Registration Dossier
Registration Dossier
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EC number: 230-565-0 | CAS number: 7195-44-0
Endpoint summary
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:
- NOAEL
- 240 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
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.
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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
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