Registration Dossier

Administrative data

Description of key information

Results are available from two modern, GLP-compliant, guideline studies that have assessed the acute toxicity of NExBTL renewable diesel in the rat following oral or dermal exposure. The LD50 in both instances exceeded 2000 mg/kg bwt. No information is available, or required (column 2 of REACH Annex VIII; 8.5.2), for acute toxicity after inhalation exposure as the available data indicate that the LC50 will exceed the saturated vapour pressure of the substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute oral toxicity (acute toxic class method, method B1 of directive 2004/73/EC) and acute dermal toxicity (method B3 of directive 2004/73/EC) were determined in the rat. In both studies the test substance was administered neat at 2000 mg/kg bwt. Both studies were GLP-compliant, and the information is reliable and fully adequate for evaluation. There were no deaths, unusual clinical signs or necropsy findings in either study.

The acute inhalation toxicity of a series on C9-C13 n-alkanes was investigated in male SD rats following a single 8-hr exposure to vapour. A calculated LC50 of 4467 ppm (equivalent to 23.4 mg/l) was determined for n-nonane. Given the extended duration of exposure used in these studies, the 4 -hr LC50 is likely to exceed this value. No mortality was recorded for C10 -C13 n-alkanes after exposure to the maximum achievable vapour concentration in air. The maximum saturated vapour concentration decreased in a predictable manner with increasing C-number. It is concluded, based on these findings, that the acute (4 -hr) inhalation LC50 of NExBTL renewable diesel vapour (comprising predominately i-C16 to i-C18) will exceed 20 mg/l, although exposure to such concentrations is unlikely given the low saturated vapour concentration of the components present.

Justification for classification or non-classification

No classification for acute oral or acute dermal toxicity required under Directive 67/548/EEC or Regulation EC 1272/2008 (oral and dermal LD50 both exceed 2000 mg/kg bwt). No classification for acute inhalation (vapour) toxicity based on read-across to related C9 -C13 n-alkanes.