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Administrative data

Description of key information

Acute oral toxicity: not classified

Acute dermal toxicity: not classified

An acute inhalation toxicity study is considered not necessary

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute Oral Toxicity: Acute oral toxicity was evaluated using a Weight of Evidence (WoE) approach using data from three experimental studies: a sub-acute, in vivo repeated dose toxicity study combined with a reproductive/developmental toxicity screening test in rats, an in vivo 14-day dose range-finding test on rats and an in vitro BALB/C 3T3 NR U cell toxicity assay. Additionally, the absence of classification for acute toxicity for the predicted structures of the substance as well as its starting materials confirms the non-classification of N-methyldiethanolamine polyborate. Consideration of all the available elements of evidence in a WoE approach found that the no adverse effect level (NOAEL) of the substance is greater than 1000 mg/kg bw/day, which is equivalent to an acute toxicity estimate (ATE), or median lethal dose (LD50) of greater than 2000 mg/kg bw. Justification for the use of a Weight of Evidence approach is provided in the attached document.

Acute Inhalation Toxicity: A study for the evaluation of the acute inhalation toxicity of the test item does not need to be conducted because exposure to humans via inhalation is not likely or expected, taking into account the possibility of exposure to aerosols, particles or droplets of an inhalable size, according to column 2 (information requirement section 8.5) of Annex VIII of the REACH Regulation. Finally, an inhalation study was deemed to be not scientifically feasible due to its nature as a liquid with an absence of boiling point before decomposition from 228.98 °C obtained in a DSC run from -50 ° to 400 °C. Inhalation exposure could still occur if mists are produced, but this would only occur under certain conditions such as formation of vapours from the substance which is unlikely due to its negligible vapour pressure.

Acute Dermal Toxicity: Although no experimental study was available for the acute dermal toxicity of the substance, it was possible to approximate the acute dermal toxicity using data from acute oral toxicity in a worst-case approach. In vivo and in vitro experimental data demonstrated that the substance is not considered acutely or sub-acutely toxic by the oral route. Based on the poor dermal absorption of the substance, acute oral toxicity data is considered a worst-case estimate of acute dermal toxicity. Therefore, the substance is not classified for acute dermal toxicity. Justification for the use of a Acute Oral Toxicity data in a worst-case scenario is provided in the attached document.

Justification for classification or non-classification

The substance is considered to have a sub-acute, oral NOAEL value greater than 1000 mg/kg bw/day, equivalent to an acute toxicity estimate (ATE), or LD50 value, of 2000 mg/kg bw, when administered by either the oral or dermal route. This exempts the substance from classification for acute oral toxicity according to the CLP Regulation (EC) No. 1272/2008 (Appendix R.7.4–1 of Chapter R.7a: Endpoint Specific Guidance). Detailed documentation for the evaluation of acute oral toxicity using a Weight of Evidence approach is provided in a separate attachment.

Due to the absence of acute oral toxicity combined with an inability to induce systemic effects following dermal exposure as demonstrated by an in vitro skin irritation study as well as the physicochemical properties of the substance, the substance is not classified for acute dermal toxicity according to the CLP Regulation (EC) No. 1272/2008.

Further, inhalation exposure to the test item is not likely or expected based on the liquid form of the test item and low vapour pressure, therefore, it was not necessary to perform an acute inhalation toxicity study in order to determine acute toxicity.