GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS

hour observation and crust formation was observed in two animals treated with C18 alpha
olefin. No skin irritancy was observed with C20-C24 branched and linear alkenes.
Volunteers experienced moderate to strong erythema, oedema and papules following patch
application of neat 1-octadecene for a 24 hour exposure period. Gulftene 16-18 is expected
to have some irritant potential and skin drying effects.
Eye Irritation
Slight, transient eye irritation was observed in rabbits treated with C12-C16 alpha olefin
blend, C16 alpha olefins, C16/C18 alpha olefins, isomerised, and C20-C24 alkenes, branched
and linear. By analogy, Gulftene 16-18 is not expected to display prolonged or significant
eye irritation.
Skin Sensitisation
The following alkenes were found to be non sensitising to guineapig skin: (C20-C24 alkenes,
branched and linear (adjuvant type test); C16/C18 alpha olefins, isomerised and C16 and C18
alpha olefins (non-adjuvant type test) * ; and C12-C16 alpha olefins (non-adjuvant type test,
Landsteiner technique). C18 alpha olefin was reported non-sensitising in a Human Repeat
Patch Insult Test*. Gulftene 16-18 is not expected to be dermally sensitising based upon the
sensitisation studies conducted on analogue alkenes and the absence on Gulftene 16-18 of
functional groups commonly associated with skin sensitisers.
Repeated Dose Toxicity
Oral
In a combined 4-week oral systemic, reproductive/developmental toxicity and neurotoxicity
study in rats, 1-tetradecene at concentrations of 100, 500 or 1 000 mg/kg/day produced no
systemic effects other than hepatocyte cytoplasmic vacuolation and increased liver weights in
both sexes at and above 500 mg/kg/day and kidney effects in males at all doses consistent
with male rat specific alpha 2 microglobulin induced hydrocarbon nephropathy. Kidney
effects are not considered relevant to human health, but precluded establishment of a
NOAEL. The NOAEL in females was 100 mg/kg/day. In the same study, neurotoxicity was
not observed in a functional observation battery or motor activity test. The NOAEL for
neurotoxic effects was established at 1 000 mg/kg/day.
Rats dosed orally with C20-C24 alkenes, branched and linear, at 100, 500 or 1 000 mg/kg/day
for 13 weeks were found to have an increased incidence of minimal centrilobular hepatocyte
hypertrophy associated with increased liver weight, and minimal or slight cortical
hypertrophy in the adrenals (with increases in adrenal weight) at 1 000 mg/kg/day. Observed
changes were reversible during the 4-week recovery period. Based upon the effects on the
liver and adrenals at 1 000 mg/kg/day, the NOAEL determined for this study is 500
mg/kg/day.
Dermal
Dermal application of 1 000 or 2 000 mg/kg/day of C12-C16 alpha olefins to rats for 2 weeks
(9 applications) resulted in decreased body weight at 2 000 mg/kg/day and a severe irritant
reaction, but no systemic or organ toxicity. The NOAEL is 1 000 mg/kg/day. Repeated
dermal application of 0.2 mL/day C16-C18 alpha olefins to rabbits for 28 days (20
applications) produced slight hyperemia, exfoliation and scab formation at the site of
* Full study report not provided.
FULL PUBLIC REPORT 26 April 2000
NA/713 Page 75 of 100