Bis(2,3-epoxypropyl) terephthalate

Endpoint summary

Description of key information

Two acute oral toxicity studies were performed in rats. The substance was administered by oral gavage in males and females Sprague-Dawley rats.
The LD50 was determined to be greater than 2500 mg/kg, the highest level tested in one study and to be greater than 5000 mg/kg in the second study.  No death occurred in the first study whereas 4 out five females and 0 out of five males died in the second study at the dose level of 5000 mg/kg.
Two acute dermal toxicity studies were performed. In the first study Male and female rats (Sprague Dawley) were treated dermally by occlusive application during 24 hours at a dosage of 1250 mg/kg body weight. The test item was diluted in vehicle (Polyethylene glycol) and administered at a dosing volume of 2.5 mL/kg.  The acute dermal median lethal dose (LD50) in rats was found to be greather than 1.25 g/kg. In a second study male and female rats were treated with the undiluted substance by semi-occlusive application during 24 hours. The dermal LD50 in rats was found to be greater than 2000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

In an acute oral toxicity study with rats, no deaths occurred at the highest dose level tested. The oral LD50 in rats was found to be greater than 2500 mg/kg. In an acute dermal toxicity study (limit test) with rats, no deaths occurred at the dose level of 2000 mg/kg. Therefore the dermal LD50 was considered to be greater than 2000 mg/kg.

Justification for classification or non-classification

- oral toxicity:

Based on the above stated assessment of the acute oral toxicity of bis(2,3 -epoxypropyl)terephthalate (absence of toxicity up to 2500 mg/kg) the substance does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and accordingCLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council)as implementation of UN-GHS in the EU.

- dermal toxicity:

Based on the above stated assessment of the acute dermal toxicity of bis(2,3 -epoxypropyl)terephthalate (absence of toxicity up to 2000 mg/kg) the substance does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and accordingCLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council)as implementation of UN-GHS in the EU.

- inhalation toxicity:

Due to the very low vapour pressure of the substance, the fact that the substance is imported into the EU in a formulated form as a granulate, the inhalation route of exposure is considered to be unlikely. Therefore no classification for acute inhalation toxicity is deemed necessary according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and accordingCLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council)as implementation of UN-GHS in the EU.