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Local Toxicity Assay Service

Local toxicity refers to the direct damage caused by some drugs at the site of contact with the body. It initially appears as cell death at the site of direct contact. It mainly includes irritant test, allergic test and hemolytic test. When the pharmaceutical preparations is administered by the non-oral routes such as skin, mucous membrane, tract and blood vessels, irritation, anaphylaxis and hemolytic may occur, causing local toxicity even systemic toxicity. The local toxicity caused by the pharmaceutical preparations is a part of safety evaluation before clinical application, so as to indicate the possible toxic reactions, toxic target organs and safety range during clinical application.

Creative Biolabs is a leading biotechnology services platform, providing pre-clinical evaluation technology. Operating in accordance with global regulations and fully accredited by AAALAC, Creative Biolabs ensure the overall health and safety of our laboratories and reduce risks to our customers. Our researchers are all from accredited organizations and institutions and are rigorously trained to ensure that the quality of local toxicity assay service meets national standards.

We provide but are not limited to:

  1. Irritant test. Irritant test is to observe whether the blood vessels, muscles, skin, mucous membrane and other sites contacting with the selected drugs appear redness, congestion, degeneration, necrosis and other local reactions.
    • Skin irritant test. Transdermal drug delivery system and other non-oral administration contacted with skin should consider skin irritant test.
    • Injection site irritant test. Irritant test at injection site should be considered for the injection.
    • Eye irritant test. Eye irritant test should be considered for eye-drops preparations and pharmaceutical that may contact with the eye.
  2. Allergic test. Allergy test is to observe whether the screened drugs induce specific immunoreactions, causing tissue damage or physiological dysfunction. What kind of allergic test should be carried out is determined by many factors, including the characteristics of the drug, the clinical indications, administration route, the mechanism of allergic reaction and the influencing factors.
    • Type I allergic reactions should be examined when the drug (such as injection and transdermal drug delivery system is given locally and performs systemic function. For the injection, Creative Biolabs can provide active systemic anaphylaxis (ASA) and passive cutaneous anaphylaxis (PCA). For the transdermal drug delivery system, Creative Biolabs can provide active cutaneous anaphylaxis (ACA).
    • Inhalation induction and stimulation test can be carried out for inhalation drug in cavy.
    • Type II and III allergic reactions can refer to the results in repetitive dose toxicity test (such as symptoms, signs, blood system, immune system and related histologic changes) to draw up the experiment scheme.
    • For the transdermal drug delivery system, Type IV allergic reactions should be performed. Creative Biolabs can provide guinea-pig maximization test (GPMT) , Buehler test and other reasonable methods such as murine local lymph node assay (LLNA).
    • If the chemical structure of the tested drug is the same or similar to the compounds reported in the literature that cause other allergic reactions, it is suggested that appropriate testing methods should be considered to investigate whether the chemical substance can cause other allergic reactions (such as photosensitized reaction).
  3. Hemolytic test. Hemolytic test is to observe whether the screened drugs induce hemolysis and erythrocyte aggregation. Hemolytic test should be performed for injections and other topical preparations that may cause immune or non-immune hemolysis
    • Hemolytic test including in vitro and in vivo tests. If in vitro result is positive, comparative studies should be carried out with marketed preparations of the same administration route. In vivo animal experiment can be carried out when necessary.
    • In combination with repetitive dose toxicity test, the indicators of hemolytic reaction (such as reticulocyte, erythrocyte number, bilirubin, urinary protein and secondary changes in kidney, spleen and liver) should be observed. If hemolysis occurs, further study should be carried out.

Creative Biolabs has many years of practical experience in local toxicity assay service, carrying out a variety of in vivo drug toxicological screening services efficiently and quickly.

Advantages of mitochondrial toxicity detection services:

  • High cost performance.
  • International leading talent team.
  • Strictly following international standards and regulations.
  • All-dimensional integration of the experimental platform.


  1. Hua-Ying C, et al. Active systemic anaphylaxis test in rats [J]. Chinese Traditional Patent Medicine, 2012, 34(7):1209-1215.
  2. Ning J, et al. Spinacetin Suppresses the Mast Cell Activation and Passive Cutaneous Anaphylaxis in Mouse Model [J]. Frontiers in Pharmacology, 2018, 9:824.
  3. Inagaki N, et al. Active Cutaneous Anaphylaxis(ACA) in the Mouse Ear [J]. Japanese Journal of Pharmacology, 1992, 59(2):201-208.

*For Research Use Only. Not for use in diagnostic procedures.

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