Table D.1.
is not intended to provide a comprehensive overview of the available data, but rather to illustrate the main findings in F344 rats exposed to different white mineral oil products. The endpoints listed include absolute and relative liver weight and histopathology, markers for immune system response, mesenteric lymph node weight and histopathology, and spleen weight. For each endpoint the lowest dose at which a relevant change is observed is reported in bracket (expressed in mg/kg bw per day), or the highest tested dose in case of no observed effects. The table includes studies reviewed in the previous opinion of the CONTAM Panel (EFSA CONTAM Panel, 2012), as well as studies reviewed in the present opinion
| Tested item | Species/strain | Liver | Immune system | Mesenteric lymph node | Spleen | Reference |
|---|---|---|---|---|---|---|
| P7H(paraffinic C14‐32) | F344 rats |
↑ weight (170) ↑ granulomas (1,690) |
↑ neutrophils (1,690) |
↑ weight and granulomas (170) |
No findings | McKee et al. (2012) |
| N10A (naphthenic C15‐30) | F344 rats |
↑ weight (17) ↑ granulomas (1,815) ↑ AST and GGT (1,815) |
↑ WBC (1,815) | ↑ weight and granulomas (173) | ↑ weight (1815) | Smith et al. (1996) |
| P15H (paraffinic C14‐32) | F344 rats |
↑ weight (17) ↑ granulomas (1815) ↑ GGT (1815) |
↑ WBC (1815) |
↑ weight (1815) ↑ granulomas (17) |
↑ weight (173) | |
| N15H (naphthenic C17‐30) | F344 rats |
↑ weight (17) ↑ granulomas (1815) ↑ AST and GGT (1815) |
↑ WBC (1815) |
↑ weight (1815) ↑ granulomas (17) |
↑ weight (1815) | |
| N70A (naphthenic C21‐35) | F344 rats |
↑ weight (17) ↑ granulomas (1815) |
↑ monocytes (1815) | ↑ weight (1815) | ↑ weight (1815) | |
| N70H (naphthenic C22‐37) | F344 rats | ↑ weight and granulomas (1815) | ↑ monocytes and neutrophils (1815) | ↑ weight (1815) | ↑ weight (1815) | |
| P70H (paraffinic C27‐43) | F344 rats |
↑ weight (1815) ↑ ALT (1815) |
No findings | No findings | ↑ weight (1815, recovery only) | |
| P100H (paraffinic C28‐45) | F344 rats | ↑ AST (1815) | ↑ WBC (1815) | No findings | No findings | |
| ‘Broad mixture’ | F344 rats |
↑ weight and granulomas (260) No clinical chemistry performed |
↑ lymphoid cells in liver parenchyma (260) No haematology performed |
Not analysed | No findings | Nygaard et al. (2023) |
|
S‐C25 (C16‐34, incl. paraffins) |
F344 rats |
↑ granulomas (226) ↑ weight (23) No clinical chemistry performed |
↑ lymphoid cells in liver parenchyma (226) No haematology performed |
Not analysed | ↑ weight (23) | |
| L‐C25 (C25‐50, deparaffinated) | F344 rats |
No findings No clinical chemistry performed |
No changes in liver parenchyma No haematology performed |
Not analysed | No findings | |
| L‐C25W (C25‐50, incl. paraffins) | F344 rats | ↑ weight and granulomas (22) |
↑ lymphoid cells in liver parenchyma (22) No haematology performed |
Not analysed | ↑ weight (22) | |
| P15H | SD rats | ↑ (minimal) multifocal inflammation (1,624) | No findings | No findings | No findings | Firriolo et al. (1995) |
| N70H | SD rats |
No findings (max dose: 200) Histopathology not performed |
No findings |
No findings Histopathology not performed |
No findings | Carrillo et al. (2022) |
| Marcol72 (paraffinic C14‐38)/LE rats | LE rats | No findings (max dose: 125) | No findings | No findings | Not analysed | Smith et al. (1995) |
| EZL550 (paraffinic C23‐44)/LE rats | LE rats | No findings | ↑ Leukocytes (125) | No findings | Not analysed | |
| Marcol72 (paraffinic C14‐38)/Beagle dogs | Beagle dogs | No findings (max dose: 52) | No findings | No findings | Not analysed | |
| EZL550 (paraffinic C23‐44)/Beagle dogs | Beagle dogs | No findings (max dose: 52) | No findings | No findings | Not analysed |