Table 6

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 conclusions

Comments

PFOS (potassium salt)

CAS no. Not given

86.9%.

Chang et al. (2017)

Cynomolgus monkeys.

Male and female

6/sex/dose.

Group 1 and 2: 0 or 9

0.5% Tween® 20 + 5% absolute ethanol in water.

Gavage

Single dose, animals not sacrificed,

Non-GL study,

GLP not stated.

Recovery period:

294 days.

At 9 mg/kg bw in males on day 113 (mean ± SD)

Serum: 67.7 ± 7.5.

At 9 mg/kg bw in males on day 420,

Serum: 14.1 ± 2.0

Liver: 7.8 ± 5.5.

At 9 mg/kg bw in females on day 113

Serum: 68.8 ± 2.5.

At 9 mg/kg bw/day in females on day 420

Serum: 9.5 ± 4.4

Liver: 8.3 ± 3.3.

Males:

No adverse effects in liver reported.

Females:

No adverse effects in liver reported.

Recovery:

No adverse effects in liver reported.

Males:

9 / NA*

Females:

9 / NA*

Recovery

Males: 9 / NA*

Females: 9 / NA*

There were no treatment related

changes in serum liver enzymes during the study.

K2

This study examined the effects of orally administered PFOS on hepatic clinical chemistry in Cynomolgus monkeys.

Only two dose groups were used i.e., control and single treatment group.

PFOS was of low purity with impurities including 3.2% PFHxS, 1.2% PFHpS, 1.1% PFPeS, 0.97% PFBS and 0.74% PFPS.

Data for clinical chemistry not presented or discussed in text.

The study was supported by 3M Company. Authors are employees, former employees or consultants of the 3M Company.

PFOS (potassium salt)

CAS no. Not given

86.9%.

Chang et al. (2017)

Cynomolgus monkeys,

Male and female,

4-6/sex/dose.

Group 1 and 3:

0, 14, 14.8 / 17.2 (male/female) and 11

0.5% Tween 20 + 5% EtoH.

Gavage,

Single doses on days 43, 288 and 358, animals not sacrificed,

Non-GL study

GLP not stated.

Recovery period:

294 days.

At 14 mg/kg bw/day in males on day 50 (mean ± SD)

Serum: 104.8 ± 5.2.

At 14 mg/kg bw/day in females on day 50

Serum: 96.5 ± 6.2.

At 14.8/17.2 bw/day in males on day 295

Serum:141.0 ± 13.1.

At 14.8/17.2 bw/day in females on day 295

Serum: 147.6 ± 17.5.

At 11 mg/kg bw in males on day 365

Serum:160.8 ± 14.2.

At 11 mg/kg bw in females on day 365

Serum: 165.0 ± 6.7.

At study termination in males on day 420

Serum: 130.5 ± 14.7

Liver: 94.5 ± 33.9.

At study termination in females on day 420

Serum: 127.0 ± 4.1

Liver: 112.0 ± 18.7.

Males:

No adverse effects in liver reported.

Females:

No adverse effects in liver reported.

Recovery:

No adverse effects in liver reported.

Males:

14.8 or 17.2 / NA*.

Females: 14.8 or 17.2 / NA*.

Recovery

Males:

14.8 or 17.2 / NA*.

Females: 14.8 or 17.2 / NA*.

There were no treatment related

changes in serum liver enzymes during the study.

K2

This study examined the effects of orally administered PFOS on hepatic clinical chemistry in Cynomolgus monkeys.

Only two dose groups were used i.e., control and single treatment group, with variable dosing of 14, 14.8/17.2 or 11 mg/kg bw/day, varying across treatment days, and between sexes on study day 288 (aiming to achieve serum concentrations ~ 100 µg/ml (on Study Day 43), 150 µg/ml (on Study Day 288), and 170 µg/ml (on Study Day 358).

PFOS was of low purity with impurities including include 3.2% PFHxS, 1.2% PFHpS, 1.1% PFPeS, 0.97% PFBS and 0.74% PFPS.

Data for clinical chemistry not presented or discussed in text.

The study was supported by 3M Company. Authors are employees, former employees or contractors of the 3M Company.