GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS

application.
Gulftene 16-18 and the analogue alkenes share similar structures and are expected to share
the same metabolic fate. Therefore, the biological activity of Gulftene 16-18 and its
metabolites would be similar to that observed for C20-24 alkenes branched and linear, and 1tetradecene
in the repeat oral dose studies and the identified target organs would be the liver
and adrenals and in male rats the kidney. However, no neurotoxicity is predicted for Gulftene
16-18. Repeated dermal exposure may cause moderate skin irritation and skin dryness.
Reproductive/Developmental Toxicity
1-Tetradecene administered orally, was evaluated for reproductive and developmental
toxicity. Male rats were exposed for 28 days prior to mating, and through mating until
euthanasia for a total of 44 consecutive days of dosing; females were dosed for 14 days prior
to mating, during mating, gestation and lactation through euthanasia at lactation day 4 (41-55
consecutive days). Doses were 0, 100, 500 and 1 000 mg/kg/day. There was no evidence of
impaired reproductive capabilities in the F0 generation. There was no evidence of
developmental toxicity in the F1 generation. The NOAEL for reproductive/developmental
effects was 1 000 mg/kg/day. As above, Gulftene 16-18 is expected to share the same
metabolic fate and is not expected to cause adverse effects on reproduction or foetal
development.
Genetic Toxicity
The C12-C24 alkenes did not display genotoxic activity in a broad range of in vitro studies:
bacterial reverse mutation (C20-C24 alkenes); mitotic gene conversion in yeast (C12 alpha
olefins); mammalian cell gene mutation, chromosome aberration and transformation; and
unscheduled DNA synthesis (C12-C16 alpha olefins). In in vivo studies, dermal application
of a C12-C16 blend of alpha olefins or intraperitoneal injection of C20-C24 alkenes branched
and linear, to mice did not induce an increase in micronucleated bone marrow erythrocytes.
Gulftene 16-18 and its metabolites are expected to be non genotoxic.
Hazard Classification of Analogue Alkenes and Gulftene 16-18
Assessment of the toxicological data of the alkene analogues against the NOHSC Approved
Criteria for Classifying Hazardous Substances, indicate that Gulftene 16-18 would be
considered hazardous based on potential aspiration hazard and skin drying effects following
repeated or prolonged exposure. The overall hazard classification is Harmful (Xn) and the
following risk phrase and safety phrases assigned:
R65 – May Cause Lung Damage if Swallowed;
R66 – Repeated Exposure May Cause Skin Dryness or Cracking 1 ;
S24/25 – Avoid Contact with Skin and Eyes;
S28 – After contact with skin, wash immediately with plenty of soap and water; and
S62 – If swallowed, do not induce vomiting: seek medical advice immediately and show this
MSDS/label.
1 This risk phrase has being recently adopted by the European Commission (European
Commission 1998). Although yet to be adopted by NOHSC, R66 should be provisionally
assigned to the Gulftene 16-18 based upon the defatting action observed with alkene
analogues.
FULL PUBLIC REPORT 26 April 2000
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