Tetraethylammonium heptadecafluorooctanesulphonate

Genetic toxicity: in vivo

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

Test material information

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