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Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: gene mutation
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:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Principles of method if other than guideline:
mouse bone marrow micronucleus assay
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
Potassium heptadecafluorooctane-1-sulphonate
EC Number:
220-527-1
EC Name:
Potassium heptadecafluorooctane-1-sulphonate
Cas Number:
2795-39-3
IUPAC Name:
potassium 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctane-1-sulfonate
Details on test material:
Identity: Potassium perfluorooctylsulfonate, CAS #2795-39-3
Remarks: FC-95, purity not specified.

Test animals

Species:
mouse
Strain:
other: Crl:CD-1®(ICR)BR
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
all treatment groups were sampled at 24, 48 and 72 hours; the test lasted 72 hours
Frequency of treatment:
single dose
Post exposure period:
none
Doses / concentrations
Remarks:
Doses / Concentrations:
237.5, 450, 950 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
5/sex/dose
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
Micronuclei were evaluated in the bone marrow of treated animals

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
valid

Any other information on results incl. tables

(1) Animals were examined approximately 1-2 hours before sampling for signs of toxicity and mortality. Animals in the 237.5 mg/kg group remained healthy throughout the treatment period. (2) Both males andfemales in the 950 mg/kg dose group began dying about 22 hours after treatment. Also at 22 hours 2 males in the 950 mg/kg dose group went into convulsions when their cage was opened but recovered in a few minutes. At about 46 hours after treatment 1 female from the 450 mg/kg dose group and more males and

females from the 950 mg/kg dose group were found dead and at about 71 hours after treatment, one male from the 950 mg/kg dose group was found dead. All surviving animals appeared normal at that point. (3) No other clinical signs were noted or reported. (4) Body weight changes were not reported. (5) Food and water consumption were not reported. (6) There was no increase in the percent of micronucleated PCEs at any dose level tested or at any time period sampled.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Executive summary:

PFOS is negative in the mouse bone marrow micronucleus assay