&EPA
United Stales
Environmental Protection
Agency
OHice of Pesticides and Toxic Substance*
Office of Pesliade Programs (TS-766C)
Washington. DC 20460
540/FS-88-089
Pesticide
Fact Sheet
, Name of Chemical: FORMALDEHYDE AND PARAFORMALDEHYDE
Reason for Issuance: REGISTRATION STANDARD
Date Issued: MAY 17,1988
Fact Sheet Number: 167
1. Description of Chemical
FORMALDEHYDE
Generic Name
Cannon Name
Formaldehyde
Formic aldehyde, Methanal,
Oxcmethane, Oxymethylene,
Methylene oxide, Formalin
Trade Name
Formaldehyde Solution
EPA/OPP Pesticide Chemical Code
043001
Chemical Abstracts Service (CAS) Number
50-00-0
Year of Initial Registration
1948
Pesticide Type
Disinfectant, Fungicide
Microbiocide
Chemical Family
Aldehydes
PARAFORMALDEHYDE
ParaformaIdehyde
Polyoxymethylene,
Mixed polyoxy-
methylene glycols
ParaformaIdehyde
043002
30525-89-4
1953
Disinfectant, Fungi-
cide, Microbiocide
Aldehydes
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Description of Ch nical (cont’d)
FO 4PILDEHYDE P RAFORMALDEHYDE
U. S • & Foreign Producers
Celanese Chènical Co., Inc.; celanese Chemical Co., Inc.,
Tenneco, Inc. E • I. dupont De The themical Supply Ccitpany
N rours & CO. Inc.; Georgia (Great Britain)
Pacific Corp., Monsanto Corp.
and The Chemical Supply Co.
(Great Britain)
2. Use Patterns and Formulations
Application Sites:
Formaldehyde
Food and non—fccd cr s; products for processing and industrial uses
(e.g., drilling muds, metal rking cutting fluids and packer fluids);
products for use on hard surfaces (e.g., livestock premises, household
premises and contents, hospital critical equi ztent, transportation
vehicles); fabrics and textiles (e.g., laundry, carpet); products for
control of microbial pests associated with hunan and animal wastes
(e.g., toilet bcwls, urinals, diaper pails); and preservative of her—
bicidal, algaecidal, bacteriostatic, disinfectant, sanitizer, fungi—
cidal and insecticidal formulations. There are 329 registered products
that contain formaldehyde (46 products in which formaldehyde has always
been considered as an active and 283 products in which formaldehyde
was previously considered as an inert but has been redesignated as an
active ingredient.)
Paraformaldehyde
Sugar maple tree tapholes; products for processing and industrial
uses (e.g., secondary oil recovery systems, mataiworking cutting
fluids, oil recovery drilling muds and packer fluids); products for
use on hard surfaces (e.g., kennels and pet animal quarters, livestock
premises and equi nt, household premises and contents, barber and
beauty shcp equipnent and instrunents); fabrics and textiles (e.g.,
laundry, mattresses, pillc s and draperies); food handling establish-
ment premise treath nt; and preservative of bacteriostatic, algaecidal
and fungicidal formulations. There are 119 registered products that
contain paraformaldehyde (44 products in which the paraformaldehyde
has always been considered as active and 75 products in which the
parafounaldehyde was previously considered as an inert but has nc
been redesignated as an active ingredient.)
NLnnber of Products
Formerly Designated
? tctive Ingredient Inert Ingredient
Formaldehyde 46 283
Paraformaldehyde 44 75
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Types of Formulations
Formaldehyde : gasea .is, pe lieted/tableted, soluble concentrate/i iquid;
37%, 44% and 45% formulation intermediate/manufacturing use products.
End use products range fran less than 0.1% to 93%.
Parafonnaldehyde : crystalline, wettable pc der/dust, pelleted/tableted.
There are not any registered manufacturing use products. End use products
range fran less than 0.1% to 100%.
Types and Methods of Applications
Formaldehyde
Spray (puop/electrical); dip; r p; brush; swab; sponge; autanatic metering;
proportioning pump; autcinatic pressure vaporizer; fumigation by (a) wet
sheet method (b) addition of product to permanganate of potash in a bucket
raised off of floor, and (C) fog application with electrical sprayer or
mechanical fogging equi inent.
Paraformaldehyde
Dip/immerse; proportioning p xnp; Jet mixer; manual insert; fumigation by
(a) hanging product in desired location, (b) generator, (C) application
fran electric hotplate, (d) plac nent of tablets in open dish and (e)
placement of opened bottle in cabinets.
Application Rates
Formaldehyde
Seed trea1 nent — Dosage rates = 1 pt 37%/30—40 gal. water; 37 lb/pt. - 40
gal. water.
Bacteric€tatic — Dosage rates = 100 ppn—21,800 ppn.
Mold/mildew control — Dosage rates = 337 pgni-27,400 ppn.
Algae, bacteria and fungi control — Dosage rates = 1 ppn-1580 pp .
Sanitizer — Dosage rates = .3 p xn — 2750 ppn.
Disinfectant — Dosage rates = 2 p xn — 370,000 ppn.
Parafonnaldehyde
Bacteria control — Dosage rates = 2 p n — 9010 ppn.
Mold/mildew control — Dosage rates = 4.9 p m — 301 ppn.
Sanitization — Dosage rates = 6.4 ppn.
Disinfectant — Dosage rates = 2.9 ppn — 6.7 pI]n.
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3. Science Findings
Formaldehyde has been found to be carcinogenic in animal studies and
there is limited evidence of carcinogenicity in humans. The ency
classified formaldehyde as a Bi oncogen. It is estimated that the
rker risk fran use of formaldehyde as an ingredient in an ricul—
tural pesticide formulation is less than i06. Areas of uncertainty
exist in dietary exposure and exposure fran other uses as an active
ingredient, many of which are non—agricultural.
Ch nical Characteristics:
Formaldehyde Paraformaldehyde
Physical State: Gas Crystalline, ttable
Lxwder/Dust, Pelleted/Tableted
CX or: Pungent Pungent
Boiling Point: —19.5°C(—3°F) NA(technical is solid at roan
tenp.)
Melting Point: NA(gas at 64°C
roan t tp.)
unusual Handling Corrosive to
Characteristics: netal
Toxicology Characteristics :
Most of the toxicological information on formaldehyde is fran published
sources. The toxicity of paraformaldehyde is believed to be identical to
that of formaldehyde because it is the solid polymer of formaldehyde.
The Piency does not have access to the raw data supporting these studies.
Therefore, none of the studies (published and/or unpublished) is adequate
for FIFRA regulatory purposes. However, based on these partially sat is—
factory studies, the following toxicological characteristics of formalde-
hyde and paraformaldehyde are expected.
Formaldehyde
Acute oral toxicity:
Toxicity Category 3; LD 0 = 800mg/kg (rat)
Acute dermal toxicity:
Toxicity Category 3; Lt 0 >2g/kg
Acute inhalation toxicity:
Toxicity Category 3;
Lowest lethal concentration = 250 p n (4hr. exposure)
Primary eye irritation: Toxicity Category 1
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Formaldehyde (continued )
Primary skin irritation: Toxicity Category 2
Major route of exposure : inhalation, dermal
Paraformaldehyde
Acute oral toxicity
Toxicity Category 3; 5O>1.6 g/kg (rat)
Acute dermal toxicity:
Toxicity Category 3; Lt 0 >2 g/kg
Acute inhalation toxicity:
Toxicity Category 1; LC 50 abcut 14 ppn
Primary eye irritation: Toxicity Category 1
Primary skin irritation: Toxicity Category 2
Major route of exposure : inhalation, dermal
Chronic feeding and oncogenicity
Formaldehyde has been found to be carcinogenic by inhalation in rats, and
there is evidence suggestive of carcinogenicity in mice. A recent drink—
irç water study with formaldehyde shc ied evidence of carcinogenicity in the
rat stanach. The ency is requiring oral oncogenicity testing. Chronic
toxicity testing (rodent and non—rodent) is also being required.
Developnerital Toxicity
Inhalation studies in animals and epid niological studies in workers have
not d i nstrated teratogenic effects. Teratogenicity studies in the rat
and rabbit are required.
Reproduction
In one study, prolonged diestrus, but no intpairrnent of reproductive
function was reported. A 2 generation rat study is required.
Mut enicity
Formaldehyde has caused genetic changes in Drosophila larvae, fungi,
bacteria and mammalian cells. It is believed that formaldehyde is a ak
muta en and that it operates by sane type of genetic interaction. Gene
inetaboli n, structural chrai sanal aberration arid other genotoxic effects
data are required.
General Metaboli n
Formaldehyde is a normal matabolite in mammalian systens. In dogs, cats,
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rabbits, guinea pigs and rats, the half life of formaldehyde is estimated
to be one minute. General n taboli n studies are not required.
Risk asses nent results
It is estiinated that the worker risks fran use of formaldehyde as an
ingredient in an agricultural pesticide formulation are <10—6. Further
estimates of the dietary risk and risk to workers fran agricultural and
non—agricultural uses will be conducted when the requested data are
received.
Physiological and Bioch nical Behavioral Characteristics :
Data are not available.
Envirorunental Characteristics :
There are no data available to assess the envirorit ntal fate of formalde-
hyde or paraformaldehyde. Data are not available to assess the ground
water contanination potential for pesticidal uses of formaldehyde or
parafornialdehyde. Also, formaldehyde was not included in the ency’ s
Data-Call—In Notice for potential ground water leathers. Degradation,
netaboli3n, nobility, dissipation and accumulation studies are required.
Indoor inhalation exposure reentry studies are required.
Ecological Characteristics:
Freshwater spec ies :
= 100 ppn — bluegill sunfish
= 118 ppn — rainba i trout
Freshwater invertebrates
5O = 14 ppn — Daphnia magna ( ter flea)
Marine and estuaririe organisi s
96 hr. LC 50 = 69.1 ppn — Trachinotus carolinus (Florida panpano)
96 hr. LC 50 = 69 p n — Menidia tnenidia (Atlantic silversides)
96 hr. LC ij = 18 ppn — Roccus saxatilis (Striped bass)
EC 50 = 1.8 ppn — Crassotrea virginica (Eastern oyster)
rAo = 143 ppn — Panaeus duorarum (Pink shrimp)
Terrestrial species :
Acute oral LL 0 = 790 ny/kg - mallard ducks
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Terrestrial species (continued )
LC 50 >5000 ppn — bo hite quail and mallard ducks
A potential hazard may exist to marine and estuarine species fran the use
of formaldehyde in secondary oil recovery systen and other industrial
effluents containing formaldehyde and use of paraformaldehyde in oil well
drilling muds. Monitoring of formaldehyde levels in waters receiving
residues fran the use of the pesticide in secondary oil recovery syst ns
and other industrial effluents (formaldehyde) and oil well drilling muds
(paraformaldehyde) is required.
Four use patterns may possibly pose a risk to aquatic endangered and
nonendangered species — use of formaldehyde on turf and the use of prod-
ucts containing formaldehyde and paraformaldehyde that are discharged as
industrial effluents into shallcM or enclosed bodies of water, use of
formaldehyde in secondary oil recovery systans and use of formaldehyde in
oil well drilling muds. However, risk to aquatic species cannot be
characterized at this time because the Agency lacks pertinent ch nical
and exposure data which are being required.
lerance Assesanents
No tolerances have been established for residues of formaldehyde or
paraformaldehyde in or on plant or animal ca nodities, with the exception
of a food additive tolerance of 2 p n for residues of formaldehyde in
maple syrup resulting fran use of paraforrnaldehyde in maple tree tapholes
(21 CFR 193.330.)
Formulations containing 1% or less of formaldehyde and 2% or less of
paraforinaldehyde are ex npt fran the requir nent of tolerances when used
as preservatives in pesticidal formulations applied to grc iing crops [ 40
CFR 180.1001(d)].
Formaldehyde is ex npt fran the requiranent of a tolerance for residues
in or on the grains of barley, corn, oats, sorgh .zn, and wheat and the
foraes of alfalfa, Bermuda grass, bluegrass, brane grass, clover, cc rJpea
hay, fescue, lespedeza, lupines, orchard grass, peanut hay, peavine hay,
rye grass, soybean hay sean grass, tiircthy and vetch resulting fran
postharvest application of formaldehyde or a mixture of methylene bispro—
pionate (M ) and oxy(bi nethy1ene)bisprcpionate (0BMP) when used as a
fungicide. These raw ricultural canrtodities are for use only as animal
feeds (40 CFR 180.1032).
ParafonTtaldehyde is ex npt fran the requirenent of a tolerance for resi-
dues in or on sugar beets (roots and tops) when applied to the soil not
later than planting (40 CFR 180.1024).
The food additive tolerance (21 CFR 193.330) and current ex ptions from
the requirenents of tolerances (40 CFR 180.1032, 180.1024 and 180.1001(d)
are not supported due to the inadequacy of available data. Plant
metaboli n data along with storage stability data are required. If
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residues of concern are fc ind in plants, then residue data on crcps are
required. If residues are found in feed caiu dities, then livestock
feeding studies must be submitted.
An acceptable daily intake (ADI) has not been established for formaldehyde.
S’ en the requested toxicological data are received, an ADI will be estab-
lished. Based on requested residue data, a tolerance reasses nent will be
performed.
4. Suim ary of Regulatory Position and Rationale
o Formaldehyde and paraformaldehyde are pesticidally active when used
in formulations as a preservative. Label ingredient statements
must be revised to include the name and percent e of either when
used as a preservative.
o Because the formaldehyde and paraformaldehyde exert their pesticidal
effect only in the formulation, and do not affect the efficacy of
the product itself, the label must include a statement to this
effect.
o Formaldehyde and paraformaldehyde are not being placed in Special
Review. Risks to rkers using formulations containing these
cheni cals as preservatives are less than 1 x 10—6, which does not
warrant Special Review. The Agency lacks data on other uses of
fo naldehyde and parafonnaldehyde to assess dietary and non—agricul-
tural risks.
o Protective equipnent (respirators) and other risk reduction measrres
are required for fumigation uses.
o Applications for new registration of products containing fonnalde—
hyde or paraformaldehyde must include exposure data to enable the
Agency to perform a risk assesanent.
o Endangered species labeling will not be required at this time.
Four use patterns-—turf use, products that are discharged into
shallow or enclosed bodies of water, secondary oil recovery systems,
and oil well drilling muds—-may pose a risk, but the Agency lacks
information needed to calculate the environmental concentrations
and risks.
o ile data gaps are being filled, products containing formaldehyde
and paraformaldehyde may continue to be sold and distributed,
provided that product labeling is revised as specified in the
Registration Standard.
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5. Sutinary of Major Data Gaps
St y 1).ie Date
Residue Ch nistry
Metab olisn 18 months
Residues (Analytical Method) 15 months
Stor e Stability 15 months
Envirorunental Fate
Hydrolysis 9 months
Photodegradation 9 months
MetabOlisn 27 months
Leaching & adsorption/desorption 12 months
Volatility 12 months
Dissipation 27 months
Wtational crc s (confined) 39 months
Ecological Effects
Avian Single Dose Oral LD gj (Paraformaldehyde only) 9 months
Avian Dietary LC 50 9 months
—upland game bird & water fail (Paraformaldehyde only)
5quatic Organi3n Testing 9—15 months
Special Test
Residue Monitoring 12 months
Toxicology
Acute st ies 9 months
Mut enicity tests 9-12 months
Dennal penetration 12 months
90 day feeding (rat & dog) 15—18 months
21 day dennal (rabbit) 15 months
90 day inhalation (rat) 15 months
Chronic toxicity (rat & dog) 50 months
Oral oricogenicity (rat & mouse) 50 months
Teratogenicity (rat & rabbit) 15 months
Reproduction (rat) 39 months
Re-entry
Inhalation exposure 27 months
6. Contact Person at EPA
John Lee, Product Manager 31
Registration Division (Ts-767C)
Disinfectants Branch
401 M St., S. W.
Washinton, D. C. 2046Q
Tel: (703) 557—3675
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