Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Multiple studies were available to assess the skin sensitising potential of VGOs/HGOs/Distillate fuels. In the first key study (Klimisch score = 2, API 1980a), dermal sensitisation potential of diesel fuel was evaluated, while the second key study (Klimisch score = 2, ), evaluated dermal sensitisation potential of #2 home heating oil. Under the conditions of this test, diesel fuel and # 2 home heating oil were considered to be non-sensitising as there was no significant difference in response to the test material between the test and control groups.

 

In supporting studies (API 1980b, ARCO 1990d, 1988g, 1986g, 1986h, 1986i; Klimisch scores = 2, ARCO 1993h, 1987m; API 1980), VGOs/HGOs/Distillate fuels were not found to be sensitisers to guinea pigs.

 

Based on these results,VGOs/HGOs/Distillate fuels are not skin sensitisers when tested using a closed patch technique in guinea pigs.

Migrated from Short description of key information:

VGOs/HGOs/Distillate fuels are not skin sensitisers when tested using a closed patch technique in guinea pigs (OECD 406).

Justification for selection of skin sensitisation endpoint:

One of eleven guinea pig sensitisation studies, all of which showed no evidence of skin sensitisation.

Justification for classification or non-classification

VGO/Hydrocracked/Distillate fuels are not classified as sensitising to the skin according to the EU CLP Regulation (EC) 1272/2008.