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Description of key information

Repeated dose toxicity: oral
NOAEL: 300 mg/kg bw/day

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

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

Additional information

In the available subacute study (14-day feeding; Virginia Chemical Inc., 1975) conducted similar to the OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents; with some deviations: no heamatology, clinical chemistry, urinanalysis, neurobehavioural examination, ophthalmoscopic examination and water consumption; no data on analytical verification of doses), the test substance was administered in the diet to 3 groups of 10 animals per sex (albino rats) at dosage levels of 75, 150 and 300 mg/kg bw per day (an additional control group received the basal diet).

 

All animals survived the 2-weeks treatment. Patterns of appearance and behavior were not remarkable in any of the treated groups throughout the study. Gross observations at necropsy and subsequent microscopic examinations of liver and kidney sections of all animals revealed no evidence of compound-related tissue alterations in any of the treated groups.

Slight dose-related decreases in the rates of body weight gain were observed in the male and female treated groups at week 1 and in the male treated groups at week 2. The weight gain of the high-dose males was approximately 20% less than that of the control gain.

Mean food consumption values were also slightly lower at week 1 and 2 in the treated male animals than in the control group, suggesting that the high-dose animals reached an unpalatability threshold.

 

Based on the result of the present study, the only dose-related effect was the reduced body weight gain particularly in male animals, an effect which may partly resulted from the concomitant slightly reduced food consumption; therefore, the lowest observed effect level (LOEL) and the no observed adverse effect level (NOAEL) were 300 mg/kg bw per day, the high dose tested.

Justification for classification or non-classification

Based on the subacute study available, there is no need for classification for repeated dose toxicity.

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