Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Species:
rat
System:
male reproductive system

Additional information

Justification for classification or non-classification

Although d-Tetramethrin (CAS nr.548460-64-6) is not specifically subject to harmonized classification according to the 13th ATP of CLP (COMMISSION REGULATION (EU) 2018/1480), Tetramethrin (CAS nr.7696-12-0) is listed in the ATP, hence, it is considered appropriate reading-across the same classification to d-Tetramethrin.

No data on carcinogenicity are available for d-Tetramethrin (CAS nr.548460-64-6) at Endura as this is not a data requirement for the current registration tonnage band (10 -100 t/y).

According to the RAC opinion, Tetramethin has been classified for carcinogenicity Category 2 (H351: Suspected of causing cancer) based on two independent rat studies not available at Endura, demonstrating a statistically significant increase in the incidence of Leydig cell tumors in male rats.

The same classification (Carcinogenicity Category 2, H351: Suspected of causing cancer) is therefore applied to d-Tetramethrin (CAS nr.548460-64-6).