Result: Alkane 4 was of very low acute inhalation toxicity to the rat. 9.1.4 Skin Irritation (Safepharm Laboratories Limited 1995b) Species/strain: Rabbit/New Zealand white Number/sex of animals: 4 females, 2 males Observation period: 3 days Method of administration: A single 4 semi occluded application of 0.5 mL of test substance to intact skin. Test method: OECD TG 404; EC Method B4. Dermal response: Grade 1 erythema (very slight erythema) was observed at two treated sites 30 minutes after patch removal and persisted at one treated site at the 24 observation. All treated sites appeared normal at the 48 hour observation time. 24, 48 & 72 hour mean score: Erythema/Eschar formation: 0.06; Oedema: 0.0. Result: Alkane 4 was very slightly irritating to rabbit skin. 9.1.5 Eye Irritation (Safepharm Laboratories Limited 1995o) Species/strain: Rabbit/New Zealand White Number/sex of animals: 5 males, 4 females Observation period: 1, 24, 48 and 72 hours post instillation Method of administration, Unirrigated eyes: A single instillation of 0.1 mL of the neat test substance into the conjunctival sac of the right eye of 6 rabbits. The left eye served as the control. Method of administration, Irrigated eyes: A single instillation of 0.1 mL of the neat test substance into the conjunctival sac of the eye of 3 rabbits; after 30 seconds the eye was gently irrigated with 100mL of lukewarm water for one minute. The untreated eye served as the control.
increases, or dose relationships were observed at any other dose or exposure time. Under the conditions of this study Alkane 4 is not considered clastogenic in vivo. Hazard Classification Under the NOHSC Approved Criteria for Classifying Hazardous Substances, (NOHSC 1999) Alkane 4 would not be classified as a hazardous substance. 10. ASSESSMENT OF ENVIRONMENTAL EFFECTS Tests were performed according to EC and OECD test guidelines (European Commission 1992), (OECD 1995-1996) at Safepharm Laboratories Limited UK. These facilities comply with the OECD principles of GLP and full test reports were submitted. All tests were performed on Alkane 4. 10.1 Summary of Effects on Biotic Systems Test Species Results Acute Toxicity Semi-static WAF a 96 hour OECD TG 203 Rainbow trout (Oncorhynchus mykiss) LLR50 b > 1 000 mg/L NOEC ≥ 1 000 mg/L Acute Immobilisation Static WAF a 48 hour OECD TG 202 Water Flea (Daphnia magna) ELR50 c > 1 000 mg/L NOEC ≥ 1 000 mg/L Growth Inhibition Static 96 hour OECD TG 201 Algae (Selenastrum capricornutum) EbLR50 d > 1 000 mg/L EµLR50 e > 1 000 mg/L NOEC ≥ 1 000 mg/L WAF: water accommodated fraction - see comments in text below. LLR: lethal loading rate. ELR: effective loading rate. EbLR50: effective loading rate that reduced biomass by 50%. EµLR 50: effective loading rate that reduced specific growth rate by 50% (24-48 hours). f) NOEC - no observable effect concentration. Based on the results of rangefinding studies, limit tests were conducted for the definitive studies. The toxicity of Alkane 4 on fish, water flea and algae was examined using a Water Accommodated Fraction (WAF) with a loading rate of 1 000 mg/L. The test media was stirred for 20 hours, with the mixture then allowed to stand for 4 hours prior to the removal of the aqueous phase or WAF.