Vivotecnia can plan and execute the complete battery of toxicology tests required to file your registration dossier according to REACH testing requirements. Our REACH toxicology testing services comprise programs tailored to facilitate your successful registration.
If you manufacture or import from outside the EU more than one ton of chemical substances per year, you may have registration obligations under REACH with a May 31st, 2018 deadline. Contact us to find out more about how Vivotecnia can help you through the registration process.
- Acute oral toxicity -fixed-dose procedure, OECD 420
- Acute oral toxicity – acute toxic class method, OECD 423
- Acute oral toxicity: up-and-down procedure, OECD 425
- Acute dermal irritation/corrosion, OECD 404
- In vitro skin corrosion: human skin model test, OECD 431
- In vitro skin irritation: reconstructed human epidermis test method, OECD 439
- Acute eye irritation/corrosion, OECD 405
- Bovine corneal opacity and permeability test method for identifying i) chemicals inducing serious eye damage, and ii) chemicals not requiring classification for eye irritation or serious eye damage, OECD 437
- Chronic toxicity study (rodents, 12 months), OECD 452
- Combined chronic toxicity/carcinogenicity studies, OECD 453
- 28 and 90 days
- 12, 18 and 24 months
Equipment and Facilities
Our newly renovated, state-of-the-art animal facilities cover over 2680 sq. ft. with 328 sq. ft. dedicated to our nonhuman primate facility. This multispecies facility is customizable to adapt to the specific requirements of each study with strict adherence to animal welfare regulations and standards as set by the relevant animal protection authorities.
The constant upgrading of our animal facilities and equipment has resulted in an energy-efficient and cost-competitive nonclinical research center. The facilities are equipped with a state-of-the-art HVAC system and animal rooms are continuously supplied with 100% fresh air. An integrated building management system (BMS) constantly monitors environmental parameters like room temperature, relative humidity and differential pressure in the animal facility.
Clinical Pathology Services
Vivotecnia offers comprehensive GLP-compliant clinical pathology testing services to support general toxicology studies. Our fully equipped, automated laboratory facilities provide consistent quality and rapid standard hematology, coagulation, clinical biochemistry and urinalysis determinations. We can provide you with specialized laboratory services to meet your particular development needs for assays or biomarkers for other specific safety studies.
Anatomic Pathology Services
Our state-of-the-art necropsy and anatomic pathology labs and selected partners are staffed by some of the best trained technicians and most experienced, board-certified toxicologic pathologists who can offer anything from routine procedures to highly specialized methods to support your nonclinical development program.
Our team and Experience
Vivotecnia employs some of the most experienced and talented minds in the industry who work closely with our clients, always flexible and responsive to find solutions and satisfy your needs. Our scientific team has extensive experience and widely varied backgrounds in multiple disciplines and is fully committed to your nonclinical development program. Their years of experience with complex general toxicology studies and their ability to respond to unexpected issues mean that you will obtain robust and regulatory compliant data, keeping you on-track and progressing with your registration process.
- REACH regulation (Regulation (EC) No 1907/2000.
- Directive 67/548/EEC and Regulation (EC) No. 1272/2008 on the classification, labelling and packaging (CLP) of substances and mixtures.
- The Globally Harmonized System of Classification and Labeling of Chemicals (GHS).
Test Methods (OECD guidelines)
- Test No. 402: Acute Dermal Toxicity
- Test No. 403: Acute Inhalation Toxicity
- Test No. 436: Acute Inhalation Toxicity – Acute Toxic Class Method
- Test No. 404: Acute Dermal Irritation/Corrosion
- Test No. 405: Acute Eye Irritation/Corrosion
- Test No. 420: Acute Oral Toxicity – Fixed Dose Procedure
- Test No. 423: Acute Oral toxicity – Acute Toxic Class Method
- Test No. 425: Acute Oral Toxicity: Up-and-Down Procedure
- Test No. 407: Repeated Dose 28-day Oral Toxicity Study in Rodents
- Test No. 412: Subacute Inhalation Toxicity: 28-Day Study
- Test No. 417: Toxicokinetics
- Test No. 408: Repeated Dose 90-Day Oral Toxicity Study in Rodents
- Test No. 409: Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents
- Test No. 411: Subchronic Dermal Toxicity: 90-day Study
- Test No. 413: Subchronic Inhalation Toxicity: 90-day Study
- Test No. 417: Toxicokinetics