PFAS/2023/06 - Annex A

Table 15

PFAS/2023/06 Annex A

Last updated: 30 September 2025

This is a paper for discussion. This does not represent the views of the Committee and should not be cited.

Table 15. Repeated dose toxicity studies for PFCAs - PFHxDA

*Derived by contractor; ** calculated according to EFSA. (2012); NR – not reported; NA – not applicable.

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

PFHxDA

CAS No. not given

95.3%.

Hirata-Koizumi (2015)

 

 

 

Crl:CD (SD) rats.

Males

and females

7/sex/dose.

Recovery group:

Males and unmated females

5/sex/dose.

 

 

0, 4, 20 or 100

0.5% water solution of carboxymethylcellulose

sodium.

Gavage.

Males: 42 days beginning 14 days prior mating.

Females: 14 days prior to mating, gestation and to PND5

OECD 422

GLP.

Recovery group:

0 or 100.

Males: 14 days.

Females: 14 days (recovery group females were not mated).

NR

Males (mean ± SD):

↑ absolute liver weight (g): 11.95 ± 1.53 vs 14.52 ± 1.82.

↑ relative liver weight (%): 2.41 ± 0.11 vs 2.87 ± 0.23.

↑ centrilobular liver hypertrophy and steatosis: 0 vs 6 (grade 1); 0 vs 2 (grade 2).

Females:

↑ relative liver weight (%): 3.33 ± 0.17 vs 3.70 ± 0.29.

↑ centrilobular liver hypertrophy and steatosis: 0 vs 9 (grade 1).

↑ microgranuloma: 0 vs 7 (grade 2).

Recovery

Males (mean ± SD):

↑ absolute liver weight (g): 13.09 ± 0.95 vs 16.41 ± 0.48.

↑ relative liver weight (%): 2.43 ± 0.15 vs 3.18 ± 0.16.

↑ centrilobular liver hypertrophy and steatosis: 0 vs 2 (grade 1); 0 vs 3 (grade 2).

Females:

↑ relative liver weight (%): 2.40 ± 0.63 vs 2.83 ± 0.27.

Males:

1 / 3.

 

Females:

3 / 10*.

 

Recovery

Males:

1 / 3.

Females:

3 / 10*.

 

 

 

The toxic potency of PFCAs was found to become weaker as the carbon chain length increased from C12 to C18 and the toxic potency of PFCAs was considered to be the strongest when the carbon length was C8 to C12.

Considering structural similarities, the gastrointestinal absorption of longer chain PFCAs may be poorer than that of PFCAs with shorter carbon chains.

K2

The study investigated the toxicity of longer chain PFAS.

The study was carried out according to OECD 422.

Funded by the Ministry of Health, Labour and Welfare, Japan, and supported by a Health and Labour Sciences Research Grant from the Ministry of Health, Labour and Welfare, Japan.