Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
NOAEL (oral; subacute; rat) = 200 mg/kg bw/day
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral administration of test item to Wistar rats of both sexes at doses of 50, 200 and 1000 mg/kg/day, for 28 days resulted in a statistically significant increase in total locomotor activity was observed in males and females at 1000 mg/kg/day. A minimal increased erythropoiesis in the bone marrow was recorded in female animals of group 4. Histopthological findings were reported in the adrenals (minimal hypertrophy of the zona fasciculata in male animals of groups 2, 3 and 4, and slight hypertrophy of the zona fasciculata in one female animal of group 4, minimal hypertrophy of the zona glomerulosa in one male animal of group 2) and an increase in mean adrenal weight, mean adrenal to terminal body weight ratio, and mean adrenal to brain weight ratio in males at 50, 200 and 1000 mg/kg/day. These findings in adrenals were considered to be stress-related and not to be test item-related. After a 14 day treatment-free recovery period none of these histopathological changes were present.
A no-observed-effect-level (NOEL) could not be established within this study.
Due to the increased locomotor activity in both sexes at 1000 mg/kg/day the no-adverse-effect-level (NOAEL) of test item was established at 200 mg/kg/day.
Justification for classification or non-classification
For the classification of the substance as STOT-RE the dose in which significant toxic effects are observed is taken into consideration. If this dose is in the range of the guidance values indicated in the CLP Regulation (EC) No. 1272/2008 Annex I: 3.9.2.9.6 and Annex I: 3.9.2.9.7 then the substance is classified in Category 1 or Category 2 respectively.
Based on the available repeated dose toxicity studies, the substance is not classified for STOT-RE according to the CLP Regulation (EC) No. 1272/2008.
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