1,1,1,3,3,3-hexafluoropropan-2-ol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The substance was investigated as part of a screening assay for 311 substances. The study protocol is outlined in broad terms. A negative result (and relevant criteria) are reported, however additional substance-specific data are lacking.

Data source

Reference

Reference Type:

publication

Title:

Salmonella mutagenicity tests: V. Results from the testing of 311 chemicals.

Author:

Zeiger E; Anderson B; Haworth S; Lawlor T; Mortelmans K.

Year:

1992

Bibliographic source:

Environmental and Molecular Mutagenesis 19 (S21), 2-141

Materials and methods

Test guideline

Test guideline 1

Qualifier:

no guideline available

Test guideline 2

Qualifier:

no guideline followed

Principles of method if other than guideline:

Ames test, similar to OECD 471.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,1,1,3,3,3-hexafluoropropan-2-ol

EC Number:

213-059-4

EC Name:

1,1,1,3,3,3-hexafluoropropan-2-ol

Cas Number:

920-66-1

Molecular formula:

C3H2F6O

IUPAC Name:

1,1,1,3,3,3-hexafluoropropan-2-ol

Constituent 2

Reference substance name:

1,1,1,3,3,3-hexafluoro-2-propanol

IUPAC Name:

1,1,1,3,3,3-hexafluoro-2-propanol

Details on test material:

- Name of test material (as cited in study report): 1,1,1,3,3,3-hexafluoro-2-propanol
- Analytical purity:>99%

Method

Target gene:

Various: reversion to histidine independence

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

Liver S9 fraction from Aroclor 1254-induced male Sprague-Dawley rats and male Syrian hamsters

Test concentrations with justification for top dose:

A range of concentrations (at least five) were tested using up to toxic concentrations, the limit of solubillity or 10 mg/plate

Vehicle / solvent:

Water, DMSO, 95% ethanol or acetone: order of preference, depending on solubility.

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

Migrated to IUCLID6: 9-aminoacridine, 4-nitro-o-phenylenediamine, mitomycin C, and methyl methanesulfonate. The positive control for metabolic activation with all strains was 2-aminoanthracene, and either sterigmatocystin or 2-aminoanthracene was used for

Details on test system and experimental conditions:

The substance was tested as part of an inter-laboratory screening of a large number of substances.

Evaluation criteria:

A two-fold increase in mutagenic frequency was judged to provide evidence of a positive response, with consideration of the dose-response relationship.

Statistics:

Not applicable.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

No further informatiuon on results to report.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

A negative result is reported in this assay.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

A negative result is reported in this screening assay.

Executive summary:

1,1,1,3,3,3 -Hexafluoro-2 -propanol was tested for mutagenicity in Salmonella typhimurium TA97, TA98, TA100 and TA1535 as part of a screening study of 311 substances. Tests were conducted using a pre-incubation protocol in the absence and presence of exogenous metabolic activation (liver S9 fraction from Aroclor 1254-induced male Sprague-Dawley rat and Syrian hamsters). The substance was tested at five concentrations up to 10 mg/plate, unless limited by toxicity or solubility. A negative result is reported for 1,1,1,3,3,3 -Hexafluoro-2 –propanol.