Specific Toxicity


SNBL knows what your team needs to accurately assess your compound's potential for toxicity: quality data from regulatory compliant studies, with timely delivery and high ROI. Our team of experienced Study Directors delivers answers to your investigative questions using methods such as human lymphocyte chromosomal aberration tests, pathogen experiments with genetically engineered virus-vectors, and ELISA serum-antibody titer determinations. With a broad range of targeted, internationally recognized studies—from phototoxicity to implantation studies—we generate for you insights and informative data about your development molecules or devices.


Timeline for Reporting

1.5 to 2.5 months, from approval of the protocol until submission of the draft report (if pathological examinations are included, the testing period is 3.5 to 4 months)

 

Local Irritation

SNBL conducts local irritation studies to investigate whether your pharmaceuticals, medical devices, chemical compounds, or agrochemicals irritate skin or muscle tissue, blood vessels, or mucosal tissues.

  • Primary skin and intracutaneous irritation
  • Ocular irritation
  • Vasostimulation
  • Intramuscular and subcutaneous local irritation
  • Cumulative skin irritation, phototoxicity test (both in vivo and in vitro)
  • Cumulative eye irritation, including contact lens application studies

Both primary and cumulative irritation studies can encompass nasal, vaginal, rectal, and oral mucosa irritancy.

 

Antigenicity and Sensitization

In antigenicity and sensitization studies, we expose the test system to your compound, device, or agrochemical, and then investigate the inducibility of immediate and delayed allergies. 

 

Antigenicity

  • Active systemic anaphylactic response
  • Passive cutaneous anaphylactic response
  • Passive hemagglutination response
  • Cutaneous response via Arthus reaction and delayed cutaneous response)
  • Determination of serum-antibody titers by ELISA
  • Determination of specificity of immunoreaction by Western blot analysis

Skin Sensitization

  • Maximization test
  • Adjuvant and patch test
  • Buehler test
  • Local lymph node assay (LLNA), RI or non-RI

Skin Photosensitization

  • Adjuvant and strip test

 Eye irritation studies

  • Macroscopic observations according to the Draize method
  • Slit lamp examinations of damage to the anterior ocular segment (damage to the cornea epithelium is examined with fluorescent dye)

We also have a wealth of experience in extensive ocular toxicity testing.

 

Other

Hemolysis Studies

We also offer skin injury model studies and peritoneal dialysis model studies.

 

Genotoxicity

With a track record spanning decades and over a thousand studies, we can perform GLP-compliant tests for any regulatory agency.

  • Bacterial reverse mutation test
  • Chromosomal aberration test using cultured cells or human lymphocytes
  • Micronucleus test using bone marrow or peripheral blood
  • In vitro micronucleus test
  • Mouse lymphoma assay
  • Comet assay
  • Cytotoxicity (colony formation inhibition test)

Phototoxicity (in vivo, in vitro)

We have an outstanding record for 3T3 neutral red uptake (NRU) phototoxicity tests in vitro, and in vivo studies using guinea pigs, rats, and mice.

 

Implantation

We are highly experienced in implanting medical devices into skin, muscle, and bone, also have experience with intraperitoneal implantation, vascular graft replacement, and dura mater replacement.

 

Experiments Using Pathogens

We perform biosafety studies in our dedicated facilities using non-human primates, rodents, and ferrets, including studies using genetically modified organisms (GMOs). We can also evaluate your vaccines with a wide variety of in vitro assays.