Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
dermal absorption in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1981

Materials and methods

Principles of method if other than guideline:
The objective of this study was to determine the percutaneous absorption potential of FC-128 in male and female albino rabbits
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Potassium N-ethyl-N-[(heptadecafluorooctyl)sulphonyl]glycinate
EC Number:
221-062-7
EC Name:
Potassium N-ethyl-N-[(heptadecafluorooctyl)sulphonyl]glycinate
Cas Number:
2991-51-7
IUPAC Name:
potassium {ethyl[(heptadecafluorooctyl)sulfonyl]amino}acetate
Details on test material:
Fluorad FC-128 = Potassium N-ethyl-N- [(heptadecafluorooctyl)sulfonyl] glycinate CAS No. 2991-51-7
Radiolabelling:
no

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive

Results and discussion

Any other information on results incl. tables

No mortalities or untoward behavorial reactions were noted during the 28 day study. Body weight losses were noted in three females at the end of the study. Necropsies were performed on all animals upon termination of the study with no visible lesions noted.

Preliminary serum analysis indicates dermal absorption of FC-128 in albino rabbits, however, due to the limited number of samples

analyzed by the sponsor, no concrete conclusion may be drawn.

Applicant's summary and conclusion

Executive summary:

The test article was administered by dermal application to ten male and ten female rabbits a dosage level of 2,000 mg/kg body weight

for a 24 hour exposure period. No mortalities or untoward behavorial reactions were noted during the 28 day study. Body weight losses were noted in three females at the end of the study. Necropsies were performed on all animals upon termination of the study with no visible lesions noted.

Preliminary serum analysis indicates dermal absorption of FC-128 in albino rabbits, however, due to the limited number of samples

analyzed by the sponsor, no concrete conclusion may be drawn.