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EC number: 206-996-5
CAS number: 420-46-2
The substance did not demonstrate mutagenic potential in a reliable in
vitro cell mutation assay in the presence or absence of a metabolic
activation system. The substance was negative (ie non genotoxic), in two
reliable in vitro bacterial gene mutation assays. A positive result was
reported in a third bacterial assay however this study is considered
unreliable. It was also negative in a reliable in vitro cytogenetics
A structurally related substance (1,1,1,2-tetrafluoroethane) gave a
negative result in a reliable in vitro mammalian cell gene mutation
Table 1: Preliminary toxicity test, relative suspension growth
i) In the absence of S9 mix – 3-hour exposure
ii) In the presence of S9 mix – 3-hour exposure
Table 2: Additional main mutation test – 3-hour treatment in the
absence of S9 mix, relative total growth
* Number of non-colony bearing wells (total number of wells)
** control = Sterile air
# Actual concentration reported
MMS - Methyl methanesulphonate
RTG - Relative Total Growth
Table 3: Additional main mutation test – 3-hour treatment in the
absence of S9mix, mutation frequency
MF - Mutant Frequency
Table 4: Additional main mutation test – 3-hour treatment in the
absence of S9mix, colony size analysis
mutagenic potential of the substance was evaluated by testing its
induce forward mutations at the thymidine kinase (TK) locus in L5178Y
mouse lymphoma cells, either in the absence or presence of a metabolic
system (S9-mix) according to the most recent OECD guideline in
compliance with GLP. This test system is based on detection and
quantitation of forward mutation in the subline 3.7.2c of mouse lymphoma
L5178Y cells, from the heterozygous condition at the thymidine kinase
locus (TK+/-) to the thymidine kinase deficient genotype (TK-/-).
The study consisted of a preliminary toxicity test and three independent
mutagenicity assays. The cells were exposed for either
3 hours in the absence of exogenous metabolic activation (S9 mix) or 3
hours in the presence of S9 mix. The substance was tested up to a
maximum final concentration of 70% v/v in the preliminary toxicity test,
in order to test up to the maximum achievable concentration in the test
system without detrimental effects on the cell culture.
Following a 3-hour exposure to the substance at concentrations from 1 to
70% v/v, no reduction in the relative suspension growth (RSG) was
observed in the absence or presence of S9 mix. The
concentrations assessed for determination of mutant frequency in the
main test were based upon these data, the objective being to test up to
the maximum achievable concentration in the test system without
detrimental effects on the cell culture.
Following 3-hour treatment in the absence and presence of S9 mix, there
were no increases in the mean mutant frequencies of any of the test
concentrations assessed that exceeded the sum of the mean concurrent
vehicle control mutant frequency and the Global Evaluation Factor (GEF),
within acceptable levels of toxicity. The maximum
concentration assessed for mutant frequency in the 3-hour treatment in
the absence and presence of S9 mix was 70% v/v. In
the both the absence and presence of S9 mix there was no significant
reduction in RTG.
In all tests the concurrent vehicle and positive control were within
It was concluded that the substance did not demonstrate mutagenic
potential in this in vitro cell mutation assay, under the experimental
HFC 134a was not mutagenic to mouse lymphoma
L51787 cells with or without metabolic activation.
Forane 143a was not mutagenic in this assay using vapor exposure up to
90% with 6 bacterial strains. Positive controls were positive
demonstrating that the assay was valid.
HFC-143a was evaluated for mutagenic activity in 5 bacterial strains
both in the absence and presence of metabolic activation. The maximum
exposure level of 35000 ppm was 50% of the lower explosivity limit for
this material. No mutagenic activity was seen.
Author concluded that test showed HFC-143a to be a weak mutagen.
However, this result was not replicated in subsequent a subsequent GLP
study at even higher exposure levels.
No statistically significant increases in chromosomally abnormal cells
occurred at any test concentration or harvest time examined. In this
study the test substance was not active.
A structurally related substance (1,1,1,2-tetrafluoroethane) was
negative in a reliable in vivo micronucleus assay and an in vivo
dominant lethal assay.
In a dominant lethal assay, CD1 male mice were exposed to up to 50000ppm
HFC 134a for 5 days. After the last exposure, each male was housed with
2 virgin females for 4 consequetive nights. Further matings with new
females were conducted at weekly intervals for a total of 8 times. The
study indicated that HFC 134a did not affect male fertility or cause
mutagenic effects through sperm.
Under the conditions of this test, HFC-143a did not induce micronuclei
in bone marrow cells of mice. The test material was not active.
Overall, negative results were consistently reported in a variety of
reliable in vitro and in vivo genotoxicity studies. Therefore, the
substance does not meet the requirement for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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