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GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS

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that sensitisation may have been induced.<br />

To confirm these results a 2 nd challenge was conducted 7<br />

days later using the same test animals and challenge<br />

concentration. Ten non previously exposed naïve animals<br />

were also concurrently treated with the test substance.<br />

2 nd challenge - number of animals exhibiting positive responses:<br />

2 nd Test Animals<br />

Naïve Control Animals<br />

Challenge<br />

Concentration 24 hours T 48 hours T 24 hours T 48 hours T<br />

5%<br />

9*/19<br />

10**/19<br />

T time after patch removal.<br />

* number of animals exhibiting Grade +/- reactions.<br />

** number of animals exhibiting Grade 1 reactions.<br />

11*/19<br />

7**/19<br />

5*/10<br />

5**/10<br />

FULL PUBLIC REPORT 26 April 2000<br />

NA/713 Page 59 of 100<br />

3*/10<br />

7**/10<br />

Comment: Following rechallenge the incidence of Grade 1 reactions<br />

was similar between test and control animals. The study<br />

authors concluded that sensitisation had not been induced.<br />

Result: <strong>C16</strong>/C<strong>18</strong> Alpha olefins, isomerised was not considered to be<br />

sensitising to guineapig skin<br />

9.1.7.3 Skin Sensitisation of C20-24 Alkenes, branched and linear (Safepharm<br />

Laboratories Limited 1998)<br />

Test substance: C20-24 Alkenes, branched and linear<br />

Species/strain: Guineapig/Dunkin Hartley White<br />

Number of animals: 20 test females, 10 control females<br />

Test method: OECD TG 406 Magnusson and Kligman Maximisation<br />

Method<br />

Induction procedure: Test animals:<br />

Day 1: three pairs of intradermal injections (0.1 mL) into the<br />

dorsal skin of the scapular region:<br />

- Freund’s complete adjuvant (FCA) 1:1 in distilled<br />

water;<br />

- the test substance diluted to 25% w/v in arachis oil;<br />

- the test substance at 25% w/v emulsified in a 50:50<br />

mixture of FCA and distilled water;

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