Registration Dossier

Administrative data

Description of key information

Studies equivalent to EC methods for oral, inhalation and dermal route of exposure were available in analogous substance Distillates (petroleum), straight-run middle (EC: 265-044-7)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
1 780 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Acute oral toxicity

A limit test (single dose: 5000mg/kg) was conducted using rat. The test substance was administered to 5 male and 5 female rats in a single dose by oral gavage. During observations the following signs were recorded: hypoactivity, ataxia, diarrhoea, lacrymation and fur staining/loss. No deaths occurred during the study.

Acute inhalation toxicity

A 4h acute inhalation study was conducted using rat. The test substance concentrations ranging 1.05 - 5.39 mg/l were prepared. 10 animals (5 male, 5 female) per dose group were exposed to the test substance by aerosol (whole body). During the post-dose observation period of 14 days: deaths were records in the high dose groups (2.25, 3.22, 5.39 mg/l). No mortality occurred in either low dose group or in the control group. Dark red lungs were seen in all animals at the higher dose levels (5.39, 3.22, 2.25 mg/l), considered to be treatment- related rather than post-mortem change. They were also seen in 3 males and 1 female exposed to 1.6 mg/l, but lungs in the 1 mg/l group were comparable to those of controls. Isolated changes did not appear to be dose-related, but scattered skin lesions did show a relationship to dose. Microscopic examination of the lungs showed acute respiratory damage in those animals dying in the early stages of the study, within 2 days of exposure, characterised by pulmonary congestion and perivascular oedema, also alveolar oedema and damage to alveolar walls. In animals surviving to termination lung damage was characterised by mild chronic inflammatory change which was slight in degree in the animals exposed to 1 mg/l.

Acute dermal toxicity

A limit test (single dose: 2000mg/kg) was conducted using rabbit. The test substance was applied to the skin of 2 male and 2 female rabbits under occlusive conditions for 24 hours. Other clinical signs were noted during the post-exposure period except for slight to moderate irritation. No deaths occurred during the study.

Justification for classification or non-classification

Based on the results obtained for the analogous substance, Distillates (petroleum), straight-run middle (EC: 265-044-7), Renewable Diesel is expected to be of similar low toxicity and not subject to classification for acute toxicity via oral and dermal routes of exposure. However, based on the data for inhalation toxicity; Renewable Diesel will be classified as an inhalation toxicant in accordance with Directive 67/458/EEC (Xn; R20) and CLP regulation 1272/2008/EC (Acute Tox. 4; H322)

Based the kinematic viscosity result of Renewable Diesel, this substance will be classified as an aspiration hazard in accordance with Directive 67/458/EEC (Xn; R65) and CLP regulation 1272/2008/EC (Asp. Tox. 1; H304). This is also consistent with the classification assigned to straight run gas oils/middle distillate.