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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, and because available data indicates that parent molecules are not reactive toward biological molecules and cannot undergo bioactivation by normal enzymatic processes, they can be considered to constitute a chemical category. Data gaps for partitioning properties, mammalian and ecological toxicity can therefore be addressed by read-across and/or trend analysis between category members.

Data source

Reference
Reference Type:
other: Read across from other interal studies
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Read across from category members
Principles of method if other than guideline:
Trend analysis from category members show no indication of mutagenicity. Slope of the trend line equals zero.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Perfluorohexanes, CAS# 1064697-81-9
Perfluoroheptanes, CAS# 1064698-16-3
Perfluorotributylamines, CAS# 1064698-37-8
Perfluorotripropylamines, CAS# 338-83-0
Perfluoro-N-methylmorpholine, CAS# 382-28-5
Perfluoro-N-C1,3-alkyl morpholines, CAS# 1093615-61-2
Perfluoro-C6,8-furans, pyrans and acyclic ethers , CAS# 1064698-52-7

Method

Species / strain
Species / strain / cell type:
not specified
Metabolic activation:
with and without
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
not specified

Results and discussion

Test results
Species / strain:
not specified
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

PFHx is a member of the Perfluorinated Organic Chemicals, C5-C18, category. All of these chemicals stem from the same manufacturing process, have similar physicochemical properties including high vapor pressure and low water solubility relative to the hydrocarbon analogs (e.g., hexanes v. perfluorohexanes), and also lack any chemically reactive groups, which forms the technical basis for the category. Members of this category are fully fluorinated, meaning that fluorine, rather than hydrogen, is bonded to all carbon atoms in the molecule. Fluorine is the most electronegative of the elements (fluorine has an electronegativity of 3.98 on the Pauling scale, as compared to 2.55 for carbon or 2.20 for hydrogen). This electronegativity is expected to dominate over all other aspects of substance chemistry and is the underlying basis for similarity of substances in this category. Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, and because available data indicates that parent molecules are not reactive toward biological molecules and cannot undergo bioactivation by normal enzymatic processes, they can be considered to constitute a chemical category. Data gaps for partitioning properties, mammalian and ecological toxicity can therefore be addressed by read-across and/or trend analysis between category members.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative criteria used for interpretation of results: OECD GHS

The category members were not considered bacterial mutagens.
Executive summary:

Ames assays were conducted on category members to determine mutagenicity. Selective agar plates containing bacterial cells Salmonella typhimurium strains and Saccharomyces cerevisiae were prepared. Increasing doses of the category members were spotted in the culture of the selective agar plate containing the indicator organisms with the presence or absence of metabolic activation. Plates were incubated at 37°C for 48 hours and revertants were counted. The category members did not demonstrate mutagenic activity in any of the assays conducted. Based on these results the category members are considered not mutagenic under the test conditions.

Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, and because available data indicates that parent molecules are not reactive toward biological molecules and cannot undergo bioactivation by normal enzymatic processes, they can be considered to constitute a chemical category. Data gaps for partitioning properties, mammalian and ecological toxicity can therefore be addressed by read-across and/or trend analysis between category members. The readacross is considered reliable with restrictions and the result is suitable for use in Risk Assessment, Classification & Labelling, and PBT Analysis.