SCREENING-LEVEL HAZARD CHARACTERIZATION
OF HIGH PRODUCTION VOLUME CHEMICALS
CHEMICAL CATEGORY NAME
AMPS® Category
SPONSORED CHEMICALS
2-Acrylomido-2-methylpropanesulfonic acid (CAS No. 15214-89-8)
[9th CI Name: 1-Propanesulfonic acid, 2-methyl-2-[l-oxo-2-propenyl) amino]-]
2-Acrylomido-2-methylpropanesulfonic acid, sodium salt (CAS No. 5165-97-9)
[9th CI Name: 1-Propanesulfonic acid, 2-methyl-2-[l-oxo-2-propenyl) amino]-, monosodium salt]
SUPPORTING CHEMICAL
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt (CAS No. 58374-69-9)
[9th CI Name: 1-Propanesulfonic acid, 2-methyl-2-[(l-oxo-2-propenyl) amino]-, monoammonium salt]
June, 2008
INTERIM
Prepared by
High Production Volume Chemicals Branch
Risk Assessment Division
Office of Pollution Prevention and Toxics
Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460-0001
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SCREENING-LEVEL HAZARD CHARACTERIZATION
OF HIGH PRODUCTION VOLUME CHEMICALS
The High Production Volume (HPV) Challenge Program1 is a voluntary initiative aimed at developing and making
publicly available screening-level health and environmental effects information on chemicals manufactured in or
imported into the United States in quantities greater than one million pounds per year. In the Challenge Program,
producers and importers of HPV chemicals voluntarily sponsor chemicals; sponsorship entails the identification and
initial assessment of the adequacy of existing toxicity data/information, conducting new testing if adequate data do
not exist, and making both new and existing data and information available to the public. Each complete data
submission contains data on 18 internationally agreed to "SIDS" (Screening Information Data Set1'2) endpoints that
are screening-level indicators of potential hazards (toxicity) for humans or the environment.
The Environmental Protection Agency's Office of Pollution Prevention and Toxics (OPPT) is evaluating the data
submitted in the HPV Challenge Program on approximately 1400 sponsored chemicals. OPPT is using a hazard-
based screening process to prioritize review of the submissions. The hazard-based screening process consists of two
tiers described below briefly and in more detail on the Hazard Characterization website3.
Tier 1 is a computerized sorting process whereby key elements of a submitted data set are compared to established
criteria to "bin" chemicals/categories for OPPT review. This is an automated process performed on the data as
submitted by the sponsor. It does not include evaluation of the quality or completeness of the data.
In Tier 2, a screening-level hazard characterization is developed by EPA that consists of an objective evaluation of
the quality and completeness of the data set provided in the Challenge Program submissions. The evaluation is
performed according to established EPA guidance2'4 and is based primarily on hazard data provided by sponsors.
EPA may also include additional or updated hazard information of which EPA, sponsors or other parties have
become aware. The hazard characterization may also identify data gaps that will become the basis for a subsequent
data needs assessment where deemed necessary. Under the HPV Challenge Program, chemicals that have similar
chemical structures, properties and biological activities may be grouped together and their data shared across the
resulting category. This approach often significantly reduces the need for conducting tests for all endpoints for all
category members. As part of Tier 2, evaluation of chemical category rationale and composition and data
extrapolation(s) among category members is performed in accord with established EPA2 and OECD5 guidance.
The screening-level hazard characterizations that emerge from Tier 2 are important contributors to OPPT's existing
chemicals review process. These hazard characterizations are technical documents intended to support subsequent
decisions and actions by OPPT. Accordingly, the documents are not written with the goal of informing the general
public. However, they do provide a vehicle for public access to a concise assessment of the raw technical data on
HPV chemicals and provide information previously not readily available to the public. The public, including
sponsors, may offer comments on the hazard characterization documents.
The screening-level hazard characterizations, as the name indicates, do not evaluate the potential risks of a chemical
or a chemical category, but will serve as a starting point for such reviews. In 2007, EPA received data on uses of
and exposures to high-volume TSCA existing chemicals, submitted in accordance with the requirements of the
Inventory Update Reporting (IUR) rule. For the chemicals in the HPV Challenge Program, EPA will review the
IUR data to evaluate exposure potential. The resulting exposure information will then be combined with the
screening-level hazard characterizations to develop screening-level risk characterizations.4'6 The screening-level
risk characterizations will inform EPA on the need for further work on individual chemicals or categories. Efforts
are currently underway to consider how best to utilize these screening-level risk characterizations as part of a risk-
based decision-making process on HPV chemicals which applies the results of the successful U.S. High Production
Volume Challenge Program and the IUR to support judgments concerning the need, if any, for further action.
1	U.S. EPA. High Production Volume (HPV) Challenge Program; http://www.epa.gov/chemrtk/index.htm.
2	U.S. EPA. HPV Challenge Program - Information Sources; http://www.epa.gov/chemrtk/pubs/general/guidocs.htm.
3	U.S. EPA. HPV Chemicals Hazard Characterization website (http://www.epa.gov/hpvis/abouthc.html).
4	U.S. EPA. Risk Assessment Guidelines; http://cfpub.epa.gov/ncea/raf/rafguid.cfm.
5	OECD. Guidance on the Development and Use of Chemical Categories; http://www.oecd.org/dataoecd/60/47/1947509.pdf.
6	U.S. EPA. Risk Characterization Program; http://www.epa.gov/osa/spc/2riskchr.htm.
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SCREENING-LEVEL HAZARD CHARACTERIZATION
AMPS® Category
Introduction
The sponsor, The Lubrizol Corporation, submitted a Test Plan and Robust Summaries to EPA for the AMPS®
Category, which was dated August 14, 2000. EPA posted the submission on the ChemRTK website on September
5, 2000 (http://www.epa.gov/oppt/chemrtk/pubs/summaries/amps/cl2958tc.htm). EPA comments on the original
submissions were posted to the website on January 3, 2001. The sponsor submitted updated/revised documents on
February 14, 2001, which were posted to the ChemRTK website on November 13, 2002. The AMPS® category
consists of the following two chemicals:
2-Acrylamido-2-methylpropanesulfonic acid	CAS No. 15214-89-8
2-Acrylamido-2-methylpropanesulfonic acid, sodium salt CAS No. 5165-97-9
The sponsor also provided data on 2-acrylamido-2-methylpropanesulfonic acid, ammonium salt (CAS No. 58374-
69-9). The sponsor used data for this chemical as supporting data for the two chemicals in this category.
This screening-level hazard characterization is based primarily on the review of the Test Plan and Robust
Summaries of studies submitted by the sponsors) under the HPV Challenge Program. In preparing the hazard
characterization, EPA considered its own comments and public comments on the original submission as well as the
sponsor's responses to comments and revisions made to the submission. The structures of the sponsored chemical(s)
are included in Appendix. Summary tables of SIDS endpoint data are included in the document. The screening-
level hazard characterization for environmental and human health toxicity is based largely on SIDS endpoints and is
described according to established EPA or OECD effect level definitions and hazard assessment practices.
Category/Supporting Chemical Justification
The sponsored category chemicals, 2-acrylamido-2-methylpropanesulfonic acid and its sodium salt, are structurally
similar differing only in the counter ion associated with the sulfonate anion. EPA agreed grouping of these
chemicals as a category. The ammonium salt of 2-acrylamido-2-methylpropanesulfonic acid is included in the
category as a supporting chemical based on its similar structure.
Sum man-Conclusion
The lou k \ allies of ilie calcuors members mdicale llial llieir potential u» hioaccuniulale is e\peeled lo he low
I lie chemicals mi ilns caleuors are not readih biodegradable. uidicaliim llial llie> lia\e llie potential in persist mi the
eiin iroiinicut
The e\ alualiou of a\ ailahle lo\icil> dala lor fish. aquatic 11 in eilehrales and aquatic plains indicates llial I lie potential
aeuie hazard of llie calcuor\ members lo aquatic oruauisnis is low.
I	lie aeule oral and dermal lo\icil> lor ihe members of ilns ealeuors is km Repealed exposure lo WII'S u ealeuors
members \ la oral mule showed low io\icit> lo rals \o effects were seen on repi'odiieli\e oi'dc\clopnieulal
parameters mi a combined rcprodiicli\ e de\ elopmeiilal lo\icit> screenum test w itli 2-acr\ lamido-2-
II	lei 11> Ipropaiicsiilfomc acid, ammoiiiiim sail 2- \cr\ loniido-2-nielh\ Ipropaiiesiilfomc acid did noi indiiee uene
miilalioii mi haeleria or in mammaliaii cells. In an in viim assas. 2-acr\ loniido-2-nielh\ Ipropaiiesulfouic acid was
clasiimeiiic in llie presence of nielaholic acli\aliou I lowe\ er. in in viva lesis. 2-aer\ loniido-2-
melh\ Ipropaiiesulfouic acid and Us aiumoiiium sail did uoi induce chromosiimal aberrations
I lie potential health lia/ard of llie eheniicals in llie VMI'S u caleuors is low
\o dala uaps were ideuiilied under llie I ll'N ( halleuue I'rourani.
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1. Physical-Chemical Properties and Environmental Fate
A summary of physical-chemical properties and environmental fate data submitted is provided in Table 1. For the
purpose of the screening-level hazard characterization, the review and summary of these data was limited to the
octanol-water partition coefficient and biodegradation endpoints as indictors of bioaccumulation and persistence,
respectively.
Octanol-Water Partition Coefficient
2-Acrylamido-2-methylpropanesulfonic acid (CAS No. 15214-89-8)
LogKow:	-2.19 (estimated)
2-Acrylamido-2-methylpropanesulfonic acid, sodium salt (CAS No. 5165-97-9)
Log Kow:	1.84 (estimated)
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt (CAS No. 58374-69-9, Supporting Chemical)
LogKow:	-3.41 (measured)
Biodegradation
2-Acrylamido-2-methylpropanesulfonic acid (CAS No. 15214-89-8)
In a Semi-Continuous Activated Sludge test (for inherent biodegradation), using secondary activated sludge from a
domestic wastewater treatment plant, less than 10 % of the test substance had degraded after 44 days.
2-Acrylamido-2-methylpropanesulfonic acid is not readily biodegradable.
2-Acrylamido-2-methylpropanesulfonic acid, sodium salt (CAS No. 5165-97-9)
In a Semi-Continuous Activated Sludge test (for inherent biodegradation) using secondary activated sludge from a
domestic wastewater treatment plant, less than 10 % of the test substance had degraded after 44 days.
2-Acrylamido-2-methylpropanesulfonic acid, sodium salt is not readily biodegradable.
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt (CAS No. 58374-69-9) (Supporting Chemical)
In a modified Sturm test using activated sludge from a domestic wastewater treatment plant, 3.3 % of the test
substance had degraded after 28 days.
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt is not readily biodegradable.
Conclusion: The log Kow values of the category members indicate that their potential to bioaccumulate is expected
to be low. The chemicals in this category are not readily biodegradable, indicating that they have the potential to
persist in the environment.
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Table 1. Siimman of Physical-Chemical Properties and l.n\iron menial l-'alc Data
l.ndpoinls
2-.\cnlamido-2-
melln Ipi'opanesiillonic
acid
(15214-X'J-X)
2-.\cr\lamido-2-
mclln Ipi'opanesiillonic
acid, sodium sail
(5l(>5-,)"7-,)|
2-.\cn lamido-2-
mclln Ipropancsiillonic
acid, ammonium sail
(Supporling chemical)
Mclling Poinl (°C)
l<><> "S (C)
2<>u '5 (c)
l«)l (111)
Decomposes abo\c 22X
Boiling Point (°C)
Not applicable1
Not applicable1
\ol applicahle
Vapor Pressure
(hPa at 25°C)
8.99 x 10-9
2.29 x 10-13
~ 4 \ In 111J;i
Log K„w
-2.19(e)
-1.84(e)
-3.41 al 22 °< (ill)
Water Solubility
(mg/L at 25°C)
106 (e)
1500 g/L (e)
"'(il g/l. (111)
Direct Photodegradation



Indirect (OH)
Photodegradation Half-life
(ti/2)
0.655 days (e)
—

Stability in Water1
(Hydrolysis)
(ti/2)
6 % in 7 days at 50 °C
5 days at 80 °C
Negligible at 50 °C
5 days at 80 °C

Fugacity
(Level III Model)
Air (%)
Water (%)
Soil (%)
Sediment (%)
The sponsor only provided
Level I model data


Biodegradation at 28 days
(%)
< 10 % (m)
< 10 % (m)
3.3 V-ii (111)
(m) = measured data (i.e., derived from testing); (e) = estimated data (i.e., derived from modeling); — indicates
that endpoint was not addressed for this chemical; 1 The submitter indicates in its test plan that "the AMPS®
monomer decomposes at, or slightly above, it's melting point temperature. As a result, boiling point determinations
are not applicable."
2. Environmental Effects - Aquatic Toxicity
A summary of aquatic toxicity data submitted for SIDS endpoints is provided in Table 2 of the test plan. The table
also indicates where data for tested category members are read-across (RA) to untested members of the category.
Acute Toxicity to Fish
2-Acrylamido-2-methylpropanesulfonic acid (CAS No. 15214-89-8)
Bluegills (Lepomis niacrochirus: 10/concentration) were exposed to 2-acrylamido-2-methylpropanesulfonic acid at
nominal concentrations of 130, 220, 360, 600 and 1000 mg/L under static conditions for 96 hours. Sub-lethal effects
including loss of equilibrium and rapid respiration were seen at 0 hours at 600 and 1000 mg/L.
96-h LCS0 = 170 mg/L
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2-Acrylamido-2-methylpropanesulfonic acid, sodium salt (CAS No. 5165-97-9)
Bluegills (Lepomis macrochiriis: 10/concentration) were exposed to 2-acrylamido-2-methylpropanesulfonic acid,
sodium salt at nominal concentrations of 130, 220, 360, 600 and 1000 mg/L under static conditions for 96 hours. No
mortality or sub-lethal effects were seen at the highest test concentration.
96-h LCS0 > 1000 mg/L
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt (CAS No. 58374-69-9) (Supporting Chemical)
Fathead minnows (Pimephales promelas) were exposed to 2-acrylamido-2-methylpropanesulfonic acid, ammonium
salt at concentrations of 200, 360, 640, 1120 and 2000 mg/L. Sub-lethal effects including loss of equilibrium were
seen at 96 hours atl 120 mg/L test concentration and after 3 hours at2000 mg/L test concentration.
96-h LCS0 = 1400 mg/L
Acute Toxicity to Aquatic Invertebrates
2-Acrylamido-2-methylpropanesulfonic acid (CAS No. 15214-89-8)
Cladoceran (Daphnia magna, 15/test group, 5/replicate)) were exposed to 2-acrylamido-2-methylpropanesulfonic
acid at nominal concentrations of 0, 78, 130, 220, 360, 600 and 1000 mg/L under static conditions for 48 hours.
48-h ECS0 = 340 mg/L
2-Acrylamido-2-methylpropanesulfonic acid, sodium salt (CAS No. 5165-97-9)
Cladoceran (Daphnia magna) (15/test group,5/replicate)) were exposed to 2-acrylamido-2-methylpropanesulfonic
acid, sodium salt at concentrations of 0, 130, 220, 360, 600 and 1000 mg/L under static conditions for 48 hours. No
mortality or sub-lethal effects were seen at the highest test concentration of 1000 mg/L.
48-h ECS0 > 1000 mg/L
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt (CAS No. 58374-69-9, Supporting Chemical)
Cladoceran {Daphnia magna) (10 per test group) were exposed to 2-acrylamido-2-methylpropanesulfonic acid,
ammonium salt at measured concentrations of 0, 36, 64, 112, 200, 360, 640, 1120, 2000 and 3600 mg/L under static
conditions for 48 hours.
48-h ECS0 = 1200 mg/L
Toxicity to Aquatic Plants
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt (CAS No. 58374-69-9, Supporting (.'Freshwater
algae (Pseudokirchneriella subcapitata) were exposed to 2-acrylamido-2-methylpropanesulfonic acid, ammonium
salt at a measured concentration of 2000 mg/L under static conditions for 96 hours.
ECso > 2000 mg/L
Conclusion: The evaluation of available toxicity data for fish, aquatic invertebrates and aquatic plants indicates that
the potential acute hazard of the category members to aquatic organisms is low.
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Table 2. Siimman of l'.n\ ironmcnlal lllTccls - \(|iialic To\ici(\ Dala
Endpoints
2-acrylamido-2-
methylpropanesulfonic
acid
(15214-89-8)
2-acrylamido-2-
methylpropanesulfonic acid,
sodium salt
(5165-97-9)
2-acn lamido-2-
mclh\ Ipi'opanesiillonic acid,
ammonium sail
(5S3"74-(>9-'))
(Supporting chemical)
I4UO
i:m
2 1000
Invertebrate
48-h ECS0 (mg/L)
340
> 1000
Alga
96-h ECS0 (mg/L)
No data
>2000
(RA)
No data
>2000
(RA)
(m) = measured data (i.e., derived from testing); (e) = estimated data (i.e., den\ ed limn modeling). (k \ i Read
Across
3. Human Health Effects
A summary of health effects data submitted for SIDS endpoints is provided in Table 3. The table also indicates
where data for tested category members are read-across (RA) to untested members of the category.
Acute Oral Toxicity
2-Acrylamido-2-methylpropanesulfonic acid (CAS No. 15214-89-8)
Sherman-Wistar rats (5 males/dose) were administered 2-acrylamido-2-methylpropanesulfonic acid via gavage at
500, 1000, 2000, 4000 and 8000 mg/kg-bw and observed for 14 days. Mortality occurred at 1000 mg/kg-bw and
above (100% at 8000 mg/kg-bw). .
LDS0 = 1830 mg/kg-bw
2-Acrylamido-2-methylpropanesulfonic acid, sodium salt (CAS No. 5165-97-9)
Sprague-Dawley rats (5 males/dose) were administered 2-acrylamido-2-methylpropanesulfonic acid, sodium salt via
gavage at 1000, 2000-, 4000, 8000 and 16000 mg/kg-bw and observed for 14 days. No mortality was seen. Gross
examination revealed no pathological findings.
LD50 > 16000 mg/kg-bw
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt (CAS No. 58374-69-9, Supporting Chemical)
Sprague-Dawley rats (5/sex) were administered 2-acrylamido-2-methylpropanesulfonic acid, ammonium salt via
gavage at 5000 mg/kg-bw. No mortality was seen. There were no test substance-related gross necropsy findings for
other animals,
LD50 > 5000 mg/kg-bw
Acute Dermal Toxicity
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt (CAS No. 58374-69-9, Supporting Chemical)
New Zealand albino rabbits (5/sex) were administered 2-acrylamido-2-methylpropanesulfonic acid, ammonium salt
dermally at 2000 mg/kg-bw under semi-occluded conditions for 24 hours and were observed for 14 days. Very
slight-to-slight erythema was seen in all animals. Edema and desquamation was observed in three rabbits. All
dermal irritation completely subsided by day 11 or earlier.
LD50 > 2000 mg/kg-bw
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Repeated-Dose Toxicity
2-Acrylamido-2-met1iylpropanesulfonic acid, ammonium salt (CAS No. 58374-69-9, Supporting Chemical)
Sprague-Dawley rats (10/sex/dose) were administered 2-acrylamido-2-methylpropanesulfonic acid, ammonium salt
via gavage at 0, 50, 150, 400, or 1000 mg/kg-bw/day 7 days/week for 28 days. All animals survived throughout the
study. . Mean body weights and body weight gains were slightly lower in males at 1000 g/kg-bw/day. There were
no effects on hematology values, clinical chemistry indices, urinalysis parameters, organ weights. No macroscopic
and microscopic changes were seen.
NOAEL = 1000 mg/kg-bw/day (based on no effects at the highest dose tested)
Reproductive /Developmental Toxicity
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt (CAS No. 58374-69-9) (Supporting chemical)
In a combined reproductive/developmental toxicity screening test, Sprague-Dawley rats (12/sex/dose) were
administered 2-acrylamido-2-methylpropanesulfonic acid, ammonium salt via gavage at 0, 100, 500, or 1000 mg/kg-
bw/day. The F0 males were dosed for approximately seven weeks, including the two weeks prior to mating, during
mating and through post-mating periods. The F0 females were dosed throughout the study, including the two weeks
prior to mating, during mating, during gestation, and following parturition. There were no effects on F0 survival or
clinical signs of toxicity. There were no differences in copulation or fertility indices among the groups. No
statistically significant differences were observed in group mean precoital intervals or gestation lengths. Gross
necropsy findings were generally unremarkable. When anomalies were observed, they were of low incidence,
randomly distributed among the groups, and were not considered to be treatment related. There were no statistically
significant or toxicologically meaningful differences in absolute or relative testes and epididymides weights between
the control and treatment groups. Histopathological examination of the testes, ovaries and epididymides from
control and high-dose rats did not reveal any test sub stance-related microscopic changes. There were no statistically
significant or toxicologically meaningful differences between control and treatment groups with respect to corpora
lutea counts, implantation scar counts, mean number of live pups, or pre- or post-implantation loss. There were no
toxicologically meaningful differences with respect to F1 pup viability, number of litter in each group with live
offspring, mean live litter size or pup sex ratios. F1 pup observations during lactation were generally unremarkable.
There were no statistically significant or toxicologically meaningful differences in F1 pup body weights during
lactation. Among the F1 pups found dead or euthanized as scheduled on lactation day 4, gross necropsy did not
reveal any findings which indicate relationship to treatment with the test material. There were no indications of
treatment-related developmental effects.
NOAEL (systemic toxicity F0) = 1000 mg/kg-bw/day (based on no effects at the highest dose tested)
NOAEL (systemic toxicity Fl) = 1000 mg/kg-bw/day (based on no effects at the highest dose tested)
NOAEL (reproductive toxicity) = 1000 mg/kg-bw/day (based on no effects at the highest dose tested)
NOAEL (developmental toxicity) = 1000 mg/kg-bw/day (based on no effects at the highest dose tested)
Genetic Toxicity - Gene Mutation
In vitro
(1)	2-Acrylamido-2-methylpropanesulfonic acid (CAS No. 15214-89-8)
Salmonella typhimurium strains TA98, TA100, TA135, TA 1537 and TA 1538 were exposed to 2-acrylamido-2-
methylpropanesulfonic acid at 0, 30, 100, 300, 1000 and 3000 |ig/plate in the presence and absence of metabolic
activation. Cytotoxicity was seen at 3000 |ig/platc)No mutagenic response was seen for strains TA98, TA 100, TA
1535 or TA 1537 either in the presence of absence of metabolic activation (Results for TA 1538 are not included in
the robust summary). Positive controls responded appropriately.
2-Acrylamido-2-methylpropanesulfonic acid was not mutagenic in this assay.
(2)	2-Acrylamido-2-methylpropanesulfonic acid (CAS No. 15214-89-8)
Salmonella typhimurium strains TA98, TA100, TA135, TA 1537, TA 1538 and it. coli WP2 were exposed to 2-
acrylamido-2-methylpropanesulfonic acid at 0, 15, 50, 150, 500, 1500 and 5000 |ig/plate in the presence and
absence of metabolic activation. The test substance was slightly toxic to all Salmonella strains at 5000 ng/plate with
and without metabolic activation. For all bacterial strains tested there was no significant increase in the number of
revertants at any dose of test material compared to the corresponding negative solvent control. The entire assay was
8

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repeated and the results seen in the first experiment were confirmed. The positive and controls responded
appropriately. 2-Acrylamido-2-methylpropanesulfonic acid was not mutagenic in this assay.
(3)	2-Acrylamido-2-methylpropanesulfonic acid (CAS No. 15214-89-8)
Chinese hamster ovary cells were exposed to 2-acrylamido-2-methylpropanesulfonic acid at concentrations ranging
from 130 to 4000 ng/mL without metabolic activation. Cytotoxicity was seen at 2000 |ig/mL. The test substance
did not increase the frequency of mutant cells when compared to the negative vehicle control. There was no
statistically significant difference between the mutation frequencies at any dose of test material and the values
obtained from the vehicle control (i.e., water). The positive and negative controls responded appropriately. 2-
Acrylamido-2-methylpropanesulfonic acid was not mutagenic in this assay.
(4)	2-Acrylamido-2-methylpropanesulfonic acid (CAS No. 15214-89-8)
Chinese hamster ovary cells were exposed to acrylamido-2-methylpropanesulfonic acid at concentrations ranging
from 10 to 5000 |ig/mL. with and without metabolic activation. The test substance was non-mutagenic in CHO cells
under the conditions of the assay. The responses of the positive and negative controls were appropriate.
2-Acrylamido-2-methylpropanesulfonic acid was not mutagenic in this assay.
Genetic Toxicity - Chromosomal Aberrations
In vitro
2-Acrylamido-2-methylpropanesulfonic acid (CAS No. 15214-89-8)
Chinese hamster ovary cells were exposed to acrylamido-2-methylpropanesulfonic acid at concentrations ranging
from 0 to approximately 6000 ng/mL with and without metabolic activation. The test substance was clastogenic in
the presence of metabolic activation. However this finding is confounded by the absence of a dose-response effect,
lack of a time-response effect, lack of reproducibility between repeat experiments and the presence of extensive
cytotoxic damage concurrent with observed chromosomal damage for one scored time point.
2-acrylamido-2-methylpropanesulfonic acid induced chromosomal aberrations in this assay.
In vivo
(1)	2-Acrylamido-2-methylpropanesulfonic acid (CAS No. 15214-89-8)
Sprague-Dawley rats (5/sex/dose) were exposed to acrylamido-2-methylpropanesulfonic acid at concentrations of
150, 500 and 1500 mg/kg-bw. Bone marrow cells were evaluated at 6, 18 and 2 hours. The results of the test
indicate that the test material did not induce clastogenicity in rat bone marrow cells under the conditions of the test.
2-Acrylamido-2-methylpropanesulfonic acid did not induce chromosomal aberrations in this assay.
(2)	2-Acrylamido-2-methy1propanesulfonic acid, ammonium salt (CASNo. 58374-69-9) (Supporting Chemical)
Crl:CD-l (1CR)BR rats (5/sex/dose /time period) were administered 2-acrylamido-2-methylpropanesulfonic acid,
ammonium salt through an intraperitoneal route at concentrations 175, 875 and 1750 mg/kg-bw. Bone marrow cells
were evaluated at 24, 48 and 72 hours for micronuclei. The test material was considered did not induce micronuclei
under the conditions of the study.
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt did not induce chromosomal aberrations in this
assay.
Conclusion: The acute oral and dermal toxicity for the members of this category is low. Repeated exposure to
AMPS® category members via oral route showed low toxicity to rats. No effects were seen on reproductive or
developmental parameters in a combined reproductive/developmental toxicity screening test with 2-acrylamido-2-
methylpropanesulfonic acid, ammonium salt. 2-Acrylomido-2-methylpropanesulfonic acid did not induce gene
mutation in bacteria or in mammalian cells. In an in vitro assay, 2-acrylomido-2-methylpropanesulfonic acid was
clastogenic in the presence of metabolic activation. However, in in vivo tests, 2-acrylomido-2-
methylpropanesulfonic acid and its ammonium salt did not induce chromosomal aberrations.
The potential health hazard of the chemicals in the AMPS® category is low.
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Table 3. Summary of Human Health Data
Endpoints
2-acrvlamido-2-
mcthylpropanesulfonic
acid
(15214-89-8)
2-acrylamido-2-
mcthylpropancsulfonic
acid, sodium salt
(5165-97-9)
2-acnlamido-2-
nii'lln IprnpancMiHonic
acid, ammonium sail
(5X3"'4-69-,)|
(Supporting chemical)
Aeute Oral Toxicity
LDS0 (mg/kg-bw)
1830
> 16000
> 5000
Acute Dermal Toxicity
LDS0 (mg/kg-bw)
No data
>2000
(RA)
No data
>2000
(RA)
> 2000
Repeated-Dose Toxicity
NOAEL/LOAEL
Oral (mg/kg-bw/day)
No data
NOAEL = 1000 (hdt)(RA)
No data
NOAEL = 1000
(hdt)(RA)
noaii. = 		lido
Reproductive Toxicity
NOAEL/LOAEL
Oral (mg/kg-bw/day)
Systemic Toxicity
No data
NO A F.I. = 1000 (hdt)
(RA)
No data
NOAEL = 1000 (hdt)
(RA)
NOAII = 1	lull)
Reproductive Toxicity
No data
NO A F.I. = 1000 (hdt)
(RA)
No data
NOAEL = 1000 (hdt)
(RA)
N()\ll = 		(lull)
Developmental Toxicity
NOAEL/LOAEL
Oral (mg/kg-bw/day)
Maternal Toxicity
Developmental Toxicity
No data
NO A F.I. = 1000 (hdt)
(RA)
No data
NO A F.I. = 1000 (hdt)
(RA)
No data
NOAEL = 1000 (hdt)
(RA)
No data
NOAEL = 1000 (hdt)
(RA)
NOAII. = 1000
no\i:i. = 		
Genetic Toxicity - Gene
Mutation
In vitro
Negative
No data
Negative
(RA)

Genetic Toxicity -
Chromosomal Aberrations
In vitro
Positive
No data
Positive
(RA)

Genetic Toxicity -
Chromosomal aberrations
In vivo
Negative
No data
Negative
(RA)
V'ga(i\e
Measured data in bold text; — indicates that endpoint was not addressed for this chemical; (RA) = Read Across;
hdt = highest dose tested
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4. Hazard Characterization
The log Kow values of the category members indicate that their potential to bioaccumulate is expected to be low.
The chemicals in this category are not readily biodegradable, indicating that they have the potential to persist in the
environment.
The evaluation of available toxicity data for fish, aquatic invertebrates and aquatic plants indicates that the potential
acute hazard of the category members to aquatic organisms is low.
The acute oral and dermal toxicity for the members of this category is low. Repeated exposure to AMPS® category
members via oral route showed low toxicity to rats. No effects were seen on reproductive or developmental
parameters in a combined reproductive/developmental toxicity screening test with 2-acrylamido-2-
methylpropanesulfonic acid, ammonium salt. 2-Acrylomido-2-methylpropanesulfonic acid did not induce gene
mutation in bacteria or in mammalian cells. In an in vitro assay, 2-acrylomido-2-methylpropanesulfonic acid was
clastogenic in the presence of metabolic activation in. However, in in vivo tests, 2-acrylomido-2-
methylpropanesulfonic acid and its ammonium salt did not induce chromosomal aberrations.
The potential health hazard of the chemicals in the AMPS® category is low.
5. Data Gaps
No data gaps were identified under the HPV Challenge Program.
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