Exposure to a crop protection chemical via inhalation poses a potential risk to human health. This is especially true for worker safety because exposure levels are far higher than they are for consumers. Preparation of solutions, application by dusting or spraying, post-application cleaning of equipment, and even crop harvesting and processing, are all opportunities for inadvertent inhalation. Exposure risk is usually acute or subacute, but toxic effects can be acute or chronic, particularly for the respiratory system.
For these reasons, inhalation studies are mandatory components of the toxicology studies in regulatory submissions for new agrochemical registrations and, often, for renewals. Additionally, inhalation data are used in establishing dose levels for other regulatory studies: human risk assessments such as worker re-entry studies and aspects such as labeling and packaging.
Labcorp can provide inhalation toxicology safety services for a broad range of assessments, be they standard studies or novel ones requiring innovative approaches and unique delivery devices.
Inhalation toxicology studies for crop protection products can be complex and need unique solutions
Inhalation toxicology safety studies on agrochemicals pose unique challenges and complexities. To maintain steady dosing in a breathing zone over many hours, and on multiple occasions in some studies, requires highly specific delivery systems. Accordingly, you need to tailor studies to your agrochemical and optimize them for its physiochemical properties to meet regulatory endpoints. You may need to refine standard test approaches to optimize study integrity, and need to provide justifications for any refinements. This means partnering with a team you can trust to design and run your inhalation toxicology studies to match your needs and the needs of your agrochemical.
An inhalation toxicology team with extensive and diverse expertise in crop protection
Our inhalation toxicology team comprises experts from diverse backgrounds and with extensive experience in planning and running inhalation toxicology studies for agrochemicals. The team includes animal welfare specialists, vets, pathologists, study managers, engineers, aerosol technologists, chemical analysts, and inhalation science toxicology experts. With regulatory scientists on hand to provide advice on regulatory compliance.
Performing recognized inhalation studies for crop protection products that deliver reliable, robust results
We have experience in performing common inhalation toxicology studies:
- A full range of endpoints including acute and chronic
- Inhalation carcinogenicity and neurotoxicity
- Studies with novel applications or dosing up to 24 hours/day
- Embryofetal, one-generation (EORGTS) and two-generation reproductive studies
Innovating to address your specific agrochemical challenges
Sometimes standard approaches don’t work — that’s when our ‘first of a kind’ inhalation toxicology mindset can create a solution suited to your unique challenge. This may be to address unusual endpoints or it may mean customizing inhalation delivery equipment to ensure regulatory acceptance. This could be via custom-built aerosol generation devices, inhalation chambers or sampling equipment, or even by 3D printing face masks specific to individual test animals. As your partner, we can innovate and enhance standard study approaches to optimize them for your agrochemical.
Utilizing state-of-the-art analytical techniques and facilities to produce high-quality data
Working hand in hand with inhalation-specific analytic scientists, the inhalation toxicology team ensures high-quality data for your crop protection product is produced in an appropriate timescale. Analytical approaches include GC, IR, photometers, UPLC and HPLC analysis and compound specific analysis. Lung-burden analysis and bronchoalveolar lavage are carried out as well as clinical observations and pathology studies.
High welfare standards assured
We are proud of the high welfare standards observed in all our in vivo work and especially in inhalation studies. An expert team of animal technicians and veterinarians ensures the highest levels of animal care in the design and conduct of studies. Inhalation studies for agrochemicals can be performed on the following species:
A comprehensive range of inhalation toxicology studies for your agrochemical
Our standard suite of inhalation toxicology studies for crop protection chemicals includes:
- OECD 403/OCSPP 870.1300: Acute inhalation toxicity
- OECD 433: Acute inhalation study (fixed concentration)
- OECD 412: Inhalation toxicity study (subacute, 28-day)
- OECD 413/OCSPP 870.3465: Inhalation toxicity study (subchronic, 90-day)
As well as standard studies, we can perform non-standard and tailored inhalation studies. Chronic toxicity and carcinogenicity and DART (developmental and reproductive toxicology) studies by the inhalation route are also available.
Chronic toxicity and carcinogenicity studies:
- OECD 451/OCSPP 870.4200: Carcinogenicity studies
- OECD 452/OCSPP 870.4100: Chronic toxicity studies
- OECD 453/OCSPP 870.4300: Combined chronic toxicity/carcinogenicity studies
- OECD 414: Prenatal developmental toxicity study
- OECD 443: Extended one-generation reproductive toxicity study (EOGRTS)
- OECD 416: Two-generation reproduction toxicity
- OECD 421: Reproduction/developmental toxicity screening test
- OECD 422: Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test