7/23/2019 Bronopol

http://slidepdf.com/reader/full/bronopol 1/3

Bronopol is moderately toxic in acute oral toxicity studies with rats, with a lethal

dose (LD) 50 of 307 milligrams!ilogram (mg!g) for males and 3"# mg!g for

females ($oxicity %ategory &&) ($oxicity %ategory & has the highest toxicity and

%ategory &' the lowest) &n an acute inhalation study on the rat, ronopol was found

to e slightly toxic with an lethal concentration (L%) 50 of 5 mgliter (L) ($oxicity

%ategory &&&)

*esults from an acute dermal toxicity study (rat) suggest that ronopol is highly

toxic y the dermal route ($oxicity %ategory &), with an L% 50 of +" to +0 mg!g

-light to moderate erythema and slight to se.ere edema was noted, and the results

of this study determined that ronopol was a slight to se.ere irritant ($oxicity

%ategory &&) &n a study to determine dermal sensiti/ation potential (ai 112,

guinea pigs), ronopol was determined not to e a s!in sensiti/er &n addition,

ronopol has een shown to e a corrosi.e eye irritation ($oxicity %ategory &)

chronic feedingcarcinogenicity study with rats resulted in high mortality, stomach

lesions, and se.ere reduction in ody weight gain $he unpalataility of ronopolreduced the water inta!e and urine output in a dose4related manner in all treated

groups, which may ha.e aected the results of the study Based on the ao.e

6ndings, the systemic 89L and L89L for oth sexes are 0 mg!gday and "0

mg!gday, respecti.ely &n a chronic dermalcarcinogenicity study, male mice

exhiited moderate reduction in ody weight gain in the high dose group Bronopol

was not determined to e carcinogenic in either study $he 9: 8;ce of :esticide

:rogram<s *eference Dose (*fD):eer *e.iew %ommittee e.aluated the carcinogenic

potential of ronopol and found there to e e.idence of non4carcinogenicity for

humans ased on a lac! of e.idence of cancer eects in acceptale studies &n

addition, ronopol was not mutagenic in four mutagenicity studies=

De.elopmental toxicity studies were conducted using rats and raits $he results

showed marginal to no eects in the rat study and eects only at the high dose

le.el in the rait study &n the study on rats, no de.elopmental eects could e

attriuted to the administration of ronopol, and the highest dose of 10 mg!gday

is considered to e the 89L for oth maternal and de.elopmental toxicity &n the

study on raits, the maternal and de.elopmental 89L and L89L are "0

mg!gday and 10 mg!gday (the highest dose group), respecti.ely $he eects

oser.ed only in the 10 mg!gday group include decreased fetal ody weight in

oth sexes (02), and an increase in fetuses with ma>or external.isceral and

s!eletal anormalities (+2 4 #52)

VI. Determination of Safety for U.S. Population, Infants and

Children Back to Top 

Based on the information in this preamble and on the modeled exposure levels that are well-

 below any dose level where adverse effects are expected, EPA concludes that there is a

7/23/2019 Bronopol

http://slidepdf.com/reader/full/bronopol 2/3

reasonable certainty of no harm to any population subgroup from aggregate exposure to residues

of bronopol. Accordingly, EPA finds that exempting bronopol from the requirement of a

tolerance will be safe for the general population including infants and children.how citation box

'&& 8ther %onsiderations Bac! to $op 

A. Endocrine Disruptors

!"PA requires EPA to develop a screening program to determine whether certain substances,

including all pesticide chemicals #both inert and active ingredients$, %may have an effect in

humans that is similar to an effect produced by a naturally occurring estrogen, or such other

endocrine effect . . . .& EPA has been wor'ing with interested sta'eholders to develop a screening

and testing program as well as a priority setting scheme. As the Agency proceeds with

implementation of this program, further testing of products containing bronopol for endocrine

effects may be required.how citation box

'&&& %onclusions Bac! to $op 

(here is sufficient information on bronopol to conduct this assessment. Bronopol has been

shown to have significant dermal acute toxicity, and eye and gastrointestinal irritation, but it is

not a s'in sensiti)er. tudy results indicate that bronopol has moderate acute and chronic oral

toxicity, and slight acute inhalation toxicity. *t is not considered to be carcinogenic. !or

developmental effects, marginal to no effects were reported in the rat study and effects were

observed only at the high dose level in the rabbit study. +eproductive toxicity was observed only

in the high-dose group as evidenced by a slight decrease in the female fertility index during the !

mating.how citation box

Although, bronopol does have toxicity, the small amount that will be permitted for use in

 pesticide formulations #./ or less by weight$ is expected to result in no effects of concern for 

all endpoints, including residential exposures. (he results from a conservative dietary screening

model show that acute and chronic dietary exposure for all population subgroups are considered

to be not of concern. (he highest dietary exposure estimates from the conservative screening

model are well-below any dose level at which an adverse effect is expected. Bronopol is

expected to have a relatively short half-life upon release into the environment, therefore, its

contribution to drin'ing water is not expected.how citation box

0onsidering the information above, there is a reasonable certainty that no harm to any populationsubgroup will result from aggregate exposure to the pesticide chemical #bronopol$ residue,

including all anticipated dietary exposures and all other exposures for which there is reliable

information. Exemptions from the requirement of a tolerance are established for 1-bromo-1-

nitro-,2-propanediol3 #0A +eg. 4o. 51-5-63$ when used as an inert ingredient in-can

 preservative at ./ or less by weight of the total pesticide formulation when applied to

7/23/2019 Bronopol

http://slidepdf.com/reader/full/bronopol 3/3

growing crops or to raw agricultural commodities after harvest under   0!+ 7.8, and when

applied to animals under 0!+ 7.82