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EC number: 232-476-2
CAS number: 8050-15-5
Not irritating to skin or eye. Low vapour pressure precludes inhalation exposure.
Adequate information exists to characterise
the skin and eye irritation potential of Rosin Esters.
The potential for Resin acids and Rosin
acids, hydrogenated, Me esters to cause skin corrosion/irritation is
well understood. Two human studies and five animal
studies were available for review. Results from six of these seven tests
showed that the test substance was not irritating to skin, with one
study (a rabbit skin test) indicating the occurrence of reversible odema
at 24 hr post-treatment. These findings are briefly discussed below.
In one human study (Biosearch Inc, 1987a),
conducted by generally accepted international methods for the testing of
skin irritation potential in human volunteers, 0.2 mL of Resin acids and
rosin acids, hydrogenated, Me esters was applied for 24 hr to the upper
arms of each of one hundred and two female subjects and covered with a
gauze pad secured with cloth tape (semi-occlusive conditions). There
were no signs of irritation in any of the test subjects following
24-hour application. In a second human study, a repeat insult patch test
(Consumer Product Testing Co., 1998a), 209 male and female subjects
received 0.2 grams of the same test material applied under occlusive
patch 3 times/week for a total of 9 applications. Each
patch was left in place for 24 hours. There were no
signs of irritation in any test subject at any time during the study.
Skin irritation studies on Resin acids and
rosin acids, hydrogenated, ME esters conducted in rabbits using a method
that was identical or equivalent to OECD Guideline 404 (Biosearch Inc.,
1986a; EVic-CEBA, 1989d; NOTOX, 1986a, 1986b, 1986c) found generally
mild, occassionally moderate, dermal responses when 0.5 mL of the
undiluted test material was applied to the skin under an occlusive or
semi-occlusive wrap for four hours. Erythema scores were in a range 0.5
to 2.0 during the period 24 to 72 -hours following patch removal. Edema
scores over the same time period were generally negligible (score = 1 or
less up to 72 -hours) although a mean score of 3 was recorded in a
single study (EVic-CEBA, 1989d) at the 24 -hour time point. Following a
weight of evidence assessment (which includes results from two studies
performed using large groups of human volunteers), it is concluded that
Resin acids and rosin acids, hydrogenated, Me esters is not irritating
In a Human Repeat Insult Patch Test, no
evidence of irritation was apparent in 202 male and female test subjects
exposed on the upper back three times per week for a total of ten
applications to 0.2 g of the test material (Foral 85 ester; Resin acids
and rosin acids, esters with glycerol) under occluded patch for 24-hours
(Consumer Product Testing Co., 1997b). There were no signs of test
material-related irritation in any subject at any time during the study
under conditions of exposure that were significantly more stringent than
the 4-hour exposures used in current animal skin irritation testing
In a dermal irritation study conducted on
Bevitack 1000 (Resin acids and rosin acids, esters with glycerol), no
erythema or edema was present on shaved dorsal skin from three New
Zealand White rabbits exposed to 0.5 g of undiluted test substance for
four hours under occlusion (Research & Consulting Company AG, 1985b). It
was concluded that Bevitack 1000 is not a skin irritant.
In a rabbit skin irritation study conducted
according to OECD Guideline 404, 3 rabbits were each exposed to 0.5 g of
the test material Hydrogral G5 (Resin acids and rosin acids,
hydrogenated esters with glycerol) under occluded contact for four hours
(EViC-CEBA, 1989c). Any responses present at the treatment site were
recorded 1, 24, 48, and 72 hours following termination of exposure.
Slight dry skin was noted in one animal at the 24 hour timepoint, but no
signs of erythema or edema were present at any time. The test sample was
not a skin irritant under the conditions of the test.
In a dermal irritation study using Dertoline
G2L (Resin acids and rosin acids, esters with glycerol), 0.5 g of
undiluted test substance was applied to the intact and abraded shaved
dorsal skin of three New Zealand White rabbits under semiocclusive
contact 4 hours (Biogir SA, 1990d). The animals were then observed for 3
days for signs of primary irritation (erythema and edema). During the
observation period, the test substance caused slight (2/3) to well
defined (1/3) erythema on abraded skin. Erythema on intact skin was
rated as slight. Edema was limited to a single animal with abraded skin
at the 24 hour observation. Dryness of the skin was noted in all animals
with abraded skin and 1 animal with intact skin starting 3 days after
test substance administration. Under the study conditions, Dertoline G2L
is, at most, minimally irritating to the skin of New Zealand White
In another dermal irritation study with
Dertoline SG2 (Resin acids and rosin, esters with glycerol) (Biogir SA,
1990f) which followed the same protocol as above, only slight reversible
erythema was apparent up to 72 hours in one animal with dryness of the
skin present at 72 hours in two animals. These findings confirmed that
Dertoline SG2 is, at most, minimally irritating to skin.
In a dermal irritation study with Tergum 390
(Resin acids and rosin acids, esters with glycerol), 0.5 g of test
substance (moistened with water) was applied to clipped intact dorsal
skin of New Zealand White male rabbits for four hours under
semiocclusive contact (Center for Applied Research and Development, S.
A. L., 1995a). The animals were then observed for a total of 3 days for
signs of primary irritation. No erythema or edema was apparent at any
timepoint indicating that the sample was not irritating to skin.
The skin irritation potential of UNITAC RLM
(Resin acids and rosin acids, esters with pentaerythritol) was
investigated in three male New Zealand white rabbits exposed dermally to
two applications of 0.5 gram for 4 hours under semi-occluded contact
with intact skin (Safepharm Laboratories Limited, 1998a). Dermal
responses were observed for 72 hours. Very slight erythema was noted at
the application site of two animals one hour after termination of
exposure, which in one animal persisted to the 24-hour observation time
before fully resolving by 48 hours. No edema was observed in any animal
during the study. The test substance produced individual Primary
Irritation Scores of 0.0, 0.0, and 0.3 for the three animals tested and
a Primary Irritation Index of 0.1 (negligible irritation). It was
concluded that the test substance is not a dermal irritant.
In a dermal irritation study conducted using
Bevitack 115/15 (Resin acids and rosin acids, esters with
pentaerythritol), 0.5 g of moistened test substance was applied for 4
hours under occlusion to the clipped intact dorum of three New Zealand
White rabbits (1 male and 2 females) (Research & Consulting Company AG,
1985a). The animals were then observed for a total of 3 days for signs
of primary irritation (erythema and edema). No dermal responses were
present, indicating that the sample was not a skin irritant.
In a dermal irritation study, 0.5 g of
undiluted Dertoline P2L (Resin acids and rosin acids, esters with
pentaerythritol) was applied to naïve and abraded clipped skin on the
backs of three New Zealand White rabbits for four hours under
semiocclusive contact (Biogir SA, 1990e). The test substance caused
slight (2/3 animals) to well defined (1/3 animals) erythema but no edema
on three naïve skin sites; two of three naïve sites were normal at the
72-hour observation. On abraded skin, the test substance caused slight
(1/3 animals) to well defined (2/3 animals) erythema accompanied by
slight edema on one animal only. The effects were readily reversible.
Slight dryness of the skin was also noted in all animals starting 72
hours after test substance administration. Under the study conditions,
the test substance was, at most, minimally irritating to the skin of New
Zealand White Rabbits.
In a dermal irritation study performed using
Bevilite 62-107 (Resin acids and rosin acids, esters with
pentaerythritol), 0.5 g of undiluted sample was applied to clipped
dorsal skin of six New Zealand White male rabbits for four hours under
semiocclusion (Centre International de Toxicologie, 1990a). The animals
were observed at 1, 24, 48, and 72 hours after removal of the dressings
for signs of primary irritation (erythema and edema). No dermal
responses were present.
In a study that investigated the skin
irritation potential of Tergum 100 (Resin acids and rosin acids, esters
with pentaerythritol), 0.5 g of undiluted sample (moistened with water)
was applied under semiocclusive contact for four hours to clipped skin
on the back of three New Zealand White male rabbits (Centro De
Investigacion Y Desarrollo Aplicado, 1995b). Mild erythema was noted 30
minutes after test substance removal in one of three animals, but this
had fully reversed by the next observation period (24 hours). Edema was
not observed in any animal during the 3 day observation period. Based on
the results of this study, Tergum 100 is not a skin irritant.
The potential for Resin acids and rosin
acids, hydrogenated, Me esters to cause eye irritation was investigated
according to OECD Guideline 405 using a group of three rabbits (NOTOX,
1986d) No irrititation of the cornea or iris were
noted during the observation period. Grade 1
conjunctival erythema was noted for all treated eyes but effects were
fully reversible by Day 7. Chemosis was noted at the
1-hour observation only, with all eyes normal by the 24-hour observation
time. Based on the results of this study, Resin acids
and rosin acids, hydrogenated, Me esters is not corrosive and is, at
most, slightly irritating to the rabbit eye.
In a primary eye irritation study conducted
using Zonester 85 (Resin acids and rosin acids, esters with glycerol),
slight signs of irritation were seen for the cornea, iris, and
conjunctiva (Carnegie-Mellon Institute of Research, 1977a). All signs of
irritation of the cornea and iris were fully reversible by the 48-hour
observation. Conjunctival irritation was fully reversible for four of
six rabbits by the 72-hour observation; two rabbits exhibited slight
irritation to the conjunctiva during the entire observation period.
Zonester 85 was, at most, a slight ocular irritant in this study.
In a primary eye irritation study with
Zonester 85 Resin Ester (A) (Resin acids and rosin acids, esters with
glycerol), 100 mg of test substance was instilled into the conjunctival
sac of each of 6 New Zealand albino rabbits (Huntingdon Research Center,
1978a). Animals were then observed for 72 hours with any ocular
reactions present graded according to the Draize scale of weighted
scores. There were no adverse effects on the cornea or iris. Signs of
irritation were limited to mild irritation (grade of 2-4 out of 20) of
the conjunctiva in 4 of six rabbits at the 24-hour observation period.
Two of six rabbits were completely normal throughout the study. One
rabbit exhibited mild irritation (grade 2 out of 20) to the conjunctiva
during the entire observation period. The test substance was, at most,
no more than slightly irritating to the eye.
The eye irritation potential of Resin acids
and rosin acids, esters with pentaerythritol was investigated in a key
study in which 100 mg of undiluted PC 12-99 was instilled into the
conjunctival sac of one eye of each of 9 New Zealand White rabbits
(Pharmakon Research International, Inc., 1982c). Six eyes were unwashed
while the remainder were immediately irrigated with water for one minute
following installation. The method was equivalent or similar to OECD
Guideline 405, with ocular reactions recorded at 24, 48, and 72 hours,
and 4 and 7 days post-treatment using the Draize scale of weighted
scores. For the six unwashed eyes, no signs of corneal opacity, iris
irritation, discharge or chemosis were noted during the observation
period. Slight conjunctival erythema (Grade 1) was noted for two treated
eyes at the 24- and 48-hour examinations. This had reversed in one
animal by the 72-hour observation and in the other by Day 4. Based on
the results of this study, the test substance was, at most, slightly
irritating to the rabbit eye.
Respiratory Tract Irritation
No studies in which animals were exposed to
members of this category were identified. However based
on a lack of significant irritation in skin irritation studies conducted
in humans and rabbits and eye irritation studies in rabbits, Rosin
esters are not expected to be irritating to the respiratory tract. It is
also noted that the vapour pressure of these substacnes is low
indicating that exposure via this route is unlikely.
for skin or eye irritation according to EU
Classification, Labelling and Packaging of Substances and Mixtures (CLP)
Regulation (EC) No. 1272/2008 or UN Globally
Harmonized System of Classification and Labelling of Chemicals (GHS).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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