Local Toxicity Testing Services

Local toxicity testing evaluates toxic responses induced by locally-administered drugs. It mainly covers pharmaceutical products for dermal, ocular, nasal and inhalation delivery, as well as rectally-and vaginally-applied formulations.

Service

Irritation Tests

•Vascular irritation

•Muscle irritation

•Ocular irritation

•Dermal irritation

•Subcutaneous irritation

•Irritation for intranasal and inhalation products

•Irritation for intestinal preparations

Sensitization Tests

•Dermal phototoxicity test

•Active systemic anaphylaxis test

•Passive systemic anaphylaxis test

•Dermal sensitization test

Hemolysis Test

•In-vitro hemolysis test

Test Animal Species & Administration Routes

Supported by robust animal husbandry and management systems and standardized animal facilities, JOINN delivers local toxicity testing across multiple animal species and administration routes. All studies comply with animal welfare requirements to guarantee animal quality and reliable test outcomes. Optimal animal species and dosing routes can be selected based on test article properties and global regulatory expectations, to meet evaluation demands for various locally-applied formulations.

Animal Species

•Rodents: rats, mice, guinea-pigs

•Non-rodents: rabbits, minipigs, etc.

Administration Routes

•Oral administration

•Parenteral administration

•Other routes of administration

Case Studies

Case 1

Local irritation and sensitization evaluation for a dermal patch

The client commissioned JOINN to perform a full package of dermal irritation, dermal sensitization and dermal phototoxicity tests. Based on the characteristics of the patch formulation, guinea-pigs and rabbits were selected as test animals with customized study designs. All work was performed in strict accordance with ICH guidelines with accurate data documentation. The compliant study results supported the client’s FDA IND submission, obtained regulatory acceptance and accelerated clinical development of the dermal patch.

Case 2

Ocular irritation test for an eye-drop product

Considering the ocular delivery feature of the eye-drop, JOINN adopted the rabbit ocular irritation model and simulated clinical dosing frequency to systematically observe mucosal irritation responses in eyes. Supported by a professional pathology team, precise pathological diagnostic reports were delivered. Study data passed NMPA review in China, providing solid non-clinical evidence for subsequent clinical studies and earning high recognition from the client.

Case 3

Vascular irritation and hemolysis tests for an injectable product

The client required concurrent vascular irritation and in-vitro hemolysis testing. A dedicated technical team at JOINN optimized study design and strictly controlled experimental conditions to ensure data accuracy and regulatory compliance. The final results passed both FDA and domestic regulatory reviews, demonstrating JOINN’s technical strengths and expertise in local toxicity assessment for injectables.