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Administrative data

Description of key information

The study was conducted according to OECD guidlines for Testing of Chemicals No. 407. The No Observed Effect Level (NOEL) was, determined to be 1000 mg/kg/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

Introduction:

The study was designed to investigate the systemic toxicity of the test material. It complies with the requirements for notification of a new chemical substance in the EC and follows the testing method described in Commission Directive 96/54/EC (Method B7) and OECD Guidelines for Testing of Chemicals No. 407 "Repeated Dose 28 Day Oral Toxicity Study in Rodents" (Adopted 27 July 1995).

Methods:

The test material was administered by gavage to three groups, each of five male and five female Sprague-Dawley Crl:CD® (SD) IGS BR strain rats, for twenty-eight consecutive days, at dose levels of 30, 300 and 1000 mg/kg/day. A control group of five males and five females was dosed with vehicle alone (Arachis oil BP).

Clinical signs, functional observations, bodyweight development and food and water consumption were monitored during the study. Haematology and blood chemistry were evaluated for all animals at the end of the study.

All animals were subjected to gross necropsy examination and histopathological evaluation of selected tissues from high dose and control animals was performed.

Results:

Mortality: There were no unscheduled deaths.

Clinical Observations: No clinically observable signs of toxicity were detected for test or control animals throughout the study period. Behavioural Assessment: There were no treatment-related changes in the behavioural parameters measured.

Functional Performance Tests: There were no toxicologically significant changes in the functional performance parameters measured. Sensory Reactivity Assessments: There were no treatment-related changes in sensory reactivity.

Bodyweight: No toxicologically significant effects in bodyweight development were detected.

Food Consumption: No adverse effect on food consumption or food efficiency was detected.

Water Consumption: No intergroup differences were detected.

Haematology. No toxicologically significant changes were detected.

Blood Chemistry: No toxicologically significant changes were detected.

Organ Weights: No toxicologically significant changes were detected.

Necropsy: No toxicologically significant macroscopic abnormalities were detected.

Histopathology: No treatment-related microscopic changes were detected.

Conclusion: The oral administration of ENORDET O241 to rats for a period of twenty-eight consecutive days at dose levels of 30, 300 and 1000 mg/kg/day produced no toxicologically significant changes in the parameters measured. The ‘No Observed Effect Level’ (NOEL) was, therefore considered to be 1000 mg/kg/day.

Justification for classification or non-classification

Results:

Mortality: There were no unscheduled deaths.

Clinical Observations: No clinically observable signs of toxicity were detected for test or control animals throughout the study period. Behavioural Assessment: There were no treatment-related changes in the behavioural parameters measured.

Functional Performance Tests: There were no toxicologically significant changes in the functional performance parameters measured. Sensory Reactivity Assessments: There were no treatment-related changes in sensory reactivity.

Bodyweight: No toxicologically significant effects in bodyweight development were detected.

Food Consumption: No adverse effect on food consumption or food efficiency was detected.

Water Consumption: No intergroup differences were detected.

Haematology. No toxicologically significant changes were detected.

Blood Chemistry: No toxicologically significant changes were detected.

Organ Weights: No toxicologically significant changes were detected.

Necropsy: No toxicologically significant macroscopic abnormalities were detected.

Histopathology: No treatment-related microscopic changes were detected.

Conclusion: The results above shows the substance produced no toxicological effects and therefore will not be classified.