Registration Dossier

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.