Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 232-304-6
CAS number: 8002-26-4
A complex combination of tall oil rosin and fatty acids derived from acidulation of crude tall oil soap and including that which is further refined. Contains at least 10% rosin.
No reliable irritation/corrosion data are
available for Distilled Tall Oil, therefore good quality guideline
studies for the related substance Crude Tall Oil are read
Crude Tall Oil was found to be not
irritating to rabbit skin and eyes in reliable studies conducted
according to the appropriate OECD test guidelines and in compliance with
GLP (ARC, 2005c-e).
Crude Tall Oil (0.5 ml) was applied via a
patch to a site of about 2.5 cm x 2.5 cm of intact skin of each of three
New Zealand white rabbits and covered by a semi-occlusive dressing for
four hours. Body weights were recorded before administration and at
termination of the test. General signs of toxicity were recorded daily.
Skin examinations were conducted at 1, 24, 48 and 72 hours after patch
removal. No signs of toxicity or death were observed. There was no
erythema or oedema in any of the animals. Therefore Crude Tall Oil was
not irritating to the skin.
Crude Tall Oil (0.1 ml) was instilled into
the conjunctival sac of the right eye of each of three New Zealand white
rabbits. The eyes were held closed for one second to prevent loss of the
test substance. The untreated left eyes served as the controls. Both
eyes were examined within 24 hours before the instillation, and
approximately 1, 24, 48 and 72 hours post-instillation. There were no
deaths or signs of toxicity in any of the animals. The untreated eyes
were normal at each observation. One hour post-instillation all animals
had grade 1 conjunctival redness, and 2/3 animals had grade 1
conjunctival chemosis. Ocular discharge was noted in all animals one
hour after instillation. There were no signs of irritation at any other
time point. There were no effects on the cornea and iris. Crude Tall Oil
was concluded not to be irritating to the eyes.
A skin irritation study is available for
Distilled Tall Oil. The study was carried out in accordance with OECD
Test Guideline 404 and in compliance with GLP, but only one animal was
tested. No skin reactions were observed up to and including the 72 hour
observation. Reliable in vitro skin corrosion and in vivo skin
irritation studies are, however, available for the related substance
Crude Tall Oil. Crude Tall Oil was shown not to be corrosive in vitro or
to be irritating to rabbit skin in vivo.
No eye irritation study is available for
Distilled Tall Oil. However a reliable study, carried out in accordance
with OECD Test Guideline 405 and in compliance with GLP, is available
for the related substance Crude Tall Oil. Minor effects were observed at
the 1 hour observation, but at no other time point.
Read-across of irritation test data from CTO
to DTO is justified on the grounds that all the chemical constituents
that are present in DTO are present in CTO i.e. fatty acids, resin
acids, polymers and neutral compounds containing alcohols, hydrocarbons
etc. The chemical constituent blocks of which they are comprised are
compositionally very similar and are made up of constituents with common
functional groups and properties. As a result the substances share very
similar physicochemical properties both in terms of their bulk
properties and the properties of the constituent blocks. CTO does
contain some constituents that are not present in DTO and for this
reason read-across from DTO to CTO is not considered appropriate.
However, for the purposes of read-across from CTO to DTO this is only
likely to make the outcome conservative i.e. if anything the hazard of
DTO is likely to be overestimated. A more detailed description of the
technical justification for read-across is given in Section 1.4 of the
According to the criteria set out in
Regulation 1272/2008, Distilled Tall Oil is not classified for skin or
eye irritation based on studies carried out using either Distilled Tall
Oil or the related substance Crude Tall Oil.
In a skin irritation test with Distilled
Tall Oil, no skin reactions were observed in one animal. In a test with
Crude Tall Oil, no erythema or oedema was observed in three animals.
In an eye irritation test with Crude Tall
Oil, minimal effects were observed which were fully resolved by the 24
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again