patchy erythema) in the test group (7 of 19) was comparable to those produced by the naïve control group (3/10) indicating that sensitisation had not been induced. All remaining test and control animals had Grade 0.5 responses, that is, slight, patchy erythema. OECD TG 406 Test method: Alkane 2 was non sensitising to guineapig skin Result: 9.2 Repeated Dose Toxicity Test (Safepharm Laboratories Limited 1995a) – Rat/Sprague-Dawley CD Species/strain: Number/sex of animals: Oral. Test substance administered by gavage as supplied. Method of administration: Treatment 0, or 1 000 mg/kg/day for 28 consecutive Dose/Study duration: days. Recovery phase: a treatment free period of 14 days. Recovery groups were separately provided for animals of the control and 1 000 mg/kg/day test groups. OECD TG 407; EC Method B7 Test method: Clinical observations There were no deaths or clinical signs of toxicity during the treatment or recovery phase. Food and water consumption and bodyweight gain were unremarkable. Clinical chemistry/Haematology/Urinalysis No findings considered related to treatment were observed for haematological indices or blood chemistry parameters. Weights & Necropsy Significantly increased absolute ovary weight, but not relative weight, in four treated females was not considered toxicologically significant. Significantly increased relative heart, brain and ovary weight for treated recovery females and increased relative testes weight for treated recovery males, were not observed in the animals of the treatment phase and therefore these effects were not considered to be related to treatment. No treatment related macroscopic abnormalities were detected. Histopathology No treatment related morphological findings were observed. Comment No adverse effects related to treatment at 1 000 mg/kg/day were observed in this 28-day study.
patchy erythema) in the test group (7 of 19) was comparable to those produced by the naïve control group (3/10) indicating that sensitisation had not been induced. All remaining test and control animals had Grade 0.5 responses, that is, slight, patchy erythema. Test method: OECD TG 406 Result: Alkane 2 was non sensitising to guineapig skin 9.2 Repeated Dose Toxicity – Test (Safepharm Laboratories Limited 1995a) Species/strain: Rat/Sprague-Dawley CD Number/sex of animals: Method of administration: Oral. Test substance administered by gavage as supplied. Dose/Study duration: Treatment 0, or 1 000 mg/kg/day for 28 consecutive days. Recovery phase: a treatment free period of 14 days. Recovery groups were separately provided for animals of the control and 1 000 mg/kg/day test groups. Test method: OECD TG 407; EC Method B7 Clinical observations There were no deaths or clinical signs of toxicity during the treatment or recovery phase. Food and water consumption and bodyweight gain were unremarkable. Clinical chemistry/Haematology/Urinalysis No findings considered related to treatment were observed for haematological indices or blood chemistry parameters. Weights & Necropsy Significantly increased absolute ovary weight, but not relative weight, in four treated females was not considered toxicologically significant. Significantly increased relative heart, brain and ovary weight for treated recovery females and increased relative testes weight for treated recovery males, were not observed in the animals of the treatment phase and therefore these effects were not considered to be related to treatment. No treatment related macroscopic abnormalities were detected. Histopathology No treatment related morphological findings were observed. Comment No adverse effects related to treatment at 1 000 mg/kg/day were observed in this 28-day study.
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