OECD SIDS

UREA

FOREWORDINTRODUCTIONUREA
CAS N°: 57-13-6

UNEP PUBLICATIONS

1

Identifiers, Physical and Chemical properties

Substance
End Point
Chemical Name
Common Name
CAS Number
RTECS Number

:
:
:
:
:

IDENTIFIERS, PHYSICAL AND CHEMICAL PROPERTIES
Urea
Urea
57-13-6
YR6250000

Synonyms
Benural 70
Carbamide
Carbonyl diamide
Nimin
UR
Ureaphil
Urepearl
Varioform II

B-I-K
Carbamimidic acid
Isourea
Pseudourea
Urea perhydrate
Ureophil
Urevert

Properties & Definitions
Molecular Formula
Molecular Weight
Melting Point
Boiling Point
State
Flamable Limit
Density
Vapour Pressure
Octanol/Water Partition
Coefficient
Water Solubility
Solubility in other
Solvents
ColourTaste
Odour
Additives
Impurities

:
:
:
:
:
:
:
:
:

CH4N2O::

1080 g/L at 20C

:
:
:
:
:

Colourless to white

General Comments

:

60.06
133C*
135C decomposition**
Crystal prismatic or powder
Non-flammable1323 kg/m3 at 20-24C
80 Pa (0.6 mmHg) at 20C CAL***log Pow = -1.59 at 20-25C experimental

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

Cooling, saline
Almost odourlessUrea-formaldehyde binder can be used in some prilling processes.
Biuret 0.3 - 2 wt%; cyanates. Analysis of technical urea gave thefollowings: 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%.
*On further heating decomposes to biuret, NH3 and cyanuric acid. On standingor on heating decomposes to NH3 and CO2. ** Urea decomposes before
boiling.***VP of saturated water solution=2kPa at 20C. Hypochlorites can reactwith urea to form the explosive compound, nitrogen trichloride. Reacts violently
with gallium perchlorate.

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

2

Identifiers, Physical and Chemical properties
Although urea has generally low ecotoxicity to organisms, its well documented indirect and longterm effects tothe 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 notbeen 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 offertilizers 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 byrain into rivers, lakes and seas.
Livestock urine can cause environmental exposure when livestock graze in the grazing season or when manureof 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 washedout 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 activatedsludge (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

3

Identifiers, Physical and Chemical properties
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 notevaporate 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 thegroundwater 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 arainfall.
(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. Ifmeat 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 wereurea), 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, theuncertainties about the quantity are great. The possible food additive use of urea apparently adds litlle to theintake 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 percent 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 torelatively 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 whendispersing urea fertilizers/urea in the fields, roads and runways. In the context of airborne exposure, the nonrespirable fraction will be mostly ingested. A part of the airborne dust will deposit onto the skin and, additionally,heavier contamination of the hands will result from the handling of urea. Accidental splashes to the skin are
possible too.
No reports on actual measurements of urea concentration in the workplace or breathing zone air were located.
The worst case scenario would assume that the exposure conforms to the permissible exposure levels of OSHA:
15 mg/m3 total dust and 5 mg/m3 respirable dust.
Uptake of respirable urea at 5 mg/m3 (with a 10 m3 volume of total ventilation and 100% absorption) would
amount to 50 mg (inhalation dose).
The non-respirable part of urea at 10 mg/m3 and 10 m3 ventilation results in the airway deposition of 100 mg,
most of which will be ingested.
The amount of urea deposited on the skin may be significant, but the fraction absorbed is likely to be less thanfrom skin preparations (the formulation affects the penetration of urea into the skin). Consequently, although noaccurate 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 TOXICITYa) 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 toammonia 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 bodyweight/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 doselevels. Thus the NOAELs were about 6750 mg/kg body weight/day for mice and about 2250 mg/kg bodyweight/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 ofmice 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 14days did not cause outstanding (external) teratogenicity; the mean birthweight of the newborn was lower but thelitter size greater. Injection of urea into the air sack of eggs shows that urea is toxic to the development of chickembryo.
No NOAEL can be given for the reproductive/developmental toxicity of urea because appropriate studies arelacking.
d) Genetic toxicity
IRPTC Data Profile

5

Identifiers, Physical and Chemical properties

Urea has been negative in several appropriately conducted bacterial mutagenicity tests. Urea caused DNA
single strand breaks in mammalian cells in vitro and was clastogenic for mammalian cells in vitro and in vivo
but only at concentrations much beyond the physiological range (about 50-100 higher concentrations than foundin human blood).
The mechanism of genotoxicity is probably non-specific (e.g. difference in osmotic pressure across the cell
membrane).
e) Any other human health related information that is available
There is little data that relates urea to human health other than its use in dermatology and some more limited
applications in clinical medicine. The use of urea (at 10% concentration or less) in ointments and creams totreat dry skin has been widespread, and long term follow-up studies have indicated that the substance is nonallergenic and virtually free from side effects. Among other clinical therapeutic uses, the treatment of
inappropriate secretion of antidiuretic hormone (SIADH) should be noted, because its chronic form has involved
long term oral administration of large amounts of urea. Most patients have tolerated urea well, althoughdiarrhoea 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 becauseof 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 ofconcentrations and even beyond. This is supported by clinical evidence from high dose administration orally andintravenously 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 thetreatment of dry skin may receive an additional but minor dose. Occupational exposure (via inhalation, ingestionand 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 fromanimal studies are difficult to find. Especially it may be noted that the existing studies for reproductive anddevelopmental 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 2060 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 oftime. 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 humanhealth and the environment.
Based on the MTC/PEC-ratio urea is considered to possess low current concern. Urea has generally low acuteecotoxicity 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 andammonia 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 notbeen rigorously studied with toxicological tests. Nevertheless, urea appears to cause little or no toxicity to most
mammalian species (ruminants are more sensitive because of microbial ammonia production) and humans at
reasonable dose levels. Based on the EHE/EDLC ratio, urea should be of low current concern to human health.
RECOMMENDATIONS
No further tests are needed.
More accurate data concerning the daily intake of urea from diet are desirable.

IRPTC Data Profile

Production-Trade

7

Production-Trade
Chemical Name
CAS Number
Geographic Area

:
:
:

Urea
57-13-6WORLD

Production
QuantityYear

19062400-27963000 t/y - P 1985-1989
41440000-60789000 t/y - P 1985-1989
89800000-+134E+5 t/y - P 1989

General Comments:

1- The total production volume of urea in metric tons of N (urea N-46%)in theworld. 2- World total production volume of urea. 3- Capacities in production or
being commissioned in December 1989 (reported in: Information Chimie No.
315, March , pp. 179-201, (1990).

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
USA
AMN

Production
QuantityYear

1470000-2350000 t/y - P
13 % - EX

1985-1989

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)

Production-Trade
Chemical Name
CAS Number
Geographic Area

:
:
:

Urea
57-13-6
AMN

Production
QuantityYear

11599000-+630000 t/y - P

General Comments:

Capacities in production or being commissioned in December 1989.

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

Production-Trade
Chemical Name
CAS Number

:
:

Urea
57-13-6

Production
QuantityYear31635000-+3617000 t/y - P

General Comments

IRPTC Data Profile:

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

Production-Trade9

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
EUR
W

Production
QuantityYear6215000-+250000 t/y - P

General Comments:

Capacities in production or being commissioned in December 1989.

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

Production-Trade
Chemical Name
CAS Number

:
:

Urea
57-13-6

Production
QuantityYear3419000-+1150000 t/y - P

General Comments:

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

IRPTC Data Profile

10

Production-Trade

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

Production-Trade
Chemical Name
CAS Number
Geographic Area

:
:
:

Urea
57-13-6
AFRI

Production
QuantityYear2957000-+575000 t/y - P

General Comments:

Capacities in production or being commissioned in December 1989.

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

Production-Trade
Chemical Name
CAS Number
Geographic Area

:
:
:

Urea
57-13-6
ASIA

Production
QuantityYear5295000-+2550000 t/y - P
28728000-+4650000 t/y - P

General Comments

IRPTC Data Profile:

1- Capacities in production or being commissioned in December 1989 in
Middle East and Persian Gulf. 2- Capacities in production or beingcommissioned in December 1989 in Asia and Oceania.

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)

Production-Trade
Chemical Name
CAS Number
Geographic Area

:
:
:

Urea
57-13-6
EUR

Production
Quantity

Year7144900-8321000 t/y - P

1985-1989

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area

:
:
:

Urea
57-13-6
ASIA

Production
Quantity

Year

8063500-12185000 t/y - P

1985-1989

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)

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6NGA
AFRI

Production
QuantityYear

70000-230000 t/y - P

1987-1988

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
CAN
AMN

Production
QuantityYear

1000000-3000000 t/y - P

1985-1989

General Comments

IRPTC Data Profile:

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

Production-Trade13

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

Production-Trade
Chemical Name
CAS Number
Geographic Area

:
:
:

Urea
57-13-6
CUB

Production
QuantityYear

20000-38000 t/y - P

1985-1989

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area

:
:
:

Urea
57-13-6
MEX

Production
QuantityYear

500000-640000 t/y - P

1985-1988

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)

Production-Trade
Chemical Name
CAS Number
Geographic Area

:
:
:

Urea
57-13-6
TTO

Production
QuantityYear

150000-250000 t/y - P

1985-1989

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
AFG
ASIA

Production
QuantityYear

45000-60000 t/y - P

1985-1989

General Comments

IRPTC Data Profile:

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

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)

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
BDG
ASIA

Production
QuantityYear

380000-680000 t/y - P

1985-1989

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
IND
ASIA

Production
QuantityYear

3400000-5750000 t/y - P

1985-1989

General Comments:

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

16

Production-Trade

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6IDN
ASIA

Production
QuantityYear

1800000-2240000 t/y - P

1986-1989

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
IRN
ASIA

Production
QuantityYear

50000-100000 t/y - P

1986-1988

General Comments

IRPTC Data Profile:

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

Production-Trade17

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
JPN
ASIA

Production
QuantityYear

300000-350000 t/y - P

1985-1989

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)

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
KWT
ASIA

Production
QuantityYear

260000-400000 t/y - P

1985-1989

General Comments:

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

18

Production-Trade

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
PAK
ASIA

Production
Quantity

Year

835000-970000 t/y - P

1985-1989

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6QAT
ASIA

Production
QuantityYear

320000-360000 t/y - P

1985-1989

General Comments

IRPTC Data Profile:

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

Production-Trade19

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
SAU
ASIA

Production
QuantityYear

400000-450000 t/y - P

1985-1989

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
SYR
ASIA

Production
QuantityYear

50000-90000 t/y - P

1985-1989

General Comments:

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

20

Production-Trade

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
TUR
ASIA

Production
QuantityYear

70000-160000 t/y - P

1985-1988

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
ARE
ASIA

Production
QuantityYear

150000-260000 t/y - P

1985-1989

General Comments

IRPTC Data Profile:

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

Production-Trade21

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
VNM
ASIA

Production
QuantityYear

3500-15000 t/y - P

1985-1988

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
BGR
EUR

Production
QuantityYear

330000-370000 t/y - P

1985-1989

General Comments:

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

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)

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
CSK
EUR

Production
QuantityYear

70000-80000 t/y - P

1987-1989

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
FRG
EUR

Production
QuantityYear

500000-520000 t/y - P

1987-1989

General Comments

IRPTC Data Profile:

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

Production-Trade23

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
HUN
EUR

Production
QuantityYear

120000-200000 t/y - P

1985-1989

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
IRL
EUR

Production
QuantityYear

127000-147000 t/y - P

1986-1988

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)

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
ITA
EUR

Production
QuantityYear

460000-600000 t/y - P

1985-1989

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
NLD
EUR

Production
QuantityYear

380000-570000 t/y - P

1985-1987

General Comments

IRPTC Data Profile:

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

Production-Trade25

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
POL
EUR

Production
QuantityYear

240000-470000 t/y - P

1985-1989

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
PRT
EUR

Production
QuantityYear

4900-9000 t/y - P

1985-1988

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)

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
ESP
EUR

Production
QuantityYear

113000-165000 t/y - P

1985-1989

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
YUG
EUR

Production
QuantityYear0-240000 t/y - P

1988

General Comments

IRPTC Data Profile:

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

Production-Trade27

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

Production-Trade
Chemical Name
CAS Number
Geographic Area
Area Specifications

:
:
:
:

Urea
57-13-6
RUS
EUR

Production
QuantityYear

4800000-4950000 t/y - P

1987-1989

General Comments:

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

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

Production-Trade
Chemical Name
CAS Number
Geographic Area

:
:
:

Urea
57-13-6
AMN

Production
QuantityYear

3140000-6278000 t/y - P

1985-1989

General Comments:

The total production volume of urea in metric tons of N (urea N-46%) in northand 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)

Production-Trade
Chemical Name
CAS Number
Geographic Area

:
:
:

Urea
57-13-6WORLD

Production
QuantityYear41440000-60789000 t - P

1985-1989

General Comments:

The capacities of urea production have increased. By the year 1994-1995 thecapacites should reach a level of the order of 60 million tonnes of nitrogen (or130 million tonnes of urea), making the third chemical product together withammonia and sulphuric acid, to cross the threshold of 100 million per year.
The largest forcasted increase in capacity are in Saudi Arabia; Iraq and the
Gulf States in general; Indonesia, India and China.

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

Production-Trade
Chemical Name
CAS Number
Geographic Area

IRPTC Data Profile

:
:
:

Urea
57-13-6
FIN

Production-Trade

29

Production
QuantityYear

13640 t/y - P
1550 t/y - P
8210 t/y - P

1986
1986
1986
1986

610 t/y - P
34010 t/y - P
40000-60000 t/y - IM

General Comments

1986

:

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 withtotal 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

Processes

30

Processes
Chemical Name
CAS Number

:
:

Urea

:

In modern synthetic processes, urea is made by reacting ammonia andcarbon dioxide at high pressure and temperature to form ammonium
carbonate and simultaneously dehydrating the ammonium carbonate tourea and water. Produced urea is purified by crystallization. Urea is alsoa natural end product of biochemical protein decomposition and themain solid component of mammalian urine (e.g. man produces urea inurine 20-35 g/24 hours, (200-500 mg/kg body weight-1 day-1). Urea is anatural constituent of many common foodstuffs. Up to 15 percent of thetotal 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.

57-13-6

Process
Process comments

References
Secondary Reference

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

Uses

31

Uses
Chemical Name
CAS Number

:
:

Urea
57-13-6

Use
QuantityYear

Comments
Use in agriculture: Urea is widely manufactured anddistributed as a nitrogenous fertilizer, particularly forfibrous-rooted crops such as
rice. It is used extensively as one of the ingredients ofnitrogen 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.

3 %
1 %

References
Primary References:

GASTR*
Oehme, F. W. and Barrel, D. Veterinary Gastrointestinal Toxicology, 489-490,(1986)

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

Uses
Chemical Name
CAS Number

:
:

Urea
57-13-6

Use
Quantity

1 %6.4-9.6 %Year

Comments
Use in consumer products: Urea is used in liquidsoaps, detergents and houshold cleaning products. It
is also used in cosmetic products ascreams, shampoos, hair conditioners, hair dyes anddye 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).

wt

References
Primary References:

COSDA*
Cosmetics and Detergent Association in Finland, (1992)

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

Uses

32

Uses
Chemical Name
CAS Number

:
:

Urea
57-13-6

Geographic Area

:

USA

Use
QuantityYear

Comments
Fertilizer, solid
Fertilizer solutions
Urea-formaldehyde resins and adhesives
Others, including animal feed and melamine

42 %
31 %
5 %
9 %

References
Primary References:

CMKRA5Karcher, AR. Chemical Profiles. Chemical Marketing Reporter, 234(13), 54,(1988)

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

Uses
Chemical Name
CAS Number

:
:

Urea
57-13-6

Geographic Area

:

FIN

Use
QuantityYear

Comments
Fertilizer, solid
Urea-formaldehyde resins and adhesives
Deicer on airport runways
Other, including use as a nutrient in waste water
treatment plant.

23 %
68 %
2 %
7 %

References
Primary References:

INFFI*
Information from Finnish Industry, (1990)

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

Uses
Chemical Name
CAS Number

:
:

Urea
57-13-6

Geographic Area

:

WORLD

IRPTC Data Profile

Uses

33

Use
QuantityYear

Comments
Fertilizer
Animal feed
Industrial use

85-90 %
2-4 %
8-11 %

References
Primary References:

CHWKA9Chemical Week, 112(4), 19, (1973)

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

Uses
Chemical Name
CAS Number

:
:

Urea
57-13-6

Geographic Area

:

FIN

Use
QuantityYear

Comments
Types of uses are divided into three: industrial use(open system and closed system), public use andexport. 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

References
Primary References:

ECAPD*
Chenier,R. Environment Canada 1974. National Inventory of Sources andEmissions of Asbestos, Beryllium, Lead and Mercury. Summary of Emissionsfor 1970, (1991)

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

IRPTC Data Profile

Uses

34

Uses
Chemical Name
CAS Number

:
:

Urea
57-13-6

Geographic Area

:

FIN

Use
QuantityYear

Comments
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/UVabsorber .

References
Primary References:

ECAPD*
Chenier, R. Environment Canada 1974. National Inventory of Sources andEmissions of Asbestos, Beryllium, Lead and Mercury. Summary of Emissionsfor 1970, (1991)

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

Uses
Chemical Name
CAS Number

:
:

Urea
57-13-6

Use
QuantityYear

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

IRPTC Data Profile

Uses

35

References
Primary References:

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

IRPTC Data Profile

Pathways into the Environment and Environmental Fate

36

Study
End Point
Chemical Name
CAS Number:::

Pathway into the Environment and Environmental Fate.
Urea
57-13-6

Test Method and Conditions
Test method
description

Mackay level 1 model:

Pathway and Transport
Pathway:

LOAD

Quantity Transported
Mediumto Medium

Quantity

to AQ

99.84 %

to AIR

0.16 %TimeYear

to YearPartitioning into water.

Partitioning into air.
to AIRNH3 emission, resulted from degradation of urea to ammonia. Emissions are higher in alkaline soil.

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

Study
End Point
Chemical Name
CAS Number:::

Pathway into the Environment and Environmental Fate.
Urea
57-13-6

Geographic Area:

FIN

Pathway and Transport
Pathway

:

NATUR

APPLI

Quantity Transported
MediumBIOTA

to Medium
AGRIC

Quantity

Time

Year

to SOIL

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

to Year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

Concentration

38

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

CONCENTRATION
Urea
57-13-6

LAB
FIN

Test Subject
Organism Medium
AQ
AQ

Specification Lifestage Sex
SEW
GRND

Species/strain/system

Waste water:

Test Method and Conditions
Test method
description

The monitoring data has been used for calculation of the predictedenvironmental concentration (PEC). For calculation of PEC the dilution
factor of 10 for domestic waste water effluent is used.

:

Test Results
MatrixConcentrations

Spec.

Date

2-6 mg/L
In domestic sewage
0.016-0.043 mg/L
In primary sewage plant effluent
0.0016-0.0043 mg/L
PEC for primary sewage plant effluent
20 ug/L
Concentration in groundwater in airport area as of 1980

General Comments

1980

The information concerning the groundwater is reported in the following
reference: National Board of Waters and the Environment, Finland(Unpublished data).

:

References
Primary Reference:

HBEDC*
Vershueren, K. Handbook of Environmental Data on Organic Chemicals,
2nd ed., 1178, (1983)

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

IRPTC Data Profile

Concentration

39

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

CONCENTRATION
Urea
57-13-6

FIELD
FIN

Test Subject
Organism Medium
AQ

Specification Lifestage Sex
SEWSpecies/strain/system

Sewage of Kemira's fertilizer factory, Finland:

Test Method and Conditions
Test method
description

The monitoring data has been used for calculation of the predictedenvironment concentration (PEC). For calculation of PEC the dilution
factor of 100 for industrial effluent is used.

:

Test Results
MatrixConcentrations

Spec.

Date

1993
0.34 mg/L
Concentration in fertilizer manufacturing plant waste water (highest monthly mean) as of 1993.
0.0034 mg/L
PEC for fertilizer factory

References
Primary Reference:

TWEDO*
Anttalainen, M. Turku Water and Environment District Oral
Communication, (1994)

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

IRPTC Data Profile

Concentration

40

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

CONCENTRATION
Urea
57-13-6

FIELD
FIN

Test Subject
Organism Medium
AQ

Specification Lifestage Sex
GRND

Species/strain/system

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

Test Method and Conditions
Test method
description

Analysis of groundwater nitrate, nitrite and ammonium concentrations:

Test Results
MatrixConcentrations

Spec.

Date

1975-1990
150 mg/L
Nitrate concentrations in the airport area groundwater increased up to 150 mg/L
80 mg/L
Due to diminished use amounts of urea in recent years, from 300 tonnes to less than 100 tonnes/year, nitrateconcentrations slowly decreased to 80 mg/L.

General Comments

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

:

References
Primary Reference:#URNWE*
National Board of Waters and the Environment Unpublished Report

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

IRPTC Data Profile

Concentration

41

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

CONCENTRATION
Urea
57-13-6

LAB
FIN

Test Subject
Organism Medium

Specification Lifestage Sex
ADULT

HUMAN

Species/strain/system

Physiological concentrations in man:

Test Results
MatrixConcentrations

Spec.

Date

URINE
20-35 g/24h
In urine (200-500 mg/kg body weight/day)
120-570 mg/L
In sweat
BLOOD
3.3-6.4 mmol/L
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, 16thed., Lange Medical Publications, Los Altos California, 1977, page 625.

:

References
Primary Reference:

FASEB*
Altman, P. L. and Dittmer, D. S. Biology Data Book, III 2nd ed.,1494&01, (1974)

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

IRPTC Data Profile

Concentration

42

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

CONCENTRATION
Urea
57-13-6

LAB
FIN

Test Subject
Organism Medium
HUMAN
PLANT

Specification Lifestage Sex

FOOD
SEED

Test Results
MatrixConcentrations

Spec.

Date

BLOOD
30-100 mg/L
In human blood
4.5 %Edible parts of plants may contain up to 4.5 per cent (oats) of their total nitrogen content as urea.
2-4 %The nitrogen content of grain seeds and grass

General Comments

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.

:

References
Primary Reference:

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

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

IRPTC Data Profile

Human Intake and Exposure

43

Study
End Point
Chemical Name
CAS Number:::

HUMAN INTAKE AND EXPOSURE
Urea:

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

57-13-6

Evaluations
Evaluation text

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

Study
End Point
Chemical Name
CAS Number
Geographic Area

:
:
:
:

HUMAN INTAKE AND EXPOSURE
Urea
57-13-6

FIN

Test Subject
Organism Medium
HUMAN
HUMAN

Specification Route Lifestage Sex
IHL
SKN

AIR

Species/strain/system:

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

Test Results
Intake

Spec.

Date

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

IRPTC Data Profile

Human Intake and Exposure

44

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

Study
End Point
Chemical Name
CAS Number
Geographic Area

:
:
:
:

HUMAN INTAKE AND EXPOSURE
Urea
57-13-6

FIN

Test Subject
Organism Medium
HUMAN
HUMAN

FOOD
PLANT
AIR

Specification Route Lifestage Sex
ANI
AGRIC

Species/strain/system

ORL
IHL
Potential anthropogenic sources of exposure are manufacturing,industrial, agricultural and consumer uses.

:

Test Results
Intake

Spec.

Date

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 inmammals and occurs in significant concentrations in blood and obviously inextracellular water, human food of animal origin contains some urea.

:

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

Study
End Point
Chemical Name
CAS Number
Geographic Area

:
:
:
:

HUMAN INTAKE AND EXPOSURE
Urea
57-13-6

USA

Test Subject
Organism Medium
HUMAN

IRPTC Data Profile

Specification Route Lifestage Sex

Human Intake and Exposure

45

Test Method and Conditions
Test method
description

The National Occupational Hazard Survey conducted by NIOSH.

:

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% fromobserved use of a tradename product known to contain this chemical, and
62% from observed use of a product in some type of general use whichleads 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 fromfertilizers occur in ruminants. (Reported in: Oehme, F. W. and Barrel, D. S.:
Veterinary Gastrointestinal Toxicology, Chapter 17 in Rozman, K. andHanninen, O. (eds).

:

References
Primary Reference:

HSDBM*
Hazardous Substances Databank HSDB, 11, (1991)

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

IRPTC Data Profile

Biodegradation

46

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

BIODEGRADATION
Urea
57-13-6

LAB
FIN

Test Subject
Organism Medium
AQ

Specification
FRESH

Test Method and Conditions
Test method
description
Temperature:

GLP: no:<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
Evans, W. H. et al. Water Research, 7, 975-985, (1973)

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

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

BIODEGRADATION
Urea
57-13-6

LAB
FIN

Test Subject
Organism Medium
AQ

Specification
SLUDG

Species/strain/system

IRPTC Data Profile:

Semi-continuous activated sludge (SCAS)

Biodegradation

47

Test Method and Conditions
Test method
description

The diappearance of urea was determined by colorimetric analysis.

:

Test Results
Quantity

Time

Comments on result

93-98 %

24 h

Mean disappearance of urea in 24-hour cycle

General Comments:

Urea is biodegradable in semi-continuous activated sludge (SCAS). (Job
No. 1449006, as cited in the reference).

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

BIODEGRADATION
Urea
57-13-6

LAB
FIN

Test Subject
Organism Medium
AQ

Specification
SLUDG

Species/strain/system:

Activated sludge from a laboratory sewage treatment facility fed withdomestic and synthetic sewage; adapted.

Test Method and Conditions
Test method
description:

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

:

AEROB

:

400 mg/L

Exposure
Dose / Concentration

IRPTC Data Profile

Biodegradation

48

Test Results
Quantity

Time

Comments on result

3 %

3h

Decomposed urea

52 %

7h

Decomposed urea

60 %

10 d

Decomposed urea

85 %

14 d

Decomposed urea

96 %

16 d

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*
BASF AG. BASF Unpublished Report, (1991)

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

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

BIODEGRADATION
Urea
57-13-6

LAB
FIN

Test Subject
Organism Medium

Specification

AQ
SOIL

Species/strain/system:

Flooded soil

:
:

30 h
30 hours of incubation

Exposure
Exposure Period
Exposure comments

IRPTC Data Profile

Biodegradation

49

Test Results
Quantity

Time

Comments on result
A laboratory study demonstrated that the main site of urea hydrolysis inflooded soil columns was in the soil and not the floodwater (ureolytic
bacterial action).

3 %

30 h

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

64 %

30 h

The added urea which was hydrolysed in the soil after 30 hours of
incubation.
Additional studies also showed that soil water content had little effect onurease activity, but other researchers have found hydrolysis rates toincrease with increasing soil water up to field capacity.

General Comments:

Report number: D/39/1978

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

BIODEGRADATION
Urea
57-13-6

LAB
FIN

Test Subject
Organism Medium
BACT

Specification

SOIL
SOIL

Test Method and Conditions
Test method
description
Temperature:

Transformation times of different nitrogen forms in soil:

2-20 C:

1-4 d

Exposure
Exposure Period

IRPTC Data Profile

Biodegradation

50

Test Results
Quantity

Time

Comments on result

4d

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

2dTransformation of urea-N to ammonium-N by urease at 10C

1d

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

50 %

6 wk

Conversion (transformation of ammonium-N to nitrate-N by bacteria) at
5C

50 %

4 wk

Conversion (transformation of ammonium-N to nitrate-N by bacteria) at
8C

50 %

2 wk

Conversion (transformation of ammonium-N to nitrate-N by bacteria) at
10C

50 %

1 wk

Conversion (transformation of ammonium-N to nitrate-N by bacteria) at
20C

References
Primary Reference:

BUARE*
Bua. BUA Report on Chemicals of Environmental Relevance, 76

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

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

BIODEGRADATION
Urea
57-13-6

LAB
FIN

Test Subject
Organism Medium

Specification

BACT

SEW

AQ

Species/strain/system:

Psychrophilic bacteria

Test Method and Conditions
Temperature
Relative Humidity

IRPTC Data Profile

:
:

20 C
2 %

Biodegradation

51

Test Results
Quantity

Time

Comments on result

11.6 mg/L

1h

Maximum degradation rate per hour at 20C

10.9 mg/L

1h

Average degradation rate per hour at 20C

4.0 mg/L

1h

Maximum degradation rate per hour at 2C

3.2 mg/L

1h

Average degradation rate per hour at 2C

References
Primary Reference:

HBEDC*
Verschueren, K. Handbook of Environmental Data on Organic
Chemicals, 2nd. ed., (1983)

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

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

BIODEGRADATION
Urea
57-13-6

LAB
FIN

Test Subject
Organism Medium
BACT

Specification

SOIL
AQ

Exposure
Exposure comments:

Main factors affecting the rates of nitrogen metabolization are the initialconcentration 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 waterurea 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
Gunkel, K. et al. Acta Hydrochimica et Hydrobiologica, 18(1), 3-20,(1990)

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

IRPTC Data Profile

53

Hydrolysis

Study
End Point
Chemical Name
CAS Number
Geographic Area

:
:
:
:

HYDROLYSIS
Urea
57-13-6

FIN

Test Method and Conditions:

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

Quantity

Time

Comments on result

50 %

>1 y

Estimated half-life. PCHYDRO-model estimated the urea hydrolysis to
be extremely slow.

Primary Reference:#URNWE*
National Board of Waters and the Environment Unpublished Report,(1994)

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

Test method
description

Test Results

References

IRPTC Data Profile

54

Sorption

Study
End Point
Chemical Name
CAS Number
Study typeMedium:::::SORPTION
Urea
LAB
-

SILT

LOAM

Specifications

:

-

SOIL

SOIL

Geographic Area

:

FIN

Time

Comments on result57-13-6

Test Results
Quantity

Urea is relatively leachable from the soil into the surface and thegroundwater because of its weak adsorption to the soil, high watersolubility and soil-water partition coefficient. This can happen especially
if the soil surface is saturated with water, as might be the case after arainfall.
Urea adsorption coefficient in Crowly silt loam flooded soil column
ranged from 0.037 (50 mg N/L) to 0.064 (1000 mg N/L) depending on
the concentration of urea water.

:

Urea adsorption by the soil was low. The following reference is also
cited: Sharply, A. N. et al. 1983. Water, Air and Soil Pollution 14(3): 425430 (1983); as cited in HSDB 1991.

Primary Reference:

SSSJD4
Hongprayoon, C. et al. Soil Science Society of America Journal, 55,
1130-34, (1991)

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

General Comments

References

IRPTC Data Profile

55

Evaporation

Study
End Point
Chemical Name
CAS Number
Study typeMediumSpecifications
Geographic Area

:
:
:
:
:
:
:

EVAPORATION
Urea:

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 toatmosphere.

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

57-13-6

LAB
AQ
FRESH
FIN

Test Results
General Comments

References
Secondary Reference

IRPTC Data Profile

56

Ecosystems

Study
End Point
Chemical Name
CAS Number
Geographic Area

:
:
:
:

ECOSYSTEMS
Urea:

Soil properties after long-term fertilization with urea

57-13-6

FIN

Test Subject
Species/strain/system
Ecosystems

:

TERR

:

Nitrogenous fertilizers

Test SubstanceDescription of the test
substance

Test Method and Conditions
Test method
description

Effects monitored: soil pH and micronutrients availabilities.

:

Exposure
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 (0.05-2mm), coarse silt (0.02-0.05 mm), fine silt (0.002-0.02 mm), clay (<0.002
mm).

Exposure comments

Test Results
General Comments

20 years of urea fertilization reduced soil pH significantly, comparedwith 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 inavailable P (phosphor) and exchangeable bases (Ca, Mg, Na). Soilacidification occurred also on areas treated with ammonia, NH4NO3
and urea-NH4NO3 mixture.

:

References
Primary Reference:

SSSJD4Darusman, L. R. et al. Soil Science Society of America Journal, 55,
1097-00, (1991)

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

IRPTC Data Profile

Absorption

57

Study
End Point
Chemical Name
CAS Number:::

ABSORPTION
Urea
57-13-6

Test Subject
Organism Medium

Specification

HUMAN

Route

Lifestage Sex Number exposed Number controls

SKN

Test Results
General Comments:

Urea penetrates rapidly into the human stratum corneum; penetration isenhanced 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.

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

References
Secondary Reference

IRPTC Data Profile

Distribution

58

Study
End Point
Chemical Name
CAS Number:::

DISTRIBUTION
Urea
57-13-6

Test Subject
Organism Medium

Specification

HUMAN

Route

Lifestage Sex Number exposed Number controls

ORL

Test Results
General Comments:

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

:

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

References
Secondary Reference

Study
End Point
Chemical Name
CAS Number:::

DISTRIBUTION
Urea
57-13-6

Test Subject
Organism Medium

Specification

RAT

Route

Lifestage Sex Number exposed Number controls

SKN

Test Results
General Comments:

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

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

References
Secondary Reference

IRPTC Data Profile

Bioconcentration

59

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

BIOCONCENTRATION
Urea:

Due to the low log Pow value urea is not likely to undergo
bioaccumulation.

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

57-13-6

LAB
FIN

Test Results
General Comments

References
Secondary Reference

IRPTC Data Profile

Excretion

60

Study
End Point
Chemical Name
CAS Number
Geographic Area

:
:
:
:

EXCRETION
Urea:

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

Primary Reference:

NATUAS
Randall, D. J. et al. Nature

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

57-13-6

FIN

Test Results
General Comments

References

IRPTC Data ProfileMammalian Acute Toxicity

61

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN ACUTE TOXICITY
Urea
57-13-6

Species/strain/system
Frequency
Dose / Concentration:::

Strain not mentioned
1x
14300-15000 mg/kg BW

Test Method and Conditions:

GLP: no

Spec.

Route

Test method
description

Test Results
Organism Medium

Lifestage Sex

LD50 Oral LD50 for male rats was establishedas 14300 mg/kg and for female rats as
15000 mg/kg body weight.
The general symptoms consisted mainly of sedation, loss of righting reflex andstaggering gait.

RAT

ORL

General Comments

Effect Effect Comments:

M
F

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN ACUTE TOXICITY
Urea
57-13-6

Frequency
Dose / Concentration::

1x
8200-9400 mg/kg BW

Test Method and Conditions
Test method
description:

GLP: no

Spec.

Route

Lifestage Sex

SCU

M
F

Test Results
Organism Medium
RAT

Effect Effect Comments
LD50 Subcutaneous LD50 for male andfemale rats was established as 9400
mg/kg and 8200 mg/kg body weight,
respectively.
IRPTC Data ProfileMammalian Acute Toxicity

62

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN ACUTE TOXICITY
Urea
57-13-6

Species/strain/system
Frequency
Dose / Concentration:::

Strain not mentioned
1x
11500-13000 mg/kg BW

Test Method and Conditions:

GLP: no

Spec.

Route

Test method
description

Test Results
Organism Medium

Effect Effect Comments

LD50 Oral LD50 for male and female micewas established as 11500 mg/kg and
13000 mg/kg, respectively.
The general symptoms consisted mainly of sedation, loss of righting reflex andstaggening gait.

MOUSE

General Comments

Lifestage Sex

ORL

:

M
F

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN ACUTE TOXICITY
Urea
57-13-6

Frequency
Dose / Concentration::

1x
9200-10700 mg/kg BW

IRPTC Data ProfileMammalian Acute Toxicity

63

Test Method and Conditions:

GLP: no

Spec.

Route

Lifestage Sex

SCU

M
F

Test method
description

Test Results
Organism Medium
MOUSE

Effect Effect Comments
LD50 Subcutaneous LD50 for male andfemale mice was established as 9200
mg/kg and 10700 mg/kg body weight,
respectively.

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN ACUTE TOXICITY
Urea
57-13-6

Species/strain/system
Dose / Concentration

:
:

Cow
510 mg/kg BW

Test Method and Conditions:

GLP: no

Spec.

Route

Test method
description

Test Results
Organism Medium
CATTL

ORL

Lifestage Sex

Effect Effect Comments
LD50 Oral LD50 for cow was established as
510 mg/kg body weight.

References
Primary Reference:

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

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

IRPTC Data ProfileMammalian Acute Toxicity

64

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN ACUTE TOXICITY
Urea
57-13-6

Dose / Concentration:

510 mg/kg BW

Test Method and Conditions:

GLP: no

Spec.

Route

Test method
description

Test Results
Organism Medium
SHEEP

Lifestage Sex

Effect Effect Comments
LD50 Oral LD50 for sheep was established as
510 mg/kg body weight .

ORL

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN ACUTE TOXICITY
Urea
57-13-6

Species/strain/system
Dose / Concentration

:
:

Cow
600-1080 mg/kg BW

Test Method and Conditions
Test method
description:

GLP: no

Spec.

Route

Test Results
Organism Medium
CATTL

IRPTC Data Profile

ORL

Lifestage Sex

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

Mammalian Acute Toxicity

65

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN ACUTE TOXICITY
Urea
57-13-6

Frequency
Dose / Concentration::

1x
5300-5400 mg/kg BW

Test Method and Conditions:

GLP: no

Spec.

Route

Lifestage Sex

IVN

M
F

Test method
description

Test Results
Organism Medium
RAT

Effect Effect Comments
LD50 Intravenous LD50 for male and female
rats was established as 5400 mg/kg and
5300 mg/kg body weight, respectively.

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN ACUTE TOXICITY
Urea
57-13-6

Frequency
Dose / Concentration::

1x
4600-5200 mg/kg BW

Test Method and Conditions
Test method
description:

GLP: noIRPTC Data ProfileMammalian Acute Toxicity

66

Test Results
Organism Medium

Spec.

MOUSE

Route

Lifestage Sex

IVN

M
F

Effect Effect Comments
LD50 Intravenous LD50 for male and female
mice was established as 4600 mg/kg
and 5200 mg/kg body weight,
respectively.

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN ACUTE TOXICITY
Urea
57-13-6

Dose / Concentration:

10000 mg/kg BW

Test Method and Conditions:

GLP: no

Spec.

Route

Test method
description

Test Results
Organism Medium
DOG

IVN

Lifestage Sex

Effect Effect Comments
LD50 Intravenous LD50 for dogs wasestablished as > 10000 mg/kg bodyweight.

References
Primary Reference:

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

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

IRPTC Data ProfileMammalian Toxicity

67

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN TOXICITY
Urea
57-13-6

Test Subject
Organism Medium

Specification

Route

Lifestage Sex Number exposed Number controls

MAMM

Species/strain/system

Ruminants:

Test Method and Conditions:

GLP: no:Urea is generally regarded a safe and efficient feed additive (substitute fornatural proteins) for ruminants. The toxicity of urea depends on the formationof 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 bodyweight. Monogastric animals, such as swine and baby calves, are not affectedby urea on biuret except for a mild diuretic action.

Primary Reference:

GASTR*
Veterinary Gastrointestinal Toxicology, 489-490, (1986)

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

Test method
description
General Comments

References

IRPTC Data ProfileMammalian Toxicity

68

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN TOXICITY
Urea
57-13-6

Test Subject
Organism Medium

Specification

Route

CATTL

Lifestage Sex Number exposed Number controls

ORL

Species/strain/system

Cow:

Test Method and Conditions
Test method
description

GLP: no:Exposure
Dose / Concentration:

116 mg/kg BW

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

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

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN TOXICITY
Urea
57-13-6

Test Subject
Organism Medium

Specification

Route

DOG

Lifestage Sex Number exposed Number controls

SCU

Test Method and Conditions
Test method
description

GLP: no:Exposure
Dose / Concentration
IRPTC Data Profile:

3000-9000 mg/kg BW

Mammalian Toxicity

69

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

MAMMALIAN TOXICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

Lifestage Sex Number exposed Number controls

SCU

12

DOG

Species/strain/system:

Strain not specified

Test Method and Conditions
Test method
description:

GLP: unknown

:
:
:
:

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

Exposure
Exposure Type
Exposure Period
Dose / Concentration
Exposure comments

IRPTC Data ProfileMammalian Toxicity

70

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

PLSMA
BIOCH
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 .

References
Primary Reference:

D8REP4
FDA (US-Food and Drug Admin.). Health Hazard Evaluation Determination
Report, PB288673, (1978)

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN TOXICITY
Urea
57-13-6

Test Subject
Organism Medium

Specification

Route

DOG

Lifestage Sex Number exposed Number controls

IVN

Test Method and Conditions
Test method
description

GLP: no:Exposure
Dose / Concentration:

3000 mg/kg BW

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

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

IRPTC Data Profile

Sex-------

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

Mammalian Toxicity

71

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN TOXICITY
Urea
57-13-6

Test Subject
Organism Medium

Specification

Route

GPIG

Lifestage Sex Number exposed Number controls

IVN

Species/strain/system

Guinea pig:

Test Method and Conditions
Test method
description

GLP: no:Exposure
Dose / Concentration:

4800 mg/kg BW

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

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

References
Primary Reference:

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

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

IRPTC Data ProfileMammalian Toxicity

72

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN TOXICITY
Urea
57-13-6

Test Subject
Organism Medium

Specification

Route

HORSE

Lifestage Sex Number exposed Number controls

ORL

Species/strain/system

Pony

:

Test Method and Conditions
Test method
description

GLP: no:Exposure
Dose / Concentration:

3310-3610 mg/kg BW

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

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

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN TOXICITY
Urea
57-13-6

Test Subject
Organism Medium

Specification

HUMAN

Route

Lifestage Sex Number exposed Number controls

SKN

Exposure
Exposure comments

IRPTC Data Profile:

Urea has been extensively used during the last two decades in the treatment ofdry skin, both clinically and in cosmetic products.

Mammalian Toxicity

73

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

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

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN TOXICITY
Urea
57-13-6

Test Subject
Organism Medium

Specification

Route

Lifestage Sex Number exposed Number controls

ORL

JUV

PIG

Species/strain/system

Young pigs:

Test Method and Conditions
Test method
description

GLP: no:Exposure
Dose / Concentration:

16000 mg/kg BW

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

LDLO
Oral LDLO for pigs was established as >16000 mg/kg body weight.
Ten % (m/m) urea in pig food over a period of 5 days was without apparent
General Comments:
deleterious effects.

References
Primary Reference:

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

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

74

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

MAMMALIAN TOXICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

RAT

Lifestage Sex Number exposed Number controls

SKN

Species/strain/system

Wistar rats:

Test Method and Conditions
Test method
description:

GLP: unknown

:
:
:

SHORT
4 wk
Urea in 10%, 20% or 40% ointment was applied to the back skin (20 cm2area) for 4 weeks.

Exposure
Exposure Type
Exposure Period
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

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

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

IRPTC Data ProfileMammalian Toxicity

75

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

MAMMALIAN TOXICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

RAT

Lifestage Sex Number exposed Number controls

ORL

Species/strain/system:

Strain not specified:

Purity not known

Test SubstanceDescription of the test
substance

Test Method and Conditions
Test method
description:

GLP: unknown

:
:
:
:

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

Exposure
Exposure Type
Exposure Period
Dose / Concentration
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

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

References
Primary Reference:

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

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

IRPTC Data ProfileMammalian Toxicity

76

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

MAMMALIAN TOXICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

RAT

Lifestage Sex Number exposed Number controls

SKN

Species/strain/system

Wistar rats:

Test Method and Conditions
Test method
description:

GLP: unknown

:
:
:

LONG
24 wk
Urea ointments of 10%, 20% or 40% concentrations were applied to the backskin on a 20 cm2 area for 24 weeks.

Exposure
Exposure Type
Exposure Period
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

NEF
There were no consistent treatment-related effects on standard heamatological parameters, clinical chemistryor different organs.

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN TOXICITY
Urea
57-13-6

Test Subject
Organism Medium

Specification

RBT

Species/strain/system
IRPTC Data Profile

Route
ORL

:

RabbitLifestage Sex Number exposed Number controls

Mammalian Toxicity

77

Test Method and Conditions
Test method
description

GLP: no:Exposure
Dose / Concentration:

5000 mg/kg BW

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

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

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN TOXICITY
Urea
57-13-6

Test Subject
Organism Medium

Specification

Route

RBT

Lifestage Sex Number exposed Number controls

SCU

Species/strain/system:

Rabbit

Test Method and Conditions
Test method
description

GLP: no:Exposure
Dose / Concentration:

3000-9000 mg/kg BW

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

IRPTC Data ProfileMammalian Toxicity

78

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN TOXICITY
Urea
57-13-6

Test Subject
Organism Medium

Specification

Route

RBT

Lifestage Sex Number exposed Number controls

IVN

Species/strain/system

Rabbit:

Test Method and Conditions
Test method
description

GLP: no:Exposure
Dose / Concentration:

7320 mg/kg BW

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

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

References
Primary Reference:

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

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

IRPTC Data ProfileMammalian Toxicity

79

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN TOXICITY
Urea
57-13-6

Test Subject
Organism Medium

Specification

Route

RBT

Lifestage Sex Number exposed Number controls

IVN

Species/strain/system

Rabbit:

Test Method and Conditions
Test method
description

GLP: no:Exposure
Dose / Concentration:

6310 mg/kg BW

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

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

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number:::

MAMMALIAN TOXICITY
Urea
57-13-6

Test Subject
Organism Medium

Specification

Route

SHEEP

Lifestage Sex Number exposed Number controls

ORL

Test Method and Conditions
Test method
description

GLP: no:Exposure
Dose / Concentration:

160 mg/kg BW
IRPTC Data ProfileMammalian Toxicity

80

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

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

References
Primary Reference:

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

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

IRPTC Data Profile

Carcinogenicity

81

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

CARCINOGENICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

MOUSE

Lifestage Sex Number exposed Number controls

ORL

Species/strain/system

M
F

CB7B1/6 mice:

Test Method and Conditions
Test method
description:

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

:
:
:

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

Exposure
Exposure Type
Dose / Concentration
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

References
Primary Reference:

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

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

IRPTC Data Profile

Carcinogenicity

82

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

CARCINOGENICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

RAT

Lifestage Sex Number exposed Number controls

ORL

Species/strain/system

M
F

Fischer 344 rats:

Test Method and Conditions
Test method
description:

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

:
:
:
:

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

Exposure
Exposure Type
Exposure Period
Dose / Concentration
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------NEF
Not carcinogenic:

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 offollow up all survivors were killed, necropsied and the tissues were fixed. The
testes, prostate and uterus were histologically examined for the occurrence oftumours. Although there was a statistically increased incidence of interstitialcell adenomas of the testis in the high dose group, its biological significancewas deemed questionable, since the lesions may occur in 100% of controls.

Primary Reference:

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

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

General Comments

References

IRPTC Data Profile

Mutagenicity

83

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

MUTAGENICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

BACT

Lifestage Sex Number exposed Number controls

VTR

Species/strain/system:

Salmonella typhimurium TA98, TA100, TA1537:

Purity unknown

Test SubstanceDescription of the test
substance

Test Method and Conditions
Test method
description

Bacterial test, Ames test; GLP: no data:

Exposure
Exposure comments:

Test performed with and without metabolic activation.

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------NEF
Negative results with and without metabolic activation

References
Primary Reference:

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

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

IRPTC Data Profile

Mutagenicity

84

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

MUTAGENICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

BACT

Lifestage Sex Number exposed Number controls

VTR

Species/strain/system:

Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538
Escherichia coli WP2uvrA

:
:

99%
Water

Test SubstancePurity Grade
Vehicle - Solvent

Test Method and Conditions
Test method
description

Bacterial test (Ames test); GLP: not known:

Exposure
Dose / Concentration
Exposure comments::

5-5000 ug/ PLATE
Tests were performed with and without metabolic activation.

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

References
Primary Reference:

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

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

IRPTC Data Profile

Mutagenicity

85

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

MUTAGENICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

BACT

Lifestage Sex Number exposed Number controls

VTR

Species/strain/system:

Salmonella typhimurium TA98, TA100, TA1535, TA1537

:
:

99%
DMSO

Test SubstancePurity Grade
Vehicle - Solvent

Test Method and Conditions
Test method
description

Bacterial test (Ames test); GLP: not known:

Exposure
Dose / Concentration
Exposure comments::

100-10000 ug/ PLATE
Tests were performed with and without metabolic activation with rat liver andhamster liver S9 mix.

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------NEF
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.

References
Primary Reference:

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

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

IRPTC Data Profile

Mutagenicity

86

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

MUTAGENICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

HAMST

Lifestage Sex Number exposed Number controls

VTR

Species/strain/system:

Chinese hamster fibroblast (CHL):

Purity unknown:

Physiological saline

Test SubstanceDescription of the test
substance
Vehicle - Solvent

Test Method and Conditions
Test method
description

Chromosomal aberration test; GLP: not known:

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

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

References
Primary Reference:

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

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

IRPTC Data Profile

Mutagenicity

87

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

MUTAGENICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

HAMST

Lifestage Sex Number exposed Number controls

VTR

Species/strain/system

Chinese hamster fibroblast (CHL):

Test Method and Conditions
Test method
description

Chromosomal aberration test; GLP: not known:

Exposure
Dose / Concentration
Exposure comments::

13 g/L
Urea concentration 216 mmolar

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

CHROM
STRUC
Positive results without metabolic activation. Chromosomal aberrations were detected in 20% of metaphases at
216 mmolar concentration.
OECD/SIDS Comment: chromosomal aberrations detected in 20% ofGeneral Comments:
metaphases at urea concentration of 13 g/L (216 mmolar) indicate a low
clastogenic potential.

References
Primary Reference:

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

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

:
:
:
:

MUTAGENICITY
Urea
57-13-6LAB

Study
End Point
Chemical Name
CAS Number
Study type

Test Subject
Organism Medium

Specification

MOUSE

Species/strain/system

Route

Lifestage Sex Number exposed Number controls

VTR:

Mouse lymphoma heterozygous L5178Y TK+/IRPTC Data Profile

Mutagenicity

88

Test SubstancePurity Grade:

AG

Test Method and Conditions
Test method
description

Mouse Lymphoma TK Locus Assay; GLP: no data:

Exposure
Dose / Concentration
Exposure comments::

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

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

References
Primary Reference:

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

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

:
:
:
:

MUTAGENICITY
Urea
57-13-6LAB

Study
End Point
Chemical Name
CAS Number
Study type

Test Subject
Organism Medium

Specification

MOUSE

Species/strain/system
IRPTC Data Profile

Route

Lifestage Sex Number exposed Number controls

VTR:

Mouse lymphoma L5178Y TK+/-Mutagenicity

89

Test SubstancePurity Grade:

AG

Test Method and Conditions
Test method
description

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

Exposure
Dose / Concentration
Exposure comments::

20.5-43.0 g/L
Concentrations of 339 - 718 mmolar of urea were used.

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

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

References
Primary Reference:

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

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

:
:
:
:

MUTAGENICITY
Urea
57-13-6LAB

Study
End Point
Chemical Name
CAS Number
Study type

Test Subject
Organism Medium

Specification

Route

MOUSE

Species/strain/system

Lifestage Sex Number exposed Number controls

ORL:

Swiss albino mice:

Purity unknown

Test SubstanceDescription of the test
substance

Test Method and Conditions
Test method
description:

Bone marrow cytogenetic assay; GLP: no data
IRPTC Data Profile

Mutagenicity

90

Exposure
Exposure Type
Exposure Period
Dose / Concentration
Exposure comments

:
:
:
:

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

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

CHROM
STRUC
Bone marrow cell, metaphases exhibited chromosome breaks, acentric fragments, translocations, gaps andconstrictions at a 7-fold rate compared to controls.
OECD/SIDS Comment: the interpretation of this clastogenic effect is limited byGeneral Comments:
the usage of a single extremely high dose level.

References
Primary Reference:

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

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

:
:
:
:

MUTAGENICITY
Urea
57-13-6LAB

Study
End Point
Chemical Name
CAS Number
Study type

Test Subject
Organism Medium

Specification

Route

RAT

Species/strain/system

Lifestage Sex Number exposed Number controlsVTR:

Rat hepatocytes

:
:

AG
Water

Test SubstancePurity Grade
Vehicle - Solvent

Test Method and Conditions
Test method
description

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

Exposure
Dose / Concentration
Exposure comments

IRPTC Data Profile::

18-180 mg/L
Concentrations of 0.3 - 3 mmolar were used.

Mutagenicity

91

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------NEF
Negative result

References
Primary Reference:

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

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

IRPTC Data Profile

Sensitization

92

Study
End Point
Chemical Name
CAS Number:::

SENSITIZATION
Urea
57-13-6

Test Subject
Organism Medium

Specification

Route

HUMAN

Lifestage Sex Number exposed Number controls

SKN

Test Substance
Vehicle - Solvent

Water

:

Test Method and Conditions
Test method
description

GLP: unknown:

Exposure
Exposure comments:

10% water solution

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------SKN
NEF
No skin sensitization

References
Primary Reference:

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

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

IRPTC Data Profile

Irritation

93

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

IRRITATION
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

HUMAN

Lifestage Sex Number exposed Number controls

SKN

Test Substance
Vehicle - Solvent

Water

:

Test Method and Conditions
Test method
description:

Chamber-Scarification Test; GLP: unknown

:
:
:

ACUTE
75-300 g/L
7.5% and 30% urea solutions in water were applied.

Exposure
Exposure Type
Dose / Concentration
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

SKN
IRRIT
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.

References
Primary Reference:

38FTAB
Frosch, P. J. et al. Cutaneous Toxicity: Proceedings of the Conference on
Cutaneous Toxicity, 127-153, (1977)

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

IRPTC Data Profile

Irritation

94

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

IRRITATION
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

HUMAN

Lifestage Sex Number exposed Number controls

SKN

Test Substance
Vehicle - Solvent

Water

:

Test Method and Conditions
Test method
description:

Not specified; GLP: unknown

:
:
:

ACUTE
100 g/L
10% water solution of urea

Exposure
Exposure Type
Dose / Concentration
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

SKIN
NEF
No irritation after 24 hours

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

IRRITATION
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

MOUSE

Species/strain/system
IRPTC Data Profile

Route
SKN

:

Nude MF1h mice

Lifestage Sex Number exposed Number controlsMIrritation

95

Test Substance
Vehicle - Solvent

Water

:

Test Method and Conditions
Test method
description:

GLP: unknown

:
:
:

ACUTE
100-109 g/L
10% solution

Exposure
Exposure Type
Dose / Concentration
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

SKIN

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

References
Primary Reference:

JPPMAB
Lashmar, U. T. et al. Journal of Pharmacy & Pharmacology, 41, 118-121,(1981)

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

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

IRRITATION
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

RBT

Species/strain/system

Lifestage Sex Number exposed Number controls

SKN:

Rabbit:Water

Test Substance
Vehicle - Solvent

Test Method and Conditions
Test method
description:

GLP: unknown

IRPTC Data Profile

Irritation

96

Exposure
Exposure Period
Dose / Concentration
Exposure comments

:
:
:

20 h
500 g/L
20 hours semiocclusive application of 50% urea water solution on the backand ear skin of rabbit.

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------SKN
NEF
No irritation of the skin after 24 hours

References
Primary Reference:#URBSF*
BASF AG. BASF Unpublished Report

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

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

IRRITATION
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

RBT

Lifestage Sex Number exposed Number controls

OCU

Species/strain/system:

Rabbit

Test Method and Conditions
Test method
description:

OECD 405; GLP: yes

Test Results
Organ---------

Effect-----------

Rev.
-------EYE
NEF
Not irritating (no irritancy after 24 hours)

IRPTC Data Profile

OnSet-------------------

Sex-------

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

Irritation

97

References
Primary Reference:#URBSF*
BASF AG. BASF Unpublished Report

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

IRPTC Data Profile

Reproduction

98

Study
End Point
Chemical Name
CAS Number:::

REPRODUCTION
Urea
57-13-6

General Comments:

OECD/SIDS Conclusion: Based on the carcinogenicity screening studies withmice and rats and repeated dose toxicity studies by dermal route with rats,
where no toxic effects were observed in the gonads, even at thehistopathological 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

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

Teratogenicity

99

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

TERATOGENICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

BIRD

Lifestage Sex Number exposed Number controls

INJ

Species/strain/system

Chick embryo:

Test Method and Conditions
Test method
description

GLP: no data:

Exposure
Exposure comments:

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

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

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

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

TERATOGENICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

BIRD

Species/strain/system

Route

Lifestage Sex Number exposed Number controls

INJ:

Chick embryo

IRPTC Data Profile

Teratogenicity

100

Test SubstancePurity Grade
Vehicle - Solvent::

AG
Distilled water

Test Method and Conditions
Test method
description

GLP: no data:

Exposure
Dose / Concentration
Exposure comments::

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

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

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

References
Primary Reference:

AVSCA7Mora, S. et al. Acta Veterinaria Scandinavica, Suppl. 87, 197-198, (1991)

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

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

TERATOGENICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

MOUSE

Species/strain/system

ORL:

Lifestage Sex Number exposed Number controls
F

ICR mice

Test Method and Conditions
Test method
description
IRPTC Data Profile:

A single oral dose study; GLP: no

10

Teratogenicity

101

Exposure
Exposure Type
Exposure Period
Frequency
Dose / Concentration
Exposure comments

:
:
:
:
:

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

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

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

Primary Reference:

TJADAB
Teramoto et al. Teratology, Journal of Abnormal Development, 23, 335-342,(1981)

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

General Comments

References

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

TERATOGENICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

RAT

Species/strain/system

ORL:

Lifestage Sex Number exposed Number controls
F

4

Wistar rats

Test Method and Conditions
Test method
description:

A single oral dose study; GLP: no

:
:
:
:
:

ACUTE
12 TDP
1x
2000 mg/kg BW
A single dose of 2000 mg/kg was administered to 4 pregnant rats on day 12 ofpregnancy.

Exposure
Exposure Type
Exposure Period
Frequency
Dose / Concentration
Exposure comments

IRPTC Data Profile

Teratogenicity

102

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------NEF
No effects on foetal data (live/dead, sex, external defects, soft tissue and skeletal defects)
NEF
No maternal toxicity:

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

Primary Reference:

TJADAB
Teramoto et al. Teratology, Journal of Abnormal Development, 23, 335-342,(1981)

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

General Comments

References

Study
End Point
Chemical Name
CAS Number
Study type

:
:
:
:

TERATOGENICITY
Urea
57-13-6
LAB

Test Subject
Organism Medium

Specification

Route

RAT

Lifestage Sex Number exposed Number controls

ORL

Species/strain/system

:

F

6

Wistar rats

Test Method and Conditions
Test method
description:

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

:
:
:
:

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

Exposure
Exposure Type
Exposure Period
Dose / Concentration
Exposure comments

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

Affected in
Exposed - Controls-----------------------------NEF
No hypertrophy or other kidney changes were detected nor were any teratogenic effects noted.
OECD/SIDS Comment: "not a full-range teratogenicity study".
General Comments:

IRPTC Data Profile

Teratogenicity

103

References
Primary Reference:

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

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

IRPTC Data Profile

Aquatic Acute Toxicity

104

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

AQUATIC ACUTE TOXICITY
Urea
57-13-6
LAB
FIN

Species/strain/system:

Snail (Helisoma trivolvis)

Test Method and Conditions
Test method
description

Static; GLP: not known:

Test Results
Organism Medium

Spec.

MOLL

FRESH

AQ

Route

Lifestage Sex

Effect Effect Comments

EGG
JUV

LC50 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.

ADULT

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

AQUATIC ACUTE TOXICITY
Urea
57-13-6
LAB
FIN

Species/strain/system:

Mosquito (Aedes aegypti) larvae

Test Method and Conditions
Test method
description:

Static; GLP: no

Test Results
Organism Medium

Spec.

INSEC

FRESH

IRPTC Data Profile

AQ

Route

Lifestage Sex

Effect Effect Comments

LARVA

LC50 LC50 for 4 hours = 60000 mg/L.

Aquatic Acute Toxicity

105

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

AQUATIC ACUTE TOXICITY
Urea
57-13-6
LAB
FIN

Species/strain/system:

Barilius barna

Test Method and Conditions
Test method
description

Static:Test Results
Organism Medium
FISH

Spec.

Lifestage Sex

Effect Effect Comments

LC50 LC50 for 96 hours > 9100 mg/L.
Urea is not acutely toxic to fish.

AQ

General Comments

Route

:

References
Primary Reference:

HCPBE5Dodriyal, A. K. and Bahuguna, A. K. Himalayan Chemical Pharma. Bulletin, 5,15-16, (1988)

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

IRPTC Data Profile

Aquatic Toxicity

106

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

AQUATIC TOXICITY
Urea
57-13-6
LAB
FIN

Test Subject
Organism Medium
ALGAE

AQ

Specification

Route

Lifestage Sex Number exposed Number controls

FRESH

Species/strain/system

Green algae (Scenedesmus quadricauda):

Test Method and Conditions
Test method
description

Cell multiplication inhibition test:

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

BIOMA
Toxicity threshold for 192 hours > 10000 mg/L
Urea is not toxic to algae.
General Comments:

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

AQUATIC TOXICITY
Urea
57-13-6
LAB
FIN

Test Subject
Organism Medium

Specification

PROTO

FRESH

AQ

Species/strain/system

IRPTC Data Profile

:

Route

Lifestage Sex Number exposed Number controls

Flagellate (Entosiphon sulcatum)Aquatic Toxicity

107

Test Method and Conditions
Test method
description

Cell multiplication inhibition test; static; GLP: no:

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

BIOMA
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 forchloroform was > 6560 mg/L.
Urea exhibits to some extent toxic action to Entosiphon sulcatum.
General Comments:

References
Primary Reference:

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

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

IRPTC Data Profile

Aquatic Toxicity

108

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

AQUATIC TOXICITY
Urea
57-13-6
LAB
FIN

Test Subject
Organism Medium
ALGAE

AQ

Specification

Route

Lifestage Sex Number exposed Number controls

FRESH

Species/strain/system

Blue-green algae (Microcystis aeruginosa):

Test Method and Conditions
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 Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

BIOMA
INHIB
Toxicity threshold for 192 hours = 47 mg/L
Urea exhibits to some extent toxic action to Microcystis aeruginosa.
General Comments:

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

AQUATIC TOXICITY
Urea
57-13-6
LAB
FIN

Test Subject
Organism Medium

Specification

BACT

MARIN

AQ

Species/strain/system
IRPTC Data Profile

:

Route

Lifestage Sex Number exposed Number controls

Bioluminiscent bacteria (Photobacterium luminescence)Aquatic Toxicity

109

Test Method and Conditions
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 Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

EC50
EC50 for 5 minutes = 24000 mg/L

References
Primary Reference:

ASTTAB
Bulich, A. A. et al. ASTM Special Technical Publication Aquatic Toxicology andHazard Assessment, ASTM STP 737, 338-347

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

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

AQUATIC TOXICITY
Urea
57-13-6
LAB
FIN

Test Subject
Organism Medium

Specification

CRUS

FRESH

AQ

Species/strain/system

:

Route

Lifestage Sex Number exposed Number controls

Water flea (Daphnia magna)

Test Method and Conditions
Test method
description:

DIN 38412 Teil 11 (modified)

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

EC50
EC50 for 24 hours > 10000 mg/L.
Urea is not acutely toxic to daphnids.
General Comments:

IRPTC Data Profile

Aquatic Toxicity

110

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

AQUATIC TOXICITY
Urea
57-13-6
LAB
FIN

Test Subject
Organism Medium

Specification

FISH

FRESH

AQ

Species/strain/system

Route

Lifestage Sex Number exposed Number controls

Golden orfe (Leuciscus idus melanotous):

Test Method and Conditions
Test method
description:

Static; GLP: no

:

ACUTE

Exposure
Exposure Type

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

LC0
LC0 for 48 hours > 10000 mg/L:

Urea is not acutely toxic to fish.

Primary Reference:

ZWABAQ
Juhnke, I. and Ludemann, D. Zeitschrift fuer Wasser und Abwasser
Forschung, 11, 5, (1978)

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

General Comments

References

IRPTC Data Profile

Aquatic Toxicity

111

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

AQUATIC TOXICITY
Urea
57-13-6
LAB
FIN

Test Subject
Organism Medium

Specification

FISH

ESTUA
FRESH

AQ

Species/strain/system

Route

Lifestage Sex Number exposed Number controls

Tilapia (Tilapia mossambica):

Test Method and Conditions
Test method
description

Test method not specified:

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

LC0
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) ofurea, there was a decrease in feeding and growth rates. In addition to the realized energy from foodconsumption, the fish lost reserve energy at the highest concentration of
urea. Conversion efficiency fell rapidly as the concentration increased.
Urea is not acutely toxic to fish. Tilapia mossambica lives under wide varity ofGeneral Comments:
environmental circumstances tolerating different osmotic conditions. Thischemical fertilizer appeared to be metabolic stressor at high concentrations.

References
Primary Reference:

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

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

IRPTC Data Profile

Terrestrial Toxicity

112

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

TERRESTRIAL TOXICITY
Urea
57-13-6
LAB
FIN

Test Subject
Organism Medium
WORM

Specification

Route

Lifestage Sex Number exposed Number controls

TERR

Species/strain/system

Grassland earthworms (Oligochaeta, Lumbricidae):

Test Method and Conditions
Test method
description:

Organic Matter
Content:

Effects monitored: earthworm numbers and biomass. Fertilizer was organic
coated urea, the organic coating being based on soybean oil at annual rate of60, 120 & 180 kg N/ha. Soil was treated annually for 20 years.
6.2-6.7 %Exposure
Exposure comments:

Sandy loam soil. The organisms relation to soil acidification was studied.

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

References
Primary Reference:

AEENDO
Wei-Chum Ma, L. et al. Agriculture, Ecosystems and Environment, 30, 71-80,(1990)

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

IRPTC Data Profile

Terrestrial Toxicity

113

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

TERRESTRIAL TOXICITY
Urea
57-13-6
LAB
FIN

Test Subject
Organism Medium
BACT

Specification

Route

Lifestage Sex Number exposed Number controls

TERR

Species/strain/system

Soil bacteria (Pseudomonas putida):

Test Method and Conditions
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 Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

BIOMA
INHIB
Toxicity threshold for 16 hours > 10000 mg/L

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

TERRESTRIAL TOXICITY
Urea
57-13-6
LAB
FIN

Test Subject
Organism Medium
BIRD

Specification

Route

Lifestage Sex Number exposed Number controls

TERR

Species/strain/system:

PigeonIRPTC Data Profile

Terrestrial Toxicity

114

Test Method and Conditions
Test method
description

Test method not specified; GLP: no:

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

LDLO
SCU
Lowest lethal dose found = 16000 mg/kg
Urea is not acutely toxic to pigeon.
General Comments:

References
Primary Reference:

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

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

Study
End Point
Chemical Name
CAS Number
Study type
Geographic Area

:
:
:
:
:

TERRESTRIAL TOXICITY
Urea
57-13-6
LAB
FIN

Test Subject
Organism Medium
PLANT

Specification

Route

Lifestage Sex Number exposed Number controls

TERR

Species/strain/system:

Soybean (Glycine max. L.) Merr

Test Method and Conditions
Test method
description:

Test method not specified; GLP: no

Test Results
Organ---------

Effect-----------

Rev.
-------

OnSet-------------------

Sex-------

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

LEAF
STRUC
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).
It was concluded in this study that necrosis resulted from accumulation of toxic
General Comments:
amounts of urea rather than from formation of toxic amounts of ammonia.
IRPTC Data Profile

Terrestrial Toxicity

115

References
Primary Reference:

PNASA6
Krogmeier, J. M. et al. Proceedings of the National Academy of Sciences of
the United States of America, 86, 8189-91, (1989)

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

IRPTC Data Profile

Recomendations/Legal mechanisms

116

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

Urea
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

GBR

PESTI
CONSM

RSTR
RSTR

Permitted for use only as a home garden fungicide on cut stumps of trees and on apple andpear trees.
Title : Pesticides 1992: Pesticides approved under the Control of Pesticides Regulations 1986

REG

USE
USE

Reference:

PACPR*, 500, xlv, 1992

Last Amendment :Effective Date :01MCH1991

Entry / Update :NOV1992

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

UREA
UREA
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

CSK

-

PRMT
MXL

COMPONENT OF RUBBER PRODUCTS PERMITTED FOR CO NTACT WITH FOOD AND
THE HUMAN BODY. MAXIMUM L IMIT FOR THE FINAL PRODUCTS: 30MG/G.
Title : DIRECTIVE NO. 62 ON HYGIENIC REQUIREMENTS ON RUBBERS AND
RUBBER GOODS COMING IN CONTACT WI TH FOODSTUFFS AND HUMANORGANISM

REG

FOOD
GOODS

Reference:

HPMZC*, 54, 1982

Effective Date :1JAN1983

HYGIENICKE PREDPISY MINISTERSTVA ZDRAVOTNICTVI CSR(HYGIENIC REGULATIONS OF MINISTRY OF HEALTH OF CSR)

Last Amendment :Entry / Update :DEC1991

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

UREA
UREA
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

CSK

-

RSTR
MXL

MAXIMUM LIMITS IN COSMETICS: 50MG/G
Title : DIRECTIVE NO. 34 ON HYGIENIC REQUIREMENTS ON COSMETICS,
DETERGENTS, AND GOODS OF PERSONAL USE

REG

GOODS

Reference:

HPMZC*, 32, 1970

Effective Date :1JAN1971

HYGIENICKE PREDPISY MINISTERSTVA ZDRAVOTNICTVI CSR(HYGIENIC REGULATIONS OF MINISTRY OF HEALTH OF CSR)

Last Amendment :IRPTC Data Profile

Entry / Update :DEC1991

Recomendations/Legal mechanisms

117

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

UREA
UREA
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

CSK

AGRIC

PRMT

SUBSTANCE IS APPROVED AS PESTICIDE. SPECIFIC USES, LIMITATIONS AND SAFETY
PRECAUTIONS ARE GIVEN.
Title : LIST OF PERMITTED CHEMICALS FOR PLANT PROTECT ION

REG

USE

Reference:

SPPOR*, 290, 1990

Effective Date :JAN1991

SEZNAM POVOLENYCH PRIPRAVKU NA OCHRANU ROSTLIN(LIST OF PERMITTED CHEMICALS FOR PLANT PROTECTION)

Last Amendment :Entry / Update :DEC1991

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

UREA
UREA
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

DEU

INDST

CLASS
RQR

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 GENERALNOT HAZARDOUS.) TH E CLASSIFICATION FORMS THE BASIS FOR WATER-PR
OTECTION REQUIREMENTS FOR INDUSTRIAL PLANTS I N WHICH WATERHAZARDOUS SUBSTANCES ARE HANDLE D.
Title : ADMINISTRATIVE RULES CONCERNING WATER-HAZARDO US SUBSTANCES(VERWALTUNGSVORSCHRIFT WASSERGE FAEHRDENDE STOFFE)

REC

AQ
USE

Reference:

GMSMA6, 8, 114, 1990

Effective Date :Gemeinsames Ministerialblatt. Joint Ministerial Papers

Last Amendment :Entry / Update :DEC1991

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

UREA
urea
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

GBR

MARIN
MARIN
EMI

RQR
RSTR
RSTR

CATEGORY C SUBSTANCE: DISCHARGE INTO THE SEA IS PROHIBITED; DISCHARGEOF TANK WASHINGS AND RESIDUAL MIXTURES IS SUBJECT TO RESTRICTIONS .
(APPLIES TO SOLUTION WITH AMMONIUM NITRATE CONTAINING AQUA AMMONIA).
Title : THE MERCHANT SHIPPING (CONTROL OF POLLUTION B Y NOXIOUS LIQUIDSUBSTANCES IN BULK) REGULATI ONS 1987, SCHEDULE 1

REG

TRNSP
AQ
AQ

Reference:

GBRSI*, 551, 15, 1987

Effective Date :06APR1987

Entry / Update :1992

Statutory Instruments

Last Amendment :GBRSI*, 2604, 2, 1990
Statutory Instruments

IRPTC Data Profile

Recomendations/Legal mechanisms

118

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

UREA
urea
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

GBR

MARIN
MARIN
EMI

RQR
RSTR
RSTR

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 WITHAMMONIUM PHOSPHATE).
Title : THE MERCHANT SHIPPING (CONTROL OF POLLUTION B Y NOXIOUS LIQUIDSUBSTANCES IN BULK) REGULATI ONS 1987, SCHEDULE 1

REG

TRNSP
AQ
AQ

Reference:

GBRSI*, 551, 15, 1987

Effective Date :06APR1987

Entry / Update :1992

Statutory Instruments

Last Amendment :GBRSI*, 2604, 2, 1990
Statutory Instruments

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

UREA
urea
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

GBR

MARIN
MARIN
EMI

RQR
RQR
RQR

CLASSIFIED AS A NON-POLLUTING LIQUID SUBSTANC E. DOCUMENTARY EVIDENCE
OF ASSESSMENT AND APP ROVAL REQUIRED BY A CARRIER. DISCHARGE INTO T HE
SEA IS NOT PROHIBITED. (APPLIES TO SOLUTIO N).
Title : THE MERCHANT SHIPPING (CONTROL OF POLLUTION B Y NOXIOUS LIQUIDSUBSTANCES IN BULK) REGULATI ONS 1987, SCHEDULE 2

REG

TRNSP
AQ
AQ

Reference:

GBRSI*, 551, 15, 1987

Effective Date :06APR1987

Entry / Update :1992

Statutory Instruments

Last Amendment :GBRSI*, 2604, 2, 1990
Statutory Instruments

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

UREA
UREA
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

KEN

ADDIT

PRMT

FOOD ADDITIVE PERMITTED AS YEAST FOOD. FOOD P RODUCTS IN OR UPON WHICH
IT IS PERMITTED ANDM AXIMUM LEVELS OF USE ARE LISTED.
Title : THE FOOD, DRUGS AND CHEMICAL SUBSTANCES (FOOD LABELLING,
ADDITIVES AND STANDARDS) REGULATI ONS, 1978

REG

FOOD

Reference:

GSKEN*, 40, 406, 1978

Effective Date :KENYA GAZETTE SUPPLEMENT NO. 40, SPECIAL ISSUE(LEGISLATIVE SUPPLEMENT NO. 27)

Last Amendment :IRPTC Data Profile

Entry / Update :SEP1982

Recomendations/Legal mechanisms

119

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

UREA
UREA
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

RUS

AMBI

MAC

0.2 MG/M3 AV/D.
Title :REG

AIR

Reference:

Last Amendment :Effective Date :PDKAV*, 3086-84, 1984

Entry / Update :AUG1984
SEP1985

PREDELNO DOPUSTIMYE KONTSENTRATSII (PDK)ZAGRYAZNYAYUSHCHIKH VESHCHESTV V ATMOSFERNOMVOZDUKHE NASELENNYKH MEST(MAXIMUM ALLOWABLE CONCENTRATIONS (MAC) OF
CONTAMINANTS IN THEAMBIENT AIR OF RESIDENTIAL AREAS)

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

UREA
UREA
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

RUS

SURF

MAC

SURFACE WATER FOR FISHING : 80.0 MG/L
Title :REG

AQ

Reference:

Last Amendment :Effective Date :PDKTV*, 1978

Entry / Update :SEP1985

PREDELNO-DOPUSTIMYE KONTSENTRATSII I
ORIENTIROVOCHNYE BEZOPASNYEUROVNI VOZDEISTVIAVREDNYKH VESHCHESTV V OBIEKTAKH VNESHNEI SREDY.
NORMATIVNYE MATERIALY.
(MAXIMUM ALLOWABLE CONCENTRATIONS AND PRELIMINARY
SAFETY LEVELSOF TOXIC SUBSTANCES IN ENVIRONMENT.
STANDARDS.)

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

UREA
UREA
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

RUS

OCC

MAC
CLASS

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

AIR

Reference:

Last Amendment :Effective Date :GOSTS*, 12.1.005, 1988

Entry / Update :01JAN1989
MAY1990

GOSUDARSTVENNYI STANDART SSSR(STATE STANDARD OF USSR)IRPTC Data Profile

Recomendations/Legal mechanisms

120

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

UREA
UREA
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

RUS

OCC

MAC
CLASS

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

AIR

Reference:

Last Amendment :Effective Date :GOSTS*, 12.1.005, 1988

Entry / Update :1JAN1989
MAY1990

GOSUDARSTVENNYI STANDART SSSR(STATE STANDARD OF USSR)

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

UREA
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

USA

PESTI
PESTI
ADDIT

RQR
PRMT
RQR

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 ANDDATA C ALL-IN FOR PRODUCTS CONTAINING THE LISTED ACTIVE INGREDIENTS.
Title : FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICI DE ACT PESTICIDESREQUIRED TO BE REREGISTERED ; LIST D

REG

CLASS
MANUF
FOOD

Reference:

FEREAC, 54, 204, 43388, 1989

Effective Date :1989

Entry / Update :JAN1992

Federal Register

Last Amendment :FEREAC, 54, 204, 43388, 1989
Federal Register

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

UREA
UREA
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

EEC

-

PRMT

TECHNICALLY PURE UREA MAY BE MARKETED AS FEED INGSTUFF UNDER THE
CONDITIONS LAID DOWN.
Title : COUNCIL DIRECTIVE OF 30 JUNE 1982 CONCERNING CERTAIN PRODUCTS
USED IN ANIMAL NUTRITION (82 /471/EEC).

REG

FEED

Reference:OJEC**, L213, 8, 1982

Effective Date :01JUL1988

Official Journal of the European (Communities)/Union

Last Amendment :OJEC**, L239, 36, 1988

Entry / Update :Official Journal of the European (Communities)/Union

IRPTC Data Profile

SEP1987

Recomendations/Legal mechanisms

121

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

UREA
UREA
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

EEC

-

RQR
MXL
RSTR

THE SUBSTANCE MAY BE USED FOR THE MANUFACTURE OF REGENERATEDCELLULOSE FILM WHICH IS INTEN DED TO OR DOES COME INTO CONTACT WITHFOODSTU FFS. IT MAY BE USED AS SOFTENER; MAXIMUM CONT ENT OF SOFTENERS
IN TOTAL: 27%.
Title : COUNCIL DIRECTIVE OF 25 APRIL 1983 ON THE APP ROXIMATION OF THE
LAWS OF THE MEMBER STATES R ELATING TO MATERIALS AND ARTICLESMADE OF REG ENERATED CELLULOSE FILM INTENDED TO COME INTOCONTACT WITH FOODSTUFFS. (83/229/EEC).

REG

FOOD
FOOD
FOOD

Reference:OJEC**, L123, 31, 1983

Effective Date :01APR1987

Official Journal of the European (Communities)/Union

Last Amendment :OJEC**, L228, 32, 1986

Entry / Update :OCT1987

Official Journal of the European (Communities)/Union

Substance
Chemical Name
Reported Name
CAS Number

:
:
:

Urea
57-13-6

Area Type Subject

Spec.

Description

Level / Summary Information :

IMO

EMI
MARIN

RSTR
RSTR

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 thetankers as well as port facilities for receiving residues or mixtures containing the regulated
substance. Technical assistance for training of scientific and technical personnel shall bepromoted where requested by the Parties of the Convention. (Applies to urea/ammonium
nitrate solution containing aqua ammonia)
Title : International Convention for the Prevention of Pollution from Ships, 1973, as modified
by the Protocol of 1978 relating thereto (MARPOL 73/78).

REC

AQ
AQ

Reference:

Last Amendment :Effective Date :IMODC*,

Entry / Update :SEP1994

IRPTC Data Profile