<p>Relative Organ Weight (%) of female rats.</p>

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（proteoglycan）与胶原蛋白（collagen）的优质来源，被广泛应用于各类食品中。日本已开发并获专利的新型提取方法，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%蛋白聚糖及40%未变性胶原蛋白），在斯普拉-道来大鼠（Sprague-Dawley rats）中开展90天重复给药经口亚慢性毒性试验，并随后设置14天恢复期以评价其毒性。试验采用每组20只大鼠（雌雄各10只），通过经口灌胃每日给药一次，给药剂量分别为0（赋形剂对照组）、10.3、20.6及41.2 mg/kg体重/日；另设恢复期组，每组10只（雌雄各5只），分别给予赋形剂或高剂量受试物。本次试验的临床观测指标包括死亡率、临床体征观察、体重、摄食量、动情周期、眼底检查、临床病理学检查、脏器重量、大体病理学检查及组织病理学检查。试验未观察到大鼠死亡或与受试物相关的临床异常体征，部分给药组的血液学、生化、尿液学或脏器重量参数偶有变化，但变化幅度较小，未呈现明确的剂量-反应关系，且未伴随组织病理学改变。组织病理学检查仅发现轻微异常，如肝、肾、肺轻度炎症或充血，发生率较低，且对照组与高剂量组的异常出现频率无显著差异。大鼠动情周期维持在正常范围内，恢复期组未观察到延迟或不可逆毒性的相关证据。基于上述试验结果，在本试验条件下，SCP Complex-LS对斯普拉-道来大鼠的未观察到有害作用水平（No Observed Adverse Effect Level）为41.2 mg/kg体重/日，支持其在预期人体摄入范围内作为食品配料使用的安全性。