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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
two-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The experimental study is referred to Potassium PFOS (Perfluorooctane sulfonic acid). The substance RM90 is a salt of PFOS too.

Data source

Reference
Reference Type:
publication
Title:
ENVIRONMENTAL AND HEALTH ASSESSMENT OF PERFLUOROOCTANE SULFONIC ACID AND ITS SALTS
Author:
3M
Bibliographic source:
Various sources listed in the assessment report.
Report date:
2003

Materials and methods

Test guideline
Guideline:
other: not known
Principles of method if other than guideline:
Method not available in the pubblication.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Potassium PFOS
IUPAC Name:
Potassium PFOS

Test animals

Species:
rat
Strain:
not specified
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

No effects on mating, fertility, or natural delivery were noted, with the exception of a decrease in implantations and litter size in F0 females at 3.2 mg/kg, the highest dose tested. The early adverse response in adults and in pups was reduced body weight gain in both sexes. Most significant was the death of all F1 pups in the perinatal period at the maternal dose of 3.2 mg/kg/day. Mortality was also seen in F1 pups from dams that received 1.6 mg/kg. The dose response for this effect was steep as demonstrated by viability indices (survival from birth to LD 4) of 98.7, 98.3, 98.3, 66.1 and 0.0% for the 0, 0.1, 0.4, 1.6 and 3.2 mg/kg dose groups, respectively. Severity of effect on F1 pups in the lactation phase of the study resulted in post weaning dose groups being reduced to 0, 0.1 and 0.4 mg/kg. These three dose groups proceeded through a mating, pregnancy and postnatal evaluation phase until F2 pups were 21 days of age.
The F1 rats in all these groups developed normally as measured by an array of developmental milestones, including neurobehavioral performance. Effects on reproduction, lactation and on postnatal viability of the F2 pups were modest and transient.

Effect levels (P0)

open allclose all
Dose descriptor:
NOAEL
Effect level:
0.1 mg/kg bw/day
Based on:
not specified
Dose descriptor:
LOAEL
Effect level:
0.4 mg/kg bw/day
Based on:
not specified
Basis for effect level:
other: Body weight gain reduction
Dose descriptor:
NOAEL
Effect level:
1.6 mg/kg bw/day
Based on:
not specified
Dose descriptor:
LOAEL
Effect level:
3.2 mg/kg bw/day
Based on:
not specified
Basis for effect level:
other: Implantation and litter size reduction.

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
0.4 mg/kg bw/day
Based on:
not specified
Basis for effect level:
other: Neonatal mortality increase and body weight reduction. Effects on reproductive parameters.

Results: F2 generation

Effect levels (F2)

Dose descriptor:
NOAEL
Generation:
F2
Effect level:
0.4 mg/kg bw/day
Based on:
not specified
Basis for effect level:
other: Effects on all measured parameters.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Maternal body weight changes are observed in the pre-natal teratology studies and the two generation studies. Results of the two-generation study indicate that fertility and reproductive performance are not impared at doses that cause adverse body weight effects on males and females. However, the mortality seen in the perinatal period of life has no parallel in the prenatal studies. While modest increase in resorptions were seen in the two-generation studies, pup development until the time of birth was fairly normal. The incidence of pup mortality was severe at the higher doses
on day of birth and in the immediate perinatal period. The study design did not permit insight as to the factor that contributed to this effect.