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EC number: 265-045-2
CAS number: 64741-45-3
A complex residuum from the atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.
-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats.
- The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.
- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw.
The acute oral toxicity of Heavy Fuel Oil
Components following gavage administration to groups of male and female
rats has been assessed in a number of GLP-compliant studies using either
a “limit study” or standard (multi-group) LD50
a key acute oral toxicity study (API, 1982a), the test substance was
administered to groups of fasted male and female SD rats (n = 5/sex) at
dose levels of 3200 – 7810 mg/kg bw followed by a 14 day observation
mortality was present at treatment levels of 4000 mg/kg bw and above,
with complete mortality in the high dose group. The main clinical signs
were hypoactivity, ataxia, prostration, diarrhoea, hair loss and eye
opacity but no lesions were visible at scheduled necropsy in survivors. The
acute oral LD50 was determined to be 4320 mg/kg bw in females
and 5270 mg/kg bw in males.
Data from multiple supporting GLP-compliant
studies validates the low oral acute toxicity potential of heavy fuel
oil components with LD50's reported to range from close to
5000 (ARCO, 1992d, e) to >5000 mg/kg bw (ARCO, 1992a-c, f-i; ARCO,
1990a, ARCO, 1989a; ARCO, 1986a,b; Mobil, 1988a,b; 1992a; and API,
1980a-d) in rats.
The acute dermal toxicity of Heavy Fuel Oil
Components has been investigated in a number of GLP-compliant “limit
In a key acute dermal toxicity study (API,
test material was administered to clipped skin from groups of male and
female NW rabbits (n = 4/sex) at 2000 mg/kg bw followed by a 14 day
observation period. The
test site from 2 animals per sex was lightly abraded prior to dosing.
There were no clinical signs or evidence of systemic toxicity, and all
animals gained weight during the post-treatment period. No lesions were
present at scheduled necropsy. The
acute dermal LD50 was >2000 mg/kg bw in both sexes.
Data from multiple supporting GLP-compliant
studies validates the low acute dermal toxicity potential of heavy fuel
oil components with LD50's reported to be >2000 mg/kg bw
(ARCO, 1987b-e; ARCO, 1989b,c; ARCO, 1990b,c; ARCO, 1992j-n; Mobil,
1988c-e, 1992b; and API, 1980a-d).
In a majority of instances in the dermal
studies cited above, groups of male and female rabbits were exposed to
neat test substance applied to a region of clipped dorsal skin (lightly
abraded in some instances) for 24 h, under occlusion. Following removal
of wrappings protecting the test site, animals were observed for
clinical signs and body weight gain prior to gross necropsy on study day
14. The experimental design used when the test substance was applied to
intact clipped skin was therefore generally consistent with that of
guideline recommendations, although use of an occlusive covering may
have resulted in enhanced dermal uptake relative to the guideline
Results are available from four studies that
investigated the acute inhalation toxicity of respirable aerosols of
Heavy Fuel Oil Components using male and female rats. No mortality was
recorded in “limit tests” involving 4 hr exposure to measured
concentrations in a range 320 – 3600 mg/m3 (ARCO,
1986c; 1994a,b) while a multi-group investigation (using exposure
concentrations of 2100, 3300 and 4800 mg/m3) returned a
calculated LC50 of 4100 mg/m3 for males and 4500
mg/m3 for females (ARCO, 1987a).
Justification for selection of acute toxicity – oral endpoint
One of 21 available studies.
Justification for selection of acute toxicity – inhalation endpoint
One of 4 available studies.
Justification for selection of acute toxicity – dermal endpoint
One of 22 available studies.
acute toxicity of Heavy Fuel Oil Components has been adequately
characterised in a large number of GLP-compliant guideline
investigations following oral, dermal or inhalation (aerosol) exposure.
Based on available data, Heavy Fuel Oils do not meet the criteria for
classification as acute oral or dermal toxicants under EU CLP Regulation
(EC No. 1272/2008). Heavy Fuel Oils are classified Acute toxicity 4;
H332 under the EU CLP Regulation (EC No. 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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