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EC number: 230-991-7 | CAS number: 7397-62-8
Endpoint summary
Administrative data
Description of key information
Animal data demonstrate that butyl glycollate (Polysolvan O) induced only very mild and reversible functional effects.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
The subacute oral toxicity of Polysolvan O (butyl glycollate, 97.3 %) was investigated in male and female Wistar rats according to OECD guideline 407 under GLP conditions. Each 5 males and 5 females received dose levels of 0, 8, 40, 200 and 1000 mg/kg bw/day by daily gavage during a period of 29 days (28 applications).The test item was dissolved in sesame oil. Mortality, clinical findings and behavior were examined at least once a day, body weight and food consumption was determined twice a week and water consumption once a week. At the end of the application, hematology, clinical chemistry and urinalysis were performed. After sacrifice, a complete necropsy was performed, organ weights were determined and the animals were subjected to histopathology.
No animal died prior to schedule and there were no clinical signs of toxicity. No effect was noted for body weight/body weight gain, food/water consumption and hematology. Gross pathology and histopathology revealed no treatment related findings and the organ weights were not affected. Only at the top dose level of 1000 mg/kg bw/day there was a slight increase in inorganic phosphor and slight decrease in protein as well as a slight increase of erythrocytes in urine sediment in both sexes. However, all findings are known to be reversible.
In conclusion, Butyl glycollate (Polysolvan O, 97.3 %) was tolerated up to the limit dose level of 1000 mg/kg bw/day without any adverse finding of systemic toxicity. Only isolated minor and reversible changes in clinical chemistry and urinalysis were noted. The NOEL for subacute toxicity was 200 mg/kg bw/day, while the NOAEL can be considered as 1000 mg/kg bw/day for male and female Wistar rats (Hofmann et al., 1990).
Justification for classification or non-classification
Based on the available data, butyl glycolate (Polysolvan O) does not have to be classified according to Directive 67/548/EEC and the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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