanisms 

CAS Number : 57-13-6

Chemical Name : UREA

Substance

Reported Name : UREA

RUS REG CLV: 25MG/M3 (VAPOUR, AEROSOL- APPLIES TO FER TILIZER MIXT. WITH AMMONIA); 

HAZ. CLASS: IV

Effective Date : 

Entry / Update :

1JAN1989

MAY1990

Title :

Reference :

Last Amendment :

OCC MAC

CLASS

Area Type Subject Spec. Description Level / Summary Information :

AIR

GOSTS*, 12.1.005, 1988

GOSUDARSTVENNYI STANDART SSSR

(STATE STANDARD OF USSR)

CAS Number : 57-13-6

Chemical Name : 

Substance

Reported Name : UREA

USA REG CASE NAME UREA; Summary - THIS SUBSTANCE IS I NCLUDED ON A LIST OF ACTIVE 

INGREDIENTS CONTA INED IN A PRODUCT FIRST REGISTERED BEFORE NOV EMBER 

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

PUBLICATION OF THIS LIST INITIATES AN ACCELERATED REREGISTRATION AND 

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

FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICI DE ACT PESTICIDES 

REQUIRED TO BE REREGISTERED ; LIST D

Effective Date : 

Entry / Update :

 1989

JAN1992

Title :

Reference :

Last Amendment :

PESTI

PESTI

ADDIT

RQR

PRMT

RQR

Area Type Subject Spec. Description Level / Summary Information :

CLASS

MANUF

FOOD

FEREAC, 54, 204, 43388, 1989

FEREAC, 54, 204, 43388, 1989

Federal Register

Federal Register

CAS Number : 57-13-6

Chemical Name : UREA

Substance

Reported Name : UREA

EEC REG TECHNICALLY PURE UREA MAY BE MARKETED AS FEED INGSTUFF UNDER THE 

CONDITIONS LAID DOWN.

COUNCIL DIRECTIVE OF 30 JUNE 1982 CONCERNING CERTAIN PRODUCTS 

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

Effective Date : 

Entry / Update :

01JUL1988

SEP1987

Title :

Reference :

Last Amendment :

- PRMT

Area Type Subject Spec. Description Level / Summary Information :

FEED

OJEC**, L213, 8, 1982

OJEC**, L239, 36, 1988

Official Journal of the European (Communities)/Union

Official Journal of the European (Communities)/Union

IRPTC Data Profile 
Recomendations/Legal mechanisms 121

CAS Number : 57-13-6

Chemical Name : UREA

Substance

Reported Name : UREA

EEC REG THE SUBSTANCE MAY BE USED FOR THE MANUFACTURE OF REGENERATED 

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

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

IN TOTAL: 27%.

COUNCIL DIRECTIVE OF 25 APRIL 1983 ON THE APP ROXIMATION OF THE 

LAWS OF THE MEMBER STATES R ELATING TO MATERIALS AND ARTICLES 

MADE OF REG ENERATED CELLULOSE FILM INTENDED TO COME INTO 

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

Effective Date : 

Entry / Update :

01APR1987

OCT1987

Title :

Reference :

Last Amendment :

- RQR

MXL

RSTR

Area Type Subject Spec. Description Level / Summary Information :

FOOD

FOOD

FOOD

OJEC**, L123, 31, 1983

OJEC**, L228, 32, 1986

Official Journal of the European (Communities)/Union

Official Journal of the European (Communities)/Union

CAS Number : 57-13-6

Chemical Name : 

Substance

Reported Name : Urea

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

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

substance shall be prohibited except where specified conditions are satisfied. 

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

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

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

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

nitrate solution containing aqua ammonia)

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

by the Protocol of 1978 relating thereto (MARPOL 73/78).

Effective Date : 

Entry / Update : SEP1994

Title :

Reference :

Last Amendment :

EMI

MARIN

RSTR

RSTR

Area Type Subject Spec. Description Level / Summary Information :

AQ

AQ

IMODC*, 

IRPTC Data Profile