Registration Dossier

Administrative data

Description of key information

Kerosines are of low acute toxicity with mortality rarely reported even at very high exposures in experimental animal studies conducted by oral (similar to OECD 420), dermal (similar to OECD 402), and inhalation (similar to OECD 403) exposure.  

• The oral LD50 was > 5000 mg/kg bw in male and female rats for kerosine.

• The dermal LD50 was > 2000 mg/kg/bw in male and female rabbits for kerosine.

• The inhalation LC50 was > 5.28 mg/L vapour in male and female rats for kerosine.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
One of 11 acute oral studies

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
5 280 mg/m³
Quality of whole database:
One of 11 acute inhalation studies

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
One of 11 acute dermal studies

Additional information

Kerosines are of low acute toxicity, with an oral LD50 greater than 5000 mg/kg (rat), a dermal LD50 greater than 2000 mg/kg (rabbit), and an inhalation LC50 greater than 5.28 mg/L (rat). The most important effects in animals following very high oral doses were slight irritation of the stomach and the gastrointestinal tract. The only adverse effects observed in acute inhalation studies were decreased activity and breathing frequency at very high doses. Dermal application of kerosine did not lead to acute toxic systemic effects. Clinical effects observed were related to dermal irritation rather than to systemic toxicity. The acute toxicity of kerosine is not classified by EU CLP Regulation (EC No. 1272/2008).

 

Acute oral toxicity 

In the key acute oral toxicity study (Klimisch score=1; ARCO, 1992a), groups of fasted (5 per sex), young adult, Sprague Dawley rats were given a single oral dose of undiluted thermocracked kerosine at a dose of 5000 mg/kg bw and observed for 14 days. There were no treatment related mortalities. All of the study animals exhibited one or more of the following clinical signs: nasal discharge, ocular discharge, abnormal stools, lethargy, stained coat, and alopecia. All animals gained weight during study period. At necropsy, one of the ten animals exhibited visual lesions, the remaining nine showed signs of alopecia in the inguinal and/or perineal regions. The oral LD50 was determined to be greater than 5000 mg/kg in males and females.

In supporting studies conducted on kerosine substances (ARCO, 1992a; ARCO, 1992b; ARCO, 1992c; ARCO, 1987a; ARCO, 1986a; ARCO, 1986b; ARCO, 1986c; API, 1985a; API, 1982; API, 1980a), rats were administered single oral gavage doses of the test substance, and results supported an oral LD50 of > 5000 mg/kg in males and females. 

 

Acute inhalation toxicity

In the key acute inhalation toxicity study (Klimisch score = 1; API, 1987a), groups of Sprague-Dawley rats, five males and five females, were exposed by inhalation route to straight-run kerosine for 4 hours to their whole body at a single dose of 5.28 mg/L (vapour, analytical). All except one animal had normal growth rates throughout the study. The one exception on day 8 had a body weight less than its starting body weight but by the end of the study normal growth had resumed. All animals exhibited decreased activity during the exposure. Otherwise there were no treatment-related clinical signs of toxicity. No macroscopic lesions were observed in any animal at post-mortem and no microscopic changes were observed in any lung section examined. The LC50 was greater than 5.28 mg/L.

In supporting studies conducted on kerosine substances (ARCO, 1992e; ARCO, 1992f; ARCO, 1987b; ARCO, 1987c; ARCO, 1987d; ARCO, 1987e; API, 1983a; Carpenter et al., 1976), rats were administered single doses of the test substance via inhalation. The LC50s as measured based on mortality and systemic effects do not indicate classification of kerosine as an acute inhalation toxicant. One supporting study on deodorised kerosine showed a lack of systemic effects after repeated exposure to rats (6 hours each day for 4 days), and resulted in an LC50 of > 7.5 mg/L (Carpenter et al., 1976). Another supporting study on deodorised kerosine showed a lack of systemic effects after a single 6 hour exposure to cats, and resulted in an LC50 of > 6.4 mg/L (Carpenter et al., 1976). 

 

Acute dermal toxicity

In the key acute dermal toxicity study (Klimisch score=1; ARCO, 1992g), groups of young adult New Zealand White rabbits, five males and five females, were dermally exposed to undiluted thermocracked kerosine for 24 hours to 10% of their body surface area at a dose of 2000 mg/kg. Animals were then observed for 14 days. There were no mortalities and all animals gained weight during the study. All of the animals exhibited one or more of the following clinical signs during the observation period: dermal irritation (erythema, edema, eschar, fissuring and/or dried skin) and/or abnormal stools. Apart from skin irritation, there were no other abnormalities noted at necropsy. The dermal LD50 was determined to be greater than 2000 mg/kg in both males and females. 

In supporting studies conducted on kerosine substances (ARCO, 1992h; ARCO, 1992i; ARCO, 1992j; ARCO, 1987f; ARCO, 1987g; ARCO, 1987h; ARCO, 1987i; API, 1985a; API, 1982; API, 1980a), rabbits were administered single dermal doses of the test substance, and results supported a dermal LD50 of > 2000 mg/kg in males and females. 

Justification for selection of acute toxicity – oral endpoint

One of 11 acute oral studies with representative members of the kerosine category which gave similar results

Justification for selection of acute toxicity – inhalation endpoint

One of 11 acute inhalation studies with representative members of the kerosine category which gave similar results

Justification for selection of acute toxicity – dermal endpoint

One of 11 acute dermal studies with representative members of the kerosine category which gave similar results

Justification for classification or non-classification

Based on evaluation of all the acute toxicity data discussed above, kerosines do not meet the criteria for classification as an acute oral, inhalation or dermal toxicant under the EU CLP Regulation (EC No. 1272/2008).