What is Acute (Single-Dose) Toxicity Studies?

Acute (single-dose) toxicity studies refer to the toxic reaction produced within a certain period of time when administered in a single dose, or in multiple doses during a period of 24 h in animals. Drugs intended for human use usually require animal acute toxicity tests, and especially ophthalmic drugs require acute ocular toxicity tests. Acute toxicity tests are an early stage of drug toxicology research, which is of great significance for clarifying the toxic effect of drugs and understanding their toxic target organs. The information obtained from the acute toxicity test has a significant reference value for the design of long-term toxicity test doses and the selection of the initial dose of certain drug phase I clinical trials. In addition, the acute toxicity study of the drug also can provide some information related to the acute poisoning of human drug overdose, which can support phase III of clinical research.

Fig. 1. Test substances that penetrate the furthest into the corneal tissue generally cause the most severe irritation. (Wilson SL, et al., 2015)

Service Overview

As a preclinical ophthalmology research CRO, Ace Therapeutics conducts safety and efficacy assessments across all ocular indications. These ocular toxicology studies can be performed under GLP or non-GLP conditions. We are pleased to offer unrivaled acute local toxicity studies for your ophthalmic products, which can also be used for early-stage studies.

Acute local toxicity studies from Ace Therapeutics provide information on possible health hazards resulting from chemical contact with the eyes. These results can be used as a reference for your follow-up toxicity study dose selection, and can also prompt some indicators to be focused on in follow-up toxicity studies.

Access Ace Therapeutics' Acute Local Toxicity Study of Ophthalmic Compounds

Ace Therapeutics quantifies acute local toxicity using the following protocol:

• Experiment Procedure

• Eye examination of the test animals (albino rabbits): Before the test, the animals should adapt to the animal laboratory environment for at least 3 days. 24 hours before the trial, both eyes of the experimental animals should be thoroughly examined. Animals with corneal defects or conjunctival lesions with eye irritation symptoms should not be used.
• Groups: 9 albino rabbits were divided into three groups, including the test product group, the vehicle (when applicable) group, and the control substance group.
• Administration: The test substance is administered at 1 x 100 µL into the conjunctival sac of one eye of each animal, while the other eye received no treatment and was used as a control.
• Evaluation: The experimental design is to conduct the Draize test on the eyes at 1h, 2h, 48h, and 72h. The observation time is based on assessing observed reversible or irreversible effects.
• Guidelines: OECD guideline for the testing of chemicals -Test No. 405: Acute Eye Irritation/Corrosion. 

Note*: Ace Therapeutics' acute local toxicity studies can be adjusted to meet specific requirements according to the characteristics of your product, such as structural characteristics, physicochemical properties, indication characteristics, and test purposes. Importantly, our talented scientists will also conduct a comprehensive evaluation of the test results in combination with other pharmacological and toxicological information to help you reduce asset risks before entering IND-supported studies.

With strong professional knowledge and an advanced technology platform, Ace Therapeutics provides comprehensive ocular toxicity study services. Our professional ocular toxicology research team will evaluate your ophthalmic products by designing the most suitable acute local toxicity test program. If you are interested in our services or need more detailed information, please feel free to contact us. Our experienced scientists are ready to help you!

References

1. Wilson SL, Ahearne M, Hopkinson A. An overview of current techniques for ocular toxicity testing. Toxicology. 2015, 327:32-46.
2. OECD (2023), Test No. 405: Acute Eye Irritation/Corrosion, OECD Guidelines for the Testing of Chemicals, Section 4, OECD Publishing, Paris.

• Chronic Local Toxicity Testing of Ophthalmic Drugs
• Maximum Tolerated Dose (MTD) Testing of Ophthalmic Drugs
• Lacrimation Testing of Ophthalmic Drugs
• Corneal Anesthesia Testing of Ophthalmic Drugs
• Pupil Diameter Testing of Ophthalmic Drugs

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