Unttrt Stttw OHio* of Pwidd* and Toxic Sub««ne«
EnvironiMnttl Protection Offlot of PMiold* Programs (T8-766C)
AgMiey Wuhlngton, DC 20460
vvEPA Pesticide
Fact Sheet
Name of Chemical:
Reason for Issuance:
Date Issued: I4arch 3' 1985
Fact Sheet Number: 47
1. Description of chemical
Generic Name: Substituted Dimethyl Hydantoin
Common name: 1,3-Bis(Hydroxymethyl)-5,5-dimethylhydantoin
Trade name: Glycoserve
EPA Shaughnessy code: 115501
Chemical abstracts service (CAS) number: 273AB
Year of initial registration: 1985
Pesticide type: Disinfectant
Chemical family (e.g., carbamates) Hydantoins
U.S. and Foreign producers: Glyco
2. use patterns and formulations
Application sites: End-use products as a preservative in
paints, room deodorizers, and dishwashing detergents as a
Manufacturing Use Pesticide for reformulating use as a
preservative in paints, room deodorizers and detergents.
Types of formulations: Liquids
Types of Methods of application: manual
Application rates: 0.2% to 1% in paints, 0.25 to 1% in
room deodorizer and detergents.
Usual carriers: water
3. Science Findings
Summary science statement: No mutagenic, or oncogenic
effects are anticipated at the use dilutions recommended
for the proposed uses.
Chemical Characteristics: physical state-liquid,
color-water white, odor-slight formaldehyde odor,
boiling point-101.2°C
Unusual handling characteristics: Protect eyes and
skin when handling.
Toxicology characteristics:
Toxicology Category and value for each acute hazard.
Testing Laboratory Warf institute
Acute oral LD5Qf Toxicity Category III
* LD50 = 2.00 to 3.65 g/kg (M)
3.00 to 5.00 g/kg (F) no signs of toxicity
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Testing Laboratory: IBT
3.72 mg/kg hypoactivity, lacrimation, weakness, labored
respiration.
b. Testing Laboratory: Warf Institute
*Acute inhalation toxicity category IV
LC 50 >204 mg/L/hr gasping
c. Testing Laboratory: Food and Drug Research Lab.
LC 50 >377.8 ug/L/4 hrs slight irritation of mucous
membranes envanol nose and eyes
d. Testing Laboratory: Bio/dynamics
*primary eye irritation Toxicity Category IV
Negative using 0.1 ml of 0.1% solution
e. Testing Laboratory: Warf Institute
*Acute Derrnal
LD 50 = >20 gm/kg
f. Testing Laboratory: Warf Institute
*Acute dermal irritation
PIS = 1.5
** Acute oral LD 50 — rat; LD 50 = 2.0 to 3.65 g/kg(male)
Warf Institute; #6051229 LD 50 = 3.0 to 5. g/kg(female)
9/30/76 (highest dose tested log/kg)
** Acute oral LD 50 — rat; LD 50 = 3.720 g/kg
IBT; *853009420; 9/22/76 (highest dose tested 15,380 g/kg)
Key * Test conducted using 1,3—hydroxymethyl)—5,5-dimethyl
hydrontoin 44% and hydroxymethyl—5,5 dimethyl hydantoin
** = Test conducted using the product as formulated glyco
Major routes of exposure in order of toxicological
significance.
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** Dermal patch test —
human; IBT; #8537—09670;
12/3/76
** Dermal absorption — rat;
EG & G Mason Research
Institute; Report MRI—
206—GC—83—35; 9/9/83
** Patch test— human; Food
and Drug Research Lab,;
#18;l0/11/8 1
** Acute oral LD 50 — rat;
Wart Institute; #6051229;
9/30/7 6
** Mutagenic; unscheduled
DNA synthesis; Lab not
stated; no. M0017;5/7/82
** Mutagenic— Ames; Litton
Bionetics; * 20838; 3/78
** Mutagenic— Ames; Micro-
biological Associates
T 1804.502; 9/3/82
** Mutagenic— Ames; Micro-
biological Associates;
T 1804.502; 9/3/82
** Mutagenic— chinese ham-
ster ovary in Vitro ;
Microbiological Assoc •;
#003—560—723—2; 2/23/82
** Mutagenic— induction in
mammalian cells— mice;
Microbiological Assoc.;
#003—561—724—7; 4/30/82
IBT — invalid Dynamac Corp. 2/25/83
Body burden <1%
< than 3% was absorbed and the main
portion was recovered in the urine.
(Note 0.1 ml = 3.15 mg)
Addendum
Maximum absorption in 10 hrs.
10.01528 ml = 0.4813 mg
1/2 hr. (minimal absorption)
0.02406 mg
10 repeated insult path test in
31 males and 171 temales with
0.21 ml of test material produced
negative results for sensitization
LD 50 = 2.00 to 3.65 g/kg (M)
3.00 to 5.00 g/kg (F)
(no signs of toxicity)
Positive induced a dose—related
increase in the number of grains
per nucleus
Negative with and without activa-
tion
Positive for TA 100 and TA 98
with and without metabolic activation
Negative for TA 1535, TA 1538
and TA 98
Positive; significant increase in
chromosomal aberrations with
and without S—9 activation
Positive with and without activa—
t ion
Key * Test conducted using l,3—hydroxymethyl)—5,5—dimethyl
hydrontoin 44% and hydroxymethyl—5,5 dimethyl hydantoin
** = Test conducted using the product as formulated glyco
3
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** Mutagenic— DNA synthesis Positive for induction of unsched—
—rat; Microbiological uled DNA synthesis
Assoc.; #M0017; 5/7/82;
Report * 25
Note: Contains up to 2% Free Formaldehyde
Chronic toxicology results, include size of data base;
conclusions in each major toxicology area:
Metabolism — rat; EG & E 97% recovered from treatment site
Mason Research Institute; 2% recovered in urine
@206—GC—35; 9/9/83 1% recovered in tissue and feces
(body burden less than 1%)
* Mutagenic Ames Negative with and without activation
salmonella; Litton
Bionetics; #20838; 3/78
* 90 Day oral — rat; NOEL > 400 mg/kg (HDT). Levels
Food and Drug Research tested by gavage in Sprague—
Lab.; #7059; 3/16/82 Dawley strain — 0,100, 200 and
400 mg/kg/day for weeks 1—8, than
0, 100, 300 and 600 mg/kg/day for
weeks 9—13.
* Mutagenic Ames Positive on tester strains TA100 and
salmonella mammalian TA98 with or without metabolic
microsome; Microbio— activation
logical Assoc; *T1804—
502; 9/3/81
* Mutagenic Ames Negative with without metabolic
salmonella mammalian activation
microsome; Microbio-
logical ASSOc; #003—
520—723—1; 2/23/82
* Mutagenic cytogenicity — Positive with or without metabolic
CR0 cell in vitro; activation. Produced chromosomal
Microbiological Assoc; aberrations
#T1721.337; 5/25/82
Key * Test conducted using 1,3—hydroxymethyl)—5,5—dimethyl
hydrontoin 44% and hydroxymethyl—5,5 dimethyl hydantoin
** = Test conducted using the product as formulated glyco
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Physiological and Biochemical Behavioral Characteristics:
Foliar absorption (if applicable). N/A
Translocation (if applicable) N/A
Mechanism of pesticidal action. Hydrolysis in water to
yield free formaldehyde (which is the disinfecting agent)
Metabolism and persistence in plants and animals. N/A
Environmental Characteristics: (for indoor use only)
Adsorption and leaching in basic soil types. N/A
Microbial breakdown. N/A
Loss from photodecomposition and/or volatization. N/A
Bioaccumulation N/A
Resultant average persistence. N/A
Ecological Characteristics:
As proposed, the product provides for minimal hazard to
non—target organisms and due to the low toxicity of the
product no F & W precautionary toxicity statements are
required.
Tolerance assessments: N/A. Registered use is not for use
on food or feed stuffs.
problems which are known to have occurred with the use of the
chemical (e.g., PIMS data). None
4. Summary of Regulatory Position and Rationale :
Use, formulation, manufacturing process or geographical
restrictions (including classification for restricted
use). No restrictions
Unique warning statements required on labels (e.g.,
protective clothing requirements, restrictions
regarding use around water, reentry intervals). None
Summary of risk/benefit review in cases where risk
assessments were conducted. Benefits exceed risks
for use of the product as a preservative in paints,
room deodorizers and soft detergents.
5. Summary of major data gaps
There are no data gaps for the approved uses.
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6. Contact person at EPA:
A. E. Castillo (PM 32)
Disinfectants Branch
Registration Division (TS—767C)
Environmental Protection Agency
401 M St., SW.
Washington, DC 20460
Phone: (703) 557—3964
DISCLAIMER: The information presented in this Chemical
Information Fact Sheet is for informational purposes only and
may not be used to fulfill the data requirements for pesticide
registration and reregistration.
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