Registration Dossier
Registration Dossier
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EC number: 204-616-2 | CAS number: 123-30-8
Endpoint summary
Administrative data
Description of key information
The following Klimisch 1 studies have been conducted: (1) a subchronic study (90 days) conducted according to GLP and per OECD guideline in the rat with a NOAEL of 10 mg/kg bw/day and a LOAEL of 30 mg/kg bw/day and (2) a subacute toxicity study (28-day) conducted according to GLP and per OECD guideline in the rat with a NOAEL of 20 mg/kg bw/day. The NOAEL from the 90-day study was used to calculate the DNEL, long-term inhalation route systemic and DNEL, long term dermal route systemic. The primary target organ of toxicity in the 28-day study and 90-day study was the kidney.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 10 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: kidneys
Justification for classification or non-classification
The subchronic 90 -day repeated dose study in the rat indicated a NOAEL of 10 mg/kg bw/day and a LOAEL of 30 mg/kg bw/day with kidney effects occurring at the LOAEL. Therefore, the classification of specific target organ toxicity (STOT) repeat exposure
category 2 is supported by the data.
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