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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, near guideline study, available as unpublished report, fully adequate for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Genotoxicity testing of the Halon replacement candidates trifluoroiodomethane (CF3I) and 1,1,1,2,3,3,3-heptafluoropropane(HFC227ea) using the Salmonella typhimurium and L5178Y mouse lymphoma mutation assays and the mouse micronucleus test.
Author:
Dodd DE, Ledbetter AD, Mitchell AD
Year:
1997
Bibliographic source:
Inhalation Toxicology 9(2):111-31
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
GLP compliance:
yes
Type of assay:
mammalian cell gene mutation assay

Test material

1
Chemical structure
Reference substance name:
1,1,1,2,3,3,3-heptafluoropropane
EC Number:
207-079-2
EC Name:
1,1,1,2,3,3,3-heptafluoropropane
Cas Number:
431-89-0
Molecular formula:
C3HF7
IUPAC Name:
1,1,1,2,3,3,3-heptafluoropropane
Details on test material:
The test material, a colorless gas, was received in a steel gas container from ManTech/Dayton on April 7, 1994, then transferred to Allen Ledbetter, ManTech/RTP, who was respinsible for handling, storage, and dilution of the test material. The HFC-227ea was stored at ManTech/RTP at room temperature (approximately 72°F). ManTechiDayton documented the strength, purity, and composition of the test material and provided a Material Safety and Data Sheet (MSDS) from Great Lakes Chemical Corporation for HFC-227ea.

Method

Species / strain
Species / strain / cell type:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9 homogenate
Test concentrations with justification for top dose:
Nominal concentrations:
Preliminary assay: 100000; 200000; 300000; 400000; 500000; 600000; 700000; 800000; 900000 ppm
Mutagenesis assay: 100000; 300000; 500000; 700000; 900000 ppm

IR determined concentrations:
Preliminary assay: 63,967, 147,112; 204,380, 269,853, 344,792; 378,811; 423,733; 458,673; 538,535 ppm
Mutagenesis assay: 84,765; 274,259; 408,759; 518,570; 568,484 ppm
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
no
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: hycanthone and cyclophosphamide

Results and discussion

Test results
Key result
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
It was concluded that the substance did not demonstrate mutagenic potential in this in vitro cell mutation assay, under the experimental conditions described.