Registration Dossier
Registration Dossier
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EC number: 419-370-3 | CAS number: 84632-66-6
Endpoint summary
Administrative data
Description of key information
The test item was administered orally by gavage to groups of 10 male and 10 female Sprague-Dawley rats at dose levels of 0 mg/kg body weight/day (vehicle CMC), 50 mg/kg bw/d, 200 mg/kg bw/d and 1000 mg/kg bw/d for 28 days (OECD guideline 407, EU method B.7, GLP conditions). Clinical examinations, clinical pathology, histopathology and gross pathology did not reveal any finding in treated animals. The no observed adverse effect level (NOAEL) for general systemic toxicity was 1000 mg/kg bw/d in both sexes.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 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
Procedure and observations
The test item was administered orally by gavage to groups of 10 male and 10 female Wistar rats at dose levels of 0 mg/kg body weight/day (vehicle corn oil), 50 mg/kg bw/d, 200 mg/kg bw/d and 1000 mg/kg bw/d for 28 days. A detailed clinical observation was performed in all animals. Body weights and food consumption were determined in all animals. Clinicochemical and hematological examinations performed in all animals towards the end of the administration period. All animals were assessed by gross pathology; weights of selected organs were recorded and a histopathological examination was performed.
Clinical examinations, clinical pathology, histopathology and gross pathology did not reveal any finding in treated animals. The only finding of note was a discoloration of the feces which occurred in animals of all treated groups during the treatment period.
Discussion
Thus, under the conditions of this 28day toxicity study the oral administration by gavage to male and female rats did not reveal signs of toxicity. Thus, the no observed adverse effect level (NOAEL) for general systemic toxicity was 1000 mg/kg bw/d in both sexes.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is notconsidered to be classified for repeated dose toxicity under Directive 67/548/EEC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for repeated dose toxicity under Regulation (EC) No. 1272/2008.
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