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EC number: 205-381-9
CAS number: 139-89-9
HEDTA-Na3 is not expected to be a skin
sensitizer based on read across.
One animal of the control group 1 was found dead on day 13. Hypoactivity
and dyspnea were observed prior to death. The authors stated that such
spontaneous clinical signs and mortality are sometimes observed in this
Under the conditions of the test there was no evidence for skin
- None of the animals treated with Na3EDTA showed positive reactions
- All animals treated with EDA were sensitized and displayed a slight to
marked edema and erythema after challenge with EDA.
- Animals which were sensitized to EDTA did not respond to a challenge
by Na3EDTA. Therefore it can be concluded that there is no cross
sensitisation between EDA and Na3EDTA.
Under the conditions of the test, the substance is not sensitizing and
does not cross react with EDA.
No skin sensitisation studies on HEDTA-Na3
or HEDTA-H3 are available. However the structural analogue, EDTA-H4 and
its various Na salts, are expected to exhibit similar properties and
therefore studies using Na2-EDTA and Na3-EDTA have been used for read
across. (For read-across justification also refer to section 13). In the
OECD 406 guideline study with Na2-EDTA 3/10 guinea pigs showed a patch
erythema after the first challenge and 1/10 after the second challenge.
The reports on humans are conflicting and in case of positive results it
was concluded that the reactions reflected irritation rather than
sensitisation. Moreover, animals treated with Na3-EDTA did not show
positive reactions. Overall, these results do not warrant classification and
labeling according to EU or GHS critieria, which was also confirmed by
the independent evaluation of the MAK Commission for the Investigation
of Health Hazards of Chemical Compounds in the work area (MAK, 46.
available information indicate that the substance should not be
classified as skin sensitising according to Regulation 1272/2008/EC
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