Hydrolysis as a Function of pH: Not applicable –see comments below Dissociation Constant: Not applicable –see comments below Flash Point: 110C (closed cup) ISO 2719 132C 154C (closed cup) >132C 132-138C 182C Flammability Limits: 0.3% LEL 4.3% UEL - - - - - Autoignition Temp: 235-239C - - - 227C 222C Explosive Properties: Not explosive. Combustible Reactivity/Stability: Stable under normal conditions Particle Size: Not applicable - Viscous liquid *notified chemical. **estimated values see comments below. - no data available.
Rabbit/NZ White C14 – C16 Non irritating Rabbit/NZ White C14 – C18 Olefin/Paraffin Non irritating Rabbit/NZ White C14 – C18 Olefin Non irritating Rabbit/NZ White C14 – C18 Olefin/Paraffin Non irritating Rabbit/NZ White C14 – C26 Olefin Non irritating Rabbit/NZ White C14 – C26 Olefin/Paraffin Non irritating Rabbit/NZ White C18 – C24 Olefins Non irritating Rabbit/NZ White C18 – C26 Olefin/Paraffin Non irritating Rabbit/NZ White C18 – C30 Olefin/Alcohol Non irritating 9.1.7 Skin sensitisation 9.1.7.1 Landsteiner technique Guineapig/albino C12 – C16 Alpha Olefin Non sensiting 9.1.7.2 Buehler technique Guineapig/Hartley C16/C18 Alpha Olefins, isomerised Non sensitising 9.1.7.3 Magnusson and Kligman Guineapig/Dunkin Hartley White C20 - 24 Alkenes, branched and linear Non sensitising 9.1.7.4 Other Alkenes 9.1.7.4.1 Buehler technique Guineapig/strain not specified Neodene 16 Olefin (1-hexadecene) Non sensitising 9.1.7.4.2 Guineapig/strain not specified Neodene 18 Alpha Olefin (1-octadecene) Non sensitising 9.1.7.5 Other Alkenes Repeated Patch Insult Test Neodene 18 Alpha Olefin (1-octadecene) Non sensitising 9.2 Repeat Dose Toxicity 9.2.1 2-week, dermal Rat/Fischer 344 Gulftene 12-16 NOAEL = 1 000 mg/kg 9.2.2 Other Alkenes 4-week, dermal Rabbit/NZ C16 - C18 Slight hyperemia, exfoliation, oedema
9.2.3 Up to 51 days, oral Rat/ Sprague Dawley Crl:CD BR VAF/Plus 1-tetradecene (blend from three suppliers) NOAEL = 1 000 mg/kg/day for reproductive neurotoxic effects; NOAEL = 100 mg/kg/day for systemic effects in females. No for males 9.2.4 13-week, oral Rat/ Crl:CD BR C20 - C24 Alkenes, Branched and Linear NOAEL = 500 mg/kg/day 9.3 Genetic Toxicity 9.3.1 in 9.3.1.1 Bacterial reverse mutation assay S.typhimurium, E.coli C20 - C24 Alkenes, branched and linear Negative with & w’out activation 9.3.1.2 Unscheduled DNA Synthesis Rat hepatocyte primary culture Gulftene 12 – 16 Negative 9.3.1.3 BALB/3T3 Transformation Test Mouse embryo cells BALB/3T3-A31-1-1 Gulftene 12 – 16 Negative 9.3.1.4 HGPRT Assay Chinese Hamster Ovary cell Gulftene 12 – 16 Negative with & w’out activation 9.3.1.5 Chromosome aberration Human peripheral lymphocytes C20-C24 Alkenes, branched and linear Negative with & w’out activation 9.3.1.6 Other Alkenes Bacterial Reverse Mutation Assay S.typhimurium, E.coli 1-Octadecene Negative with & w’out activation Mitotic Recombination Rat liver RL1 cells. 1-Octadecene Negative with & w’out activation Chromosome AberrationH18 Rat RL1 cells. 1-Octadecene Negative with & w’out activation 9.3.2 in vivo
9.1 Acute Toxicity 9.1.1 Acute Oral Toxicity 9.1.1.1 Acute Oral Toxicity of C12-C16 Alpha Olefin (Rinehart 1967) Test Substance: C12-C16 alpha Olefin (98.5% olefins, 1.5% saturates) Species/strain: Rat/Wistar Number/sex of animals: 10 males Observation period: 14 days Method of administration: Gavage 5 000 mg/kg or 10 000 mg/kg (dose volume of 2.65 – 3.50 mL/kg). Test method: US Federal Hazardous Substances Labelling Act Clinical observations: A few days after dosing, animals had very coarse oily fur over the whole body, particularly severe in the hindquarter area. This observation persisted for the remainder of the observation period. Mortality: Two deaths observed in the 10 000 mg/kg dose; considered to be due to pneumonia. Morphological findings: Not reported LD50: > 5 000 mg/kg Result: C12-C16 Alpha Olefin was of very low acute oral toxicity in rats. 9.1.1.2 Acute Oral Toxicity of C16 Alpha Olefin (Rinehart 1967) Test Substance: C16 alpha Olefin (98.5% olefins, 1.5% saturates) Species/strain: Rat/Wistar Number/sex of animals: 10 males Observation period: 14 days Method of administration: Oral, gavage 5 000 mg/kg or 10 000 mg/kg (dose volume of 2.65 – 3.50 mL/kg). Test method: US Federal Hazardous Substances Labelling Act.
Species/strain: Rat/Sprague Dawley Number/sex of animals: 5/sex Observation period: 14 days Method of administration: Oral, (gavage) 5 050 mg/kg (dose volume of 5.92 mL/kg) Test method: OECD TG 420 – fixed dose method Clinical observations: In life observations of note included diarrhoea, piloerection and polyuria, which were no longer evident by Day 11. Mortality: Nil Morphological findings: No abnormalities detected. LD50: > 5 050 mg/kg Result: C18 Isomerised Olefin was of very low acute oral toxicity in rats. 9.1.1.5 Acute Oral Toxicity of C20-24 Alkenes, branched and linear (Safepharm Laboratories Limited 1998) Test Substance: C20-24 Alkenes, branched and linear Species/strain: Rat/Sprague Dawley Crl:CD BR Number/sex of animals: 5/sex Observation period: 14 days Method of administration: Oral, gavage 5 000 mg/kg (dose volume of 6.29 mL/kg) Test method: OECD TG 420 – fixed dose method Clinical observations: Hunched posture and piloerection in all animals on day of dosing; Mortality: One female found dead one day after dosing Morphological findings: The female found dead had haemorrhagic lungs, dark liver and dark kidneys; No abnormalities detected at terminal kill. LD50: > 5 000 mg/kg Result: C20-24 Alkenes, branched and linear was of very low oral toxicity in rats.
Number/sex of animals: 10 males Observation period: 14 days Method of administration: Whole body exposure to saturated mists for one hour; exposure concentration to aerosol size of <8m was 9 900 mg/m3; and 0.45m – 2.0 m was 100 mg/m3. Test method: US Federal Hazardous Substances Labelling Act. Clinical observations: Animals were drowsy upon removal from the chamber. Animals had very oily fur over. Mortality: Nil. Morphological findings: No gross pathology at necropsy. LD50: > 9 900 mg/m3 mist (1 hour) Result: C12-C16 Alpha Olefin was of low acute inhalation toxicity in rats. 9.1.3.2 Acute Inhalation Toxicity of C16 Alpha Olefin (Rinehart 1967) Test Substance: C16 alpha Olefin (98.5% olefins, 1.5% saturates) Species/strain: Rat/Wistar Number/sex of animals: 10 Observation period: 14 days Method of administration: Whole body exposure to saturated mists for one hour; exposure concentration to aerosol size of <8m was 8 500 mg/m3; and 0.45m – 2.0 m was 150 mg/m3. Test method: US Federal Hazardous Substances Labelling Act Clinical observations: Animals were drowsy upon removal from the chamber. Animals had very oily fur over. Mortality: Nil. Morphological findings: No gross pathology at necropsy. LD50: > 8 500 mg/m3 mist (1 hour) Result: C16 Alpha Olefin was of low acute inhalation toxicity in rats. 9.1.3.3 Acute Inhalation Toxicity of C16-C18 Alkene (EU 1995)
(24, 48 & 72 hour observation): Conjunctival redness: 0.0 Conjunctival chemosis: 0.0 Ocular effects, Irrigated eyes: Conjunctival redness was noted in 2 treated eyes at the 1 hour observation; all treated eyes appeared normal at the 24 hour observation; no iridial or conjunctival effects noted Result: C20-24 Alkenes, branched and linear were very slightly irritating to the eyes of rabbits. 9.1.6.5 Acute Eye Irritation of Other Alkenes The following data, unless otherwise indicated, are taken from HEDSET data sheets for 1-tetradecene 1-hexadecene and 1-octadecene. The full study reports were not provided in the submission. The HEDSET documents indicate tests were not conducted in accordance with GLP or OECD or EC testing guidelines. In each case the following test substances were instilled into the eyes of New Zealand rabbits, without eye irrigation. The HEDSET documents reported each of the test substances as non-irritating. Test Substance Mean group score (24, 48 & 72 hour observation) Corneal opacity Iridial inflammation Conjunctival redness Conjunctival chemosis C12 – C14H14 0.0 0.0 Draize Score = 3.0** C12 - C26* Olefin/ParaffinH18 0.0 0.0 0.2 0.06 C14 – C16H14 0.0 0.0 Draize Score = 2.1** C14 – C18* OlefinH14 0.0 0.0 Draize Score = 2.7** C14 – C18* Olefin/ParaffinH18 0.0 0.0 0.22 0.4 C14 – C26* OlefinH14 0.0 0.0 Draize Score = 2.7** C14 – C26* Olefin/ParaffinH18 0.0 0.0 0.1 0.3 C18 – C24* OlefinsH18 0.0 0.0 0.5 0.6 C18 – C26* Olefin/ParaffinH18 0.0 0.0 0.2 0.3
C18 – C30* Olefin/AlcoholH18 0.0 0.0 0.5 0.6 *Purity not specified. ** Individual scores not given. H14 (EU 1995) H16 (EU 1995) H18 (EU 1995) 9.1.7 Skin Sensitisation 9.1.7.1 Skin Sensitisation of C12-C16 Alpha Olefins (Rinehart 1967) Test substance: C12 – C16 alpha olefin (98.5% olefins, 1.5% saturates) Species/strain: Guineapig/albino Number of animals: 10 males/group Test method: Landsteiner technique in (Rinehart 1967), 1967 #29]) Induction procedure: Test sites on the backs of animals were clipped and scored with a needle. 0.1mL of test substance was applied by glass rod to the test site three times weekly for nine applications. Positive control: 0.5% chlorodinitrobenzene in 50% ethyl alcohol; Vehicle control: 50% alcohol. Challenge procedure: Following a 2 week rest period after the last induction application 0.1 mL of test article was applied to the skin Challenge Outcome: No dermal response with test substance. The positive control, chlorodinitrobenzene responded appropriately. Result: C12 – C16 alpha olefins was non sensitising to guineapig skin. 9.1.7.2 Skin Sensitisation of C16/C18 Alpha olefins, isomerised (Hill Top Biolabs Inc 1995) Test substance: C16/C18 Alpha olefins, isomerised Species/strain: Guineapig/Hartley White Number of animals: 20 test animals 10 primary challenge naïve control animals; 10 rechallenge naïve control animals
The HEDSET documents indicate these tests were not conducted in accordance with GLP or OECD or EC testing guidelines. 1-Octadecene was considered not mutagenic or clastogenic in the following test systems: Test Comment Result Bacterial Reverse Mutation AssayH18 S. typhimurium TA98, TA 100, TA 1535, TA 1537, TA 1538. E. coli WP2, WP2uvrA. 0.2 to 2 000 with and without metabolic activation. Negative Mitotic RecombinationH18 S.cerevisiae JD1. 0.01 to 5.0 mg/mL; with and without metabolic activation. Negative Chromosome AberrationH18 Rat liver RL1 cells. 0 to 500 g/mL as acetone solution. With and without metabolic activation. Negative 9.3.2 In Vivo 9.3.2.1 Mammalian Erythrocyte Micronucleus Test Using Gulftene 12-16 (Gulf Life Sciences Center 1983) Test substance: Gulftene 12-16 Species/strain: (ICR) BR Number and sex of animals: Doses/Method of administration: Test substance: 1 000, 2 500 or 5 000 mg/kg; Vehicle control: corn oil; Test and vehicle control administered dermally to shaven backs of mice once per day for 2 days; Positive control, cyclophosphamide 75 mg/kg, administered via intraperitoneal injection; Sampling schedule: Test and vehicle control animals were sacrificed 24 or 48 after last dosing; Positive control group animals were sacrificed 24 hours after dosing. Clinical observations: No mortality; No clinical signs of toxicity;
Erythema Formation Rating Oedema Formation Rating No erythema 0 No oedema 0 Very slight erythema (barely perceptible) 1 Very slight oedema (barely perceptible) 1 Well-defined erythema 2 Slight oedema (edges of area well-defined by definite raising 2 Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4 The Draize scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible 1 slight 25% to 50% 2 Easily visible translucent areas, details of iris slightly obscure 2 mild 50% to 75% 3 Opalescent areas, no details of iris visible size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse deeper crimson red with individual vessels not easily discernible Diffuse beefy red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids Swelling with lids to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to haemorrhage gross destruction 2 severe