Registration Dossier
Registration Dossier
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EC number: 441-100-8 | CAS number: 351197-46-1
Endpoint summary
Administrative data
Description of key information
28 days oral NOAEL (rat) = 150 mg/kg bw /d
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
There is one subacute 28-day oral toxicity study with UAX-1179 in the Wistar rat (GLP, OECD Guideline No. 407) performed by Braun, Knuppe, Gretener and Heider, 2002.
Oral administration of UAX-1179 to Wistar rats at doses of 30, 150 and 450 mg/kg/day, for 28 days resulted in:
Mortality of two males and four females treated with 450 mg/kg/day and no effects upon: Food consumption, grip strength and urinalysis.
Treatment-related findings were generally restricted to various transient, slight clinical signs (slight piloerection, slight ataxia, slight tremor, slight spasm, slight sedation, slight dyspnea, slight bradypnea and breathing noise daily and/or weekly) at 450 mg/kg/day, significantly decreased locomotor activity at 150 or 450 mg/kg/day at different time points, significantly decreased mean body weights and body weight gain in males treated with 450 mg/kg/day and significantly decreased body weight gain in females at 150 and 450 mg/kg/day, and a number of gross findings distinguishing some treated decendents from rats at terminal sacrifice.
Based on the results of this study, 30 mg/kg body weight/day of UAX-1179 was established as the no-observed-effect-level (NOEL) and 150 mg/kg body weight/day of UAX-1179 as the no-observed-adverse-eff ect-level (NOAEL).
Repeated dose toxicity: via oral route - systemic effects (target organ) neurologic: central nervous system
Justification for classification or non-classification
According to DSD (67/548/EEC) and CLP (1272/2008/EC) UAX-1179 does not need meet the criteria to be classified regarding this endpoint.
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