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Administrative data

Description of key information

Guideline acute oral and dermal toxicity studies in rats indicating a low order of acute toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute Oral Toxicity

  

The acute oral toxicity of dibutyl terephthalate is well understood. In an acute oral toxicity fixed dose study conducted according to OECD Guideline 420, no deaths were observed when animals were administered a single dose of the undiluted material and the acute oral LD50 value for dibutyl terephthalate was > 2000 mg/kg bw in female rats. There were no clinical signs, body weight changes or gross pathological observations to indicate systemic toxicity at the highest dose tested. Based on the results of this study, dibutyl terephthalate presents a low toxicity hazard by the oral route.

  

Dermal Toxicity

  

The acute dermal toxicity of dibutyl terephthalate is well understood. In an acute dermal toxicity study conducted according to OECD Guideline 402, no deaths were observed when animals were administered a single limit dose of the undiluted material under occluded contact for 24 hours and the acute dermal LD50 value for dibutyl terephthalate was > 2000 mg/kg bw in male and female rats. There were no significant clinical signs, body weight changes or gross pathological observations to indicate systemic toxicity at the limit dose tested. Based on the results of this study, dibutyl terephthalate presents a low toxicity hazard by the dermal route.

  

Acute Inhalation Toxicity

  

No acute inhalation toxicity studies conducted according to regulatory guidelines were identified. Dibutyl terephthalate is a liquid at room temperature, has a boiling point of 341.8 °C at 760 mmHg, and has an extremely low vapor pressure (0.0000784 mmHg) at room temperature. Based on the physical properties of dibutyl terephthalate, the potential for significant inhalation exposure is limited. In addition, based on the absence of mortality or other signs to suggest systemic toxicity when a limit dose of 2000 mg/kg bw was administered to rats by the oral or dermal routes, dibutyl terephthalate is also expected to present a low toxicity hazard by the inhalation route.

Justification for classification or non-classification

Based on a weight-of-the-evidence assessment, dibutyl terephthalate is not classified for lethality by the oral or dermal routes according to the GHS guidelines. Based on a weight-of-the-evidence assessment, dibutyl terephthalate 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 the oral or dermal routes at dose levels up to 2000 mg/kg bw. Although no inhalation studies were available for review, based on the physical properties of dibutyl terephthalate which limit the potential for inhalation exposure and the absence of adverse effects by the oral or dermal routes, dibutyl terephthalate is predicted to not be classified for acute lethality or systemic toxicity by the inhalation route.