GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS

GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS

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9.1.5.9 Evaluation of Primary Skin Irritation in Humans of Neodene 18 alpha olefin (HEDSET 1-octadecene) Test substance: Neodene 18 alpha olefin (1-octadecene) Number/sex of volunteers: 12 females, 6 males Procedure: Each volunteer received to the upper arm 0.2 mL (100%, 25%, 10% and 1% dilution in mineral oil) of test substance in a semi occluded patch for an exposure period of 24 hours Sodium lauryl sulphate (0.25% in water) served as the control. Outcome: Test sites were scored at 30 minutes and 24 hours after patch removal. Test substance at 100%: at the 30 minute observation, 16/18 volunteers exhibited moderate to strong erythema, oedema and papules. At 24 hours, 17 volunteers showed similar signs and 9 of these had effects spreading beyond the application site. Mean score: 4.28. Test substance at 25%, 10% and 1%: no evidence of irritation. Mean score:0. Control: two volunteers showed mild to moderate erythema. Mean score:0.22. Result: Neodene 18 alpha olefin was reported irritating to human skin 9.1.6 Eye Irritation 9.1.6.1 Acute Eye Irritation of C12-C16 Alpha Olefins (Rinehart 1967) Test Substance: C12-C16 Alpha Olefins (98.5% olefins, 1.5% saturates) Species/strain: Rabbit/New Zealand White Number/sex of animals: 6 males Observation period: 24, 48 and 72 hours post instillation Test method: US Federal Hazardous Substances Labelling Act FULL PUBLIC REPORT 26 April 2000 NA/713 Page 50 of 100

Draize scores of non irrigated eyes: Time after instillation Animal 24 hours 48 hours 72 hours Conjunctiva r c d r c d r c d 1 1 0 0 0 0 0 0 0 0 2 1 0 0 0 0 0 0 0 0 3 0 0 0 0 0 0 1 0 0 4 1 0 0 1 0 0 1 0 0 5 0 0 0 1 0 0 1 0 0 6 0 0 0 0 0 0 1 0 0 Cornea All individual scores were zero Iris All individual scores were zero 1 see Attachment 1 for Draize scales r = redness c = chemosis d = discharge. Ocular effects: Transient conjunctival redness; No iridial or conjunctival effects noted (all individual scores were zero). Mean group score (24, 48 & 72 hour observation): Corneal opacity: 0.0 Iridial inflammation: 0.0 Conjunctival redness: 0.4 Conjunctival chemosis: 0.0 Result: C12-C16 Alpha Olefins were slightly irritating to the eyes of rabbits FULL PUBLIC REPORT 26 April 2000 NA/713 Page 51 of 100

9.1.5.9 Evaluation of Primary Skin Irritation in Humans of Neodene <strong>18</strong> alpha<br />

olefin (HEDSET 1-octadecene)<br />

Test substance: Neodene <strong>18</strong> alpha olefin (1-octadecene)<br />

Number/sex of volunteers: 12 females, 6 males<br />

Procedure: Each volunteer received to the upper arm 0.2 mL (100%,<br />

25%, 10% and 1% dilution in mineral oil) of test substance<br />

in a semi occluded patch for an exposure period of 24 hours<br />

Sodium lauryl sulphate (0.25% in water) served as the<br />

control.<br />

Outcome: Test sites were scored at 30 minutes and 24 hours after patch<br />

removal.<br />

Test substance at 100%: at the 30 minute observation, 16/<strong>18</strong><br />

volunteers exhibited moderate to strong erythema, oedema<br />

and papules. At 24 hours, 17 volunteers showed similar<br />

signs and 9 of these had effects spreading beyond the<br />

application site. Mean score: 4.28.<br />

Test substance at 25%, 10% and 1%: no evidence of<br />

irritation. Mean score:0.<br />

Control: two volunteers showed mild to moderate erythema.<br />

Mean score:0.22.<br />

Result: Neodene <strong>18</strong> alpha olefin was reported irritating to human<br />

skin<br />

9.1.6 Eye Irritation<br />

9.1.6.1 Acute Eye Irritation of C12-<strong>C16</strong> Alpha Olefins (Rinehart 1967)<br />

Test Substance: C12-<strong>C16</strong> Alpha Olefins (98.5% olefins, 1.5% saturates)<br />

Species/strain: Rabbit/New Zealand White<br />

Number/sex of animals: 6 males<br />

Observation period: 24, 48 and 72 hours post instillation<br />

Test method: US Federal Hazardous Substances Labelling Act<br />

FULL PUBLIC REPORT 26 April 2000<br />

NA/713 Page 50 of 100

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