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(**.~** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 • 

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### S'1 

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### 2-/ OFFICEOF PR£VENTIOH, PESTICIOEI ANDTOXICIUIIITANCU 

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### c ':i VINOV 2 7 iljr)' ' '· 

### MEMORANDUM

SUBJECT:
FROM:

THRU:

TO: Rereg;stratlon Eligibility Document (RED) for Iron Salts Case #4058

### ',A~ Jane Smith, Chemist 

# !tu(,fYf

- Chemical Coordination

## ~hch Health Effects Division (H7509CI Esther Saito, Acting Branch Chief

# ~**~** Chemical Coordination Branch Health Effects Division (H7509CI and Penelope**Fenner-~J"h.D,** Direct()[ )•"' Health Effects

### Di~sMir" (H7509CI 

### utV' Jay Ellenberger, Chief Accelerated Reregistration Branch Special Review and Reregistration Branch (H7508WI

Attached pleasefindthe Human HealthAss;;,ssmentforthe IronSalts (to Includeferric sulfateandferroussulfatehepta-andmonohydrate)ReregistrationEligibilityDocument. This chapter includesthe Hazard Assessment from Beth Doyle and Pat Mclaughlinof ToxicologyIIandtheOccupationai/Resid,ntialExposureAssessmentfromJudySmith. Thereare noactive labels involvingpesticidal usesonfood ora11imal feed. Therefore, thereare notolerancesorexemptionsfromthe requirementscrtolerancesestablished for Ironsalts. Sincethere are notoxicologicalendpointsofconcernand nofood uses, no risk assessment was performed for dietaryexposure. Ferrous sulfate is generally recognized as safe as noted in 40CFR§180.2(a). The Food and Drug Administration has affirmed that ferric sulfate and ferrous sulfate (hepta· and monohydrate) are generally recognized as safe (GRAS) foruse infood asaflavoringagentand a nutrient

# O supplement, respectively, with no limitations otherthan current good manufacturi7 {) / 

# @ ns:;•I'R:eu•b 

# ........

# _ .......
......,..

# .........practice. Basad onthese factors, the human risksfrom both dietaryand occupational exposures areconsidered to be negligible. No additional hazard orexposuredata are required for reregistration eligibility.
cc: Marcia Van Gernert Beth Doyle Pat Mclaughlin Larry Dorsey AI Nielsen Judy Smith Attachments 

# 009885B. Hyman Health Assessment

## 00~)385 1 . Toxicology Assessment

TEST Oral LD50 rat The toxicological data base on ferric sulfate, ferrous sulfate heptahydrate, and ferrous sulfate monohydrate Is adequate and will support reregistration eligibility.
a. Acyte and Sybchronic Toxicity Ferric sulfate, in an acute oral toxicity study**~,** rats, had an LD50 of 

### 1487 mg/kg In females and of

### 2102 mg/kg in males. An acute dermal toxicity test In rabbits with ferric sulfJte found an LD50 greate;than 

### 2000 mg/kg. An acute inhalationtoxicitystudy in rats with ferric sulfate found an LC50 greater than 

### 1 .10 mg/L. Ferrous sulfate heptahydrate, in an acute oral study in rats, showed an LD1 • of 

### 1389 mg/kg; an acute oral study in rabbits showed an LD1 • of 

### 2778 mg/kg (4). The LD50 found for this compound in mice was 

### 1520 mg/kg 

### (4). A sensitization study in guinea pigs with ferrous sulfate monohydrate found no indication of contact sensitization by this compound. The table below summarized the toxicity values and categories:

Acute Toxicity Data--FERRIC SULFATE
RESULT CATEGORY 

### 1487- 2102 mg/kg 

### Ill Inhalation LC., rat 

### >1.1 mg/L Ill Dermal LD50 rabbit 

### >2000 mg/kg 

### Ill
b. Mytagenicity A mutation study in 

### .E...!t.2ll reported positive results at 

### 30 umoi/L (4). With due regard for the continuing exposure that hun1an beings have had to the Iron and sulfate components of these chemicals over many, many generations, it is considered unlikely that this reported result in microorganisms has any bearing on probable effects in humans or other mammals at the levels expected from use ofthese compounds as pesticides.



### 3c. Matabgllam 

# 009885
Iron and sulfate are normal constituents ofthe diet and are metabolized and utilized by the body.

d. Other Toxicolog .a! Considerations The toxicological data on Iron sulfates withtheagsncyand in the literature are adequate for assasslng risk to humans. Not all of the toxicity data usually required for pesticide registration are necessary for the present uses of iron sulfates. There are some unusual factors In this case which Indicate that specific studies to fulfill the usual data requirements are not necessaryto regulate these substances as pesticides. Iron sulfates are normally present in the environment. They may be present in foods naturally and as added Ingredients. There Is no reason to expect reasonable pesticide usage to constitute any hazard beyond that from ordinary exposure. 2. Exposyre Assessment
a. Qletary ·Dietary exposure to ferric sulfate, ferrous sulfate heptahydrate, and ferrous sulfate monohydrate is notexpectedto occur from pesticidal use. There are no active labels involving pesticidal uses on food or animal feed. Therefore, there are no tolerances or exemptions from the requirements of tolerances established for Iron salts. Since there are no toxicological endpoints ofconcern and no food uses, no risk assessment was performed for dietary exposure. Ferrous sulfate is generally recognized as safe as noted In 40 CFR§180.2(a). The Food and Drug Administration has affirmed that ferric sulfate and ferrous sulfate (hepta- and mom1hydratel are generally recognized as safe (GRAS) for use in food as a flavoring agent and a nutrient supplement, respectively, with no limitations other than current good manufacturing practice. b. Occypatjgnal and hesjdentjal Ferric sulfate and ferrous sulfate h3pta- and monohydrate areappliedtoturfand ornamental lawns using dropand broadcast


### 4

# 009885 spreaders, sprlroKier cans, and by hand. These lnorgan!csalts are formulated as agranularand solubleconcentrate (liquidand solid), They are used as a herbicideto control moss on residential lawns and ornamental turf. The potential for mixer/loader/applicator exposure exists; however, these Inorganic salts are of little concern from atoxicity perspective. Any mixer/loader/applicator exposure to these Inorganic salts Is considered Inconsequential and no additional exposure data are required for reregistration eligibility. 3. Risk Cbaracterizatjon The human risks from both dietary and occupational exposuresareconsideredtobe negligible. The general knowledge of ferric sulfate and ferrous sulfate hepta- ao1d monohydrate Indicate low toxicities associated with these compounds. They are used by humans as a food**flavorint~** agent and food nutrient supplement, and haveinherentfunctioninthe metabolic pathways of humans and domestic animals. No additional hazard or exposure data are required for reregistration eligibility.



### 5BIBLIOGRAPHY (1) MRID# 42171701 (2) MAID# 42171702 (3) MAID# 42171703 

### (4) Sax, N. 1., and Lewis, R. 

### J. SR, 

### 1989. Qangeroua Properties of !ndystrlal Materials, 7th Ed. Van Nostrand Reinhold, New York. (5) MAID# 41763701



### 6,

__ ,• UNITEDSTATES ENVIRONMENTALPROTECTION AGENCY WAaHINGTON, D.C. 10

.. 0 •


## AUG 2 7 1992 

# 009885

MEMQRANQUM: OP'P'IC. OP P.8TICIII.8 AIIID TOXIC 8U.aTAIIICU 

### Subject:

To:



### From:

Thru:

Thru:



### Chemical:
Caset:
Chemicalt: Company:

Defer 

### toa Review of potential Occupational and Reaidential Expoaure to Iron for the Reregiatration Phaae 4 Reviuw and the Reregistration Eligibility Document (RED). !ather Saito, Chief Science Adminiatration Section Science Analyaia ' coordination Branch (SACB) Health Effects Division**(~09C)** 

### Judy Smith, PhD, Chemist ')

## ~j)L 

# '/+r/?.z.. Reregiatration Section 

# iz/1 Occupational and**Resident~al** 

### Exposure Branch Health**~~f,cts** 

### Division (H7509C)**()1..~** 

### Alan Nialaen, Chief Reregistration Section II occupational and Residential Exposure Branch Health Effects Division (H7509C) Larry Dorsey, Acting Chief Occupational and Residential Exposure Branch Health Effects Division

## p~ 

# C/,**o-~-4** 

# i-")1,;,,_ Ferric sulfate

034902
000802 

### Chas. H. Lilly Company

Biological ADalyaia Br&Dcb/BBAD Accalarata4 Raraqiatratioa Braach/SRRD TB-Iaaactici4e/Rc4aatici4a Support lactioa TB-Rarbici4e/WU.qici4e/ADtiaiorobial 

# 1

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&ilt*:.!·y**·'·~fi'~.** 4t·;@;it&h;·,**:.,~. --~~-** **,tt~en'1·•rt-•ti,il~_,~. "'~~--** ..**~~~.~W~. ~~U.l;."** **-~.-414**

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# 009885 PHASE ' DATA REQUIREMENTS Guideline f: 1l2-1Cal 

### Deacription: Foliar Raaidut Qissipation Ia requirement applicable? (Y/N): _1_ 

### Diacussion: Irgn i• u1ed '' a

**be~igidg** to contrgl moat on turf and 

### ornamental 1ayn1. Tht 

### potential fgr exposure to 

### treated foliage oxiata. Howoyor. ;ron is of little cons;ern frgm a tgxigity par•p•gtiya. Thorofort. ORIB 

## do•• not roquir• a foliar r••idut di•aipatign wtcdv fgr roreq!ttration. 

### Guidoline t: 13&-lCbl 

### Doacription: Soil Residue Qissipation Is requirement applicable? (Y/N): _a_ 

### Discussion: trgn is ueed os a hefbicide to control 

### mo•• qn 

### tyrt and ornamantal lawnt. The potential for expoapro dut tg contact with the traotad soil 

### axi1t1. Howayer. 

### iron is 

### o;. little concern from a toxicity perspoctiya; Tb•r•fgra. OBEB doe• 

### not require a •gil 

### retidue ditsipotiqn study fgr rereqiatrotiqn. 

### Guideline f: 133-3 

### Description: Dermal Exposure Is requirement applicable? (Y/N): _H_ 

### Dtscussion: Irgn is used aa o berbfcide to cpntrpl 

### moss gn turt and ornamtntal lawns. Tha pgtontiol for postappligptipn dermal expgsure exists. Howayar. iron

# i'

of little concern from a toxicity perspectiye. Thareforo. OREB doe1 ngt require 1 dermol axposure 

### study for reregistration. Guideline f: 133-4 

### Description: Inhalation Exposure Is requirement applicable? (Y/N): 

### _u_ Discussion: Iron is used as a herbicide to control moss on turf and grnamental lawns. 1 The potential fgr inhalation expgsure may axist. However. irfn is of little 

### concern frgm ' tgxigity perspective; 

### Therefore. QREB dgas not requir• on inhalation axpg•urt 1tudy fgr 

### reregistration.

I
2 UN tnf-tton ta beald on

**t~e** LUIS report dltld

### J.,_ry 27, 199Z 

### c- 2119/92) fr

..Phyllta Jollnaon of HAD, 11111 the prooi.lct llbtl CEPA

.... Mo. 802•509), Toa tnfo,.tlon- retrl- fr

..the toa -·llnor dltod 6/9192 (.cute 111,.1/

.. t....., Ill 11111 .cute -1/cot....., Ill boald on 19 percent •.I.).

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# 009885 caset 

## •osa »aqe 3 

### of 3 ch

.. 

### ioalt 010507 

### Applicator Exposure Monitorinq (Subdivision U) Guideline 1231: 

### Estimation of Dermal Expcsure at outdoor Site• Estimation of Inhalation Exposure at Outdoor sites Estimation of Dermal Exposure at Indoor Sites Estimation of Inhalation at Indoor sites Guideline 12321 Guideline f233: 

### Guideline f234: 

### lron is applied to turf and ornamental lawns usinq drop and broadcast spreaders, sprinkler cans, and by hand. 1 

### The potential for mixer/loader/applicator exposure exists. However, iron is of little concern from a toxicity perspective. 2 

### Therefore, OREB does not require a mixerjloader;applicator exposure study for rereqistration.

Cpp•ptwa 

### Iron, formulated as a qranular and soluble concentrate (liquid and solid), is used as a herbicide to control moss on residential lawns and ornamental turf. 1 Homeowners apply iron usinq drop and broadcast spreader11, sprinkler cans, e.nd by hand. 1



### cc:

1 

### Linda Kutney/SACB Pat McLauqhlin/TOX II Circulation Correspondence Chemical File

UH lnf-tlan Ia biNd an the LUll report •ttd

### J.,...ry Z7, 1992 

### c- 2/19/92) f,_ Pllyllla 

### J......., of IUD, and theprocNct labela CEPA les. lloa. 7404·4, i'001·290, 3234•44, andl02•558). 2. TDillcolltc•l lnf-tlon retrl.,... fr,. tha tDil -·liner dlttd 7131192; IIC\Ite oral/.,..1/lnhelatiOII/

.. 

# t_., Ill biNd an 1191 a.l.UNiftDITATUINVIIIIOHIIIDTALPR011CTIOHAOINCY 

### WASHINGTON, D.C. 20480 • 

# 009885

Z661 8 I AON OffiCIOf PEITICIDEIANDTlliKIC IUIITAHCEI 

### MEMORANDUM subject: Toxicoloqy Review for the Rereqistration Document on Iron Sulfates Eliqibility

To:



### From: Thru: Esther Saito, Actinq Chief Chemical Coordination Branch Health Effects Division (H7509C) Patricia McLauqhlin, Ph.D. 

## 5' 

# /l

# ~**ltj;;~.J/17-** Toxicoloqy II Branch, HED (H7509C) Elizabeth Doyle, Ph.D., Head

# ~- 

# a•**~0** I {/

# ).;_3 section IV, Toxicoloqy II Branch, HED (H7509C!_. 

# Q ;· Marcia van Gernert, Ph.D., Chief 

# 1?7 fJ)

__,} Toxicoloqy II Branch, HED (H7509C)**t(~~** 

### Chemicals: Ferric sulfate, ferrous sulfate heptahydrate, ferrous sulfate monohydrate case/chemical number: 4058/34902, 50502, 50507 Products: Herbicides for lawns Considerations: The Food and oruq Administration has affirmed ferric sulfate as qenerally**recoqni~ed** 

### as safe (GRAS) for use as a food flavorinq aqent. Also, FDA has affirmed ferrous sulfate (heptahydrate and monohydrate) as GRAS for use in food as a nutrient supplement with no limitation other than current qood manufacturinq practice. The toxicoloqical data on iron sulfates with the aqency and in the literature are adequate for assessinq risk to humans. Not all of the toxicity data usually required for pesticide reqistration are necessary for the present uses of iron sulfates. There are some unusual factors in this case which indicate that specific studies to fulfill the usual data requirements are not necessary to requlate these substances as pesticides. Iron sulfates are normally present in the environm£..:-.t. They may be present in foods naturally and as added inqredients. There is no reason to expect reasonable pesticide usaqe to constitute any hazard beyond ordinary exposure.,•• 

### . 1. Toxicology Data Base 

## 0098[i5· The toxicological data base on ferric sulfate, ferrous sulfo.te heptahydrate, and ferrous sulfate monohydrate is adequate and will support reregistration eligibility.
a. Acute Toxicity

TEST 

### RESULT CATEGORY 

### LDSO rat 1487 3 

### Inhalation rat >1.1 

### 3



### an LDSO of 1487 mg/kg in females and of 2102 rnq/kg in males. An acute dermal toxicity test in rabbits with ferric sulfate found an LD50 greater than 2000 rnq/kg, An acute inhalation toxicity study in rats with ferric sulfate found an LC50 greater than 1.10 rnq/L. Ferrous sulfate heptahydrate, in an acute oral study in rats, showed an LDlo of 1389 rnq/kg; an acute oral study in rabbits showed
an LOla of 2778 mg/kg (4). The LDSO found for this compound in mice was 1520 rnq/kg (4)

. A sensitization study in guinea pigs with ferrous sulfate monohydrate found no indication of contact sensitization by this compound. b. Metabolism Iron and sulfate are normal constituents of the diet and are metabolized and utilized by the body.
c. Mutagenicity A mutation study in**~** 

### 2Q!i reported positive results at 30 umol/L (4). With due regard for the continuing exposure that human beings have had to the iron and sulfate components of these

# II•



### ··. 

# 009885**ch~aicals** 

### over many, many generations, it is considered**~nlikely** 

### that this reported result in microorganisms has any bearing on probable effects in humans or other mammals at the levels expected from use of these compount.:·• as pesticides. BIBLIOGRAPHY (1) 42171701 (2) 42171702 (3) 42171703 

### (4) Sax, N. I., and Lewis, R. J. 

### SR, 1989. Dangerous Properties of Industrial Materials, 7th Ed. Van Nostrand**~einhold,** 

### New York. (5) 41763701 

### ONE-LINERS