Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Acute Oral Toxicity:
Acute oral toxicity of diesel fuel and #2 home heating oil, was evaluated in male and female rats following a single oral gavage administration of the test material at different concentrations (similar to OECD 401). The LD50 for diesel fuel is 9 mL/kg body weight (approx 7600 mg/kg) and the LD50 for #2 home heating oil is 21.2 mL/kg body weight (approx 17,900 mg/kg). Based on these studies, the LD50 for VGOs/HGOs/Distillate fuels is > 2000 mg/kg bw.
Acute Inhalation Toxicity:
Acute inhalation toxicity of naval distillate in male and female rats was evaluated in a key study via whole-body exposure at various measured concentrations for 4 hours (OECD 403). The acute inhalation LC50 is 4.1 mg/L for VGOs/HGOs/Distillate fuels.
Acute Dermal Toxicity:
Acute dermal toxicity of diesel fuel and #2 home heating oil in male and female rabbits was evaluated in two key studies following administration of 5 mL doses of undiluted test material (OECD 434). Based on these studies, the acute dermal LD50 is > 5000 mg/kg for VGOs/HGOs/Distillate fuels.

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 inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
4 100 mg/m³

Acute toxicity: via dermal route

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

Additional information

Acute Oral Toxicity:

A key study (Klimisch score = 1, API 1980b) investigated the acute oral toxicity of diesel fuel, while a second key study (Klimisch score = 1, API 1980a) investigated the acute oral toxic effects of #2 home heating oil. 

 

Undiluted diesel fuel was administered to Sprague Dawley rats by gavage at doses of 2.5, 5, 10, 15 or 20 ml/kg body weight. Home heating oil was given to animals at doses of 10, 20, 22.5, 23, or 25 mL/kg body weight by gavage. In the animals administered diesel fuel, signs of toxicity were observed in all dose groups. Severity increased with increased dose. The majority of the animals that died before day 14 showed intestinal damage including, hemorrhaging, thinning of intestinal walls, and increased gas in the gastrointestinal tract. Under the conditions of this study, diesel fuel had an oral LD50of 9.0 mL/kg body weight (approx 7600 mg/kg bw). In the animals administered #2 home heating oil, signs of toxicity were also observed in all dose groups while severity also increased with increased dose.  Under the conditions of this study, #2 home heating oil had an oral LD50 of 21.2 mL/kg body weight (approx 17,900 mg/kg bw).

 

In supporting studies conducted onVGOs/HGOs/Distillate fuels(Klimisch scores = 2; ARCO 1993a, 1993b, 1992a, 1987a, 1987b, 1987c, 1987d, 1985, 1973a), rats were administered single oral gavage doses ranging from 1000 mg/kg to 11,400 mg/kg bw. LD50s for all studies were > 2000 mg/kg for males and females.

 

Based on these studies, the oral LD50 for VGOs/HGOs/Distillate fuels is > 2000 mg/kg bw.

 

Acute Inhalation Toxicity:

A key study investigated the effects of inhalation of naval distillate in male and female Sprague Dawley rats exposed by aerosol for 4 hours via whole body exposure at measured concentrations of 2.3, 3.5, or 4.9 mg/L aerosol (Klimisch score = 1, ARCO, 1988a). Animals were observed for 14 days. Clinical signs commonly included labored breathing and discharge from the nose and eyes. Decreased activity and mobility was reported at all concentrations during exposure. Macroscopic and microscopic findings included discoloration of the lungs and red staining around the snout of spontaneously dying animals. During the observation period, mortality was observed in 0 of 10, 4 of 10, and 4 of 10 male rats at measured exposures of 2.3, 3.5, and 4.9 mg/L, respectively. In females, mortality was observed in 1 of 10, 7 of 10, and 6 of 10 animals at the measured exposures of 2.3, 3.5, and 4.9 mg/L, respectively.  The inhalation LC50 was determined to be 5.4 mg/L in males, 3.6 mg/L in females, and 4.1 mg/L in combined sexes for VGOs/HGOs/Distillate fuels.

 

Supporting acute inhalation studies were performed onVGO/HGO/Distillate fuels. These can be used to support the conclusions of the key study, which serves as a worst case scenario and provides an LC50 that can be used for classification purposes. In the supporting studies, rats were exposed via inhalation to VGOs/HGOs/Distillate fuels for 4 hours(Klimisch scores = 1). In general, LC50s as measured based on mortality and systemic effects were > 5.00 mg/L for aerosols (ARCO 1992b, 1988b, 1988c, 1988d, 1987e), however, additional studies showed LC50s that could indicate possible harmful effects via inhalation (ARCO 1993c: LC50 > 1.7 mg/L aerosol; ARCO 1991: LC50 > 4.81 mg/L aerosol). 

 

Based on results of these studies,VGOs/HGOs/Distillate fuelsare classified as harmful by inhalation with an LC50 of 4.1 mg/L (aerosol). 

 

Acute Dermal Toxicity 

Multiple studies were available to assess the acute dermal toxicity of VGOs/HGOs/Distillate fuels. In the first key study (Klimisch score = 1, API 1980a), the acute dermal toxic effects of diesel fuel were investigated. In the second key study (Klimisch score = 1, API 1980b), the acute dermal toxic effects of #2 home heating oil were investigated. Both key studies used eight New Zealand White rabbits (4 male/4 female) receiving 5 mL of applied test material.  Test material was applied under occlusive dressing to groups of 4 animals on intact or abraded skin. No signs of systemic toxicity were observed in either study. Based on the lack of mortality, the LD50 is > 5000 mg/kg bw/day and the test material is not classified for acute dermal toxicity.

 

In supporting studies conducted on VGOs/HGOs/Distillate fuels(Klimisch scores = 2; ARCO 1993d, 1992c, 1990a, 1987f, 1987g, 1987h, 1987i, 1986a), rabbits were administered single dermal doses of 2000 mg/kg bw (one study administered a dose of 1800 mg/kg bw). LD50s for all studies were greater than the maximum dose administered.

 

Based on results of these studies, the dermal LD50 for VGOs/HGOs/Distillate fuels is > 5000 mg/kg bw.

Additional data support that VGOs/HGOs/Distillate Fuels are not acute oral or dermal toxicants (API, 1980aa; API, 1980bb; Beck et al., 1984; API, 1982a; API, 1982b; API, 1985b; API, 1985c; NTP, 1986). Additional data support that VGOs/HGOs/Distillate fuels are acute inhalation toxicants (Dalbey et al., 1982; API, 1983a; API, 1983b; Kainz and White, 1984). This information is presented in the dossier.

 

Justification for classification or non-classification

VGOs/HGOs/Distillate Fuels are not classified for acute oral toxicity based on an oral LD50 > 2000 mg/kg bw, according to the EU CLP Regulation (EC)1272/2008.  Based on acute inhalation data, VGOs/HGOs/Distillate Fuels are classified as H332 (harmful by inhalation) with an LC50 of 4.1 mg/L for male and female rats, according to the EU CLP Regulation (EC)1272/2008.  VGOs/HGOs/Distillate Fuels are not classified for acute dermal toxicity based on a dermal LD50 of > 2000 mg/kg body weight for male and female rabbits, respectively, according to the EU CLP Regulation (EC)1272/2008.

Regulatory classification and labelling for aspiration toxicity relies on the measured or calculated kinematic viscosity of a substance at 40°C rather than results from toxicological studies with animals. Hydrocarbons with kinematic viscosities less than or equal to 20.5 mms/sec are classified for aspiration toxicity according to the EU CLP Regulation (EC)1272/2008. As members of this category may exist as low viscosity liquids that meet these criteria, substances in this category are classified for aspiration hazard unless the viscosity at 40oC is greater than the regulatory thresholds based on the measured or calculated kinematic viscosities. 

Vacuum gas oils, hydrocracked gas oils, and distillate fuels having a kinematic viscosity of 20.5 mm2/s at 40°C would meet classification criteria as aspiration hazard (H304) under CLP.