Registration Dossier

Administrative data

Description of key information

For acute oral, dermal and inhalation toxicity studies, no mortality was observed at the highest doses tested, i. e. doses equal to or greater than 2000 mg/kg bw, and 2000 mg/kg bw , respectively.

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

One study was available for acute oral toxicity, dealing with the toxicity of NExBTL renewable diesel. Acute oral toxicity was determined in GLP compliant guideline study (acute toxic class method, method B1 of directive 2004/73/EC) using 6 young adult female Sprague Dawley rats (age 8-12 wk, bw 210-243 g). The test substance was administered neat as a single dose by gavage (2000 mg/kg bw) following an overnight fast, and the animals observed for 14 days post-treatment. Access to food recommenced 3-4 hr post-treatment. There were no deaths or any clinical signs noted following treatment and the animals gained weight normally. No gross abnormalities detected at on study day 14. The results demonstrate that the acute oral LD50 of NExBTL renewable diesel is greater than 2000 mg/kg bw.

One study was available for acute dermal toxicity, dealing with the toxicity of NExBTL renewable diesel. Acute dermal toxicity was determined in GLP-compliant guideline study (method B3 of directive 2004/73/EC) using groups of 5 male and 5 female SD rats . The test material was applied undiluted to an area of clipped dorsal skin (approx. 10% of body surface) at a dose of 2000 mg/kg bw, the site covered (semi-occlusive dressing) for 24 hr and the animals housed individually. The wrappings were then removed, the test skin wiped clean with cotton wool moistened with distilled water and the animals returned to group housing. Skin at the test site was examined daily for evidence of primary irritation and any reactions present recorded using Draize criteria. There were no deaths or significant clinical findings either during or following treatment and all animals gained weight normally during the 14 day observation period. No dermal reactions at the test site noted in males, however all females showed evidence of hyperkeratinisation or crust formation from the third day after removal of the dressings which generally resolved after days 8-12 but persisted in one animal until day 14. Small superficial scatter scabs were present in three females during the second part of the study (i.e. on days 7-14). No gross abnormalities were detected at necropsy. The results demonstrate that the acute dermal LD50 of NExBTL renewable diesel in the rat is greater 2000 mg/kg bw. Dermal responses recorded in the females were considered to reflect drying/defatting of the test site.

In accordance with column 2 of REACH Annex VIII (8.5.2), testing by the inhalation route is appropriate if exposure of human via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Renewable hydrocarbons, C15-C18, branched alkanes has a low vapour pressure and the possibility of exposure to aerosols, particles and droplets of an inhalable size i slow. In addition, results of acute inhalation toxicity of a series of C9-C13 n-alkanes indicates a low potential for harm following acute exposure to vapour. Information on acute toxicity of Hydrocarbons, Renewable hydrocarbons, C15-C18, branched alkanes following inhalation exposure is therefore not required.

Justification for classification or non-classification

As all studies show LD50 > 2000 mg/kg, and LD50 > 2000 by oral, and dermal routes, respectively. Substances in this category do not need to be classified for acute oral and dermal toxicity according to the criteria of Annex VI of Directive 67/548/EEC and EU GHS.