Di(µ-2,2´,2´´-nitrilotris(ethanol)-diperchlorato)dinatrium

Endpoint summary

Description of key information

LD50 (oral) > 2000 mg/kg b.w.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

The acute oral toxicity of the test material in the female Sprague-Dawley strain rat was assessed in this limit acute toxic class test coducted according to the OECD Guideline 423 and EU Method B.1 tris. For this reason, three female rats were used in each step and they were given one single oral dose of the substance at dose level of 2000 mg/kg b.w. The animals were observed for fourteen days for signs for clinical signs, toxicity and for deaths. Body weights were recorded prior to dosing, weekly thereafter and at the end of the test. At the end of the test the survived animals were killed and were subjected to gross pathological examination.

No mortality occured and no macroscopic changes were observed. The animals showed normal bodyweight gain in bodyweight. The only observation was the decrease of spontaneous activity in the treated animals (6/6) from 3 hrs after administration. However, the animals recovered a normal activity the 2nd day of the test. LD50 > 2000 mg/kg b.w.

Acute inhalation toxicity

The substance has a low volatility (V.P.< 0.5 kPa) and does not present any inhalable/respirable particles. In humans, particles with aerodynamic diameters below 100 μm have the potential to be inhaled. Particles with aerodynamic diameters below 50 µm may reach the thoracic region and those below 15 µm the alveolar region of the respiratory tract. Τhe substance does not contain any particles with a diameter less than 15 μm. Furthermore, no systemic toxicity occurred during the acute oral toxicity test; the absence of systemic toxicity and the absence of other data that could indicate the potential for absorption following ingestion, support the idea that it is unlikely that the substance will be absorbed in case it is inhaled. The properties of the substance and the absence of systemic toxicity in the oral toxicity test indicate that human exposure is not possible via inhalation, therefore testing via this route for acute toxicity should not be conducted.

Acute dermal toxicity

The physicochemical properties of the substance suggest a low dermal absorption in case of dermal exposure. In addition, the absence of systemic toxicity and mortality in the available in-vivo studies (skin sensitisation and acute oral toxicity) permit the waiving of the acute dermal toxicity test.  Furthermore, in a study by Moore et al. (2013) the acute systemic toxicity data (LD50 values) and hazard classifications derived in the rat following oral administration and dermal application have been analysed to examine whether or not orally-derived hazard classification or LD50 values can be used to determine dermal hazard classification. The authors suggest that no substance (out of the 355 substances reviewed) with an oral LD50 of >2000 mg/kg was classified for acute systemic toxicity by the dermal route, suggesting that dermal testing for acute systemic toxicity of such substances adds nothing to the hazard characterisation and should be removed from routine regulatory data requirements.

Moore, N. P., Andrew, D. J., Bjerke, D. L., Creton, S., Dreher, D., Holmes, T., Prieto, P., Seidle, T. and Rowan, T.G. (2013). Can acute dermal systemic toxicity tests be replaced with oral tests? A comparison of route-specific systemic toxicity and hazard classifications under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).Regulatory Toxicology and Pharmacology, 66(1), 30-37.

Justification for classification or non-classification

The LD50 of the substance found in the limit test in the acute oral toxicity study was greater than 2000 mg/kg bw.

The LD50 of the tested substance is greater than 2000 mg/kg bw, it doesn't meet the classification criteria of the CLP regulation n. 1272/2008, and thus is not classified for acute toxicity.