Registration Dossier

Administrative data

Description of key information

Animal studies demonstrate that kerosine was found to be irritating to rabbit skin (similar to OECD 404).  The degree of irritancy is substance-, dose- and exposure-time dependent.
Kerosine was found to be non-irritating to rabbit eyes when exposed to 0.1 mL of test substance (OECD 405).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Animal studies demonstrate that kerosine may act as a skin irritant. The degree of irritancy is substance-, dose- and exposure-time dependent. The kerosines and jet fuels range from essentially non-irritating after 4 hours of semi-occlusive exposure to severely irritating after 24 hours of occluded exposure. Symptoms vary strongly and range from very faint erythema to severe irritation in humans and from epidermal changes (e. g., hyperkeratosis) to necrosis and ulceration of the epidermis in animals. The mechanisms of the irritation and the following inflammatory reaction have been studied in further detail, showing that fuel may induce the production and release of proinflammatory factors such as cytokines.

 

Kerosines are considered irritating to the skin, but are not considered eye irritants.

 

Skin irritation

In a guideline key study conducted according to GLP and in accordance with current guidelines (Shell, 1991a), young adult New Zealand White rabbits (3 per sex) were dermally exposed (semi-occlusive coverage) to 0.5 mL of undiluted odourless kerosine, for 4 hours. Animals were observed for seven days after exposure. Irritation was scored based on the Draize method (1959). The mean erythema score from 24 to 72 hours was 0.17/4 while the mean edema score from 24 to 72 hours was 0/4.

 

In another key study (ARCO, 1986d), young adult rabbits (6 females) were dermally exposed (occlusive coverage) to 0.5 mL of undiluted kerosine/heating oil for 24 hours on both intact and abraded skin sites. Each of the test sites was evaluated for skin responses for 9 days post-exposure, and was scored using the Draize scale. The mean erythema score from 24 to 72 hours was 3.46/4 while the mean edema score from 24 to 72 hours was 2.33/4. While this protocol deviates from current guidelines that state exposure should be semi-occlusive over 4 hours, and to intact skin only, this study is included as key to show the irritating nature of kerosine products.

 

Additional supporting studies are provided on straight run kerosine, odourless kerosine, hydrocracked kerosine, hydrodesulfurised kerosine, Jet Fuel A, Jet Fuel A1, JP-5, and Cherry Point Jet Fuel A (ARCO, 1992k; ARCO, 1992l; ARCO, 1992m; Shell, 1991b; Shell, 1991c; Shell, 1991d; ARCO, 1986e; ARCO, 1986f; ARCO, 1986g; API, 1985a; API, 1982; API, 1980a). Most of the studies are valid in their methodology, but they differ from the current OECD guidelines in that animals were exposed under occluded conditions for 24 hours instead of semi-occluded conditions for 4 hours. Considering the conditions of the test, results must be interpreted carefully for the purposes of classification and labelling. The mean scores for erythema and edema have been assessed against the deviations, and provided the test would be conducted under standard conditions, the overall weight of evidence indicates that kerosines are irritating to skin. Kerosines are classified as irritating to the skin according to E byEU CLP Regulation (EC No. 1272/2008).

 

Eye irritation

A number of well-controlled (GLP) animal experiments performed on a variety of kerosines indicate that none of the kerosines and jet fuels tested were more than slightly irritating to the eyes. In addition, a number of short reports on eye irritation studies on JP-5 and JP-8 show no eye irritation whatsoever in rabbits (6 unwashed eyes; 3 washed eyes): all scores 0.0 for up to 7 days (end of the study). None of the hazard assessments of kerosine and jet fuel constituents have resulted in classification for eye irritation.

 

In the key study selected for primary eye irritation (ARCO, 1992n), 0.1mL of undiluted thermocracked kerosine was instilled into the conjunctival sac of the right eye of three female young adult New Zealand White rabbits, and observed through 72 hours. Irritation was scored according to the Draize method (1959). There was no evidence of damage to the cornea or iris for all animals over all scoring periods. Mild conjunctivae indicators such as redness, chemosis, and discharge were evident at the one hour scoring interval, but not at any of the other scoring intervals. Fluorescein staining scores were zero for all study animals over all scoring periods.

The average irritation score was 0.0 for the cornea, iris and conjunctivae.

Based on the evidence, kerosine is not an eye irritant.

 

In additional eye irritation supporting studies (ARCO, 1992o; ARCO, 1992p; ARCO, 1991a; ARCO, 1986h; ARCO, 1986i; ARCO, 1986j; ARCO, 1986k; API, 1985a; API, 1982; API, 1980a), rabbits were exposed to kerosines and observed for irritation. The studies did not result in irritation according to the mean cornea, iris or conjunctivae scores.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the overall weight of evidence of skin irritation scores, kerosines are classified as irritating to the skin as defined by EU CLP Regulation (EC No. 1272/2008). They are classified as Skin Irritant Category 2 (H315), irritating to the skin. 

Based on a lack of corneal, iridial, and conjunctival irritation, kerosines do not meet the criteria for classification as an eye irritant as defined by EU CLP Regulation (EC No. 1272/2008).