Registration Dossier

Diss Factsheets

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, API 1980b), 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 (Klimisch scores = 1, ARCO 1990d, 1988g, 1986g, 1986h, 1986i; Klimisch scores = 2, ARCO 1993h, 1987m), VGOs/HGOs/Distillate fuels were not found to be sensitisers to guinea pigs.

 

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

Additional data support that VGOs/HGOs/Distillate fuels are not skin sensitisers (API, 1980aa; API, 1980bb; Beck et al., 1984; API, 1984a; API, 1984b). This information is presented in the dossier.


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 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.