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Key value for chemical safety assessment

Additional information

Acute Oral Toxicity

 

The acute oral toxicity of 1-isopropyl-2,2-dimethyltrimethylene diisobutyrate is well understood. In an acute oral toxicity limit study conducted according to EPA OPPTS 870.1100 and OECD 425 guidelines, 1-isopropyl-2,2-dimethyltrimethylene diisobutyrate had an acute oral LD50 value of >2000 mg/kg bw in female rats. There were no significant clinical signs, body weight changes or gross pathological observations to indicate systemic toxicity. Two lesser non-guideline studies in rats and mice support the oral LD50 value. In these studies, no deaths were observed in rats receiving 3200 mg/kg bw while a single death was recorded in mice administered doses up to 6400 mg/kg bw. The death in the single mouse did not occur in the high-dose group. While moderate weakness and some vasodilatation occurred following dosing in the older non-guideline rat study, no clinical signs were observed in mice or the more recent rat study. 

 

Acute Dermal Toxicity

 

The acute dermal toxicity of 1-isopropyl-2,2-dimethyltrimethylene diisobutyrate is well understood. In an acute dermal toxicity study conducted according to OECD Guideline 402, 1-isopropyl-2,2-dimethyltrimethylene diisobutyrate had an acute dermal LD50 value of >2000 mg/kg bw in male and female rabbits. There were no significant clinical signs, body weight changes or gross pathological observations to indicate systemic toxicity. In a non-guideline study in which three guinea pigs were exposed to 5, 10 or 20 mL/kg bw of the undiluted test material on shaved intact skin under occlusive wrap for 24-hours, no animals died. No clinical signs indicating systemic toxicity were reported and while animals receiving the low- and mid-doses lost weight during the study, the animal receiving the highest dose gained weight. 

 

Acute Inhalation Toxicity

 

The acute inhalation toxicity of 1-isopropyl-2,2-dimethyltrimethylene diisobutyrate is well understood. Although a study has not been conducted according to OECD Guideline 403, a non-guideline study conducted in rats was available for review. No deaths, significant clinical signs, or adverse effects on body weight gain were observed in groups of three rats exposed to 0.12 mg/L (10 ppm) or 5.3 mg/L (453 ppm) of the test substance for 6 hours followed by a 2-week observation period. The latter exposure level could only be generated by heating the test material to 100 °C in a washing bottle before it was passed into the chamber containing the rats. 1-isopropyl-2,2-dimethyltrimethylene diisobutyrate is a liquid at room temperature, has a boiling point of 281.5°C, and has an extremely low vapor pressure (0.00088 mbar) at room temperature. Based on the physical properties of 1-isopropyl-2,2 -dimethyltrimethylene diisobutyrate, the potential for significant inhalation exposure is limited.

Justification for classification or non-classification

Based on a weight-of-the-evidence assessment 1 -isopropyl-2,2 -dimethyltrimethylene diisobutyrate is not classified for lethality by the oral, dermal, or inhalation routes according to EU CLP. Based on a weight-of-the-evidence assessment, 1 -isopropyl-2,2 -dimethyltrimethylene diisobutyrate is also not classified for “Specific Target Organ Effects – Single Exposure” according to GHS. No significant clinical signs, body weight changes or gross pathological observations to indicate systemic toxicity were observed by any route of exposure.