Registration Dossier

Toxicological information

Specific investigations: other studies

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

The following sources of information are available for the cataractogenicity potential of the registered substance:
Goldenthal, E. I. (1979a). Cataractogenic study in chicks. Report no.: 163-650. Report date: 1979-06-12.
Goldenthal, E. I. (1979b). Pilot Cataractogenic Study in Chicks. Report no.: 163-649. Report date: 1979-03-02.
Both studies are rated as reliability 2 according to the criteria of Klimisch et al. (1997). The studies were conducted sequentially utilising the results of the initial study to refine the definitive study. Although no guideline for testing was available for this type of investigation the studies were conducted in accordance with generally accepted scientific principles and therefore are of a reliable standard.

Additional information

Goldenthal (1979b) was conducted as an initial study to define a useful testing range for the definitive study (Goldenthal, 1979a). Both studies were conducted on chicks dosed orally in feed. Goldenthal (1979a) was conducted over an exposure period of 20 days where chicks were dosed at concentrations of 1.0 and 1.5% dietary level (nominal), in diet. 20 animals were used per dose level (10 males/10 females) and the positive control substance 2,4-dinitrophenol was utilised to provide a reference group for comparison of tissues. No changes considered to be related to the registered substance were seen in general behaviour, appearance, body weight or food consumption. No cataracts were found for any of the chicks in the control or treated groups. No gross pathologic lesion which were considered due to exposure to the registered substance were seen in the eyes of the test group chicks at necropsy. No compound related microscopic ocular lesions were seen in the eyes of any chicks from either treated groups.