Table 12
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Skip the menu of subheadings on this page.This is a paper for discussion. This does not represent the views of the Committee and should not be cited.
Table 12. Repeated dose toxicity studies for PFCAs - PFUnDA
*Derived by contractor; ** calculated according to EFSA. (2012); NR – not reported; NA – not applicable.
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Substance / CAS no. / purity / reference |
Strain & species / sex / no. of animals |
Dose (mg/kg bw/day) / vehicle / route of admin / duration / Guideline (GL) study / Good Laboratory Practice (GLP) status |
PFAS concentration (µg/mL / µg/g) |
Observed effects at LOAEL (controls vs treated groups). Recovery (controls vs treated groups). |
Published NOAEL / LOAEL (mg/kg bw/day) |
Study author comments |
Comments |
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PFUnDA CAS No. 2058-94-8 98.5%. Takahashi et al. (2014) |
Crl:CD (SD) rats. Male and female. 12/sex/dose. Recovery: 5 males and females. |
0, 0.1, 0.3 or 1. Corn oil, Gavage, 42 days (males), 41-46 days (females), OECD 422, GLP not stated. Recovery: 0 or 1, 14 days . |
NR |
Males (mean ± SD): ↑ relative liver weight (%): 2.88 ± 0.27 vs 3.39 ± 0.16#. ↓ total cholesterol (mg/dL): 56 ± 14 vs 34 ± 6#. ↑ albumin/globulin ratio: 0.80 ± 0.07 vs 0.93 ± 0.05#. ↑ hepatocyte centrilobular hypertrophy: 0 vs 3 (2 minimal; 1 mild). Females: ↓ total cholesterol (mg/dL): 60 ± 11 vs 41 ± 13#. ↑ hepatocyte centrilobular hypertrophy: 0 vs 1 (1 minimal). Recovery: Data not presented as animals only treated with 200 mg/kg bw/day and not 0.3 mg/kg bw/day (LOAEL). |
Males: 0.1 / 0.3.
Females: 0.1 / 0.3.
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Data suggest that the liver is a sensitive target organ as the liver weight increased, centrilobular hypertrophy of hepatocytes was seen in both sexes and focal necrosis and/or diffuse vacuolation of hepatocytes was seen at higher doses. The NOAEL for repeated dose toxicity is 0.1 mg/kg bw/day based on centrilobular hypertrophy of hepatocytes in both sexes at 0.3 mg/kg bw/day. |
K1 The study investigated the toxicity of PFUnDA in rats. The study was carried out according to OECD 422. #measured in 5 animals/dose. Study was funded under the Japanese safety programme for existing chemicals, funded by the Ministry of Health, Labour and Welfare, Japan.
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