Conventional Test Method:

Chronic Toxicity Study, second species, for pesticides (OECD TG 452)

Alternative Test Method:

Name & Description:

Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents

There is no further need to require a one year dog study for the evaluation of repeated dose toxicity of pesticides. Instead the short-term oral toxicity of the active substance to non rodents can be reported only in a 90-day study, usually in dogs. The test substance is orally administered daily in graduated doses to several groups of experimental animals, one dose level per group for a period of 90 days. During the period of administration the animals are observed closely for signs of toxicity.

Validation Status:

EU: Endorsed as a valid strategy by ECVAM (2006)

Regulatory Status:

OECD: TG 409 (1998)

US: Accepted by EPA (2007)

Effect or Potential Effect on Animal Use:

Refinement
(Duration of animal test period is shorter)

References:

• European Commission (2006) Statement on dog toxicity studies.
• OECD (1998) Test No. 409: Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents, OECD Guidelines for the Testing of Chemicals, Section 4 Health Effects.
• US Federal Register (2007) Pesticides; Data requirements for conventional chemicals, technical amendments, and data requirements for biochemical and microbial pesticides; Final rules. Dans: Code of Federal Regulations, Chapter 1 Environmental Protection Agency, Title 40 Protection of environment, CFR Parts 9, 152, 156, 159.

Information Last Reviewed:

May 2012