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EC number: 814-155-4
CAS number: 13188-82-4
OECD 422, oral, gavage (corn oil): severe local effects leading to systemic changes and death at 600mg/kg
NOAEL systemic: 200mg/kg
NOAEL local: 60mg/kg
Isopropylidenglycerinacrylat was administered in an OECD 422 guideline study at doses of 60, 200, and 600mg/kg in corn oil. Male rats were treated for 31 days, females to app. day 13 of lactation. Two high dose females died. Cause of death could be determined for one female and was due to a forestomach ulcer. All high dose animals showed severe local effects (grade 3-4, partly transmural forestomach ulcers, adaptive responses of the basal layer (stomach), thickening of the duodenal wall) accompanied by bleeding into the stomach. As a consequence, hematology showed changes indicative of continued inflammation and regenerative anemia. The latter also matched findings in the spleen. Anemia was more pronounced in males than females, but affected all high dose animals.
Minimal erosions and squamous cell hyperplasia was still observed in some mid dose animals.
The following NOAELs were obtained: parental, systemic: 200mg/kg, parental, local: 60mg/kg
There was no direct organ toxicity and all changes are very likely secondary to severe local effects. Besides, the LOAEL of 600mg/kg in a subacute study is above the proposed classification limit of 300mg/kg according to Regulation (EC) No 1272/2008 (CLP). Consequently, the registered substance does not need to be classified for specific target organ toxicity.
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