Division 3.2.1.3 Metabolic and disposition studies
United Kingdom
A metabolism study including the metabolic balance, metabolic profile and identification of the main metabolites in the urine and faeces shall be performed. If another laboratory species shows a marked difference in the sensitivity from the rat, additional information will be required.
Notes on Division 3.2.1
Textual amendments
- F1
Words in Annex 2 point 3.2.1 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 83(d)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Word in Annex 2 s. 3 point 3.2.1 substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 11(d)(i)
- F3
Words in Annex 2 point 3.2.1 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 83(d)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)