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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

A 28-day repeated dose oral toxicity study in rats conducted according to OECD test guideline 407 demonstrated a NOAEL of 240 mg/kg body weight/day for systemic toxicity of bis(2,3-epoxypropyl)terphthalate.  A repeated dose 90-day oral toxicity study is proposed by the lead registrant, subject to approval of the Test Plan by ECHA.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
240 mg/kg bw/day
Study duration:

Additional information

The oral toxicity of bis(2,3 -epoxypropyl) terephthalate was assessed in 28 -day oral toxicity study in rats performed under GLP and according to OECD guideline 407 (Allingham, P. 2011). No effects of bis (2,3-epoxypropyl) terephthalate were found at dose levels of 40 and 80 mg/kg bw. The NOEL of bis (2,3-epoxypropyl) terephthalate is considered to be 80 mg/kg bw. At a dose level of 240 mg/kg bw slight clinical symptoms occurred in few more animals than in control animals and a tendency towards an attenuated body weight gain and food intake were observed. A slightly lower heamoglobin level in male animals was associated with a slight compensatory increase in reticulocytes. These effects are not considered to be in the respective toxic range. Thus, the NOAEL in this study is considered to be 240 mg/kg bw. Diffuse minimal hyperkeratosis of the nonglandular part of the stomach was found in the majority of female rats dosed with 240 mg/kg bw. This effect might be related to a local irritant effect of the test item formulation when administered repeatedly by oral gavage and was therefore not considered relevant for humans.


Justification for classification or non-classification

Specific Target Organ Toxicity – Repeated Exposure: The notifiable substance did not exhibit significant toxic effects arising from a repeated exposure. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.9