Registration Dossier

Administrative data

Description of key information

Acute Oral Toxicity:

Acute oral toxicity of cracked gas oils was evaluated in male and female rats by a single oral gavage administration of a dose ranging from 2050 to 6250 mg/kg body weight.  Based on mortality and toxicity findings, an oral LD50 of 4660 mg/kg body weight and 3200 mg/kg body weight were reported for males and females, respectively.  

Acute Inhalation Toxicity:

Acute inhalation toxicity of cracked gas oils in rats was evaluated via whole-body exposure to test material at various measured concentrations for 4 hours.  The acute inhalation LC50 was 4.65 mg/L in males and females.

Acute Dermal Toxicity:

Acute dermal toxicity of cracked gas oils was evaluated in male and female rabbits at a single dose of 2000 mg/kg body weight.  Based on a lack of adverse systemic effects or mortality, the acute dermal LD50 for light catalytically cracked distillate was >2000 mg/kg body weight.  

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 200 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
4 650 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute Oral Toxicity:

A key study investigated the acute oral toxic effects of light catalytically cracked distillate in fasted male and female Sprague Dawley rats (API 1985a). The test substance was administered undiluted at dose levels of 2050, 3200, 5000, or 6250 mg/kg in females and 3200, 5000, or 6250 mg/kg in males. After 14 days of observation, clinical signs included hypoactivity; diarrhoea; yellow or brown-stained anal, genital and abdominal areas; hair loss on abdomen; ataxia; red-stained nose and mouth; prostration; lacrimation; hypothermic to touch; and death. Mortality was observed in 1 of 5, 3 of 5, and 4 of 5 males at dose levels of 3200, 5000, and 6250 mg/kg, respectively. In females, mortality was observed in 0 of 5, 3 of 5, 4 of 5, and 5 of 5 animals at dose levels of 2050, 3200, 5000, and 6250 mg/kg, respectively. The acute oral LD50 was 4660 mg/kg body weight in males and 3200 mg/kg body weight in females. 

In supporting studies conducted on cracked gas oils (ARCO 1992a, 1989a, 1989b, 1989c), rats were administered single oral gavage doses ranging from 1000 mg/kg to 7000 mg/kg bw. LD50s for all studies were > 2000 mg/kg for males and females 

In a further acute oral toxicity study (ARCO 1992b), rats were given doses of FCC light cycle oil ranging from 1500 to 11,400 mg/kg bw (one rat/dose). The assumption that the LD50 is greater than 5060 mg/kg was made because 2 out of 6 total animals tested died during the study.

Based on results of these studies, cracked gas oils are not classified as acute oral toxicants.

 

Acute Inhalation Toxicity

A key study evaluated the effects of light catalytically cracked distillate in male and female Sprague Dawley rats, exposed by inhalation to aerosol for 4 hours via whole body exposure at measured concentrations of 0, 2.34, 3.47, 5.06, 6.34, or 7.29 mg/l (Klimisch score = 1, API 1986a). Animals were observed for 14 days. Clinical signs commonly included dyspnoea and discharge from the nose and eyes. Decreased activity and mobility was reported at concentrations of 3.47 mg/L or 6.34 mg/L. There were no deaths during the exposure period in any of the investigations, and macroscopic and microscopic findings were limited to the lungs, where moderate to severe pulmonary irritation was apparent. During the observation period, mortality was observed in 0 of 5, 1 of 5, 0 of 5, 3 of 5, 3 of 5, and 5 of 5 male rats at measured exposures of 0, 2.34, 3.47, 5.06, 6.34, and 7.29 mg/L, respectively. In females, mortality was observed in 0 of 5, 0 of 5, 1 of 5, 1 of 5, 5 of 5, and 5 of 5 animals at the measured exposures of 0, 2.34, 3.47, 5.06, 6.34, and 7.29 mg/L, respectively. The inhalation LC50 was determined to be 4.65 mg/L in males and females for cracked gas oils.

In supporting studies, rats were exposed via inhalation to cracked gas oils. LC50s as measured based on mortality and systemic effects were > 4.98 mg/L aerosol (ARCO 1992c) and > 3.19 mg/L aerosol (ARCO 1993). 

Based on results of these studies, cracked gas oils are classified as harmful by inhalation.

 

Acute Dermal Toxicity

A key study on acute dermal toxicity of light catalytically cracked distillate was investigated in male and female New Zealand White rabbits, at a dose of 2000 mg/kg body weight, applied under occlusion for 24 hours ( API 1985a). Animals were observed for 14 days during which no mortality or systemic toxicity was observed. The dermal LD50 was determined to be greater than 2000 mg/kg body weight in males and females.  

In supporting studies conducted on cracked gas oils (ARCO 1992d, 1989d, 1992e, 1989e), rats were administered single dermal doses of 2000 mg/kg bw. LD50s for all studies were > 2000 mg/kg.

Based on results of these studies, cracked gas oils are not classified as acute dermal toxicants.

Additional data support that cracked gas oils are not oral or dermal toxicants (API, 1985b; TNO-CIVO, 1989c; TNO-CIVO, 1989d). Additional data support that cracked gas oils are inhalation toxicants (API, 1986aa; ). This information is presented in the dossier.

Aspiration Hazard

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 7 mms/sec are classified for aspiration toxicity according to EU CLP Regulation (EC No. 1272/2008) criteria. As members of this category exist as low viscosity liquids that meet these criteria, substances in this category are classified for aspiration hazard. 

Justification for selection of acute toxicity – oral endpoint

One of 7 acute oral toxicity studies showing similar results

Justification for selection of acute toxicity – inhalation endpoint

one of 4 acute inhalation studies, but lowest value chosen

Justification for selection of acute toxicity – dermal endpoint

One of 6 studies available showing similar results

Justification for classification or non-classification

Cracked gas oils are not classified for acute oral toxicity based on an oral LD50 of 4660 mg/kg body weight and 3200 mg/kg body weight for male and female rats, respectively, according to EU CLP Regulation (EC No. 1272/2008) legislation. Cracked gas oils are classified as Acute Toxicity Cat.4, H332, harmful by inhalation based on an LC50 of 4.65 mg/L aerosol for male and female rats, according to EU CLP Regulation (EC No. 1272/2008) criteria. Cracked gas oils are not classified for acute dermal toxicity based on a dermal LD50 > 2000 mg/kg body weight for male and female rabbits, respectively, according to EU CLP Regulation (EC No. 1272/2008) criteria.

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 20 mm2/sec are classified for aspiration toxicity according to EU CLP Regulation (EC No. 1272/2008) criteria. As members of this category exist as low viscosity liquids that meet these criteria, substances in this category are classified for aspiration hazard. Cracked gas oils are classified as aspiration hazards according to EU CLP Regulation (EC No. 1272/2008).