Registration Dossier

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 guidelineopen allclose all
Qualifier:
no guideline available
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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:
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:
Water, DMSO, 95% ethanol or acetone: order of preference, depending on solubility.
Controls
Negative controls:
not specified
Solvent 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 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 valid:
yes
Negative controls valid:
not applicable
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Additional information on results:
No further informatiuon on results to report.

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.