Registration Dossier

Administrative data

Description of key information

In contact with water,mist or rat plasma, the substance immediately and spontaneously hydrolize into its parent substances: diethylene glycol and boric acid.

Boric acid

Eight out of the ten males and six out of the ten females from the 20000 ppm group died and one of the ten males from the 10000 ppm group died before end of study. Symptoms included nervousness, haunched appearance, dehydration, foot lesions and scaly tails. Incidences of extra medullary heamatopoiesis of spleen observed of varying severity in all dose groups for both males and females and hyperkeratosis and/or acanthosis of the stomach observed at the highest dose only in both males and females. At doses > 5,000 ppm (142 mg B/kg bw for the male), degeneration or atrophy of the seminiferous tubules was observed

Diethylen glycol

A single group of eight adult female Sprague-Dawley rats was exposed daily to 0 or 200 mg/kg body weight DEG in drinking water for 90 days. In a preliminary acute range-finding study

conducted as part of this study, single oral (gavage) doses of 700, 2,000, or 8,000 mg/kg DEG were shown to produce dose-related changes in renal function, as measured by several urinalysis parameters. A single (gavage) dose of 200 mg/kg DEG produced no changes. Oral (drinking water) exposure to 200 mg/kg/day DEG for 90 days resulted in no significant effects on body weight or relative kidney weight versus the control groups.


Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification