Organ weighted and collected for histopathology.

Salmon nasal cartilage is a rich source of proteoglycan and collagen that is widely used in food products. In Japan, a novel extraction method has been developed and patented that enable the simultaneous production of proteoglycan and undenatured collagen from salmon nasal cartilage. This study evaluated the subchronic oral toxicity of this extract mixture (SCP Complex-LS, containing 40% proteoglycan and 40% undenatured collagen) in a 90-day repeated toxicity study in Sprague-Dawley rats, following by a 14-day recovery period. Rats (20/group; 10 males and 10 females) were administered SCP Complex-LS once daily by oral gavage at doses of 0 (vehicle), 10.3, 20.6, or 41.2 mg/kg body weight/day, with additional recovery groups (10/groups; 5 males and 5 females) receiving vehicle or the high dose. Clinical endpoints included mortality, clinical observations, body weight, food consumption, estrous cyclicity, ophthalmoscopy, clinical pathology, organ weights, gross pathology, and histopathology. No deaths or test item-related clinical signs were observed. Sporadic changes in hematological, biochemical, urinary, or organ weight parameters occurred in some dose groups but were small in magnitude, showed no consistent dose-response relationship, and were not corroborated by histopathological alterations. Histopathology revealed only minimal findings, such as mild inflammation or congestion in the liver, kidneys, and lungs, occurring at low incidence and with similar frequency in both control and high-dose groups. Estrous cycles remained within normal limits, and recovery groups showed no evidence of delayed or irreversible toxicity. Based on these findings, the No Observed Adverse Effect Level (NOAEL) for SCP Complex-LS was determined to be 41.2 mg/kg body weight/day in Sprague-Dawley rats under the conditions of this study, supporting its safety for use as a food ingredient within the expected range of human intake.

鲑鱼鼻软骨是蛋白聚糖与胶原蛋白的优质天然来源，被广泛应用于食品加工领域。日本已研发出一种获专利授权的新型提取方法，可从鲑鱼鼻软骨中同步制备蛋白聚糖与未变性胶原蛋白。本研究针对该提取物混合物（SCP Complex-LS，含40%蛋白聚糖与40%未变性胶原蛋白），以斯普拉-道来（Sprague-Dawley）大鼠为受试对象，开展了为期90天的亚慢性经口重复给药毒性试验，并增设14天恢复期以评估毒性可逆性。试验组大鼠每组20只，雌雄各10只，每日经口灌胃给予SCP Complex-LS，给药剂量分别为0（溶媒对照组）、10.3、20.6及41.2 mg/kg体重/日；恢复期组每组10只，雌雄各5只，分别给予溶媒或高剂量受试物。本次试验的临床观察终点包括死亡率、临床体征、体重、摄食量、动情周期、眼科检查、临床病理学指标、脏器重量、大体病理学检查及组织病理学检查。试验期间未出现与受试物相关的死亡及临床体征异常。部分剂量组的血液学、生化、尿液学或脏器重量参数偶见异常，但变化幅度极小，未呈现一致的剂量-反应关系，且未得到组织病理学改变的佐证。组织病理学检查仅见轻微异常，如肝脏、肾脏及肺部轻度炎症或充血，发生率较低，且对照组与高剂量组的出现频率无显著差异。受试大鼠的动情周期均维持在正常范围内，恢复期组未观察到延迟性或不可逆毒性反应。基于上述试验结果，本研究条件下SCP Complex-LS在斯普拉-道来大鼠中的未观察到有害作用水平（NOAEL）为41.2 mg/kg体重/日，该结果支持其在预期人体摄入范围内作为食品原料使用的安全性。