I UCLID 

Data Set 

Existing Chemical : ID : 108-19-0 

CAS No. : 108-19-0 

EINECS Name : biuret 

EC No. : 203-559-0 

Molecular Formula C2H5N302 

Producer related part 

Company : Epona Associates, LLC 

Creation date : 05.06 .2007 

Substance related part 

Company : Epona Associates, LLC 

Creation date : 05 .06.2007 

Status . 

Memo : Fulfillment of data requirements under TSCA section 4 

Printing date : 03.07 .2007 

Revision date . 

Date of last update : 03.07 .2007 

Number of pages : 64 

Chapter (profile) : Chapter : 1, 2, 3, 4, 5, 6, 7, 8, 10 

Reliability (profile) : Reliability : without reliability, 1, 2, 3, 4 

Flags (profile) : Flags: without flag, confidential, non confidential, WGK (DE), TA-Luft (DE), 

Material Safety Dataset, Risk Assessment, Directive 67/548/EEC, SIDS 

CONTAINS NO CB1 

1/64 371 
1 . General Information 

1 .0.1 APPLICANT AND COMPANY INFORMATION 

1 .0 .2 LOCATION OF PRODUCTION SITE, IMPORTER OR FORMULATOR 

1 .0.3 IDENTITY OF RECIPIENTS 

1 .0 .4 DETAILS ON CATEGORY/TEMPLATE 

1 .1 .0 SUBSTANCE IDENTIFICATION 

IUPAC Name . 

Smiles Code . 

Molecular formula : C2H5N302 

Molecular weight : 103.09 

Petrol class . 

05.06 .2007 

1 .1 .1 GENERAL SUBSTANCE INFORMATION 

Purity type . 

Substance type . 

Physical status . 

Purity , 

Colour 

Odour : odorless 

05.06 .2007 

1 .1 .2 SPECTRA 

1 .2 SYNONYMS AND TRADENAMES 

AI3-14905 

25.06 .2007 

Allophanamide 

05.06 .2007 

Allophanic acid amide 

05.06 .2007 

Id 108-19-0 

Date 03.07 .2007 

2/64 
p. 3 

1 . General Information 

Allophanimidic acid 

25 .06 .2007 

Allophanimidic acid (VAN) 

05.06 .2007 

Biuret 

25.06 .2007 

Biuret (ACN)(8C1) 

05.06 .2007 

Carbamoylurea 

25.06 .2007 

Carbamylurea 

05 .06 .2007 

Caswelt No. 106A 

25.06 .2007 

Caswell No. 159A 

25.06 .2007 

Dicarbamylamine 

05.06 .2007 

EPA Pesticide Chemical Code 206200 

25 .06 .2007 

Imidodicarbonic diamide (9C1) 

05.06 .2007 

Isobiuret 

25.06 .2007 

lsobiuret (VAN) 

05.06 .2007 

L-101 

05.06 .2007 

Id 108-19-0 

Date 03 .07.2007 

3/64 
p. 4 

1 . General Information 

NSC 8020 

25.06 .2007 

Urea, (aminocarbonyl)- 

05 .06.2007 

Ureidoformamide 

05.06 .2007 

1 .3 IMPURITIES 

1 .4 ADDITIVES 

1 .5 TOTAL QUANTITY 

Quantity 

Remark 

03 .07 .2007 

1 .6 .1 LABELLING 

1 .6.2 CLASSIFICATION 

1 .6.3 PACKAGING 

1 .7 USE PATTERN 

Type of use 

Category 

Remark 

03.07 .2007 

Id 108-19-0 

Date 03.07 .2007 

0 - 0 tonnes produced in 2005 

: Biuret is considered an impurity of urea with no commercial purpose for reporting under TSCA Section 8 Inventory Update Reporting (IUR), is not manufactured or processed for distribution in commerce as a chemical substances per se and, relative to the fertilizer industry, has no commercial 

purpose separate from the substance mixture or article of which they may be a part (40 CFR § 710.4(d) . biuret is not a commercial product ; it is produced incidentally during the production of urea fertilizers and as such is not reportable under the Inventory reporting Rule. The members of The Fertilizer Institute are not Tier 1 producers of biuret. 

(37) 

. use 

: Biuret is produced incidentally in the production of urea fertilizers ; it is produced commercially by the members of The Fertilizer Institute . 

(37) 

4/64 
p. 5 

1 . General Information 

Type of use : use 

Category . 

Remark 

ld 108-19-0 

Date 03.07 .2007 

Use: Feed Grade Food Additive: 

[Federal Register: May 22, 2003 (Volume 68, Number 99)] 

[Rules and Regulations] 

[Page 27904] 

From the Federal Register Online via GPO Access [wais.access .gpo.gov] 

[DOCID:fr22my03-5] 

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 573 

[Docket No . 02F-0327] 

Food Additive Permitted in Feed and Drinking Water of Animals; 

Feed-Grade Biuret 

AGENCY: Food and Drug Administration, HHS. 

ACTION : Final rule . 

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

SUMMARY: The Food and Drug Administration (FDA) is amending the 

regulations for food additives to provide for the safe use of feedgrade biuret in lactating dairy cattle feed. This action is in response 

to a food additive petition filed by ADM Alliance Nutrition, Inc. 

DATES: This rule is effective May 22, 2003; written objections and 

request for hearing should be submitted by July 23, 2003. 

ADDRESSES: Submit written objections to the Dockets Management 

Branch 

(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm . 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Sharon Benz, Center for Veterinary 

Medicine (HFV-228), Food and Drug Administration, 7500 Standish PI., Rockville, MD 20855, 301-827-6656. 

SUPPLEMENTARY INFORMATION: 

I . Background 

In a notice published in the Federal Register of August 28, 2002 (67 FR 55269), FDA announced that a food additive petition (FAP 2248) had been filed by ADM Alliance Nutrition, Inc., 1000 North 30th St., 

5/64 
p. 6 

1 . General Information Id 108-19-0 

Date 03.07 .2007 

P.O. Box C1 ., Quincy, IL 62305-7100. The petition proposed to amend the 

food additive regulations in Part 573 Food Additives Permitted in Feed 

and Drinking Water of Animals (21 CFR part 573) to provide for the use of feed grade biuret in the diets of lactating dairy cows. The notice 

of filing provided for a 75-day comment period on the petitioner's 

environmental information . No substantive comments have been received . 

II . Conclusion 

FDA has evaluated data submitted by the sponsor of the petition and 

concludes that the data establish the safety and functionality of feedgrade biuret for use as proposed. 

III . Public Disclosure 

In accordance with Sec. 571 .1(h) (21 CFR 571 .1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Veterinary Medicine by appointment with the information 

contact person listed above. As provided in Sec. 571 .1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection . 

IV. Environmental Impact 

The agency has determined under 21 CFR 25.32(r) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental 

assessment nor an environmental impact statement is required. 

V. Objections and Hearing Requests 

Any person who will be adversely affected by this regulation may at 

any time on or before July 23, 2003, file with the Dockets Management Branch (address above) written objections thereto . Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection . Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection . Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection . Three copies of all documents shall be submitted and shall be identified with the docket number found in brackets in the heading of this document. Any objections received in 

response to the regulation may be seen in the Dockets Management Branch 

between 9 a.m . and 4 p.m., Monday through Friday. 

List of Subjects in 21 CFR Part 573 

Animal feeds, Food additives . 
p. 7 

1 . General Information 

Test substance 

03.07 .2007 

Id 108-19-0 

Date 03.07 .2007 

0 

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and 

redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is amended as follows : 

PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF 

ANIMALS 

0 

1 . The authority citation for 21 CFR part 573 continues to read as follows : 

Authority: 21 U.S .C . 321, 342, 348 . 

Sec. 573.220 Feed-grade biuret. 

0 

2. Section 573 .220 Feed-grade biuret is amended by removing paragraph (c)(1)(iii) . 

Dated : May 14, 2003. 

Stephen F. Sundlof, 

Director, Center for Veterinary Medicine. 

[FR Doc. 03-12785 Filed 5-21-03; 8:45 am] 

Biuret 

Type of use : use 

Category , 

Remark 

(46) 

On April 15, 2002, the Environmental Protection Agency (EPA) issued its tolerance reassessment decision for the frost protectant pesticide urea, and is inviting public comment until May 15, 2002. EPA finds that urea poses no risk concerns within the limits of the existing tolerance exemptions . Therefore, no additional risk mitigation is needed, and no changes will be made to the 78 urea tolerance exemptions as a result of this reassessment decision. EPA regards the 78 exemptions as completed tolerance reassessments, contributing toward the Agency's goal of completing 66% of all required tolerance reassessment decisions by August 3, 2002. A naturally occurring compound in humans, urea is approved for several human therapeutic uses. In addition, urea is considered "Generally Recognized As Safe" (GRAS) as affirmed by the U. S. Food and Drug Administration for use in food. Urea is an active ingredient in only one registered pesticide product, Enfrost, which is registered for commercial application to a wide variety of field crops, vegetables, fruit trees, and ornamentals to reduce frost formation by ice-nucleating bacteria naturally present on leaf surfaces . Urea also is an inert ingredient included in pesticide products as a stabilizer, inhibitor, or intensifier . Outside the pesticide realm, urea is included in fertilizer, used as an animal feed supplement, and used in the manufacture of dyes, fire retardant paints, plasticizers, and stabilizers for explosives. The Federal Register notice is available on EPA's website at http://www.epa.gov/fedrgstr. Risk assessments and related documents for urea also are available at http://www .epa.gov/oppsrrdl/reregistration/urea/ . 

7/64 
p. 8 

1 . General Information 

Test substance : Urea 

03.07 .2007 

Type of use : use 

Category 

Remark : 21 C.F .R. § 184.1923 Urea . 

Title 21 - Food and Drugs 

Test substance 

03.07 .2007 

Id 108-19-0 

Date 03.07 .2007 

(44) 

Title 21 : Food and Drugs 

PART 184-DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY 

RECOGNIZED AS SAFE 

Subpart B-Listing of Specific Substances Affirmed as GRAS 

Browse Previous I Browse Next 

§ 184.1923 Urea. 

(a) Urea (CO(NH2)2, CAS Reg. No. 57-13-6) is the diamide of carbonic acid and is also known as carbamide. It is a white, odorless solid and is commonly produced from C02 by ammonolysis or from cyanamide by 

hydrolysis . 

(b) FDA is developing food-grade specifications for urea in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of 

a purity suitable for its intended use. 

(c) In accordance with §184 .1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: 

(1) The ingredient is used as a formulation aid as defined in §170.3(o)(14) of this chapter and as a fermentation aid . 

(2) The ingredient is used in yeast-raised bakery products; in alcoholic beverages as defined in §170 .3(n)(2) of this chapter; and in gelatin products . 

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. 

(48 FR 51616, Nov. 10, 1983, as amended at 49 FR 19816, May 10, 1984) Urea 

(43) 

Type of use : use 

Category 

Remark 

Test substance 

03.07 .2007 

Urea is approved for several therapeutic uses in humans with relatively few toxicities . Urea is used primarily as an osmotic agent for inducing diuresis and reducing intraoccular and intracranial pressure. Urea has also been used as a topical anesthetic for the treatment of mouth and throat inflammation (10-15% urea gel, liquid or solution), to debride necrotic and infected tissues, i .e . fingernails and toenails . It is also used in the treatment of sickle- cell anemia and to ammoniate dentrifices as well as a basic ingredient in the synthesis of medically important compounds such as barbiturates and urethanes . 

http://www .epa.gov/oppsrrd1/REDs/urea_tred .htm ; http://216 .239.51 .104/search?q=cache:p1264Z8FFIJ :www.fda .gov/cder/ogd/rld/12154s24 .pdf+FDA+category+C+ure a&hl=en&ct=clnk&cd=1 &gl=us 

Urea 

(45) 

8/64 
p. 9 

1 . General Information 

1 .7 .1 DETAILED USE PATTERN 

1 .7.2 METHODS OF MANUFACTURE 

1 .8 REGULATORY MEASURES 

Id 108-19-0 

Date 03.07 .2007 

Remark : Fertilizers, fertilizer materials, and their manufacturing facilities are highly regulated at the federal and state level . At the federal level, standards are in place to govern: (I) air emissions from fertilizer and 

fertilizer material manufacturing facilities [These regulations are found at: (1) 40 C.F .R . Part 60, Subpart G (standards of performance for nitric acid plants) ; (2) 40 C.F.R. Part 60, Subpart H (standards of performance for sulfuric acid plants) ; (3) 40 C .F.R. Part 60, Subpart T (standards of performance for wet process phosphoric acid plants) ; (4) 40 C.F.R. Part 60, Subpart U 

(standards of performance for superphosphoric acid plants) ; (5) 40 C.F.R. Part 60, Subpart V (standards of 

performance for diammonium phosphate plants) ; (6) 40 C.F.R. Part 60, Subpart W (standards of performance for 

triple superphosphate plants) ; (7) 40 C.F.R. Part 60, Subpart X (standards of performance for granular triple 

supetphosphate storage facilities) ; (8) 40 C.F .R. Part 60 , Subpart NN (standards of performance for phosphate rock 

plants) ; (9) 40 C.F.R. Part 60, Subpart PP (standards of performance for ammonium sulfate plants) ; (10) 40 C.F.R. 

Part 61, Subpart R (national emission standards for radon emissions ftom phosphogypsum stacks) ; (11) 40 C.F.R.] ; (2) solid and hazardous waste generation, storage, 

transportation, and disposal [40 C.F.R. §§ 260-299 .] ; (3) water discharges [40 C.F.R. Part 122.] ; (4) accident prevention and mitijation [40 C.F.R. Part 68 and 29 C.F.R. § 1910 .119.] ; (5) release reporting [40 C.F.R. §§ 302.4, 355.40 and 40 C.F .R. Part 372. ] ; (6) worker exposure [29 C.F.R. §§ 1910 .1000 and 1910.1020.] ; (7) hazard communication [29 C.F.R. § 1910.1200]; and 

(8) transportation [49 C.F.R.SubchapterC] . These regulations provide a comprehensive federal program to regulate fertilizers and fertilizer materials . In addition, and without conceding any arguments that could be made to the contrary, TSCA § 6 provides EPA with the authority to either prohibit or limit the manufacture of a chemical substance upon a finding that its manufacture, processing, distribution in commerce, use, or disposal "presents or will present an unreasonable risk of injury to health or the environment." Also, under TSCA § 7, the Agency has the authority to take certain actions in 

response to an "imminently hazardous chemical substance or mixture ." In addition to federal regulations, the states regulate fertilizers and fertilizer materials . As noted 

in the attached document, entitled Summary of State Fertilizer Laws, 48 states have laws and 

regulations in place to regulate fertilizers and fertilizers materials . Many of these states have an 

"adulteration" clause in their laws that enable the responsible state agency to stop the sale of 

9/64 
p. 10 

1 . General Information Id 108-19-0 

Date 03.07 .2007 

fertilizers and fertilizer materials that are dangerous to human health . 

Notably, five states have adopted comprehensive regulations to limit the 

amounts of nonnutritive elements in fertilizers . These states are 

Washington, California, Oregon, Florida and 

Texas. EPA, in response to a congressional inquiry, endorsed these 

programs. Other states are developing similar regulations fostered by the work of the Association 

of American Plant Food Control Officials (AAPFCO) . 

03.07 .2007 

1 .8.1 OCCUPATIONAL EXPOSURE LIMIT VALUES 

1 .8 .2 ACCEPTABLE RESIDUES LEVELS 

1 .8.3 WATER POLLUTION 

1 .8 .4 MAJOR ACCIDENT HAZARDS 

1 .8.5 AIR POLLUTION 

1 .8 .6 LISTINGS E.G. CHEMICAL INVENTORIES 

1 .9 .1 DEGRADATION/TRANSFORMATION PRODUCTS 

1 .9.2 COMPONENTS 

1 .10 SOURCE OF EXPOSURE 

1 .11 ADDITIONAL REMARKS 

1 .12 LAST LITERATURE SEARCH 

Type of search . External 

Chapters covered : 3, 4, 5 

Date of search : 01 .06 .2007 

Remark : BibIioLine 

03.07 .2007 

10/64 
p. 11 

1 . General Information 

1 .13 REVIEWS 

Id 108-19-0 

Date 03.07 .2007 

11/64 
p. 12 

2. Physico-Chemical Data 

2.1 MELTING POINT 

Value 

Sublimation 

Method 

Year 

GLP 

Test substance 

Remark 

Reliability 

05.06 .2007 

Value . = 190 °C 

Decomposition : yes, at = 190 °C 

Sublimation , 

Method : other 

Year ; 1979 

GLP : no data 

Test substance : as prescribed by 1 .1 - 1 .4 

Reliability 

27.06 .2007 

2.2 BOILING POINT 

Value . = 193 °C at 1013 .25 hPa 

Decomposition : yes 

Method : other 

Year : 1976 

GLP : no data 

Test substance : as prescribed by 1 .1 - 1 .4 

Remark : HYGROSCOPIC; PYROLYSIS @ HIGH TEMP (GREATER THAN 193 DEG C) YIELDS MELAMINE 

=188-190°C 

other 

2000 

no data 

as prescribed by 1 .1 - 1 .4 

Id 108-19-0 

Date 03 .07 .2007 

This record originally appeared in the ISHOW database. 

ISHOW - Information System for Hazardous Organics in Water Details : Sample Record ISHOW, sponsored by the Office of Toxic Substances of the EPA, was developed by the EPA laboratory in Duluth, Minnesota in conjunction with the University of Minnesota. This database of 17,159 

records includes physical property data on more than 5,700 different chemicals with bibliographic references to the original sources. Not all properties are recorded for all substances. 

(2) valid with restrictions 

Handbook data 

(2) valid with restrictions 

Handbook data 

(35) (36) 

(11) 

This record originally appeared in the ISHOW database . ISHOW - Information System for Hazardous Organics in Water Details : Sample Record ISHOW, sponsored by the Office of Toxic Substances of the EPA, was developed by the EPA laboratory in Duluth, Minnesota in conjunction with the University of Minnesota. This database of 17,159 records includes physical property data on more than 5,700 different chemicals with bibliographic references to the original sources. Not all properties are recorded for all substances. 

12/64 
p. 13 

2. Physico-Chemical Data 

Reliability : (2) valid with restrictions 

Handbook data 

05.06 .2007 

2.3 DENSITY 

Type : relative density 

Value . = 1 .467 at °C 

Method : other 

Year : 1976 

GLP : no data 

Test substance : as prescribed by 1 .1 - 1 .4 

Remark : Density/Specific Gravity : 1 .467 @ -5 DEG C/4 DEG C Reliability : (2) valid with restrictions 

Handbook data 

05.06 .2007 

2.3.1 GRANULOMETRY 

2.4 VAPOUR PRESSURE 

Value . .000013599 hPa at °C 

Decomposition . 

Method : other (calculated) 

Year : 2007 

GLP : no 

Test substance : as prescribed by 1 .1 - 1 .4 

Method : SUMMARY MPBPW IN v1 .42 ---------------- 

Remark 

Result 

Boiling Point: 323.89 deg C (Adapted Stein and Brown Method) 

Melting Point: 309.34 deg C (Adapted Joback Method) Melting Point: 75.46 deg C (Gold and Ogle Method) Mean Melt Pt : 192.40 deg C (Joback; Gold,Ogle Methods) Selected MP: 122.23 deg C (Weighted Value) No physical properties input by user 

SUMMARY MPBPWIN v1 .42 

Vapor Pressure Estimations (25 deg C) : 

(Using BP: 323.89 deg C (estimated)) 

(Using MP: 190 .00 deg C (exp database)) 

VP: 6.39E-006 mm Hg (Antoine Method) VP: 1 .02E-005 mm Hg (Modified Grain Method) VP: 2.45E-005 mm Hg (Mackay Method) 

Selected VP: 1 .02E-005 mm Hg (Modified Grain Method) Subcooled liquid VP: 0.000544 mm Hg (25 deg C, Mod-Grain method) 

-------+-----+------------------+---------+--------

TYPE I NUM I BOIL DESCRIPTION I COEFF I VALUE 

-------+-----+---------------+----------+-------- 

Id 108-19-0 

Date 03.07 .2007 

(38) 

(38) 

13/64 
p. 14 

2. Physico-Chemical Data 

Reliability 

27.06 .2007 

Id 108-19-0 

Date 03.07 .2007 

I I Equation Constant ~ ~ 198.18 

-------------+-----_____------__-_+_--------- ------------- ----- ------ - ----------+_________ 

RESULT-uncorrj BOILING POINT in deg Kelvin 1 658.96 

RESULT- corr I BOILING POINT in deg Kelvin 1 597 .05 

1 BOILING POINT in deg C 1 323 .89 

Group 1 2 1 -C(=0)NH2 1 230.39 1 460 .78 

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

----- ----- -+---------------+--------+------ 

TYPE I NUM I MELT DESCRIPTION I COEFF I VALUE 

------- --------- ----------___+--------+--------

Group ~ 2 1 -C(=0)NH2 ~ 230.00 1 460.00 

" I ~ Equation Constant ~ 1 122.50 

--

RESULT I MELTING POINT in deg Kelvin 1 582.50 

1 MELTING POINT in deg C 1 309.34 

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

(2) valid with restrictions - -

Modeled data 

2.5 PARTITION COEFFICIENT 

Partition coefficient 

Log pow 

pH value 

Method 

Year 

GLP 

Test substance 

Method 

Remark 

Result 

: octanol-water 

. -1 .399 at °C 

other (calculated) 

2007 

no 

as prescribed by 1 .1 - 1 .4 

KOWWIN Program (v1 .67) 

SMILES : 0=C(NC(=0)N)N 

CHEM : Imidodicarbonic diamide 

MOL FOR: C2 H5 N3 02 

MOL WT : 103.08 

No physical properties input by user 

KOWWIN Program (v1 .67) Results : 

(7) 

Log Kow(version 1 .67 estimate): -1 .40 

------+-----+----------------------------------+------+-_---

TYPE I NUM ~ LOGKOW FRAGMENT DESCRIPTION ~ COEFF 

~ VALUE 

------+-----+--------------------------------------+-------+---- 

Frag ~ 2 ~ -NH2 [aliphatic attach] 1-1 .4148 1-2 .8296 Frag ~ 1 ~ -NH- [aliphatic attach] 1-1 .4962 1-1 .4962 Frag ~ 2 ~ -NC(=0)N- [urea] 11 .0453 1 2.0906 Factorl 1 1 -N-CO-N-CO- structure correction ~ 0 .6074 1 0.6074 Const I ~ Equation Constant ~ ~ 0.2290 

-------+-----+---------------------------------+---------+-----

= Reliability : (2) valid with restrictions 

Log Kow -1 .3988 

14/64 
p. 15 

2. Physico-Chemical Data 

Modeled data 

Id 108-19-0 

Date 03 .07 .2007 

27.06 .2007 

2.6 .1 SOLUBILITY IN DIFFERENT MEDIA 

Solubility in : Water 

Value . 87.77 g/I at °C 

pH value . 

concentration . at °C 

Temperature effects . 

Examine different pol. . 

pKa . at 25 °C 

Description , 

Stable , 

Deg. product . 

Method : other 

Year ; 1992 

GLP : no 

Test substance : as prescribed by 1 .1 - 1 .4 

Method Water Sol from Kow (WSKOW v1 .41) 

SMILES : 0=C(NC(=0)N)N 

CHEM : Imidodicarbonic diamide 

MOL FOR: C2 H5 N3 02 

MOL WT : 103.08 

Remark : No physical properties input by user Result : Water Sol from Kow (WSKOW v1 .41) Results: 

Water Sol: 8.777e+004 mg/L 

Reliability 

Experimental Water Solubility Database Match: 

Name : Imidodicarbonic diamide 

CAS Num : 000108-19-0 

Exp WSol : 1 .52E+004 mg/L (15 deg C) 

Exp Ref : YALKOWSKY,SH & DANNENFELSER,RM (1992) 

-------- WSKOW v1 .41 Results -------- -------_---

Log Kow (estimated) : -1 .40 

Log Kow (experimental) : not available from database Log Kow used by Water solubility estimates: -1 .40 

Equation Used to Make Water Sol estimate : Log S (mol/L) = 0.796 - 0 .854 log Kow - 0.00728 MW + Correction (used when Melting Point NOT available) 

Correction(s) : Value 

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

Multi-Nitrogen Type -1 .310 

Log Water Solubility (in moles/L) : -0.070 

Water Solubility at 25 deg C (mg/L): 8.777e+004 (2) valid with restrictions 

(7) 

15/64 
p. 16 

2. Physico-Chemical Data 

27 .06.2007 

Handbook data 

Solubility in 

Value 

pH value 

concentration 

Temperature effects 

Examine different pol. 

pKa 

Description 

Stable 

Deg. product 

Method 

Year 

GLP 

Test substance 

Remark 

Result 

Reliability 

Flag 

27.06 .2007 

Solubility in 

Value 

pH value 

concentration 

Temperature effects 

Examine different pol. 

pKa 

Description 

Stable 

Deg. product 

Method 

Year 

GLP 

Test substance 

Reliability 

27.06.2007 

. Water 

. =2 .01 other: g/100 g at 25 °C 

at °C 

. at 25 °C 

other 

1976 

no data 

as prescribed by 1 .1 - 1 .4 

Id 108-19-0 

Date 03 .07 .2007 

(49) 

: This record originally appeared in the ISHOW database . 

ISHOW - Information System for Hazardous Organics in Water Details : Sample Record ISHOW, sponsored by the Office of Toxic Substances of the EPA, was developed by the EPA laboratory in Duluth, Minnesota in conjunction with the University of Minnesota. This database of 17,159 

records includes physical property data on more than 5,700 different chemicals with bibliographic references to the original sources. Not all properties are recorded for all substances. 

: Solubility in 100 g water: 

2.01 G@25DEGC 

7G@50DEGC 

20G@75DEGC 

53.5G@105 .5DEGC 

(2) valid with restrictions 

Handbook data 

Critical study for SIDS endpoint 

(38) 

: other: rumen fluid 

. =2.2 at °C 

at °C 

at 25 °C 

. other 

: 1972 

. no 

: as prescribed by 1 .1 - 1 .4 

: (4) not assignable 

Original reference not reveiwed 

(40) 
p. 17 

2. Physico-Chemical Data 

2.6 .2 SURFACE TENSION 

2.7 FLASH POINT 

2.8 AUTO FLAMMABILITY 

2.9 FLAMMABILITY 

2.10 EXPLOSIVE PROPERTIES 

2.11 OXIDIZING PROPERTIES 

2.12 DISSOCIATION CONSTANT 

2.13 VISCOSITY 

2.14 ADDITIONAL REMARKS 

Id 108-19-0 

Date 03.07 .2007 

17164 
p. 18 

3. Environmental Fate and Pathways Id 108-19-0 

Date 03.07 .2007 

3.1 .1 PHOTODEGRADATION 

Type . air 

Light source . 

Light spectrum . 

Relative intensity . 

INDIRECT PHOTOLYSIS 

Sensitizer . 

Conc. of sensitizer , 

Rate constant . 

Degradation . 

Deg. product . 

Method , 

Year . 

GLP 

Test substance . 

Method 

Remark 

Result , 

nm 

based on intensity of sunlight 

OH 

5000 molecule/cm3 

.000000000003 cm3/(molecule"sec) 

50 % after 3 .7 day(s) 

other (calculated) 

2007 

no 

as prescribed by 1 .1 - 1 .4 

AOP Program (v1 .92) 

SMILES : 0=C(NC(=0)N)N 

CHEM : Imidodicarbonic diamide 

MOL FOR: C2 H5 N3 02 

MOL WT : 103 .08 

No physical properties input by user 

AOP Program (v1 .92) Results : 

-----------

- SUMMARY (AOP v1 .92): HYDROXYL RADICALS -----------------

Hydrogen Abstraction = 0.0000 E-12 cm3/molecule-sec 

"*Reaction with N, S and -OH = 3.0000 E-12 cm3/molecule-sec Addition to Triple Bonds = 0.0000 E-12 cm3/molecule-sec 

Addition to Olefinic Bonds= 0 .0000 E-12 cm3/molecule-sec 

Addition to Aromatic Rings= 0 .0000 E-12 cm3/molecule-sec Addition to Fused Rings = 0.0000 E-12 cm3/molecule-sec 

OVERALL OH Rate Constant = 3.0000 E-12 cm3/molecule-sec 

HALF-LIFE= 3.565 Days (12-hr day; 1 .5E6 OH/cm3) HALF-LIFE = 42 .784 Hrs 

. . . . . . . . . . . . . . . . . . . . . . . "' Designates Estimation(s) Using ASSUMED Value(s) 

------------------ SUMMARY (AOP v1 .91): OZONE REACTION ---------------- 

"""`"'* NO OZONE REACTION ESTIMATION *"`**" (ONLY Olefins and Acetylenes are Estimated) 

Reliability , 

03.07 .2007 

3.1 .2 STABILITY IN WATER 

Experimental Database: NO Structure Matches 

Fraction sorbed to airborne particulates (phi) : 0.00239 (Junge,Mackay) Note : the sorbed fraction may be resistant to atmospheric oxidation (2) valid with restrictions 

Modeled data 

(7) 

18/64 
p. 19 

3. Environmental Fate and Pathways 

Type 

t112 pH4 

t112 pH7 

t1/2 pH9 

Deg. product 

Method 

Year 

GLP 

Test substance 

abiotic 

at °C 

at °C 

at °C 

other (calculated) 

2007 

no 

as prescribed by 1 .1 - 1 .4 

Id 108-19-0 

Date 03 .07 .2007 

Method : HYDROWIN Program (v1 .67) 

SMILES : 0=C(NC(=0)N)N 

CHEM : Imidodicarbonic diamide 

MOL FOR: C2 H5 N3 02 

MOL WT : 103.08 

Result : HYDROWIN Program (v1 .67) Results : 

------

------ HYDROW I N v1 .67 Results ------------------------- 

UREA: -N-C(=0)-NCompound has a urea group; C=0 located at SMILES atom #: 2 Hydrolysis Rate Extremely Slow or t1/2 > 1 Year 

"""""` CALCULATION NOT PERFORMED *"*" 

Reliability 

27.06 .2007 

3.1 .3 STABILITY IN SOIL 

Type : laboratory 

Radiolabel , 

Concentration . 

Soil temperature . °C 

Soil humidity . 

Soil classification . 

Year 

Deg. product . 

Method : other 

Year : 1965 

GLP : no 

Test substance : as prescribed by 1 .1 - 1 .4 

Result 

UREA: -N-C(=0)-NCompound has a urea group; C=0 located at SMILES atom #: 4 Hydrolysis Rate Extremely Slow or t1/2 > 1 Year 

"""""' CALCULATION NOT PERFORMED "`*' (2) valid with restrictions 

Modeled data 

An enzyme tentatively named the biuret-hydrolyzing enzyme, capable of decomposing biuret into urea, ammonia, and carbon dioxide was isolated from Mycobacterium ranae and purified 28-fold was investigated . The properties of this enzyme were investigated in detail with the following results : 

(7) 

19/64 
p. 20 

3. Environmental Fate and Pathways 

03 .07 .2007 

Type 

Radiolabel 

Concentration 

Soil temperature 

Soil humidity 

Soil classification 

Year 

Result 

The optimum pH of the enzyme is about 9.5. 

Id 108-19-0 

Date 03.07 .2007 

The most purified enzyme preparation is strictly specific for biuret, among 

the compounds tested . 

Heavy metal ions, such as Ag+, Hg2+, Pb2+ and Mn2+, inhibit the 

enzymatic activity more than 85% . 

A low concentration of p-chloromercuribenzoate completely inactivates the 

enzyme, and its activity is restored by addition of glutathione or cysteine. 

These results suggest that a sulfhydryl group is essential for the enzyme 

activity . 

Although magnesium ion has not been confirmed to be an activator, it 

shows a slight activating effect on the enzymatic activity and restores the 

activity after inhibition oby ethylenediaminetetraacetate . 

The Michaelis constant of this enzyme was calculated to be 6.1 x 10E-4 M . 

Results indicate that biuret is decomposed by the enzyme into urea, 

ammonia, and carbon dioxide . 

: laboratory 

. °C 

(26) 

Various fungi and bacteria capable of using biuret as nitrogren were isolated from soil and leaf material in selective media. Prominent among the fungi were Coniosporium fuckelii, Penicillium spp. (particularly P. vermiculatum and P. lilacinum), and Auerobasidium pululans, further 

Myrothecium verrucaria, Humicola grisea, Alternaria sp . And Macrosporium 

sp. All grew over a wide pH range with typical optima at pH 4.0 - 5.0. Approximately 60 to 85% of the biuret-nitrogen could be recovered in the mycelium. Biuret-grown and washed mycelia produced ammonia from 

urea although the urease did not appear to be a constitutive enzyme; ammonia formation from biuret could not be detected with certainty . 

The most frequently encountered group of biuret-utilizing bacteria were strains of Pseudomonas trifolii . Pure cultures could under favorable conditions attain maximum growth in glucose-biuret medium within less than 48 hours when 80-85% of the biuret nitrogen was assimilated in the cell material . Growth could be initiated from pH approx. 4 to 8, with apparent optimum at pH 5 to 6. Washed biuret-grown cells produced ammonia more rapidly from urea than from biuret. 

Another group was represented by bacteria that culturally resembled the rapidly growing type of legume root nodule bacteria (Rhizobium) but were not definitely identifiable as such and were also different from 

Agrobacterium radiobacter . Two strains of these "quasi-rhizobia" grew 

even better with biuret than with urea as nitrogen source . Another series of experiments showed that many strains of genuine rhizobia were capable of utilizing biuret although this nitrogen source was mostly inferior to urea. 

20/64 
p. 21 

3 . Environmental Fate and Pathways Id 108-19-0 

Date 03.07 .2007 

Except for the rhizobia and certain strains of Aureobasidium pullulans, 

stock cultures of several fundi, actinomycetes and bacteria showed very 

little or no evident of metabolizing biuret. 

Experiments in soil showed that the total soil microflora was able to utilize 

biuret for the decomposition of straw and pure cellulose, as evidenced by 

the production of carbon dioxide, and that nitrogen in biuret added in doses 

of 50-100-200 ppm not accompanied by other organic substances was 

nitrified to the extent of 80-100% in the course of two to three months. 

The results as a whole show that there can be no risk of the biuret from 

synthetic urea fertilizer accumulating in the soil . At the same time they 

seem to offer some explanation for the well-known fact that the phytotoxic 

effect of biuret is considerable greater by foliar application than by uptake 

through the root. 

25.06 .2007 (20) 

3.2.1 MONITORING DATA 

3.2 .2 FIELD STUDIES 

3.3.1 TRANSPORT BETWEEN ENVIRONMENTAL COMPARTMENTS 

Type 

Media 

Air 

Water 

Soil 

Biota 

Soil 

Method 

Year 

Method 

fugacity model level III 

% (Fugacity Model Level I) 

% (Fugacity Model Level I) 

% (Fugacity Model Level I) 

% (Fugacity Model Level II/III) 

% (Fugacity Model Level II/III) 

other 

2007 

: Level III Fugacity Model 

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

Chem Name : Imidodicarbonic diamide 

Molecular Wt: 103.08 

Henry's LC : 2.03e-013 atm-m3/mole (Henryvirin program) 

Vapor Press : 1 .02e-005 mm Hg (Mpbpwin program) 

Liquid VP : 9.34e-005 mm Hg (super-cooled) 

Melting Pt : 122 deg C (Mpbpwin program) 

Log Kow :-1 .4 (Kowwin program) 

Soil Koc : 0.0163 (calc by model) Remark : No physical properties input by user Result : Level III Fugacity Model (Full-Output) : 

Mass Amount Half-Life Emissions 

(percent) (hr) (kg/hr) 

Air 4.83e-006 85 .6 1000 

Water 39 360 1000 

21/64 
3. Environmental Fate and Pathways 

Reliability 

03 .07 .2007 

Type 

Media 

Air 

Water 

Soil 

Biota 

Soil 

Method 

Year 

Remark 

Soil 60.9 720 1000 

Sediment 0 .0713 3.24e+003 0 

Id 108-19-0 

Date 03.07 .2007 

Fugacity Reaction Advection Reaction Advection 

(atm) (kg/hr) (kg/hr) (percent) (percent) 

Air 1 .97e-016 0 .000679 0 .000839 2.26e-005 2 .8e-005 

Water 6.67e-018 1 .3e+003 677 43 .5 22 .6 

Soil 3.86e-016 1 .02e+003 0 34 0 

Sediment 6.1e-018 0.265 0 .0248 0.00883 0.000826 

Persistence Time : 579 hr 

Reaction Time : 748 hr 

Advection Time: 2.57e+003 hr 

Percent Reacted : 77.4 

Percent Advected : 22 .6 

Half-Lives (hr), (based upon Biowin (Ultimate) and Aopwin) : 

Air: 85 .56 

Water: 360 

Soil: 720 

Sediment: 3240 

Biowin estimate : 2 .971 (weeks ) 

Advection Times (hr) : 

Air: 100 

Water: 1000 

Sediment: 5e+004 

(2) valid with restrictions 

Modeled data 

other 

% (Fugacity Model Level I) 

% (Fugacity Model Level I) 

% (Fugacity Model Level I) 

% (Fugacity Model Level II/Ili) 

% (Fugacity Model Level II/III) 

(7) 

Biuret does not accumulate in soil and is mineralized within a single 

growing season . Biuret is not retained in soil (Orgata, year) and is easily 

leached (Gadet et al ., 1959). Nishihare et al . (1965) found an enzyme, 

biuret-hydrolyzing enzyme, capable of decomposing biuret into urea, 

ammonia, and carbon dioxide . Jensen (1966) found several widespread 

species of soil fungi and bacteria capable of degrading biuret. Jensen also 

reported that biuret at a concentration of 100 ppm was almost completely 

nitrified after two to three months. Several studies have concluded that the 

rate of biuret mineralization depends on soil composition, temperature, and 

biuret concentration (Mithyantha et al ., 1977). 

03 .07 .2007 (10)(20)(24)(27)(28) 

., . . .. ... . .~... ., . .~ . ., . . 
p. 23 

3 . Environmental Fate and Pathways 

3.4 MODE OF DEGRADATION IN ACTUAL USE 

3.5 BIODEGRADATION 

Contact time 

Degradation 

Result 

Deg. product 

Method 

Year 

GLP 

Test substance 

Method 

Result 

(±) % after 

other: likely to be biodegradable 

other 

2007 

no 

as prescribed by 1 .1 - 1 .4 

BIOWIN (v4 .10) Program 

SMILES : 0=C(NC(=0)N)N 

CHEM : Imidodicarbonic diamide 

MOL FOR: C2 H5 N3 02 

MOL WT : 103.08 

BIOWIN (v4 .10) Program Results : 

------ BIOW IN v4.10 Results ------------------------ 

Id 108-19-0 

Date 03.07 .2007 

Biowin1 (Linear Model Prediction) : Biodegrades Fast 

Biowin2 (Non-Linear Model Prediction) : Biodegrades Fast 

Biowin3 (Ultimate Biodegradation Timeframe) : Weeks 

Biowin4 (Primary Biodegradation Timeframe): Days-Weeks 

Biowin5 (MITI Linear Model Prediction) : Does Not Biodegrade Fast 

Biowin6 (MITI Non-Linear Model Prediction) : Does Not Biodegrade Fast 

Biowin7 (Anaerobic Model Prediction) : Biodegrades Fast 

Ready Biodegradability Prediction: NO 

------+-----+---------------------------------__+__---__+------ 

TYPE I NUM ~ Biowin1 FRAGMENT DESCRIPTION ~ COEFF ~ 

VALUE 

------+-----+--------------------------------------+--------+-------

MoIWtj " I Molecular Weight Parameter 1 I-0 .0491 

Constj " I Equation Constant I I 0.7475 

--------- ---------___+_________________________------------------- ------------------- 

------______+-_-----__-----------__-_-

+_________+_________ 

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

RESULT I Biowin1 (Linear Biodeg Probability) ~ ~ 0.6985 

------+-----+------------------------------------+--------+-------- 

TYPE I NUM ~ Biowin2 FRAGMENT DESCRIPTION ~ COEFF ~ 

VALUE 

------------ ------------+____________________ ~______---------------- ---------------- 

------+-----+--------------------------------------+--------+--------

MoIWtj '" I Molecular Weight Parameter 1-1 .4638 

------------+---__--__-------_-------

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

RESULT I Biowin2 (Non-Linear Biodeg Probability) 1 1 0.8242 

23/64 
p. 24 

3. Environmental Fate and Pathways Id 108-19-0 

Date 03.07 .2007 

A Probability Greater Than or Equal to 0.5 indicates --> Biodegrades Fast 

A Probability Less Than 0 .5 indicates --> Does NOT Biodegrade Fast 

---------------- ----------- ------------- --------+-------+----__ 

TYPE INUM I Biowin3 FRAGMENT DESCRIPTION I COEFF I 

VALUE 

------+----+----------------------------------+--------+--------

MoIWtj " I Molecular Weight Parameter 1 1-0 .2278 

Constj " I Equation Constant 1 1 3.1992 

------------+-_---__-----__----------___-_---------_----- ------------ ----- ----- ---------- - --------- ----- 

RESULT I Biowin3 (Survey Model -Ultimate Biodeg) ~ ~ 2.9714 

------------+-_--_--____------------_--------- ----------- 

-----+----+------------------------------------+-----+-------

TYPE INUM I Biowin4 FRAGMENT DESCRIPTION I COEFF ~ 

VALUE 

------+-----+--------------------------------------+-------+-------

MoIWtj ' I Molecular Weight Parameter 1 I-0 .1487 

Constj ` I Equation Constant 1 3.8477 

------------+-_-_--_____----------------------

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

RESULT I Biowin4 (Survey Model -Primary Biodeg) ~ ~ 3.6990 

Result Classification : 5.00 -> hours 4.00 -> days 3.00 -> weeks (Primary & Ultimate) 2.00 -> months 1 .00 -> longer 

------+-----+----------------------------------+-------+------- 

TYPE INUM I Biowin5 FRAGMENT DESCRIPTION I COEFF ~ VALUE 

MoIWtj ' ~ Molecular Weight Parameter I 1-0 .3067 

------+-----+---------------------------------------+--------+------- 

------------+-----------------_-------------- 

Constj ' I Equation Constant 1 1 0.7121 

------------+--------------------------------

---------------------___ 

RESULT I Biowin5 (MITI Linear Biodeg Probability) 1 1 0.4055 

------+----+------------------------------------+------+-------

TYPE I NUM ~ Biowin6 FRAGMENT DESCRIPTION ~ COEFF ~ VALUE 

------+-----+---------------------------------------+--------+------ 

MoIWtj " I Molecular Weight Parameter I 1-2 .9758 

_-----______+___----____-_-------_-- ------- 

RESULT jBiowin6 (MITI Non-Linear Biodeg Probability)l 1 0.3893 

A Probability Greater Than or Equal to 0.5 indicates --> Readily Degradable 

A Probability Less Than 0.5 indicates --> NOT Readily Degradable 

24/64 
p. 25 

3 . Environmental Fate and Pathways 

Reliability 

27 .06 .2007 

Id 108-19-0 

Date 03.07 .2007 

------+----+---------------------------------+--------+-------

TYPE INUM I Biowin7 FRAGMENT DESCRIPTION ~ COEFF I 

VALUE 

------+----+----------------------------------+--------+-------

Constj * I Equation Constant ~ ~ 0 .8361 

------------+-----------_______-------------_------------ ------------ ----------- ------------- ------------ 

RESULT I Biowin7 (Anaerobic Linear Biodeg Prob) ~ ~ 0.8361 

A Probability Greater Than or Equal to 0.5 indicates --> Biodegrades Fast 

A Probability Less Than 0.5 indicates --> Does NOT Biodegrade Fast 

(2) valid with restrictions 

Modeled data 

(7) 

3.6 BOD5, COD OR BOD5/COD RATIO 

3.7 BIOACCUMULATION 

3.8 ADDITIONAL REMARKS 

25/64 
p. 26 

4. Ecotoxicity 

4.1 ACUTE/PROLONGED TOXICITY TO FISH 

4.2 ACUTE TOXICITY TO AQUATIC INVERTEBRATES 

4.3 TOXICITY TO AQUATIC PLANTS E.G. ALGAE 

4.4 TOXICITY TO MICROORGANISMS E.G . BACTERIA 

4.5 .1 CHRONIC TOXICITY TO FISH 

4.5.2 CHRONIC TOXICITY TO AQUATIC INVERTEBRATES 

4.6.1 TOXICITY TO SEDIMENT DWELLING ORGANISMS 

4.6.2 TOXICITY TO TERRESTRIAL PLANTS 

4.6.3 TOXICITY TO SOIL DWELLING ORGANISMS 

4.6.4 TOX. TO OTHER NON MAMM. TERR. SPECIES 

4.7 BIOLOGICAL EFFECTS MONITORING 

4.8 BIOTRANSFORMATION AND KINETICS 

4.9 ADDITIONAL REMARKS 

Id 108-19-0 

Date 03.07 .2007 

26/64 
p. 27 

5. Toxicity 

5.0 TOXICOKINETICS, METABOLISM AND DISTRIBUTION 

Method 

Year 

GLP 

Test substance 

Remark 

1975 

no 

as prescribed by 1 .1 - 1 .4 

Id 108-19-0 

Date 03.07 .2007 

: It has been well established through the use of biuret as an non-protein 

nutrient, that in the rumen, biuret and urea are hydrolyzed to ammonia and 

simple carbon compounds. The complete hydrolysis and deamination of 

protein involves numerous enzymes. Biuret is decomposed by biuretase 

(within bacterial cells) to urea, ammonia, and carbon dioxide . Biuret is 

more slowly hydrolyzed than urea . 

Reliability : (2) valid with restrictions 

Provides basic data 

03.07 .2007 

Method . 

Year : 1958 

GLP : no 

Test substance : as prescribed by 1 .1 - 1 .4 

Remark : Biuret is not accumulated in the body of rats or chickens Reliability : (4) not assignable 

27.06 .2007 

Method 

Year 

GLP 

Test substance 

Original reference not reveiwed 

1968 

no 

as prescribed by 1 .1 - 1 .4 

(9) 

(15) 

Remark : Sheep, given 14C - biuret i .v . excreted 98% in the urine within 48 hours . Reliability : (4) not assignable 

27 .06.2007 

Original reference not reveiwed 

5.1 .1 ACUTE ORAL TOXICITY 

Type : other 

Value 

Species : sheep 

Strain . no data 

Sex : no data 

Number of animals . 

Vehicle 

Doses : 4, 8 and 16 g/kg 

Method : other 

Year , 1972 

GLP : no 

Test substance : other TS 

Method Sheep were drenched (to administer a large oral dose of a liquid to an 

(8) 

27/64 
p. 28 

5. Toxicity Id 108-19-0 

Date 03.07 .2007 

animal) with 4, 8 or 16 g/kg bw of feed grade Biuret . 

Result : No signs of toxicity observed in sheep administered 4 g/kg bw. Distress 

was observed in sheep treated with 8 g/kg bw. Death occurred in sheep 

treated with 16 g/kg bw. 

Test substance : Kedlor feed grade Biuret 

Reliability : (4) not assignable 

Original reference not reveiwed 

27 .06.2007 

Type : other 

Value . 

Species : sheep 

Strain : no data 

Sex : no data 

Number of animals . 

Vehicle . 

Doses . .6 g/kg bw 

Method : other 

Year . 1955 

GLP : no 

Test substance : other TS 

(33) 

Method : Sheep were drenched (to administer a large oral dose of a liquid to an 

animal) with crude Biuret at 0.68 g/kg bw and observed for signs of toxicity 

and death . 

Result : No signs of toxicity or death were reported . 

Test substance : crude Biuret 

Reliability : (4) not assignable 

Original reference not reveiwed 

27.06 .2007 

Type : other 

Value . 

Species : sheep 

Strain : no data 

Sex : no data 

Number of animals . 

Vehicle . 

Doses : 6.9 g/kg bw 

Method : other 

Year . 1963 

GLP : no 

Test substance : other TS 

(23) 

Method : Sheep were drenched (to administer a large oral dose of a liquid to an animal) with feed grade Biuret at 6.9 g/kg bw (250 g) and observed for signs of toxicity and death. This massive dose of biuret was administered to sheep before and after an extended adaptation period. The animals 

were fed a low protein, high roughage diet. Result : No signs of toxicity or death were reported irrespective of the period of adaptation. 

Test substance . Feed grade Biuret 

Reliability : (4) not assignable 

27.06 .2007 

Original reference not reveiwed 

(5)(6)(9) 

Type : other 

28/64 
p. 29 

5. Toxicity 

Value 

Species 

Strain 

Sex 

Number of animals 

Vehicle 

Doses 

Method 

Year 

GLP 

Test substance 

Method 

Result 

Reliability 

27 .06 .2007 

5.1 .2 ACUTE INHALATION TOXICITY 

5.1 .3 ACUTE DERMAL TOXICITY 

5.1 .4 ACUTE TOXICITY, OTHER ROUTES 

5.2 .1 SKIN IRRITATION 

5.2 .2 EYE IRRITATION 

5.3 SENSITIZATION 

5.4 REPEATED DOSE TOXICITY 

Type 

Species 

Sex 

Strain 

Route of admin. 

Exposure period 

Frequency of treatm. 

Post exposure period 

Doses 

Control group 

Method 

Year 

GLP 

. sheep 

. no data 

. no data 

4 .7 g/kg bw 

other 

1959 

no 

as prescribed by 1 .1 - 1 .4 

Id 108-19-0 

Date 03.07 .2007 

4 .7 g/kg body weight of purified biuret was administered to sheep. The 

animals were observed for death and signs of toxicity . 

Signs of toxicity (not specified) were observed . 

(4) not assignable 

Original reference not reveiwed 

. rat 

. male 

: Sprague-Dawley 

oral feed 

30 or 140 days 

: daily 

. none 

. Exp 1 : 0.2 - 1 .0% ; Exp 2: 5% and 10% 

: yes, concurrent no treatment 

. other 

: 1956 

. no 

(9) (12) 

29/64 
5. Toxicity 

Test substance : other TS 

Method 

Result 

Test substance 

Reliability 

27.06 .2007 

Type 

Species 

Sex 

Strain 

Route of admin. 

Exposure period 

Frequency of treatm. 

Post exposure period 

Doses 

Id 108-19-0 

Date 03.07 .2007 

Experiment I : Male Sprague-Dawley rats (6/group) were fed a basal diet 

supplemented with Biuret at levels of 0.2, 0 .4, 0.6, 0.8 and 1 .0% for 30 

days . A control group (6 rats) was fed the basal diet without added Biuret . 

Animals were observed for signs of toxicity and body weights were 

recorded after 30 days . 

Experiment II : After 30 days it was evident that rats could tolerate Biuret in 

their diets up to 1 % without any apparent toxic effects . Based on the lack 

of toxicity noted in animals in Experiment 11, a second experiment was 

initiated . Animals in groups 1 (control), 3 (0.4%) and 4 (0 .6%) were used in 

the second experiment. The control group was continued as previously 

described . Biuret was added to the basal diet at the rate of 5.0% and 

10.0% and fed to groups 3 and 4, respectively . This feeding experiment 

was continued for 140 days to observe any long range effects of a high 

Biuret diet. On the 35th and 98th days, one randomly selected animal from 

each of the three groups was killed and subjected to gross necropsy. 

There were no significant differences in growth rates among the six groups 

fed for only 30 days or the three test groups that were fed for 140 days . 

The appetites were normal, all animals appeared thrifty throughout the 

duration of the experiment, and no illnesses or deaths occurred. All 

specimens submitted for histological examination were found to be normal . 

Slight changes which occurred could not be attributed to Biuret toxicity . 

Since Biuret is chemically related to urea it might be expected that the 

reaction of the rat body to Biuret would be similar to its reaction to urea. 

Observation of a higher water intake among the Biuret-fed groups with no evident histological changes was noted . 

Effects of Various Levels of Biuret in the Diet on Laboratory Rats : 

Exp . Days on Biuret (N) Average Gain 

Test (%) (gm) 

1 30 0 .0 6 139.6 

0.2 6 135 .0 

0.4 6 130 .3 

0.6 6 141 .0 

0.8 6 142.4 

1 .0 6 137.0 

11 140 0.0 4 206.8 

5.0 4 203 .1 

10.0 4 198 .2 

99.1 % purity 

(2) valid with restrictions 

Provides basic data 

Sub-acute 

other: steer 

male 

other: Angus and Hereford 

oral feed 

84 days 

daily 

none 

see Method 

(3) 

30/64 
5 . Toxicity 

Control group 

Method 

Year 

GLP 

Test substance 

Method 

Id 108-19-0 

Date 03.07 .2007 

yes 

other 

1956 

no 

other TS 

: Forty-five yearling steers, 25 Angus and 20 Herefords, ranging in weight 

from 450 to 650 pounds were randomly sorted into five groups according to weight and breed. The five groups were fed a high-roughage, lowconcentrate wintering ration in dry lot for 84 days. The basal ration was 

made up of 36.5% Atlas silage (hay basis), 24% cottonseed hulls, 6% 

alfalfa leaf meal, 11% blackstrap molasses, and from 13% to 20% milo 

grain and 1 % minerals (bonemeal and salt) . The crude protein 

supplements used were 7.5% cottonseed meal (Group 1), 1 % feed-urea (Group 2), 1 % crude Biuret (Group 3), 1 .5% a mixture of crude Biuret and 

feed-urea (Group 4), and 1 .25% of a urea-fatty acid complex (Group 5). The total intake of each group was adjusted to that of the lowest 

consuming group. This was accomplished by hand feeding . Each ration 

was calculated to supply equal amounts of dry matter, total digestible nutrients, and except for Group 4, protein equivalent. Group 4 was 1 .4% higher in crude protein equivalent. The urea-fatty acid complex was 75% 

urea and 25% cottonseed foots . Animals were observed for signs of 

toxicity and average weight gain was calculated at study termination . Result : As shown in the table below, the average gains made by the control group and the urea group (Group 2) were not significantly different. However, when the urea was replaced with the crude Biuret (Group 3), a significantly lower gain resulted (p<0.01). This group also consumed the least feed and therefore, restricted the intake of the other groups. When additional urea (42 gm) was included with the crude Biuret (Group 4), the average gain 

was increased 0.50 pounds, a difference highly significant statistically 

(p<0.01). Thus, simply adding urea overcame the adverse effects of Biuret . Although Group 4 gained slightly more than the group fed urea alone (Group 2), the difference was not significant. The increase of 0.18 pounds in daily gain may suggest that contrary to the results obtained with Group 3, the Biuret nitrogen was utilized to some extent by the ruman bacteria . 

The group fed urea-fatty acid complex (Group 5) gained essentially the 

same as the urea fed group (Group 2). Based on this single study it 

appears that urea fed as a urea-fatty acid complex is efficiently utilized . 

Test substance 

Reliability 

Group Av. Gain Av. Daily Gain 

(Ib) (Ib) 

1 (control) 94.7 1 .13** 

2 (urea) 88 .4 1 .05** 

3 (crude Biuret) 60.5 0 .72 

4 (crude Biuret-urea) 102.9 1 .23** 

5 (urea-fatty acid) 91 .5 1 .09* 

*Values significantly (p<0.05) greater than for the group fed crude Biuret alone. 

**Value highly significantly (p<0.01) greater than for group fed crude Biuret atone. 

crude Biuret (60% Biuret and 40% urea) 

Diets containing crude Biuret (60% Biuret and 40% urea) (2) valid with restrictions 

31/64 
p. 32 

5. Toxicity 

27.06 .2007 

Provides basic data 

Id 108-19-0 

Date 03.07 .2007 

(3) 

Type . 

Species : other: pullets (New Hampshire poultry) 

Sex : no data 

Strain : no data 

Route of admin. : oral feed 

Exposure period ; not specified 

Frequency of treatm. : daily 

Post exposure period : none 

Doses . 1 % 

Control group : yes, concurrent no treatment 

Method : other 

Year . 1956 

GLP : no 

Test substance : other TS 

Method 

Remark 

Result 

Test substance 

Conclusion 

Reliability 

27.06 .2007 

Type : Sub-acute 

Species : other: lamb 

Sex . no data 

Strain : no data 

Route of admin. : oral feed 

Exposure period : 84 days 

Frequency of treatm. : daily 

Post exposure period : none 

Doses , 

Control group : yes, concurrent no treatment 

Method : other 

Year : 1956 

Eighty New Hampshire pullets, 8 weeks of age, were randomly selected 

and divided into eight groups of 10 each according to weight. Four dietary 

treatments (basal, urea, Biuret, and soybean) allowed two groups of 10 

within each treatment. Group 1 (control) was fed a milo-soybean meal 

basal ration calculated to contain 14.5% crude protein. It consisted of 

83.5% milo grain, 12.0% soybean oil meal, 0.5% vitamin mixture, and 4.0% 

of a mineral mixture. Groups 2 and 3 were fed the same basal diet except 

1 % of the milo of each ration was replaced with 1 % % feed urea or 1 % 

purified Biuret, respectively, which raised the calculated crude protein 

equivalents to 17.3%. Group 4 was fed the basal diet with enough milo 

replaced by soybean oil meal to raise the calculated crude protein value to 

17.3% . 

Duration of the study was not reported . 

Feed consumption was about 5% lower for the Biuret and urea 

supplemented groups than for the control and soybean oil meal 

supplemented groups. The body weight gain of the birds receiving the 

added soybean oil meal (Group 4: 458.0 gm) was significantly higher than that of the basal (399.8 gm), urea (393.5 gm) and Biuret (359.0 gm) 

groups. The inclusion of Biuret or urea had no statistically significant effect 

on body weight gain . 

99.1 % purity 

Neither urea nor Biuret is toxic to 8-week old pullets when added to the ration at this level . 

(2) valid with restrictions 

Provides basic data 

(3) 

32/64 
p. 33 

5 . Toxicity 

GLP 

Test substance 

Method 

Result 

Test substance 

Conclusion 

Reliability 

25 .06 .2007 

Type : Sub-chronic 

Species : cattle 

Sex : female 

Strain : other: Ayrshire 

Route of admin. : oral feed 

Exposure period : 15 weeks 

Frequency of treatm. : daily 

Post exposure period : 3 week period for subgroup of 3 animals 

Doses : 2.6% 

Control group : yes, concurrent no treatment 

Method : other 

Year : 1968 

GLP : no 

Test substance : other TS 

(3) 

Method : Experiment 2: A continuous-type design was used to examine the effect of 

more prolonged treatment and in order to minimize the effects of individual 

animal variation with the small number of cows (21), a preliminary feeding period of 4 weeks was given during which all cows received a high-quality 

commercial concentrate and the same hay that was to be fed during the 

experimental period . The results obtained in the preliminary period was later used to adjust the results from the experimental period by covariance 

analysis. 

Twendy-one Ayrshire cows, 30 to 80 days old, were used for this 15-week 

feeding study. Groups of 3 were organized based on stage of lactation, 

no 

other TS 

Id 108-19-0 

Date 03.07 .2007 

Twenty-seven fine wool lambs, weighing 50-70 pounds, were divided into 

three groups of nine each and for 84 days fed rations consisting of 42.5% 

cottonseed hulls, 10% blackstrap molasses, and 40-45% ground milo . The 

various crude protein supplements were 7.5% cottonseed meal (Group 1), 

1 % cottonseed meal plus 1 % urea feed-urea (Group 2), and 1 % 

cottonseed plus 1 % crude Biuret (Group 3). All three rations were 

calculated to supply equal levels of dry matter, total digestible nutrients and 

crude protein . In order to prevent differences related to palatability of the 

rations, the total intake of each was adjusted to that of the lowest 

consuming group. This was accomplished by hand feeding twice daily. 

Daily observations of water intake and urination were monitored . Average 

weight gain was calculated at study termination. One lamb from each test 

group was killed and a gross necropsy conducted. 

The Biuret group was the slowest, the urea group intermediate and the 

control group the fastest in cleaning up the rations . Therefore, feed 

consumption of the Biuret-fed group controlled the feed intake of the other 

groups. Daily observations indicated greater water intake and urination for 

the NPN-fed groups, these conditions being more apparent for the Biuret 

group than for the urea group. An examination of the internal organs 

showed no changes among the lambs from the three treatment groups. 

Diets containing crude Biuret (60% Biuret and 40% urea) 

It was apparent that the consumption of the crude Biuret-urea mixture or of 

urea along did not cause toxic symptoms, unless the depression of appetite 

is considered a symptom . 

(2) valid with restrictions 

Provides basic data 

33/64 
5. Toxicity Id 108-19-0 

Date 03.07 .2007 

number of lactations and milk production in earlier lactations . The 

experimental feeding treatments (control, biuret, urea) were randomly 

allocated to the 3 cows in each group. The average number of 

lactations/cow was 3. 

In order to make the total amount of N supplied in the diets more critical in 

this experiment, the concentration of urea was reduced from 2.9% to 2.1 % 

and of biuret from 3.9% to 2.6%. This change lowered the contribution of 

the 2 NPN sources to 43% from 52% in Exp 1 . The total N content of the 

concentrates in Exp 2 was about 80% of that fed in Exp 1 . The formulation 

of the 3 concentrate mixtures used in Exp 2 is provided below. The 

changes compared to Exp 1 were made to provide a control concentrate 

with a less soluble form of protein and one which was less dependent on 

the N content of a single cereal. 

Composition % on air-dry basis 

Ingredient Control Biuret Urea 

Biuret* - 2.6 -

Urea" - - 2.1 

Soybean meal 2.5 

Decorticated 

Groundnut cake 5.8 - -

Decorticated 

Cotton cake 2 .5 - -

Linseed cake 3 .5 - -

Copra cake 10 .7 - -

Barley 33.0 43.7 44.0 

Maize 33 .0 43.7 43.9 

Starch - 2.0 2 .0 

Minerals" 3.0 3.0 3.0 

Molasses 5.0 5.0 5.0 

"Biuret : 7% moisture, 39% N in D.M . 

Urea : 0 .7% moisture, 46% N in D.M . 

Supplements of vitamins A and D3, trace minerals and spices were added 

to all concentrates, and in addition elemental suphur (520 g/ton) was added 

to the biuret and urea concentrates. 

Milk samples from the whole udder were taken at 4 consecutive milkings 

once a week and the 4 samples pooled in proportion to yield for chemical 

analysis . Cell count was measured weekly on the pooled sample and 

monthly on quarter samples for each cow. 

At the end of Exp 2, 3 cows continued on the same biuret treatment diet for 

a further 3 weeks to allow a measurement of the nitrogen balance of each 

cow to be made. Feces (8-hr intervals), urine (24-hr intervals), and milk 

(collected every milking period; averaged each 48 h) were analyzed for 

nitrogen content 

Result : The estimated energy intake in Exp 2 was 108-109% using the Woodman standard calculation . The milk production was about 10% less on the biuret diet compared to control . The percentages of fat and protein in the milk from the biuret treatment was higher than from the control treatment, but the weights of the milk constituents was slightly lower in the biurettreated group than from the control treatment. Liveweight changes and 

water consumption were not affected by experimental treatment. The 

three cows that had received biuret concentrated continued to do so during 

a nitrogen balance trial that lasted 3 weeks . Each cow was slightly in 

34/64 
p. 35 

5 . Toxicity Id 108-19-0 

Date 03 .07 .2007 

negative balance, the average being - 4 g N/cow/day. 

Reliability : (2) valid with restrictions 

Provides basic data 

27.06 .2007 

Type 

Species 

Sex 

Strain 

Route of admin . 

Exposure period 

Frequency of treatm. 

Post exposure period 

Doses 

Control group 

Method 

Year 

GLP 

Test substance 

Method 

(48) 

. Sub-acute 

: cattle 

. female 

: other: Ayrshire 

: oral feed 

. 7 weeks 

: daily 

. none 

: 3.9% 

: yes, concurrent no treatment 

. other 

: 1968 

. no 

: other TS 

Experiment 1 : The design of Exp 1 was of the balanced change-over type 

with 18 Ayrshire cows . The animals were divided into 6 groups with the 

cows in each group as similar as possible in milk yield and stage of 

lactation . They were then allotted at random to the treatment sequences 

in2 orthogonal 3 x 3 Latin squares . The average lactation number of the 

cows was 3, with only 4 of them have had more than 3 lactations . Each 

cow had been milking for 60-70 days before the experiment started . 

Each diet consisted of good quality hay with one of the 3 concentrate 

mixtures and was fed for periods of 7 weeks. The formulation of the 3 

concentrate mixtures is provided below: 

Composition % on air-dry basis 

Ingredient Control Biuret Urea 

Biuret* - 3.9 -

Urea* - - 2,9 

Decorticated 

Groundnut cake 23.3 - -

Barley 66.6 81 .9 85.7 

Starch - 7.0 4.2 

Oat husks 2 .9 - -

Minerals* 2.4 2.4 2.4 

Molasses 4.8 4.8 4.8 

*Biuret : 7% moisture, 39% N in D.M. 

Urea: 0.7% moisture, 46% N in D.M. 

Supplements of vitamins A and D3, trace minerals and spices were added 

to all concentrates, and in addition elemental suphur (520 g/ton) was added 

to the biuret and urea concentrates . 

It can be seen that the biuret and urea N replaced that derived from the 

groundnut cake in the control concentrate . The biuret and the urea both 

supplied 52% of the total N in these concentrates . 

On 2 separate days each week in the final 2 weeks of each feeding period 

the cows were milked with a quarter milking bucket . Samples of milk from 

each quarter were taken for chemical analysis and for cell count. In each 

35/64 
5 . Toxicity 

Result 

Reliability 

Id 108-19-0 

Date 03.07 .2007 

of the other weeks one 24-h whole-udder sample was taken for analysis . 

The cows were weighed at the same time on 2 consecutive mornings of 

each week. 

Experiment 1 : The estimated energy intake in Exp 1 was 102-104% using 

the Woodman standard calculation . The milk production was about 10% 

less on the biuret diet compared to control . The percentages of fat and 

protein in the milk from the biuret treatment was higher than from the 

control treatment, but the weights of the milk constituents was slightly lower 

in the biuret-treated group than from the control treatment. Liver weight 

changes and water consumption were not affected by experimental 

treatment. 

(3) invalid 

Does not provide useful hazard information 

27.06 .2007 (48) 

Remark 

Reliability 

27.06 .2007 

Type : Sub-acute 

Species : other: lamb 

Sex . no data 

Strain : no data 

Route of admin. : oral feed 

Exposure period : 72 days 

Frequency of treatm . : daily 

Post exposure period . none 

Doses : 3% 

Control group : yes, concurrent no treatment 

Biuret is an FDA-approved (Federal Register. Rules and Regulations . 21 

CFR Part 573. Federal Register 68(99) :27904 . 2003) nonprotein nutrient 

(NPN) supplement for ruminants and a good deal of data exists for toxicity 

and nutritive dosages of urea/Biuret combinations for these animals . 

Generally, plant proteins stimulate the most efficient animal growth and 

milk production. Animal response is satisfactory, however, when biuret and 

other NPN products provide part of the nitrogen requirements . When low 

quality forage diets deficient in nitrogen were fed to ruminants, response to 

feed grade biuret was very good . Supplementation with biuret stimulated 

good response from animals receiving medium and high energy diets. 

Biuret is an ideal supplement because ruminant animals may be fed more 

biuret than urea. The low solubility of biuret allows it to remain longer in the 

rumen. Biuret is hydrolyzed more slowly to ammonia and carbon dioxide in 

the rumen than urea and thereby eliminates toxic accumulation of ammonia 

in blood plasma. This is cited as the primary reason biuret is readily 

consumed by animals at high levels . Biuret is comparatively non-toxic 

even when supplying nitrogrn at levels several times the requirements of 

the animal . This enlarges the margin of safety permitting feeding of higher 

concentrations of biuret in the diet than of other commercial NPN products. 

Biuret exhibits no undesireable palatability characteristics . Its low solubility 

and slow degradation rate reduces the hazard of self-feeding on a 

continuing or intermittent basis. 

Additional studies to support the low toxicity of biuret to animals are 

summarized in this article . 

(2) valid with restrictions 

Provides basic data 

(9) 

36/64 
p. 37 

5 . Toxicity 

Method : other 

Year . 1956 

GLP : no 

Test substance : other TS 

Method 

Result 

Test substance 

Reliability 

27.06 .2007 

Type : Sub-acute 

Species : cattle 

Sex : female 

Strain : no data 

Route of admin. : oral feed 

Exposure period : 7 to 10 days 

Frequency of treatm. : daily 

Post exposure period : none 

Doses : see Method 

Control group : no data specified 

Method : other 

Year : 1959 

GLP : no 

Test substance : other TS 

Method 

Result 

Id 108-19-0 

Date 03.07 .2007 

Two lambs were individually penned and for 72 days fed twice daily the 

same ration fed the control group in the 84 day lamb feeding study. Crude 

Biuret was added to the ration of one of the lambs to provide a level of 3% 

Biuret and 2% urea. Animals were observed for signs of toxicity, food 

consumption was monitored, and average weight gain was calculated. 

This addition of crude Biuret to a cottonseed meal supplemented ration did 

not appear to reduce the rate of feed consumption . Gains were essentially 

the same, 25.5 pound and 25.0 pounds for the control and treated lamb, 

respectively . Although only two lambs were involved the limited data 

indicated that Biuret added in excess to a diet already adequate in protein 

was relatively inert . Even at this high level, approximately 68 gm/day, no 

toxic symptoms or depression of appetite occurred . 

Diets containing crude Biuret (60% Biuret and 40% urea) 

(3) invalid 

Insufficient number of animals 

: 20 g 80% biuret was added to a regular diet and fed to dairy cows for a period of 7 to 10 days. Animals were observed for signs of toxicity . Milk yield and the content of fat/nonprotein nitrogen in the milk and nonprotein nitrogen content of the blood were measured. 

: There were no effects on their health, yield of milk or contents of fat and nonprotein nitrogen in the milk, nor on the nonprotein nitrogen content of the blood. 

Reliability : (3) invalid 

27.06 .2007 

Type 

Species 

Sex 

Strain 

Route of admin. 

Exposure period 

Frequency of treatm. 

Post exposure period 

Doses 

Does not provide useful hazard information 

: Sub-acute 

: other: horses, rabbits and sows 

. no data 

. no data 

: oral feed 

: see Method 

: daily 

: see Method 

(3) 

(9) (16) 

37/64 
p. 38 

5. Toxicity 

Control group 

Method 

Year 

GLP 

Test substance 

no data specified 

other 

1959 

no 

other TS 

Id 108-19-0 

Date 03.07 .2007 

Method : Horses were fed 10 g 80% biuret daily (duration not specified); 

15 g 80% biuret was given to sows daily for 8 days; 

3 g pure biuret was given to adult rabbits daily for 7 days. All animals were 

observed for signs of toxicity . 

Result : There were no apparent effects on the health of any species. Reliability : (3) invalid 

Does not provide useful hazard information 

27.06 .2007 

Type : Sub-chronic 

Species : sheep 

Sex : no data 

Strain : no data 

Route of admin. : oral feed 

Exposure period : 593 days 

Frequency of treatm. : daily 

Post exposure period . 

Doses : 3.78 g/kg bw 

Control group : no data specified 

NOAEL . = 3780 - mg/kg bw 

Method : other 

Year : 1959 

GLP : no 

Test substance : other TS 

Method 

Result 

Test substance 

Reliability 

27.06 .2007 

(9) (17) 

Sheep were fed diets containing Biuret in amounts equal to 75% of the daily nitrogen intake for 593 days. 

Growth, reproduction and wool production were not adversely affected . Feed grade Biuret 

(3) invalid 

Does not provide useful hazard information 

Type : Sub-acute 

Species : cattle 

Sex : female 

Strain : no data 

Route of admin. : oral feed 

Exposure period : 84 days 

Frequency of treatm. : daily 

Post exposure period . none 

Doses , 

Control group . 

Method : other 

Year , 1972 

GLP : no 

Test substance : other TS 

Method Comparison of feed grade biuret with other nitrogen supplements for maintenance of cattle grazing or being fed protein deficient forage. 

(12) 

38/64 
p. 39 

5 . Toxicity 

Result 

Reliability 

27.06 .2007 

Type 

Species 

Sex 

Strain 

Route of admin . 

Exposure period 

Frequency of treatm . 

Post exposure period 

Doses 

Control group 

Method 

Year 

GLP 

Test substance 

Method 

Result 

Id 108-19-0 

Date 03 .07 .2007 

Average initial weight (kg) and average daily weight gain (kg) were 

reported . 

Basal Diet: Dormant range grass (winter) 

Source Animal No . Days Wt (kg) Daily gain (kg) 

57% SM PG 10 84 487 - .66 

17% SM Cows 10 84 469 - .96 

5 .3% urea Cows 9 84 465 -.84 

5 .5% biuret Cows 9 84 477 -.95 

where SM = soybean meal ; PG = pregnant 

Pregnant cows maintained their weight as well on a dry biuret supplement 

as on a liquid urea supplement or soybean meal supplement, when fed (or 

grazing on) low protein forage or roughages. 

(3) invalid 

Does not provide useful hazard information 

. Sub-acute 

. cattle 

. female 

. no data 

: oral feed 

: 107 to 113 days 

: daily 

. none 

other 

1971 

no 

other TS 

Comparison of feed grade biuret with other nitrogen supplements for 

maintenance of cattle grazing or being fed protein deficient forage. 

Average initial weight (kg) and average daily weight gain (kg) were 

reported . 

(9) (32) 

Basal Diet: Grass hay, straw and supplement 

Pregnant cows maintained their weight as well on a dry biuret supplement 

as on a liquid urea supplement or soybean meal supplement, when fed (or grazing on) low protein forage or roughages. 

Source Animal No. Days Wt (kg) Daily gain (kg) 

Biuret PG 42 107 493 .10 

Biuret Beef 40 113 488 .15 

SM Cows 44 107 474 .16 

SM Cows 42 113 483 .16 

where SM = soybean meal; PG = pregnant 

Reliability : (3) invalid 

27.06 .2007 

Does not provide useful hazard information 

Type : Sub-acute 

Species : cattle 

Sex : female 

(1) (9) 

39/64 
p. 40 

5. Toxicity 

Strain . no data 

Route of admin. : oral feed 

Exposure period . 

Frequency of treatm. . 

Post exposure period . 

Doses . 

Control group . 

Method : other 

Year : 1971 

GLP : no 

Test substance : other TS 

Method 

Result 

Id 108-19-0 

Date 03.07 .2007 

Comparison of feed grade biuret with other nitrogen supplements for 

maintenance of cattle grazing or being fed protein deficient forage . 

Average initial weight (kg) and average daily weight gain (kg) were 

reported. 

Basal Diet: Corn stalk pasture 

Source Animal No. Days Wt (kg) Daily gain (kg) 

None Beef 51 84 435 - .42 

Biuret Cows 64 84 452 .08 

Pregnant cows grazing corn stalks maintained their weight when 

supplemented with nitrogen from biuret, but lost considerable weight without a nitrogen supplement. 

Reliability : (4) not assignable 

27.06 .2007 

Original reference not reveiwed 

(9) (13) 

Type : Sub-chronic 

Species : cattle 

Sex . male 

Strain : no data 

Route of admin . : oral feed 

Exposure period : 91 days 

Frequency of treatm . : daily 

Post exposure period . 

Doses 

Control group . 

Method : other 

Year : 1969 

GLP : no 

Test substance : other TS 

Method Comparison of feed grade biuret with other nitrogen supplements for maintenance of cattle grazing or being fed protein deficient forage . Average initial weight (kg) and average daily weight gain (kg) were reported . 

Basal Diet: Grass pasture (winter) and pelleted supplement Result : Source Animal No. Days Wt (kg) Daily gain (kg) 

None Beef 8 91 218 .08 

50% Biuret Steers 8 91 218 .25 

75% Biuret Steers 8 91 218 .17 

50% Urea Steers 8 91 218 .17 

40/64 
p. 41 

5 . Toxicity 

Reliability 

27.06 .2007 

Type 

Species 

Sex 

Strain 

Route of admin. 

Exposure period 

Frequency of treatm. 

Post exposure period 

Doses 

Control group 

Method 

Year 

GLP 

Test substance 

Method 

Result 

Reliability 

Id 108-19-0 

Date 03 .07 .2007 

33% Urea Steers 8 91 218 .09 

CM Steers 8 91 218 .28 

where CM = cottonseed meal 

On winter range biuret was as effective as cottonseed meal and better than 

urea for wintering beef calves. 

(4) not assignable 

Original reference not reveiwed 

(9) (41) 

. Sub-acute 

. cattle 

. male 

: oral feed 

: 84 days 

: daily 

. none 

other 

1970 

no 

other TS 

Comparison of feed grade biuret with other nitrogen supplements for 

maintenance of cattle grazing or being fed protein deficient forage. 

Average initial weight (kg) and average daily weight gain (kg) were 

reported. 

Basal Diet: Grass pasture plus liquid supplement (winter) 

Source Animal No. Days Wt (kg) Daily gain (kg) 

None Beef 12 84 204 - .14 

Molasses Calves 12 84 202 - .05 

Biuret Calves 12 84 205 .07 

Biuret+salt Calves 12 84 213 .02 

Urea Calves 12 84 204 - .11 

On winter range biuret was better than urea for wintering beef calves. 

(3) invalid 

Does not provide useful hazard information 

27.06 .2007 (9) (34) 

Type 

Species 

Sex 

Strain 

Route of admin. 

Exposure period 

Frequency of treatm. 

Post exposure period 

Doses 

Control group 

Method 

Year 

: Sub-acute 

. cattle 

. male 

. no data 

: oral feed 

: 84 days 

: daily 

. none 

. other 

: 1964 

41/64 
p. 42 

5 . Toxicity 

GLP 

Test substance 

Method 

Result 

Reliability 

27 .06 .2007 

no 

other TS 

Id 108-19-0 

Date 03.07 .2007 

Comparison of feed grade biuret with other nitrogen supplements for 

maintenance of cattle grazing or being fed protein deficient forage . 

Average initial weight (kg) and average daily weight gain (kg) were 

reported . 

Basal Diet: Veld hay (4.2% protein) 

Source Animal No. Days Wt (kg) Daily gain (kg) 

None Beef 15 84 371 - .24 

Biuret Steers 15 84 381 .07 

Urea Steers 15 84 382 .06 

70%Biuret, Steers 15 84 380 .06 

30% Urea 

Cattle would maintain weight on low quality hay (4.2% protein) 

supplemented with biuret or urea, while control animals not receiving either 

biuret lost weight. 

(3) invalid 

Does not provide useful hazard information 

(9) (21) 

Type : Sub-acute 

Species : sheep 

Sex . female 

Strain . no data 

Route of admin. : oral feed 

Exposure period : 63 days 

Frequency of treatm. : daily 

Post exposure period . none 

Doses . 

Control group . 

Method : other 

Year : 1964 

GLP : no 

Test substance : other TS 

Method : Comparison of feed grade biuret with other nitrogen supplements for 

maintenance of mature ewes. Average initial weight (kg) and average 

daily weight gain (kg) were reported. 

Basal Diet: Veld hay (3.0% protein) 

Animal type and sex: Wintering ewes 

Result : Source No. Days Wt (kg) Daily gain (kg) 

None 10 63 34.6 -78 

Biuret 10 63 34.5 -13 

Reliability 

27.06 .2007 

21 g of biuret in a supplement would maintain ewes on veld hay contaiing 

less than 3% crude protein . The ewes cupplemented with biuret consumed 

about 12% more hay. 

(3) invalid 

Does not provide useful hazard information 

(9) (22) 

42/64 
p. 43 

5. Toxicity 

Type 

Species 

Sex 

Strain 

Route of admin. 

Exposure period 

Frequency of treatm. 

Post exposure period 

Doses 

Control group 

Method 

Year 

GLP 

Test substance 

Method 

Result 

Reliability 

27.06 .2007 

Sub-chronic 

sheep 

female 

no data 

oral feed 

93 days 

daily 

none 

other 

1969 

no 

other TS 

Id 108-19-0 

Date 03.07 .2007 

Comparison of feed grade biuret with other nitrogen supplements for 

maintenance of mature ewes. Average initial weight (kg), average daily 

weight gain (kg), and average weight of lamb weaned per ewe were 

reported . 

Basal Diet: Winter range plants plus supplements (1967) 

Animal type and sex: Pregnant range ewes 

No. of animals / group: 30 

Days on test: 93 

Source Wt (kg) Daily gain (kg) Avg . lamb wt (kg) 

SM 65.5 48 19.8 

12.5% B 65.0 34 15.8 

25% B 65.9 48 18.6 

50% B 65.5 38 18.2 

SM 66.4 39 14.9 

12.5% urea 66.4 39 16.0 

25% urea 65.0 44 16.2 

50% urea 64.5 44 16.1 

Where B = biuret; SM = soybean meal 

There were no significant differences in weight gains among the ewes nor 

in kilograms of lamb weaned per ewe among the supplement treatments . 

(3) invalid 

Does not provide useful hazard information 

(9) (47) 

Type : Sub-chronic 

Species : sheep 

Sex : female 

Strain : no data 

Route of admin. : oral feed 

Exposure period : 93 days 

Frequency of treatm. . daily 

Post exposure period . none 

Doses . 

Control group . 

Method : other 

Year : 1969 

GLP : no 

Test substance : other TS 

43/64 
p. 44 

5. Toxicity 

Method 

Id 108-19-0 

Date 03.07 .2007 

Comparison of feed grade biuret with other nitrogen supplements for 

maintenance of mature ewes . Average initial weight (kg), average daily 

weight gain (kg), and average weight of lamb weaned per ewe were 

reported . 

Basal Diet: Winter range plants plus supplements (1968) 

Animal type and sex: Pregnant range ewes 

No. of animals / group: 30 

Days on test : 93 

Result : Source Wt (kg) Daily gain (kg) Avg. lamb wt (kg) 

SM 64 .1 28 17.0 

12.5% B 63 .9 28 18.5 

25% B 63.5 30 16.3 

50% B 64 .8 28 17.9 

SM 63 .9 41 18.6 

12.5% urea 63 .9 32 18.2 

25% urea 64.5 31 18.1 

50% urea 64.5 28 17.0 

Reliability 

27.06 .2007 

Type : Sub-chronic 

Species : sheep 

Sex : female 

Strain . no data 

Route of admin . : oral feed 

Exposure period : 112 days 

Frequency of treatm. : daily 

Post exposure period : none 

Doses , 

Control group . 

Method : other 

Year . 1964 

GLP : no 

Test substance : other TS 

Method 

Result 

Where B = biuret; SM = soybean meal 

There were no significant differences in weight gains among the ewes nor 

in kilograms of lamb weaned per ewe among the supplement treatments . 

(3) invalid 

Does not provide useful hazard information 

(9) (47) 

Comparison of feed grade biuret with other nitrogen supplements for 

maintenance of mature ewes. Only the average daily weight gain (kg) was reported. 

Basal Diet: Veld grass hay (4.2% crude protein) 

Animal type and sex: Maiden ewes 

No. of animals/ group: 10 

Days on test : 112 

Source Avg. daily gain (kg) 

None -70 

Cornmeal + phosphate -41 

Biuret 10 

44/64 
p. 45 

5. Toxicity 

Reliability 

27.06 .2007 

Type : Sub-acute 

Species : sheep 

Sex : female 

Strain : no data 

Route of admin . : oral feed 

Exposure period : 42 days 

Frequency of treatm. : daily 

Post exposure period : none 

Doses . 

Control group . 

Method : other 

Year : 1964 

GLP : no 

Test substance : other TS 

Id 108-19-0 

Date 03.07 .2007 

(9) (21) 

Method : Comparison of feed grade biuret with other nitrogen supplements for 

maintenance of mature ewes. Only the average daily weight gain (kg) was 

reported . 

Basal Diet: Telf hay (7.9% crude protein) 

Animal type and sex: Maiden ewes 

No. of animals / group: 10 

Days on test: 42 

Result : Source Avg . daily gain (kg) 

None 17 

Cornmeal + phosphate 77 

Biuret 64 

Urea 40 

30% biuret; 70% urea 89 

40% biuret; 60% urea 65 

50% biuret; 50% urea 69 

60% biuret; 40% urea 90 

70% biuret; 30% urea 72 

Reliability 

27 .06 .2007 

Type 

Species 

Sex 

Strain 

Route of admin . 

Exposure period 

Urea 14 

30% biuret ; 70% urea 1 

40% biuret ; 60% urea 1 

50% biuret ; 50% urea 11 

60% biuret ; 40% urea -3 

70% biuret ; 30% urea 10 

(3) invalid 

Does not provide useful hazard information 

All supplements containing either biuret or urea produced substantial ewe 

growth (40 to 90 g per day). 

(3) invalid 

Does not provide useful hazard information 

Sub-acute 

cattle 

male 

no data 

oral feed 

70 days 

(9) (21) 

45/64 
5. Toxicity 

Frequency of treatm. : daily 

Post exposure period : none 

Doses . 

Control group . 

Method : other 

Year : 1964 

GLP : no 

Test substance : other TS 

Method 

Result 

Reliability 

27.06 .2007 

Type 

Species 

Sex 

Strain 

Route of admin. 

Exposure period 

Frequency of treatm. 

Post exposure period 

Doses 

Control group 

Method 

Year 

GLP 

Test substance 

Method 

Result 

Id 108-19-0 

Date 03.07 .2007 

Comparison of feed grade biuret with other nitrogen supplements for 

growth of cattle grazing or being fed low protein forage. Average initial 

weight (kg) and the average daily weight gain (kg) was reported . 

Basal Diet: Telf hay (7.9% crude protein) 

No. of animals / group: 15 

Days on test: 70 

Source Animal type Avg . initial wt (kg) Avg. daily gain (kg) 

None Beef 344 .43 

Biuret Steers 342 .56 

Urea Steers 343 .56 

70%B,30%U Steers 343 .54 

(3) invalid 

Does not provide useful hazard information 

Sub-acute 

cattle 

male 

no data 

oral feed 

84 days 

daily 

none 

other 

1969 

no 

other TS 

(9) (21) 

Comparison of feed grade biuret with other nitrogen supplements for 

growth of cattle grazing or being fed low protein forage. Average initial 

weight (kg), average daily weight gain (kg), and Feed/kg gain (air dry basis) 

were reported . 

Basal Diet: Bermuda grass hay (6.25% crude protein) and supplement 

No. of animals / group: 32 

Days on test: 84 

Source Animal type Avg. initial wt (kg) Avg. daily gain (kg) 

Feed/kg gain 

33% B mix Beef 203 .42 10 .2 

67% B mix Steers 202 .39 11 .6 

33% U mix Steers 202 .33 12 .9 

CM Steers 202 .37 10 .9 
p. 47 

5. Toxicity 

Reliability 

27 .06.2007 

Type 

Species 

Sex 

Strain 

Route of admin. 

Exposure period 

Frequency of treatm. 

Post exposure period 

Doses 

Control group 

Method 

Year 

GLP 

Test substance 

Method 

Result 

Reliability 

27.06 .2007 

Where B = biuret; U = urea; CM = cottonseed meal 

Id 108-19-0 

Date 03.07 .2007 

Cattle receiving biuret supplements gained faster than cattle receiving urea 

or cottonseed meal . 

(3) invalid 

Does not provide useful hazard information 

Sub-chronic 

cattle 

male 

no data 

oral feed 

120 days 

daily 

none 

other 

1971 

no 

other TS 

(9) (41) 

Comparison of feed grade biuret with other nitrogen supplements for 

growth of cattle grazing or being fed low protein forage. Average initial 

weight (kg) and average daily weight gain (kg) were reported . 

Basal Diet: Elephant grass, fresh chopped (6.7% crude protein) dry basis 

No. of animals / group: 8 

Days on test: 120 

Source Animal type Avg. initial wt (kg) Avg . daily gain (kg) 

ControlBeef 256 .24 

Biuret Bulls 256 .33 

Urea Bulls 256 .28 

Cattle receiving biuret supplements gained faster than cattle receiving no 

supplements or urea. 

(3) invalid 

Does not provide useful hazard information 

(4) (9) 

Type : Sub-acute 

Species : cattle 

Sex . male 

Strain . no data 

Route of admin. : oral feed 

Exposure period : 84 days 

Frequency of treatm. : daily 

Post exposure period . none 

Doses . 

Control group . 

Method : other 

Year : 1971 

GLP : no 

Test substance : other TS 
p. 48 

5 . Toxicity 

Method 

Result 

Id 108-19-0 

Date 03.07 .2007 

Comparison of feed grade biuret with other nitrogen supplements for 

growth of cattle grazing or being fed low protein forage. Average initial 

weight (kg) and average daily weight gain (kg) were reported . 

Basal Diet: Oat hay (4.5% crude protein) 

No. of animals / group: 8 

Days on test: 84 

Source Animal type Avg . initial wt (kg) Avg. daily gain (kg) 

None Beef 253 .14 

Biuret Steers 255 .31 

Urea Steers 259 .47 

Molasses plus urea Steers 251 .49 

Cottonseed meal Steers 25 .06 

Cattle supplemented with urea grew faster than control cattle, or those 

receiving supplements of biuret or cottonseed meal. Another group, 

receiving a urea-molasses liquid supplement had higher gains, but this was 

attributed to an increase in consumption of energy and nitrogen . The 

energy and nitrogen contents of all the diets were much below the 

requirement for efficient gains. 

Reliability : (3) invalid 

Does not provide useful hazard information 

27 .06.2007 

Type : Sub-acute 

Species : cattle 

Sex . male 

Strain , no data 

Route of admin. : oral feed 

Exposure period : 66 days 

Frequency of treatm . : daily 

Post exposure period : none 

Doses . 

Control group . 

Method : other 

Year : 1972 

GLP : no 

Test substance : other TS 

Method 

Result 

Reliability 

27 .06.2007 

(9) (14) 

Comparison of feed grade biuret with other nitrogen supplements for 

growth of cattle grazing or being fed low protein forage . Average initial 

weight (kg) and average daily weight gain (kg) were reported. 

Basal Diet: Sagebrush-bunch grass range - summer 

Days on test: 66 

Source Animal type No. Avg. initial wt (kg) Avg. daily 

gain (kg) 

None Beef 42 234 .44 

Biuret Steers 49 237 .53 

Cattle receiving biuret supplements gained faster than cattle receiving no 

supplements . 

(3) invalid 

Does not provide useful hazard information 

(9) (29) 

48/64 
p. 49 

5 . Toxicity 

Type : Sub-chronic 

Species : cattle 

Sex : female 

Strain : no data 

Route of admin. : oral feed 

Exposure period : 100 days 

Frequency of treatm . : daily 

Post exposure period : none 

Doses 

Control group . 

Method : other 

Year : 1968 

GLP : no 

Test substance : other TS 

Method 

Result 

Reliability 

27.06 .2007 

Type : Sub-chronic 

Species : cattle 

Sex . male 

Id 108-19-0 

Date 03.07 .2007 

Comparison of feed grade biuret with other nitrogen supplements for 

growth of cattle grazing or being fed low protein forage with added energy 

feeds . Average initial weight (kg) and average daily weight gain (kg) were 

reported . 

Basal Diet: Range forage (summer) 

No. of animals per group: 5 

Days on test : 100 

Source Animal type Avg. initial wt (kg) Avg. daily gain (kg) 

No additional supplement: 

None Beef 253 .35 

Biuret Heifers 253 .68 

Urea Heifers 253 .57 

Cottonseed meal Heifers 253 .58 

Plus barley supplement: 

None Beef 253 .58 

Biuret Heifers 253 .77 

Urea Heifers 253 .68 

Cottonseed meal Heifers 253 .77 

Cattle grazing crested wheatgrass grew faster with the nitrogen from biuret 

supplements than that from urea or cottonseed meal. In a second study, 

each animal received 300 g barley grain daily as a carrier for the NPN 

supplements . The authors postulated that feed grade biuret may stimulate 

a greater intake of forage than cottonseed meal while cattle fed urea often 

refuse to consume their entire supplement. Other groups of cattle on the 

same range pastures and nitrogen supplements were also supplemented 

with energy (barley grain) to provide for .9 kg daily gain. Barley feeding 

was increased as the range forage matured in order to compensate for its 

declining quality. The animal response to biuret was equivalent to that with 

cottonseed meal and better than with urea. The most economical gains 

were by cattle receiving biuret and the higher level of energy. 

(3) invalid 

Does not provide useful hazard information 

(9) (31) 

49/64 
p. 50 

5. Toxicity 

Strain . no data 

Route of admin. : oral feed 

Exposure period . 112-113 days 

Frequency of treatm . : daily 

Post exposure period : none 

Doses . 

Control group . 

Method : other 

Year . 1969 

GLP : no 

Test substance : other TS 

Id 108-19-0 

Date 03.07 .2007 

Method : Comparison of feed grade biuret with other nitrogen supplements for 

growth of cattle grazing or being fed low protein forage with added energy 

feeds. Average initial weight (kg) and average daily weight gain (kg) were 

reported . 

Basal Diet: Meadow hay plus barley 

Days on test: 112-113 

Result : Source Animal type No. Avg. initial wt (kg) Avg. daily 

gain (kg) Feed/kg gain 

Biuret Beef 12 212 .55 10 .7 

CM Steers 12 218 .58 10.3 

B & CM Steers 12 214 .61 9.8 

Reliability 

Biuret Beef 18 184 .48 10.8 

Urea Steers 18 194 .47 11 .7 

CM Steers 18 189 .55 10.2 

Biuret Beef 12 177 .43 13.4 

CM Steers 12 180 .45 12.9 

B & CM Steers 12 178 .48 12.2 

Where B = Biuret, CM = Cottonseed meal 

Growing cattle fed native meadow hay plus barley grain gained almost as 

well on a biuret supplement as on cottonseed meal, but a combination of 

biuret and cottonseed meal produced the most efficient gains. 

(3) invalid 

Does not provide useful hazard information 

27.06 .2007 (9) (42) 

Type : Sub-acute 

Species : cattle 

Sex : female 

Strain : no data 

Route of admin. : oral feed 

Exposure period : 81 days 

Frequency of treatm. : daily 

Post exposure period . none 

Doses . 

Control group . 

Method : other 

Year . 1972 

UP : no 

Test substance : other TS 

50/64 
p. 51 

5. Toxicity 

Method 

Result 

Id 108-19-0 

Date 03.07 .2007 

Comparison of feed grade biuret with other nitrogen supplements for 

growth of cattle grazing or being fed low protein forage with added energy 

feeds. Average initial weight (kg) and average daily weight gain (kg) were 

reported . 

Basal Diet: Grass hay and grain 

Days on test: 173 

No . of animals per group : 81 

Source Animal type Avg. initial wt (kg) Avg. daily gain (kg) 

Alfalfa hay Beef 199 .47 

Biuret Heifers 210 .35 

Alfalfa hay replacing one-half of the grass hay (12.8% crude protein) 

produced more rapid gains than grass hay plus a biuret supplement (11 .5% 

crude protein) . 

Reliability : (3) invalid 

Does not provide useful hazard information 

27.06 .2007 

Type 

Species 

Sex 

Strain 

Route of admin. 

Exposure period 

Frequency of treatm. 

Post exposure period 

Doses 

Control group 

Method 

Year 

GLP 

Test substance 

Method 

(9) (25) 

Sub-chronic 

cattle 

male 

no data 

oral feed 

112 days 

daily 

none 

other 

1968 

no 

other TS 

Comparison of feed grade biuret with other nitrogen supplements for 

growth of cattle grazing or being fed low protein forage with added energy 

feeds. Average daily weight gain (kg) was reported. 

Basal Diet: Wheat straw plus energy feed in supplement (about 7% crude 

protein) 

Days on test: 112 

No. of animals per group: 10 

Result : Source Animal type Avg. daily gain (kg) 

ControlBeef .17 

Biuret Steers .34 

Urea Steers .37 

Soybean meal Steers .46 

Cattle fed wheat straw plus corn grain supplemented with biuret or urea 

gave improved growth over non-nitrogen supplemented controls, but they 

did not gain as rapidly as cattle fed soybean meal supplements . Reliability : (3) invalid 

Does not provide useful hazard information 

27.06 .2007 (9) (39) 

51/64 
5. Toxicity 

Type 

Species 

Sex 

Strain 

Route of admin. 

Exposure period 

Frequency of treatm . 

Post exposure period 

Doses 

Control group 

Method 

Year 

GLP 

Test substance 

Method 

Result 

Test substance 

Conclusion 

Reliability 

Sub-acute 

rat 

male 

no data 

i .p . 

21 days 

daily 

7 days 

150 mg 

yes, concurrent no treatment 

other 

1956 

no 

other TS 

Id 108-19-0 

Date 03.07 .2007 

Eight 300- to 400-gm male rats were divided into a control and treatment 

group. All rats had been treated alike from weaning time. The four rats of 

each group were individually housed and continued to be fed a basal diet . 

Biuret of C.P . quality (150 mg) was dissolved in a minimum volume of 

physiological saline solution and administered by a single daily 

intraperitoneal injection for a period of 21 days to the treated group. After 

the 21-day injection period, both groups of animals were held for an 

additional 7 days prior to study termination. All animals were weighed at 

study initiation and termination, observed for signs of toxicity, and 

subjected to gross necropsy. 

Average daily body weight gains of 2.38 and 2.05 grams were reported for 

the control and Biuret-treated groups, respectively. The difference in 

weight gain was not statistically significant and was likely due to the daily 

use of the needle (the control group did not receive sham injections). All 

animals maintained normal appetites, appeared thrifty, and no mortality 

occurred . After termination of injections, the treated group made slightly 

higher gains that the control group during the next seven-day period. 

On gross examination of the body cavity and organs of the control and 

injected animals, the peritoneum of the injected animals showed slightly 

greater vascularity. 

99.1 % purity 

The authors concluded that evidently the Biuret was absorbed and 

eliminated without serious toxic effects . 

(3) invalid 

Route not relevant 

27.06 .2007 (3) 

5.5 GENETIC TOXICITY `IN VITRO` 

5.6 GENETIC TOXICITY `IN VIVO` 

5.7 CARCINOGENICITY 
5. Toxicity 

5.8 .1 TOXICITY TO FERTILITY 

5.8 .2 DEVELOPMENTAL TOXICITY/TERATOGENICITY 

5.8.3 TOXICITY TO REPRODUCTION, OTHER STUDIES 

Type 

In vitro/in vivo 

Species 

Sex 

Strain 

Route of admin. 

Exposure period 

Frequency of treatm. 

Duration of test 

Doses 

Control group 

Method 

Year 

GLP 

Test substance 

Method 

Result 

Reliability 

27.06 .2007 

Type : other 

In vitro/in vivo . In vivo 

Species . cattle 

Sex : female 

Strain : no data 

Route of admin. : oral feed 

Exposure period : during lactation 

Frequency of treatm. : daily 

Duration of test . 105-115 days 

other 

In vivo 

cattle 

female 

no data 

oral feed 

during lactation 

daily 

114 days 

other 

1969 

no 

other TS 

Id 108-19-0 

Date 03 .07 .2007 

Comparison of feed grade biuret with other nitrogen supplements for cows 

nursing calves and lactating dairy cows. Average initial weight (kg) and 

average daily weight gain (kg) were reported. 

Basal Diet: Meadow hay, barley plus fat (fed to cows) 

No. of animals per group: 26-28 

Days on test: 114 

Source Animal type Avg . initial wt (kg) Avg. daily gain (kg) 

Biuret Nursing61 .62 

Urea Beef 63 .60 

CM Calves 64 .65 

Where CM = cottonseed meal 

Beef calves grew as well when the lactating cows were fed meadow hay 

supplemented with biuret compared to calves nursing cows supplemented 

with cottonseed meal or urea . 

(4) not assignable 

Original reference not reveiwed 

(9) (30) 

53/64 
5. Toxicity 

Doses 

Control group 

Method 

Year 

GLP 

Test substance 

Method 

Result 

Reliability 

27.06 .2007 

Type 

In vitro/in vivo 

Species 

Sex 

Strain 

Route of admin. 

Exposure period 

Frequency of treatm. 

Duration of test 

Doses 

Control group 

Method 

Year 

GLP 

Test substance 

Method 

Id 108-19-0 

Date 03.07 .2007 

other 

1971 

no 

other TS 

Comparison of feed grade biuret with other nitrogen supplements for cows 

nursing calves and lactating dairy cows. Average initial weight (kg) and 

average daily weight gain (kg) were reported. 

Basal Diet: Mountain meadow pasture 

No . of animals per group: 46-52 

Days on test: 105-115 

Source Animal type Days Avg . initial wt (kg) Avg. daily 

gain (kg) 

None Nursing 105 -- .97 

Biuret Beef calves 105 -- .95 

None Lactating 115 424 .26 

Biuret Cows 115 414 .30 

There was no difference in weight gains of cows or nursing calves when 

supplemented with biuret while grazing mountain meadow pasture . The 

author speculated that perhaps nitrogen was not deficient in the diet . 

(4) not assignable 

Original reference not reveiwed 

. other 

. In vivo 

: cattle 

no data 

oral feed 

see results 

see results 

other 

1971 

no 

other TS 

(2) (9) 

Comparison of feed grade biuret with other nitrogen supplements for cows 

nursing calves and lactating dairy cows . Average daily weight gain (kg) 

was reported . 

Basal Diet: Native salt grass pasture 

Result : Source Animal type No . Days Avg. daily gain (kg) 

None Nursing 11 132 .71 

Biuret Beef calves 21 132 .72 

born before 

54/64 
p. 55 

5. Toxicity 

test 

25 .06.2007 

Type : other 

In vitro/in vivo . In vivo 

Species : cattle 

Sex : female 

Strain . no data 

Route of admin. . 

Exposure period . 

Frequency of treatm . . 

Duration of test . 

Doses . 

Control group . 

Method : other 

Year . 1956 

GLP : no 

Test substance : other TS 

(2) (9) 

Result : When cows were fed 20 g biuret and 20 g urea, there was no difference in 

milk production, milk composition or health of the cows when compared to 

control animals. 

27.06 .2007 (9)(19) 

Type : other 

In vitro/in vivo : In vivo 

Species : other: cattle, goat, sheep 

Sex : female 

Strain , no data 

Route of admin . . 

Exposure period . 

Frequency of treatm. . 

Duration of test . 

Doses . 

Control group . 

Method : other 

Year . 1959 

GLP : no 

Test substance : other TS 

Result 

None Nursing beef 14 132 .68 

Biuret calves born 14 132 .80 

after test 

Id 108-19-0 

Date 03.07 .2007 

None Weaned beef 35 54 .68 

Biuret calves 38 54 1 .03 

None Lactating 83 132 - .06 

Biuret Cows 79 132 .02 

Both nursing calves and lactating cows on salt grass pasture gained faster 

when fed a biuret supplement. 

Concentrate mixtures containing 2 to 3% urea and 25 to 40% molasses, 

replacing soybean meal in diets for milking cows, left milk yields 

unaffected. Biuret or crude biuret was given to daily cows, goats, and 

sheep without affecting their health, milk production, quality of milk, or 

55/64 
p. 56 

5. Toxicity 

blood composition . 

Id 108-19-0 

Date 03.07 .2007 

25.06 .2007 (9) (18) 

5.9 SPECIFIC INVESTIGATIONS 

5.10 EXPOSURE EXPERIENCE 

5.11 ADDITIONAL REMARKS 

56/64 
6 . Analyt. Meth . for Detection and Identification 

6.1 ANALYTICAL METHODS 

Id 108-19-0 

Date 03 .07 .2007 

6.2 DETECTION AND IDENTIFICATION 
7 . Eff. Against Target Org . and Intended Uses 

7.1 FUNCTION 

7.2 EFFECTS ON ORGANISMS TO BE CONTROLLED 

7.3 ORGANISMS TO BE PROTECTED 

7.4 USER 

Id 108-19-0 

Date 03 .07.2007 

7 .5 RESISTANCE 
8. Meas. Nec. to Prot. Man, Animals, Environment 

8.1 METHODS HANDLING AND STORING 

8.2 FIRE GUIDANCE 

8.3 EMERGENCY MEASURES 

8.4 POSSIB. OF RENDERING SUBST. HARMLESS 

8.5 WASTE MANAGEMENT 

8.6 SIDE-EFFECTS DETECTION 

8.7 SUBSTANCE REGISTERED AS DANGEROUS FOR GROUND WATER 

Id 108-19-0 

Date 03.07 .2007 

8.8 REACTIVITY TOWARDS CONTAINER MATERIAL 
9 . References 

(1) 

Id 108-19-0 

Date 03.07 .2007 

Anonymous (1971) Kedlor or soybean oil meal as a protein source for cows wintered on 

hay and straw. Annual Livestock Roundup 22:17 . Dickinson Exp. St. N. Dakota State Univ., 

Dlckinson (as cited in Fonnesbeck et al ., 1975) 

(2) Behrens, W.C. (1971) Protein-mineral supplements for ruminants grazing notive forage . 

Anim . Nutr. and Health July, p. 12 (as cited in Fonnesbeck et al ., 1975) 

(3) Berry, W.T ., Riggs, J .K ., and Kunkel, H .O. (1956) The lack of toxicity of biuret to animals . 

Journal of Animal Sciences 15:225. 

(4) Chicco, C .F ., T.A. Schultz, A.A. Carnerali, L. Oropeza and C.B. Ammerman (1971) Biuret 

and urea in supplements for bovines fed green chop elephant grass. J . Anim. Sci . 33:133 

(as cited in Fonnesbeck et al ., 1975) 

(5) Clark, R., Barrett, E.L ., and J.H . Kellerman (1965) A comparison between nitrogen 

retention from urea, buiret, triuret and cyanuric acid by sheep on a low protein roughage 

diet. J. S. African Vet. Med . Ass. 36: 79 

(6) Clark, R., E.L . Barrett and J .H . Kellerman (1963) A comparison between nitrogen retention 

from biuret and urea by sheep on a low protein roughage diet . J .S. African Vet. Med. Ass. 

34 :419 (as cited in Fonnesbeck et al ., 1975) 

(7) Epiwin, v3.20 

(8) Farlin et al ., (1968) Cited in Fonnesbeck et al ., 1975 

(9) Fonnesbeck, P.V., Kearl, L .C . and Harris, L .E. (1975) Feed Grade Biuret as a Protein 

Replacement for Ruminants . Journal of Animal Science, vol 40, no. 6, pp. 1150-1184. 

(10) Gadet, R. Soubies, L. and Fourcassie, F. (1959) Investigations on the toxic effects and 

evolution of biuret in soil . Ann Agron Paris 10:609-660 . 

(11) Handbook of Chemistry and Physics (1979) 60th ed . Weast, R.C. (ed .) Boca Raton, FL: CRC Press Inc ., p. C-214. (cited in BibIioLine(c) 1997-2006, NISC International, Inc . All 

Rights Reserved . www.nisc.com) 

(12) Hatfield, E.E., Garrigus, U .S., Forbes, R.M., Neumann, A.L . and Gaither, W. (1959) J. Animal Sci . 18: 1208. (as cited in Fonnesbeck et al ., 1975) 

(13) Heath, M.E. and M .P. Plumlee (1971) Using cornstalks for pasture . Purdue Agronomy Field Day Rep. Purdue Univ., Lafayette, Indiana (as cited in Fonnesbeck et al ., 1975) 

(14) Hull, J .L ., W.N. Garrett and J .G . Morris (1971) Wintering beef steers on low quality roughages with nitrogen supplements . Calif. Agr. 25(3):10 (as cited in Fonnesbeck et al ., 1975) 

(15) Iwata et al ., (1958; 1961) cited in Fonnesbeck et al ., 1975 

(16) Iwata, H. (1959) Effects of urea and its derivatives on milk production and quality. Inter. Dairy Cong. Proc. 15th Cong. London, 1 :54. 

(17) Iwata, H., K. Kobayashi, Y. Sato and Y. Watanabe. (1959) Effects of biret and heated urea 

on farm animals. Kyushu Univ. Fac. Ast. Sci . Bull . 17 :69 . 
p. 61 

9. References Id 108-19-0 

Date 03.07 .2007 

(18) Iwata, H ., K. Kobayashi, Y. Sato and Y. Watanabe. (1959) Effects of biret and heated urea 

on farm animals. Kyushu Univ. Fac. Ast. Sci. Bull. 17:69 . (as cited in Fonnesbeck et al ., 

1975) 

(19) Iwata, H ., Y. Sato and K. Arima (1956) The effect of biuret on domestic animals in relation 

to the utilization of urea. Chikusan No. Kenkyu. 10:31 (as cited in Fonnesbeck et al ., 1975) 

(20) Jensen, H .L . (1966) Transformation of biuret by microorganisms. Tidsskr . Planteavi . 

70 :160-170. 

(21) MacKenzie, H.I . and R.E. Altona (1964) Biuret as a supplement to roughage rations for 

sheep and cattle . J . S . African Vet. Med. Ass. 35:301 (as cited in Fonnesbeck et al ., 1975) 

(22) MacKenzie, H.I . and R.E . Altona (1964) Observations on a biuret-containing lick as a 

nitrogen supplement to low-quality roughage. J .S. African Vet. Med . Ass. 35:309 (as cited 

in Fonnesbeck et al ., 1975) 

(23) Mieske, J .C., W.J . Van Arsdell, R.W . Luecke and J .A. Hoefer (1955) The utilization of urea 

and biuret as sources of nitrogen for growing-fattening lambs . J. Anim. Sci . 14:941 (as cited 

in Fonnesbeck et al ., 1975) 

(24) Mithyantha, M.S., Kulkarni, D.S., Tripathi, S.C., and Agnihothrudu, V. (1977) Biuret and 

Crop Production . Fertilizer News, 23(3): 13-18. 

(25) Nichols, N .E., A.L. Lesperance and W.C. Behrens (1972) Performance of beef cows fed 

biuret or alfalfa . Proc. Western Sect. Amer. Soc. Anim. Sci . 23:582 (as cited in Fonnesbeck 

et al ., 1975) 

(26) Nishihara, H., Shoji, K., and Hori, M. (1965) Studies on the biuret hydrolyzing enzyme from 

Mycobacterium ranae. Biken Journal 8(1):23-34. 

(27) Nishihara, H ., Shoji, K., and Hori, M. (1965) Studies on the biuret hydrolyzing enzyme from Mycobacterium ranae. Binen's Journal 8(1):23 . 

(28) Orgata, T. (year not specified) The injurious effect of biuret on plant growth . Mem Ehime Univ. 8 :449-564. 

(29) Probert, C.L . and A.L . Lesperance (1972) A biuret supplement for steers on summer range . Proc . Western Sect . Amer. Soc. Anim . Sci . 23 :176 (as cited in Fonnesbeck et al ., 1975) 

(30) Raleigh, R.J . (1969) Biuret, urea, and cottonseed meal as nitrogen supplements for range livestock production. Proc. Mont. Nutr. COnf. Mont. State Univ. Bozeman. 20:39 (as cited in Fonnesbeck et al ., 1975) 

(31) Raleigh, R.J . and H .A. Turner (1968) Biuret and urea in cattle supplements . Proc. Western Sect. Amer. Soc. Anim. Sci. 19:301 (as cited in Fonnesbeck et al ., 1975) 

(32) Rush, I ., W.E . Sharp and R. Totusek (1972) Self fed dry and liquid supplements containing natural protein and non-protein nitrogen for wintering range cows . Okla. Agr. Exp. Sta. Range Sci. Res. 43 (as cited in Fonnesbeck et al ., 1975) 

(33) Swart, R.W. and W.M. Lynch (1972) The low toxicity of feed grade biuret to cattle and sheep. Practicing Nutr. 6:6 (as cited in Fonnesbeck et al ., 1975) 
p. 62 

9 . References Id 108-19-0 

Date 03.07 .2007 

(34) Templeton, J .A ., R.W . Swart and O .C . Bucek (1970) Use of biuret in liquid supplements for 

ruminants . Proc. Western Sect. Amer. Soc. Anim . Sci . 21 :183 (as cited in Fonnesbeck et 

al ., 1975) 

(35) The 1977-78 Aldrich Catalog/Handbook of Organic and Biochemicals . (1978) No. 18 . 

Aldrich Chemical Co., Milwaukee, WI . (cited in BibIioLine(c) 1997-2006, NISC International, 

Inc . All Rights Reserved. www.nisc .com) 

(36) The 2000-2001 Aldrich Handbook of Fine Chemicals and Laboratory Equipment (2000) 

Aldrich Chemical Co., Milwaukee, WI. (cited in BibIioLine(c) 1997-2006, NISC International, 

Inc . All Rights Reserved. www.nisc .com) 

(37) The Fertilizer Institute (2007) Personal Communication with William Herz, VP, Scientific 

Affairs, TFI, Washington, DC 

(38) The Merck Index (1976) 9th Edition . Windholz, M . (ed .) Merck and Company, Inc., Rahway, 

NJ ., pg 170. (cited in BibIioLine(c) 1997-2006, NISC International, Inc . All Rights Reserved . 

www.nisc.com) 

(39) Thomas, O.O., J.L . Van Horn and R.L . Blackwell (1968) Biuret and urea in supplements fed 

cattle grazed on native range. Feeders Day, Rep. PR-53 (as cited in Fonnesbeck et al ., 

1975) 

(40) Tiwari, A.D . (1972) Metabolism of biuret by rumiinants : In vitro and in vivo studies . Ph.D. 

Theses. Univ. of Illinois, Urbana-Champaign . (as cited in Fonnesbeck et al ., 1975) 

(41) Tollett, J.T., R.W. Swart, R.M. loset and J .A. Templeton (1969) Biuret as a nitrogen source 

for wintering steers. Proc. Western Sect. Amer. Soc. Anim . Sci . 20:325 (as cited in 

Fonnesbeck et al ., 1975) 

(42) Turner, H .A. and R .J . Raleigh (1969) Biuret and urea for growing cattle . Proc. Western 

Sect. Amer. Soc. Anim. Sci. 20:331 (as cited in Fonnesbeck et al ., 1975) 

(43) USEPA (1983) 21 C.F.R. § 184.1923 Urea. Title 21 - Food and Drugs 

(44) USEPA (2002) http ://www .epa.gov/fedrgstr 

(45) USEPA (2002) http://www.epa.gov/oppsrrd1/REDs/urea tred.htm ; 

http ://216 .239.51 .104/search?q=cache :p1264Z8FFIJ :www.fda.gov/cder/ogd/rld/12154s24.pdf+FDA+category+C+urea&hl=en&ct=cln 

k&cd=1 &gl=us 

(46) USEPA (2003) [Federal Register : May 22, 2003 (Volume 68, Number 99)] [Rules and 

Regulations] [Page 27904] 

From the Federal Register Online via GPO Access [wais.access.gpo.gov] 

[DOCID :fr22my03-5] 

(47) Van Horn, J.L., 0.0 . Thomas, J. Drummond and R.L . Blackwell (1969) Biuret and urea 

supplements for range ewes . Proc. Western Sect. Amer. Soc. Anim . Sci . 20:319 (as cited 

in Fonnesbeck et al ., 1975) 

(48) Waite, R., Castle, M.E., Watson, J.N. and Drysdale, A.D. (1968) Biuret and urea in 

concentrates for milking cows. J. Dairy Res. 35: 191 . 

62/64 
p. 63 

9 . References Id 108-19-0 

Date 03.07 .2007 

(49) YALKOWSKY, SH and DANNENFELSER, RM (1992), as cited in EPIWIN v.3 .20 Database 

63/64 
p. 64 

10 . Summary and Evaluation 

10.1 END POINT SUMMARY 

10.2 HAZARD SUMMARY 

10.3 RISK ASSESSMENT 

Id 108-19-0 

Date 03.07 .2007 

Memo . Pesticide Tolerance Reassessmet Risk Assessment 

Remark . From the available animal studies and other data, EPA has concluded that 

urea exhibits a low toxicity and exposures to urea used either as an active 

or inert pesticide ingredient present a reasonable certainty of no harm to 

human health . The Agency's analysis of extensive toxicological data in 

numerous species supports the 1995 decision to grant permanent 

exemptions from the requirement of a tolerance for residues of the frost 

protectant when used before harvest in the production of raw agricultural 

commodities . 

Source : http ://www .epa.gov/oppsrrdl/REDs/urea tred.htm 

03.07 .2007 

Memo : Estimating Risk From Contaminants Contained in Agricultural Fertilizers 

Remark : " . . .(M)ost fertilizers do not pose harm to human health or the environment. 

Risks of concern from fertilizer products can be attributed to arsenic, and 

dioxins found in select liming agents and micronutrients." 

Biuret is not found in liming agent sor micronutrients . 

Source : http ://www .epa.gov/epaoswer/hazwaste/recycle/fertiliz/risk/ 

03 .07 .2007