Registration Dossier
Registration Dossier
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EC number: 203-328-4 | CAS number: 105-76-0
Endpoint summary
Administrative data
Description of key information
Based on a combined repeated dose toxicity study with reproduction/developmental toxicity screening test (OECD 422 and under GLP conditions; RL1)) in rats and a 90-day oral toxicity study (OECD 408 and under GLP conditions), the subchronic oral via gavage LOAEL for systemic toxicity of dibutyl maletae is considered to be 30 mg/kg/day, based on chronic progressive nephropathy and mineralization in the kidneys and increased liver and kidney weights.
Repeated dose dermal studies of dibutyl maleate have not been reported.
Repeated dose inhalation studies of dibutyl maleate have not been reported.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- LOAEL
- 30 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
In a combined repeated dose and reproductive/developmental toxicity screening test, an increased absolute and/or relative liver and kidney weights in female and male rats and renal tubular lesions in male rats were observed in high dose animals (300 mg/kg). No adverse effect on reproductive performance was found. The NOEL was determined to be 95 mg/kgBW/day. The kidney and liver were identified as the main target organs.
In addition, a 90-day oral subchronic toxicity study have been conducted. Dibutyl maleate was adminestered via oral gavage to rats at 30, 95 and 300 mg/kgBW/day. Based on the results, chronic progressive nephropathy and mineralization in the kidneys, the LOAEL was determined to be 30 mg/kgBW/day.
Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: kidneys
Justification for classification or non-classification
According to regulation (EC) No 1272/2008, dibutyl maleate is classified category 2 for STOT-RE due to chronic progressive nephropathy and mineralization in the kidneys seen in the 90 -day oral subchronic toxicity study in rats.
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