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EC number: -
CAS number: -
- in vitro
bacterial gene mutation:
One fully reliable study is available (Sokolowski (2010) Genetic
toxicity in vitro)) conducted according to OECD TG 471 and GLP (3, 10,
33, 100, 333, 1000, 2500 and 5000 µg/plate; two independent experiments
both with and without liver microsomal activation). No toxic effects,
evident as a reduction in the number of revertants (below the indication
factor of 0.5), occurred in almost all strains with and without
metabolic activation. A minor reduction in the number of revertants
(below the indication factor of 0.5), occurred in strain TA 1537 and TA
98. No substantial increase in revertant colony numbers of any of the
five tester strains was observed following treatment with FAT 40849/A TE
at any dose level, neither in the presence nor absence of metabolic
activation (S9 mix). There was also no tendency of higher mutation rates
with increasing concentrations in the range below the generally
acknowledged border of biological relevance.
mammalian gene mutation:
no data available to date
mammalian chromosome aberration:
One fully reliable study is available (Hall (2010) Genetic
toxicity in vitro - Chromosome abberation) conducted according to OECD
TG 473 and GLP (experiment I :19.5 - 5000.0 μg/mL 4 h exposure and 14 h
recovery ith and without activation; experiment II: 2.4 – 625 µg/mL
without activation in experiment II (18 h exposure), 9.8 – 312.5 µg/mL
with activation in experiment II (4 h exposure + 14 h incubation)).
The following test results were reported: positive (a
statistically significant increase in the number of aberrant cells
excluding gaps (5.3 %) at the highest valuable concentration of 78.1
µg/mL) for Chinese hamster lung fibroblasts (V79) with activation.
Cytotoxicity occurred at 78.1 to 156.3 µg/mL under all conditions. The
results can be summarised in that FAT 40849/A TE is negative forin
vitromammalian chromosome aberration without metabolic activation,
but positive with metabolic activation.
- in vivo
One fully reliable study is available (Merker (2010) Genetic
toxicity in vivo - chromosome aberration - micronucleus assay) conducted
according to OECD TG 474 and GLP (male NMRI mice; doses: 500, 1000, 2000
mg/kg bw, dissolved in 1% (w/v) carboxymethylcellulose (CMC) in water;
collection of cells 24 and 48 h post administration).
As estimated by pre-experiments 2000 mg FAT 40849/A TE per kg b.w.
(the maximum guideline-recommended dose) was suitable.
The mean number of polychromatic erythrocytes was not decreased
after treatment with the test item as compared to the mean value of PCEs
of the vehicle control indicating that FAT 40849/A TE did not have any
cytotoxic properties in the bone marrow. However, the animals showed
discoloured urine after treatment with at least 1000 mg/kg bw indicating
the bioavailability of the test item.
In comparison to the corresponding vehicle controls there was no
statistically significant or biologically relevant enhancement in the
frequency of the detected micronuclei at any preparation interval and
dose level after administration of the test item. The mean values of
micronuclei observed after treatment with FAT 40849/A TE were near to
the value of the vehicle control group. Additionally the values of all
test item treated animals were within the range of the historical
vehicle control data.
The results can be summarised in that FAT 40849/A TE is negative
forin vivomammalian chromosome aberration while being
The negative result in thein vivocytogenetic assay
overrules the positive result from the respectivein vitrotest.
Therefore it can be concluded that FAT 40849/A TE is not clastogenic or
According to ECHA Helpdesk the conducted tests are sufficient to
fulfil the data requirements for genotoxicity:
“– The registrant will have fulfilled the data requirements by
providing the following information: a negative resultin vitrogene
mutation test in bacteria (as required in Annex VII, Section 8.4.1), a
positive resultin vitromicro-nucleus test in mammalian cells (as
required in Annex VIII, Section 8.4.2) and a negative findingin vivomicro-nucleus
study (as required in Annex VIII, Section 8.4, Column 2). Anin vitrogene
mutation study in mammalian cells (Annex VIII, Section 8.4.3) are only
required if the firstin vitrocytogenetic study (Annex VIII,
Section 8.4.2) produce a negative result.”
Accordingly it can be concluded that FAT 40849/A TE is not
Based on the above stated assessment of the genotoxic potential
FAT 40849/A TE (Ames test negative, in vitro mammalian chromosome
aberration test positive, in vivo mammalian micronucleus test in
bone marrow cells negative) the substance is deemed non-genotoxic and
accordingly does not need to be classified according to Council
Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to
CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL) as implementation of UN-GHS in the EU.
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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