Registration Dossier

Administrative data

Description of key information


The study was based on the following guidelines.

- EC Directive 96/54/EEC, B.7 Repeated Dose (28 days) Toxicity (oral), 1996.

- OECD 407, Repeated Dose 28-day Oral Toxicity Study in Rodents, 1995.

- OPPTS 870.3050, Repeated dose 28-day oral toxicity study in rodents. Office of Prevention, Pesticides and Toxic Substances (7101), EPA 712-C-00-366, 2000.

Rationale for dose levels

Based on the results of a 5-day range finding study, the dose levels for this 28-day oral gavage study were selected to be 0, 50, 150 and 1000 mg/kg/day.

Study outline

The test substance was administered daily for 31 days by oral gavage to SPF-bred Wistar rats. One control group and three treated groups were tested, each consisting of 5 males and 5 females.

Evaluated parameters

Chemical analyses of formulations were conducted once during the study to assess accuracy and homogeneity.

The following parameters were evaluated: clinical signs daily; functional observation tests in week 4; body weight and food consumption weekly; clinical pathology and macroscopy at termination; organ weights and histopathology on a selection of tissues.


Formulation analyses confirmed that formulations of test substance were prepared accurately and homogenously.

No treatment-related toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination).

From the results presented in this report a definitive No Observed Adverse Effect Level

(NOAEL) for the test substance of 1000 mg/kg/day was established

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
1 000 mg/kg bw/day
Study duration:
Quality of whole database:
High quality

Additional information

Justification for classification or non-classification