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EC number: 221-070-0 | CAS number: 2997-92-4
Endpoint summary
Administrative data
Description of key information
One 28 -days repeated dose toxicity study for the oral route is available.
A NOAEL of 25 mg/kg bw/day is identified. No studies for other routes are available.
One 90 -days repeated dose toxicity study for the oral route is available.
A NOAEL of 150 mg/kg bw/day is identified. No studies for other routes are available.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- One 28 day repeated dose toxicity study and one 90 day repeated dose toxictiy study available.
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
Mode of Action Analysis / Human Relevance Framework
The OECD 407 reported adverse effects at 75 mg/kg bw, but it showed in the OECD 408 that these reported effects (increased kidney size, decreased adrenal gland, effect on serum potassium) do not prolong in longer exposure. Therefore these effects are rated as non-adverse for long-time exposure. In addition, the OECD 408 uses more animals per dose group, and hence presents a statistically more robust data basis.
The NOAEL for Hazard assessment is 150 mg/kg bw/day, derived from the OECD 408 90 day study.
Effects seen in the OECD 408 study are either rated as non-adverse (effects seen only in high dose group) or present a species and sex specific effect (hyaline droplets in male rats, all groups including control).https://ntp.niehs.nih.gov/nnl/urinary/kidney/rtaccum/kidney-renal-tubule-accumulation-hyaline-pdf_508.pdf
Additional information
Justification for classification or non-classification
The presented data for repeated dose toxicity is reliable and based on two adequate guideline studies. The observations within the studies are conclusive but not sufficient for a classification as Specific Target Organ Toxicant according to Regulation (EC) No. 1272/2008.
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