SCREENING-LEVEL HAZARD CHARACTERIZATION
OF HIGH PRODUCTION VOLUME CHEMICALS
CHEMICAL CATEGORY NAME
Rosin and Rosin Salts
SPONSORED CHEMICALS
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
Rosin
Rosin, sodium salt
Rosin, potassium salt
Rosin, hydrogenated
Rosin, distillation overheads
Rosin, low boiling fraction
CAS No. 8050-09-7
CAS No. 61790-51-0
CAS No. 61790-50-9
CAS No. 65997-06-0
CAS No. 68425-08-1
CAS No. 68783-82-4
October 2007
INTERIM
Prepared by
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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 characterizations4'6. 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
Rosin and Rosin Salts Category
Introduction
The sponsor, Pine Chemicals Association, Inc. submitted a Test Plan and Robust Summaries to EPA for the Rosins
and Rosin Salts Category on July 23, 2001. EPA posted the submission on the ChemRTK HPV Challenge website
on October 4, 2001 (http://www.epa.gov/chemrtk/pubs/summaries/rosnsalt/cl3134tc.htm'). EPA comments on the
original submission were posted to the website on March 22, 2002. Public comments were also received and posted
to the website. The sponsor submitted updated/revised documents on June 3, 2002 and September 7, 2004, which
were posted to the ChemRTK website on June 21, 2002 and September 22, 2004, respectively. The Rosin and Rosin
Salts Category consists of the following substances:
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 chemicals
are included in the 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 Justification
The six members of the rosin and rosin salts category are all derived from rosin. The substances in this category are
complex mixtures; also called Class 2 substances, which means that they are composed of several chemicals with
concentrations that vary depending on their source and methods of derivation. Each category member is derived
from rosin, either by high temperature distillation or by reacting with appropriate bases to form salts, and is also a
complex mixture. Hydrogenated rosin (CAS No. 65997-06-0) is similar to rosin except that some of the double
bonds in the resin acids are saturated. Rosin distillation overheads (CAS No. 68425-08-1) and rosin, low boiling
fraction (CAS No. 68783-82-4) are products obtained when rosin is heated to the temperature at which it degrades.
The rosin potassium and sodium salts are salts of rosin made by treating rosin with appropriate bases.
Rosin is a naturally occurring substance found predominantly in pine trees and is obtained by chemical or distillation
processes from the pulping of pine wood. There are three different types of rosins: gum, wood and tall oil rosin—
the type depends on the way it is extracted from the pine tree. Gum rosin is derived by slashing the tree and
collecting the gummy exudates, which are further distilled; wood rosin is obtained by solvent extraction of pine
wood; and tall oil rosin is obtained by distillation of tall oil (the Tall Oil and Related Substance Category has also
been sponsored and assessed under the HPV Challenge Program). Rosin is composed primarily of resin acids, a
class of tricyclic carboxylic acids, and contains minor amounts of dimerized rosin and unsaponifiable matter.
Chemically, the three rosins are very similar, containing the same resin acids in slightly different ratios, and have the
same CAS No. 8050-09-7. The sponsor reported typical compositions of the three types of rosins, as presented in
the table below. Representative resin acid structures are depicted in the appendix.
Rosin
Rosin, sodium salt
Rosin, potassium salt
Rosin, hydrogenated
Rosin, distillation overheads
Rosin, low boiling fraction
CAS No. 8050-09-7
CAS No. 61790-51-0
CAS No. 61790-50-9
CAS No. 65997-06-0
CAS No. 68425-08-1
CAS No. 68783-82-4
3
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(icucral ('omposiiiou of (iiim. Wood and l all ()il kosius
Components
Gum
Wood
Tall Oil
Abietic acid
20%
45%
35%
Palustric acid
18%
10%
10%
Isopimaric acid
18%
11%
7%
Dehydroabietic acid
4%
8%
20%
Neoabietic acid
18%
7%
4%
Pimaric acid
2%
3%
3%
In comments on the original test plan EPA agreed that rosin, its sodium and potassium salts and hydrogenated rosin
are structurally similar and can be evaluated together. However, EPA noted that rosin distillation overheads and
rosin low boiling fraction, although similar to each other, are different in composition from the other category
members in that they have a lower percentage of rosin acids and higher percentages of fatty acids, hydrocarbons and
rosin aldehydes, alcohols and esters. For this reason, EPA recommended additional testing to demonstrate similarity
of these substances to rosin. In its revised test plan and data submissions, the sponsor conducted additional testing
and demonstrated similar acute toxicity of rosin distillation overheads to the other tested members of the category.
Based on these data, EPA has concluded that the chemicals in this category can be grouped and evaluated together
as they have similar structure, composition, physical-chemical and environmental fate properties and toxicity to
aquatic and mammalian species.
Sum m ;m-Conclusion
The Ion k \ allies of rosin and rosin sails \ ar\ reflecliim the coniple\ nature ol" these Class 2 substances. The
upper ranue ol" I lie Ion k \ allies lor ilie caleuor\ members indicates ilial llieir poieuiial lo hioaccuniulale is
e\peeled lo he limli The ealeuors members are uoi readiK biodegradable. uidicaliuu 11ie\ ha\e llie poieuiial lo
persist in ihe eu\ iroumeui
I lie aquatic lo\ieil> dala subniiiied were ueneraled usiiiu llie Water \eeonimodaled fraction nielhod I lie
e\ alualiou of a\ ailahle lo\icit> dala lor fish and aquatic plains nidieale llie poieuiial lia/ard lo iliese aquatic
organisms is low based on no ell eels obser\ ed al llie waler soluhiliis 11 null saturation) ol' rosin. The e\ alualiou ol'
a\ ailahle lo\ieil> dala for aquatic iu\ eriehrales mdieales llie poieuiial lia/ard lo iliese aquatic oruauisnis is lnuli
While llie aeuie lesiiuu did uoi show io\ieil\ in aquatic oruauisnis. ilie ph\ sieal-eheniieal properties ol' ihe
suhsiauees in ilns ealeuors nidieale lhe> are soluble or miseihle in waleral concentrations ilial eoukl eause chrome
e Heels
\euie oral to\icil> or rosin and hulroucualed rosui low Repealed oral exposures u> rosui and hulroucualed rosm
resulted in reduced urowtli and increased oruau weiuhis \i \er\ liiuli doses i 5t>uo nm ku-hw da> i. niortalils
oeeurred as ilie result of siar\aliou (animals refused lo eal. possibk due u> palalabiliis of dieli \l !<>(><) nm ku-
bw da\. increased h\ er weiuhis lahsoluie and relali\ e lo bod> weiuhl i w ere llie niosi common I'uidiim.
I lisiopallK. obser\ ed as a slmhi decrease in ilie mean iiuniber of implaiiialiou
sues per preunaiies and eorrespoudiuu rediieliou in hiiersi/e. was seen in animals reeei\ iiiu Iii.ikki ppm ( S25
niu ku-hw da> i Mean liueraud pup hods weiuhis were also slmhiK reduced. There were no ireainieui-relaled
niallornialioiis seen in ihe pups \lalerual lo\ieil> was seen al ^iiki ppm i nm ku-hw da> i niauifesied as
reduced urowili. food eoiisiinipiiou and mean hods weiuhl l lie ealeuors members were uoi lesied Ibrueuelie
lo.\ieil\ ( areiiioueuieils siudies showed no increase in incidence or i\ pe of luniors in rals. howe\er. ihe rehabiliis
of iliese dala is quesiiouahle
I lie poieuiial hcallh lia/ard of llie rosui and rosm sails ealeuors low \o dala were suhmiiied for ueue miiialiou and
chromosomal aherraliou eudpouiis and llie eareiuouemeils lesis suhmiiied in lieu of uciioIomciis dala are of
questionable reliability
l lie elirome m\ ertebniie lo\ieil\ lest reniains a dala uap under the 11 lJ\" ( hallenue I'rourani Siibseqiieiit
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consideration of fate and exposure information will inform a determination of the need to obtain chronic aquatic
toxicity data for these substances. Genetic toxicity (gene mutation and chromosomal aberration) were identified as
data gaps under the High Production Volume Challenge Program.
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
Because these substances in this category are Class 2 mixtures, the procedure (OECD 117) to determine the Kow
yields a range of Kow values rather than a single value representative of the mixture. Thus, the results reflect the
partition coefficients of the components rather than the mixture.
Rosin (CASNo. 8050-09-7)
Log Kow: 1.9-7.7 (measured at pH 2)
4.5 - 7.2 (measured at pH 2)
3.6 (measured at pH 7.5 for one component of the mixture)
Rosin, sodium salt (CAS No. 61790-51-0)
Log Kow: 3.5-6.6 (measured at pH 2)
Rosin, potassium salt (CAS No. 61790-50-9)
Log Kow: 3.0 - 7.0 (measured at pH 2)
Rosin, hydrogenated (CAS No. 65997-06-0)
Log Kow: 2.5-7.6 (measured at pH 2)
Rosin, distillation overheads (CAS No. 68425-08-1)
Log Kow: 2.5-7.8 (measured at pH 2)
Biodegradation
Rosin (CASNo. 8050-09-7)
In a closed bottle test using secondary effluent from the Rungsted treatment plant as inoculum, 28 - 32% of rosin
had degraded after 28 days.
Tall oil rosin is not readily biodegradable.
Rosin, sodium salt (CAS No. 61790-51-0)
A biodegradation test in soil was submitted for this substance. The soil biodegradation test is not adequate for the
purposes of the HPV Challenge Program. Therefore, ready biodegradation for rosin (CAS No. 8050-09-7) was used
to evaluate the biodegradation of rosin, sodium salt.
Rosin, sodium salt is not readily biodegradable based on the data for rosin.
Rosin, potassium salt (CAS No. 61790-50-9)
An inherent biodegradation test was submitted for this substance. The inherent biodegradation test is not adequate
for the purposes of the HPV Challenge Program. Therefore, ready biodegradation for rosin (CAS No. 8050-09-7)
was used to evaluate the biodegradation of rosin, potassium salt.
Rosin, potassium salt is not readily biodegradable based on the data for rosin.
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Rosin, hydrogenated (65997-06-0)
In a Modified Sturm Test using activated sludge from the Municipal sewage treatment works as inoculum, 0.95% of
hydrogenated rosin had degraded after 29 days.
Rosin, hydrogenated is not readily biodegradable.
Rosin, distillation overheads (68425-08-1)
In a Modified Sturm Test using activated sludge from the Municipal sewage works as inoculum, 30% of rosin,
distillation overheads had degraded after 28-days.
Rosin, distillation overheads is not readily biodegradable.
Conclusion: The log Kow values of rosin and rosin salts vary reflecting the complex nature of these Class 2
substances. The upper range of the log Kow values for the category members indicates that their potential to
bioaccumulate is expected to be high. The category members are not readily biodegradable, indicating they have the
potential to persist in the environment.
Table 1. Summary of Physical-Chemical Properties and Environmental Fate Data
Endpoints
Rosin
(8050-09-7)
Rosin,
sodium salt
(61790-51-0)
Rosin,
potassium salt
(61790-50-9)
Rosin,
hydrogenated
(65997-06-0)
Rosin,
low boiling
fraction
(68783-82-4)
Rosin,
distillation
overheads
(68425-08-1)
Melting Point (°C)
Boiling Point (°C)
Melting point and boiling points were not determined because these substances are complex mixtures and will either
not give a sharp melting point when heated or will decompose before they melt or boil.
Vapor Pressure
(hPa at 25°C)
Under ambient conditions, accurate measurement of vapor pressure of these mixtures is difficult; based on their
physical characteristics (solid at room temperature), their vapor pressure is expected to be negligible.
Log K„w
1.9 - 7.7 (m)
3.5 - 6.6 (m)
3.0- 7.0 (m)
2.5 - 7.6 (m)
—
2.5 - 7.8 (m)
Water Solubility
(mg/L at 25°C)
0.9 (m)
Miscible
Miscible
1.18 (m)
"
19.85 (m)
Direct Photodegradation
Direct photolysis is not expected to contribute to degradation.
Indirect (OH )
Photodegradation (t1/2)
Not expected to undergo photodegradation, as the vapor pressure is negligible.
Stability in Water
(Hydrolysis) (t1/2)
Not subject to hydrolysis at environmentally relevant pH values (no hydrolysable groups).
Fugacity
(Level HI Model)
Not estimated due to inability to obtain input values for the required model because the substances are complex
mixtures.
Biodegradation
at 28 days (%)
32 (m)
Not readily
biodegradable
No Data1
32
Not readily
biodegradable
(RA)
No Data2
32
Not readily
biodegradable
(RA)
0.95 (m)
Not readily
biodegradable
No Data
30
Not readily
biodegradable
(RA)
30 (m)
Not readily
biodegradable
(m) = measured data (i.e., derived from experiment); (RA) = Read Across; — indicates endpoint was not addressed for this
substance; 'soil biodegradation test submitted; 2Inherent biodegradation test submitted.
2. Environmental Effects - Aquatic Toxicity
A summary of aquatic toxicity data submitted for SIDS endpoints is provided in Table 2. The table also indicates
where data for tested category members are read-across (RA) to untested members of the category.
Acute Toxicity to Fish
Rosin (CASNo. 8050-09-7)
Fathead minnows (Pimephales promelas) were exposed to the test substance as water accommodated fractions
(WAFs) under static conditions for 96 hours. The loading rates were 0, 1, 10, 100 or 1000 mg/L and no analytical
measurements were made on the WAFs. No effects were noted at any of the WAF loading rates. EPA does not
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consider the loading rate as the no effect concentration when the concentration exceeds the water solubility of the
substance. Assuming exposure concentration in the WAF is the water solubility limit (saturation) for rosin, the no
effect concentration would be approximately 0.9 mg/L.
No effects at saturation
Acute Toxicity to Aquatic Invertebrates
Rosin (8050-09-7)
Daphnia magna were exposed to the test substance as water accommodated fractions (WAFs) under static
conditions for 48 hours. The loading rates were 0, 125, 250, 500 and 1000 mg/L and no analytical measurements
were made on the WAFs. Exposure to the 1000 mg/L WAF resulted in 50% mortality at 24 hours and 85%
mortality at 48 hours. The sponsor reported the 48-h EL50 as 911 mg/L and no effect loading rate as 750 mg/L.
EPA does not consider the loading rate as the effect concentration when the concentration exceeds the water
solubility of the substance. Assuming exposure concentration in the WAF is the water solubility limit (saturation)
for rosin, the 24-h LC50 would be approximately 0.9 mg/L and the 48-h LC50 would be less than 0.9 mg/L, both
indicative of high acute toxicity to aquatic invertebrates.
Toxicity to Aquatic Plants
Rosin (CASNo. 8050-09-7)
Green algae (Pseudokirchneriella subcapitata) were exposed to the test substance as water accommodated fractions
(WAFs) under static conditions for 72 hours. The loading rates were 0, 1, 10, 100 or 1000 mg/L and no analytical
measurements were made on the WAFs. No effects were noted at any of the WAF loading rates. EPA does not
consider the loading rate as the no effect concentration when the concentration exceeds the water solubility of the
substance. Assuming exposure concentration in the WAF is the water solubility limit (saturation) for rosin, the no
effect concentration would be approximately 0.9 mg/L.
No effects at saturation
Conclusion: The aquatic toxicity data submitted were generated using the Water Accommodated Fraction method.
The evaluation of available toxicity data for fish and aquatic plants indicate the potential hazard to these aquatic
organisms is low based on no effects observed at the water solubility limit (saturation) of rosin. The evaluation of
available toxicity data for aquatic invertebrates indicates the potential hazard to these aquatic organisms is high.
In comments on the original test plan, EPA recommended that the sponsor conduct chronic toxicity testing on
invertebrates (i.e. the daphnid 21-day reproduction test). While the acute testing did not show toxicity in aquatic
organisms, the physical-chemical properties of the substances in this category indicate they are soluble or miscible
in water at concentrations that could cause chronic effects. Therefore, the chronic invertebrate toxicity test remains
a data gap under the HPV Challenge Program. Subsequent consideration of fate and exposure information will
inform a determination of the need to obtain chronic aquatic toxicity data for these substances.
Table 2. Summary of Environmental Effects - Aquatic Toxicity Data
Endpoints
Rosin
(8050-09-7)
Rosin,
sodium salt
(61790-51-0)
Rosin,
potassium
salt
(61790-50-9)
Rosin,
hvdrogenated
(65997-06-0)
Rosin,
low boiling
fraction
(68783-82-4)
Rosin,
distillation
overheads
(68425-08-1)
Fish
96-h LCS0 (mg/L)
NES1
No Data
NES1
(RA)
No Data
NES1
(RA)
No Data
NES1
(RA)
No Data
NES1
(RA)
No Data
NES1
(RA)
Aquatic
Invertebrates
48-h ECsn (mg/L)
<0.9
No Data
<0.9
(RA)
No Data
<0.9
(RA)
No Data
<0.9
(RA)
No Data
<0.9
(RA)
No Data
<0.9
(RA)
Aquatic Plants
72-h ECS0 (mg/L)
NES1
No Data
NES1
(RA)
No Data
NES1
(RA)
No Data
NES1
(RA)
No Data
NES1
(RA)
No Data
NES1
(RA)
'NES = No effects at saturation (water solubility limit); (RA) = Read Across
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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
Rosin (CASNo. 8050-09-7)
Multiple acute oral toxicity data for three different forms of rosin - gum, wood and tall oil - were submitted.
Gum Rosin
Rats, mice and guinea pigs received unspecified graded doses of gum rosin in corn oil via oral gavage and were
observed for 14 days.
LDS0 (rat) = 7600 mg/kg-bw
LDS0 (mouse) = 4600 mg/kg-bw
LDS0 (guinea pig) = 4100
Wood Rosin
Rats, mice and guinea pigs received unspecified graded doses of wood rosin in corn oil via oral gavage and were
observed for 14 days.
LDS0 (rat) = 8400 mg/kg-bw
LDS0 (mouse) = 4100 mg/kg-bw
LDS0 (guinea pig) = 4100 mg/kg-bw
Tall Oil Rosin
Rats, mice and guinea pigs received unspecified graded doses of tall oil rosin in corn oil via oral gavage and were
observed for 14 days.
LDS0 (rat) = 7600 mg/kg-bw
LDS0 (mouse) = 4600 mg/kg-bw
LDS0 (guinea pig) = 4600 mg/kg-bw
Rosin, hydrogenated (65997-06-0)
Wistar Rats (10/sex) were administered hydrogenated rosin as a single oral dose of 30 mL/kg-bw (approximately
31,500 mg/kg-bw base on density of 1.05 g/mL) and were observed for 14 days. No deaths occurred.
LDS0 > 31,500 mg/kg-bw
Rosin, distillation overheads (68425-08-1)
Female Sprague-Dawley rats (5) were administered rosin, distillation overheads as a single dose in corn oil via
gavage and were observed for 14 days. All rats survived.
LDS0 > 2000 mg/kg-bw
Repeated-Dose Toxicity
Five of the submitted repeated-dose toxicity studies were conducted at the Industrial Bio-Test Laboratories (IBT),
Inc. Based on guidance on the acceptance and use of IBT studies (as discussed in the Organization for Economic
Cooperation and Development's SIDS Initial Assessment Meeting 21), when the study has not been audited by
either EPA or FDA or by Industry, and if the findings of the IBT study were consistent with a study conducted at
later date in another laboratory, then the data may be used but should be considered as weak evidence. As
summarized below, toxicity data derived from the reproductive/developmental toxicity study are consistent with the
IBT data.
Rosin (CASNo. 8050-09-7)
(1) Five separate dietary studies in rats (one using gum rosin, two using wood rosin and two using rosin with no
trade name given) were conducted by IBT Laboratories in 1960. Each was a 90-day repeated-dose toxicity study
where Sprague-Dawley rats (10/sex/treatment) were exposed to rosin in the diet at concentrations of 0, 0.01, 0.05,
0.2, 1.0 or 5.0% (approximately corresponding to 0, 10, 50, 200, 1000 or 5000 mg/kg-bw/day). In all studies,
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animals exposed to 5% rosin exhibited weight loss and a marked decrease in food consumption followed by
mortality. Starvation through refusal to eat (possibly related to palatability) was stated as the primary cause of
death. At 1% dietary exposure, reduced food consumption, decreased mean body weight and decreased body weight
gain were reported. No treatment-related effects on hematology or urinalysis parameters were reported in any study.
At necropsy, no treatment-related changes were noted. An increase in absolute liver weights was reported in three
of the five studies and relative organ weights were reported as 'altered' in two studies and increases in relative organ
weights (liver, kidney and/ or spleen) were reported in three studies. Histological changes in kidneys of high dose
animals were found in one study. No histopathological findings were indicated in the remaining four studies. No
evidence of toxicity to reproductive organs was observed at any dose level in any of the five studies.
LOAEL ~ 1000 mg/kg-bw/day (based on reduced growth and increased organ weights)
NOAEL ~ 200 mg/kg-bw/day
(2) The systemic toxicity data derived from the reproductive/developmental toxicity study (conducted at Inveresk
Research in 2002) on rosin is consistent with results of the IBT studies. Sprague-Dawley rats (10/sex/dose) were
administered rosin via the diet at concentrations of 0, 1000, 3000 and 10,000 ppm (approximately corresponding to
0, 105, 275 or 825 mg/kg-bw/day). The males were dosed for at least 4 weeks, starting from 2 weeks prior to
mating. The females were dosed from 2 weeks prior to mating until at least day 4 of lactation. Treatment with rosin
at 10,000 ppm was associated with reduced weight gain and weight loss and reduced food consumption for the first
few weeks of treatment. Food consumption was reduced throughout gestation and body weight gain was reduced
during the first half of gestation. Body weight gain was slightly reduced in males at 3000 ppm.
LOAEL (systemic toxicity) ~ 275 mg/kg-bw/day (based on reduced growth)
NOAEL (systemic toxicity) ~ 105 mg/kg-bw/day
Rosin, hydrogenated (CAS No. 65997-06-0)
Sprague-Dawley rats (10/sex/group) were administered hydrogenated rosin in the diet at concentrations of 0, 0.01,
0.05, 0.2, 1 or 5% (approximately corresponding to 0, 10, 50, 200, 1000 or 5000 mg/kg-bw/day) for 90 days. All of
the animals in the high-dose group died prior to study termination. These deaths occurred between study day 3 and
11 and were attributed to starvation through food refusal (i.e., treatment-related, marked decrease in food
consumption). Rats in this group expressed weight loss. In the 1% dose group, food consumption and body weight
were decreased in both males and females. With the exception of the first week of dosing, food utilization (grams
gained/gram food consumed) was not affected at a dietary concentration of 1% indicating that the reduced food
consumption may have been related to palatability. No treatment-related effects on hematology, urinalysis or gross
or microscopic pathology were observed. Organ weight effects were also reported in the 1% dose group.
Reproductive organs (i.e., testes, ovaries and uterus) showed no evidence of toxicity at any dose level.
LOAEL ~ 1000 mg/kg-bw/day (based on reduced growth, increased organ weights)
NOAEL ~ 200 mg/kg-bw/day
9
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Reproductive/Developmental Toxicity
Rosin (CASNo. 8050-90-7)
Sprague-Dawley rats (10/sex/dose) were administered rosin via the diet at concentrations of 0, 1000, 3000 and
10,000 ppm (approximately corresponding to 0, 105, 275 or 825 mg/kg-bw/day). The males were dosed for at least
4 weeks, starting from 2 weeks prior to mating. The females were dosed from 2 weeks prior to mating until at least
day 4 of lactation. Treatment with rosin at 10,000 ppm was associated with reduced weight gain and weight loss
and reduced food consumption for the first few weeks of treatment. Food consumption was reduced throughout
gestation and body weight gain was reduced during the first half of gestation. At 10,000 ppm, the mean number of
implantation sites per pregnancy was slightly decreased resulting in a subsequent reduction in litter size. Mean litter
and pup weights were also slightly reduced. The effects on implantation, litter size and fetal weight were likely
secondary to the effects on food intake and subsequent reduced weight gain in the adult females. Litter survival, as
indicated by the birth index and viability index, was similar in all groups. There were no effects of treatment on
mating performance, fertility or duration of gestation. No obvious external abnormalities were noted in the pups at
any dose level. Testes and epididymides weights were similar in all groups. No histological findings could be
attributed to treatment with rosin. Body weight gain was slightly reduced in males at 3000 ppm.
LOAEL (systemic toxicity) ~ 275 mg/kg-bw/day (based on reduced growth)
NOAEL (systemic toxicity) ~ 105 mg/kg-bw/day
LOAEL (reproductive/developmental toxicity) ~ 825 mg/kg-bw/day (based on a decrease in mean number of
implantations)
NOAEL (reproductive/developmental toxicity) ~ 275 mg/kg-bw/day
Genetic Toxicity
No data were submitted for gene mutation and chromosomal aberration endpoints. Instead, PCA submitted negative
cancer bioassays as a suitable surrogate for genetic toxicity testing. However, the negative carcinogenicity studies
were conducted at IBT and there is no evidence that data from these studies were audited by EPA or FDA.
Therefore, their adequacy is questionable. Therefore, the genetic toxicity endpoints are data gap under the HPV
Challenge Program.
Additional Information
Carcinogenicity
The carcinogenicity studies submitted were conducted at the Industrial Bio-Test Laboratories (IBT), Inc. Based on
guidance on the acceptance and use of IBT studies (as discussed in the Organization for Economic Cooperation and
Development's SIDS Initial Assessment Meeting 21), when the study has not been audited by either EPA or FDA or
by Industry, and if the findings of the IBT study were consistent with a study conducted at later date in another
laboratory, then the data may be used but should be considered as weak evidence. There is no evidence that data
from these studies were audited by EPA or FDA. Therefore, their reliability is questionable.
Gum rosin (CAS No. 8050-09-7)
Sprague-Dawley rats (30/sex/dose) were exposed to gum rosin at dietary concentrations of 0, 0.05 or 1%
(approximately 0, 50 or 1000 mg/kg-bw/day) for 2 years. No treatment-related increase in mortality was reported
and the only clinical signs were generalized inactivity and weakness in the animals dying on study. Mean body
weight and body weight gain were markedly decreased at 1% treatment. Food consumption was also decreased in
the high-dose group, but food utilization was unaffected. The effects on body weight and food consumption were
attributed to the palatability of the test diet. No treatment-related effects were reported on hematology, urinalysis,
and gross and microscopic pathology parameters. Relative liver weights were increased at 1% treatment.
Reproductive organs (i.e., testes, ovaries and uterus) showed no evidence of toxicity at any dose level. The tumor
incidence and tumor types were similar in the test and control groups. Dietary administration of rosin up to
approximately 1% in the diet (approximately 1000 mg/kg-bw/day) did not show increase in the incidence of tumor
in rats.
Rosin, hydrogenated (CAS No. 65997-06-0)
Sprague-Dawley rats (30/sex/dose) were exposed to hydrogenated rosin at dietary concentrations of 0, 0.05, 0.2 or
1% (approximately equivalent to 0, 50, 200 or 1000 mg/kg-bw/day) for 2 years. No treatment-related increase in
10
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mortality occurred and the only clinical signs were lethargy in animals near death on study. A decrease in body
weight gain was noted in the 1% dose group at the interim sacrifice (12 months) only. Body weights were also
decreased in this group at the 12-month time point. After 24 months, no effect of treatment on body weight or body
weight gain was observed. Food consumption was decreased in the high-dose group. No effects on hematology,
urinalysis, organ weights and gross and microscopic pathology were reported. Reproductive organs (i.e., testes,
ovaries and uterus) showed no evidence of toxicity at any dose level. The tumor incidence and tumor types were
similar in the test and control groups. Dietary administration of rosin up to 1% in the diet (approximately 1000
mg/kg-bw/day) did not show increase in the incidence of tumor in rats.
Conclusion: Acute oral toxicity or rosin and hydrogenated rosin low. Repeated oral exposures to rosin and
hydrogenated rosin resulted in reduced growth and increased organ weights. At very high doses (~ 5000 mg/kg-
bw/day), mortality occurred as the result of starvation (animals refused to eat, possibly due to palatability of diet). At
1000 mg/kg-bw/day, increased liver weights (absolute and relative to body weight) were the most common finding.
Histopathological evaluation of all other tissues and organs including reproductive organs were normal at all dose
levels. Reproductive and developmental toxicity, observed as a slight decrease in the mean number of implantation
sites per pregnancy and corresponding reduction in litter size, was seen in animals receiving 10,000 ppm (~ 825
mg/kg-bw/day). Mean litter and pup body weights were also slightly reduced. There were no treatment-related
malformations seen in the pups. Maternal toxicity was seen at 3000 ppm (~ 275 mg/kg-bw/day) manifested as
reduced growth, food consumption and mean body weight. The category members were not tested for genetic
toxicity. Carcinogenicity studies showed no increase in incidence or type of tumors in rats.
The potential health hazard of the rosin and rosin salts category low. No data were submitted for gene mutation and
chromosomal aberration endpoints and the carcinogenicity tests submitted in lieu of genotoxicity data are of
questionable reliability. Therefore, the genetic toxicity endpoints are data gap under the HPV Challenge Program.
Tabic 3. Summary of Human Health Data
Endpoints
Rosin
(8050-09-7)
Rosin,
sodium salt
(61790-51-0)
Rosin,
potassium salt
(61790-50-9)
Rosin,
hydrogenated
(65997-06-0)
Rosin,
low boiling
fraction
(68783-82-4)
Rosin,
distillation
overheads
(68425-08-1)
Acute Oral Toxicity
LDS0 (mg/kg-bw)
4100-8400
No Data
4100-8400
(RA)
No Data
4100-8400
(RA)
>31,500
No Data
>2000
(RA)
>2000
Repeated-Dose Toxicity
NOAEL/ LOAEL
(mg/kg-bw/day)
NOAEL-200
LOAEL -1000
No Data
NOAEL-200
LOAEL ~ 1000
(RA)
No Data
NOAEL-200
LOAEL - 1000
(RA)
NOAEL-200
LOAEL -1000
No Data
NOAEL-200
LOAEL-1000
(RA)
No Data
NOAEL-200
LOAEL -1000
(RA)
Reproductive/
Developmental Toxicity
(mg/kg-bw/day)
Systemic Toxicity
NOAEL -105
LOAEL -275
No Data
NOAEL-105
LOAEL-275
No Data
NOAEL-105
LOAEL-275
No Data
NOAEL-105
LOAEL-275
No Data
NOAEL -105
LOAEL-275
No Data
NOAEL - 105
LOAEL-275
Reproductive/
Developmental Toxicity
NOAEL-275
LOAEL-825
NOAEL-275
LOAEL - 825
(RA)
NOAEL-275
LOAEL - 825
(RA)
NOAEL-275
LOAEL - 825
(RA)
NOAEL-275
LOAEL - 825
(RA)
NOAEL-275
LOAEL - 825
(RA)
Genetic Toxicity -
Gene Mutation
_
_
_
_
_
_
Genetic Toxicity -
Chromosomal Aberrations
_
_
_
_
_
_
Other -
Carcinogenicity
Data available1
Data available1
Measured data in bold text; (RA) = Read Across; — indicates that endpoint was not addressed for this chemical; 'The carcinogenicity studies
submitted were conducted at the Industrial Bio-Test Laboratories (IBT), Inc. Based on guidance on the acceptance and use of IBT studies (as
discussed in the Organization for Economic Cooperation and Development's SIDS Initial Assessment Meeting 21), when the study has not been
audited by either EPA or FDA or by Industry, and if the findings of the IBT study were consistent with a study conducted at later date in another
laboratory, then the data may be used but should be considered as weak evidence. There is no evidence that data from these studies were audited by
EPA or FDA. Therefore, their reliability is questionable.
-------
4. Hazard Identification
The log Kow values of rosin and rosin salts vary reflecting the complex nature of these Class 2 substances. The
upper range of the log Kow values for the category members indicates that their potential to bioaccumulate is
expected to be high. The category members are not readily biodegradable, indicating they have the potential to
persist in the environment.
The aquatic toxicity data submitted were generated using the Water Accommodated Fraction method. The
evaluation of available toxicity data for fish and aquatic plants indicate the potential hazard to these aquatic
organisms is low based on no effects observed at the water solubility limit (saturation) of rosin. The evaluation of
available toxicity data for aquatic invertebrates indicates the potential hazard to these aquatic organisms is high.
While the acute testing did not show toxicity in aquatic organisms, the physical-chemical properties of the
substances in this category indicate they are soluble or miscible in water at concentrations that could cause chronic
effects.
Acute oral toxicity or rosin and hydrogenated rosin low. Repeated oral exposures to rosin and hydrogenated rosin
resulted in reduced growth and increased organ weights. At very high doses (~ 5000 mg/kg-bw/day), mortality
occurred as the result of starvation (animals refused to eat, possibly due to palatability of diet). At 1000 mg/kg-
bw/day, increased liver weights (absolute and relative to body weight) were the most common finding.
Histopathological evaluation of all other tissues and organs including reproductive organs were normal at all dose
levels. Reproductive and developmental toxicity, observed as a slight decrease in the mean number of implantation
sites per pregnancy and corresponding reduction in litter size, was seen in animals receiving 10,000 ppm (~ 825
mg/kg-bw/day). Mean litter and pup body weights were also slightly reduced. There were no treatment-related
malformations seen in the pups. Maternal toxicity was seen at 3000 ppm (~ 275 mg/kg-bw/day) manifested as
reduced growth, food consumption and mean body weight. The category members were not tested for genetic
toxicity. Carcinogenicity studies showed no increase in incidence or type of tumors in rats; however, the reliability
of these data is questionable.
The potential health hazard of the rosin and rosin salts category low. No data were submitted for gene mutation and
chromosomal aberration endpoints and the carcinogenicity tests submitted in lieu of genotoxicity data are of
questionable reliability.
5. Data Gaps
The chronic invertebrate toxicity test remains a data gap under the HPV Challenge Program. Subsequent
consideration of fate and exposure information will inform a determination of the need to obtain chronic aquatic
toxicity data for these substances. Genetic toxicity (gene mutation and chromosomal aberration) were identified as
data gaps under the High Production Volume Challenge Program.
12
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APPENDIX
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Figure 1. Representative resin acids found in rosin and its derivatives.
13
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