3,7,11,15-tetramethylhexadecane-1,2,3-triol

Endpoint summary

Description of key information

The acute oral toxicity of the test substance was assessed according to OECD Test Guideline 423 (acute toxic class method), EU Method B.1 tris and EPA OPPTS 870.1100 using a single oral dose of the test material preparation in olive oil at a dose level of 2000 mg/kg body weight.

No mortality occurred.  No abnormalities were noted at necropsy of animals sacrificed at the end of the study. Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.  The test substance is therefore not classified for acute oral toxicity.

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

The acute oral toxicity of the test substance was assessed according to EC, OECD and EPA / OPPTS guidelines.

The test substance was applied as a solution in olive oil to a group of six fasted Wistar rats (three males and three females) as a single dose by oral gavage at a dose level of 2000 mg/kg bodyweight. One female rat was observed with unspecific toxicity symptoms but appeared normal one day after application. No symptoms were observed in male rats. There was no mortality during the test and the expected body weight gain was observed. No abnormalities were noted at necropsy.

Under the conditions of the test, the median lethal dose of the test substance after oral application was > 2000 mg/kg body weight.

Justification for classification or non-classification

Acute toxicity is defined as the adverse effects occurring following administration of a single dose of a substance by the oral or dermal routes, or inhalation exposure of four hours.

Substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the Globally Harmonized Classification System and Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures. Acute toxicity values are expressed as approximate LD50 or LC50 (inhalation) values.

A test substance is classified according to one of these four toxicity categories when the acute LD50 value is ≤ 2000 mg/kg for exposure via the oral and dermal routes and when the acute LC50 value is ≤ 5.0 mg/L for inhalation exposure conducted with dusts and mists.

An in vivo study performed according to internationally recognised guidelines and conducted according to GLP gave an acute oral LD50 of > 2000 mg/kg and therefore the test substance is not classified for acute oral toxicity.