Registration Dossier

Diss Factsheets

Administrative data

Description of key information

VGO/HGO/Distillate fuels were found to be irritating to the skin of rabbits after a 24-hour, occlusive exposure (similar to OECD 404).  The key data showed mean erythema scores of 3.9 and 2.5, and mean oedema scores of 2.96 and 1.5.  
VGO/HGO/Distillate fuels were considered non-irritating to the rabbit eye (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

Skin Irritation

Multiple studies were available to assess the skin irritation potential of VGOs/HGOs/Distillate fuels. In the first key study (Klimisch score = 1, API 1980a), the irritation potential of diesel fuel to rabbits was evaluated after application to one abraded area and one intact area per animal, under occlusion, for 24 hours. Pronounced erythema and oedema were present at both abraded and intact test sites at 24 hours, with blistering and peeling. The erythema was largely resolved by day 14, and the oedema was fully resolved by day 14. The mean 24 and 72 hour score for erythema was 3.9 and oedema was 2.96. In the second key study (Klimisch score = 1, API 1980b), the skin irritation potential of #2 home heating oil (50% catalytically-cracked) to rabbits was evaluated after application to two abraded areas and two intact areas per animal, under occlusion, for 24 hours. Moderate erythema was present at 24 hours with all three animals, which was increased in severity at 72 hours before declining at 7 days and fully resolving by day 14. Moderate oedema was also present at 24 hours, which increased to moderate-to-severe oedema by 72 hours but fully resolving by day 14. The mean erythema score (24 and 72 hour) score was 2.5 and the oedema was 1.5. 

 

In supporting studies, rabbits were dermally exposed to VGOs/HGOs/Distillate fuelsunder occlusive conditions for 24 hours (Klimisch scores = 2, ARCO 1993e, 1993f, 1990b, 1988e, 1987j, 1987k, 1986b, 1986c). Mean erythema scores ranged from 1.5 to 3.25, and mean oedema scores ranged from 1.2 to 2.65. 

These studies were performed with a 24 hour exposure rather than 4 hours recommended by the current OECD guidelines. Consequently, the result from a shorter exposure time will likely not cause as much irritation as these records indicate. However, based on these results and evidence of irritation in all studies, VGOs/HGOs/Distillate fuels are classified as irritating to the skin. 

Eye Irritation 

Multiple studies were available to assess the eye irritation potential of VGOs/HGOs/Distillate fuels. In both key studies, 9 New Zealand White rabbits (5 males and 4 females) received 0.1 mL of undiluted test material in the right eye. Treated and control eyes from three rabbits from each study were flushed with lukewarm water for one minute starting 30 seconds after test material instillation. The eyes of the other 6 rabbits in each study remained unwashed. In the first key study (Klimisch score = 1, API 1980a), diesel fuel was non-irritating to the eyes of rabbits. In the second key study (Klimisch score = 1, API 1980b),only one rabbit, in the unrinsed group, exhibited minor conjunctival erythema at the 24 and 48 hour reading. All other animals were normal. Under the conditions of this study, the test material exhibited no corneal opacity and the slight irritation was reversible within seven days, indicating a non-irritating response. 

 

In additional eye irritation supporting studies (Klimisch scores = 2, ARCO 1993g, 1992d, 1990c, 1988f, 1987l, 1986g, 1986e, 1986f), rabbits were exposed toVGOs/HGOs/Distillate fuelsand observed for irritation. Any irritation noted was fully reversible and mild. 

 

Based on these results,VGOs/HGOs/Distillate fuelsare not classified as irritating to the rabbit eye.

Additional data support that VGOs/HGOs/Distillate Fuels are skin irritants but not eye irritants (API, 1980aa; API, 1980bb; Beck et al., 1984; API, 1985b; API, 1985c). This information is presented in the dossier.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on mean erythema scores of 3.9 and 2.5 (24, 72 hours), and mean oedema scores of 2.96 and 1.5 (24, 72 hours), VGOs/HGOs/Distillate Fuels are classified as irritating to the skin, H315, according to the EU CLP Regulation (EC)1272/2008. 

 

Based on a lack of significant eye irritation, VGOs/HGOs/Distillate Fuels are not classified as irritating to eyes according to the EU CLP Regulation (EC)1272/2008.