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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 acute toxicity data are available for
Distilled Tall Oil. Good quality, guideline studies for the related
substance Crude Tall Oil are therefore read across.
The key acute oral toxicity study gave an LD50
(oral) >2000 mg/kg bw (OECD 423, acute toxic class method) in rats (ARC,
2005a). There were no clinical signs or necropsy findings.
The key acute dermal toxicity study gave an
LD50 (dermal) >2000 mg/kg bw (OECD 402, limit test) in rats
(ARC, 2005b). There were no clinical signs, signs of local irritation or
values are read across to the registered substance, Distilled Tall Oil.
Crude Tall Oil was administered once as a
solution in corn oil (10 ml/kg bw), given orally via gavage to female
Crl:CD(SD)IGS BR rats. The dosing was performed sequentially to groups
of three animals per step using a starting dose of 300 mg/kg bw and 2000
mg/kg bw as the second dose. The animals were then observed for 14 days.
Clinical observations were noted at least once per day, body weights
were recorded before administration, and on days 7 and 14. At the end of
the observation period all animals were sacrificed and necropsied. There
were no clinical signs of toxicity, no deaths and all animals gained
weight normally. The oral LD50 was therefore greater than
2000 mg/kg bw.
A single dermal administration of Crude Tall
Oil was performed, by spreading the test substance on an area of skin
that was at least 10% of the estimated body surface of male and female
CRL: CD(SD)BR SPF rats. 2000 mg/kg bw of the test substance was held in
place with a semi-occlusive dressing for 24 hours. At the end of the
exposure period the residual test substance was wiped off with a wet
cellulose tissue, when necessary. The animals were then observed for 14
days. Clinical observations were noted at least once per day, body
weights were recorded before administration, and on days 7 and 14. At
the end of the observation period all animals were sacrificed and
necropsied. There were no clinical signs of toxicity, no deaths and
there were no treatment-related effects on body weight. The dermal LD50
was therefore greater than 2000 mg/kg bw.
is no acute toxicity data are available for Distilled Tall Oil. Acute
oral and dermal toxicity studies are, however, available for the related
substance Crude Tall Oil.Read-across of acute toxicity 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. It
should be noted that Distilled Tall Oil contains a higher proportion of
non-hazardous fatty acids that are exempt from REACH in accordance with
Annex V of the Regulation. In addition, 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 CSR.
acute oral toxicity studies are available for Crude Tall Oil. In all
cases, the observed LD50 was greater than 2000 mg/kg bw. The
key study was selected as the most recent study which was conducted in
accordance with OECD Test Guideline 423 and in compliance with GLP.
acute dermal toxicity study is available for Crude Tall Oil. The test
was carried out in accordance with OECD Test Guideline 402 (limit test)
and in compliance with GLP. The observed LD50 was greater
than 2000 mg/kg bw.
acute inhalation studies in animals are available for Distilled Tall
Oil. Testing is not required since a reliable acute dermal study is
available for a related substance, and inhalation exposure is not
expected for this very low volatility substance.
According to the criteria in Regulation
1272/2008, Distilled Tall Oil is not classified for acute toxicity based
on read-across from Crude Tall Oil, for which LD50 values for
oral and dermal toxicity were greater than 2000 mg/kg bw.
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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