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EC number: 233-072-9
CAS number: 10028-22-5
This endpoint is covered by the category approach for soluble iron salts
(please see the section Toxicokinetics, metabolism and distribution for
the category justification/report format).
• Animal data:
Stizinger (2010) performed a LLNA assay conducted according to OECD 429
and GLP using up to 50 % of the test item in acetone/olive oil (4:1
v/v). The test item was a 42.6 % solution of FeSO4 in water (plus some
impurities). Therefore the final concentration of FeSO4 was about 21.3 %
w/w in the applied test solution. Nevertheless this test is regarded
suitable for read across to the other iron salts as generally the
bioavailability of ferrous iron is higher, while it is rather quickly
oxidised in watery solutions to ferric iron and therefore can function
as surrogate for the latter. Only for FeCl3 information from two
secondary sources (that most probably have the same primary source given
the results reported) is available showing an ambiguous picture. As
these sources are very unreliable this result is disregarded.
• Human data
For human data two case reports and a human patch test with 31
volunteers are available. Baer (1973) reports contact sensitization to
iron and a positive patch test to a 2 % ferric chloride (FeCl3) solution
for a 66-year old white male tool maker. The patient's 5 -year history
of allergic contact dermatitis was not associated with any other
exposure to metals.
Nater (1960) describes a 44 year old male with eczema-type
reactions on his skin in areas that were exposed to steel particles
during his job using high pressure cleaning equipment to remove steel
particles from construction elements. After testing against 16 other
metal salt present in low concentrations in the steel (including nickel
and cobalt) and comparing the results to 30 volunteer control people
ferric chloride (FeCl3) was identified as the substance triggering
Oshima (1991) conducted a human patch test with metals salts from
all metals used in a dental clinic. 30 volunteers from the staff of the
clinic were tested. All were negative for skin sensitisation effects
from the metal salts tested.
The available animal data is limited but a fully reliable study on
FeSO4 is deemed valid for read across for the other salts of the iron
salt category. The available human data are limited. Two cases of skin
sensitisation reactions against ferric chloride are reported for two
workers that have been highly exposed occupationally through frequent
contact with steel products. Nevertheless in one study in 30 individuals
no comparable effects were seen. This is in line with the findings of
the third available human study where 31 employees of a dental clinic
were tested for contact allergy reactions against the metals that they
are occupationally exposed to. They were all negative for reactions
against metal salts. Finally iron additives are in widespread use as
nutritional supplements. If iron ions had a high potency for causing
sensitisation this would most probably be realised by now.
Finally it is concluded that in rare cases the development of
sensitisation against iron salt is possible. Nevertheless in general
iron salts are deemed not to have a potential to cause sensitisation
that is relevant for classification.
No specific information on respiratory sensitisation is available. In
absence of skin sensitisation and in view of the long occupational use
of soluble iron salts, a respiratory sensitisation potential seems
Based on the above stated assessment of the skin sensitisation
potential of iron salts, none of the members of the iron salt category
needs to be classified according to Council Directive 2001/59/EC (28th
ATP of Directive 67/548/EEC) or according to CLP (5th ATP of Regulation
(EC) No 1272/2008 of the European Parliament and of the Council) as
implementation of UN-GHS in the EU.
Thus no classification for pure grades of the submission item
Possible impurity-triggered classification may however be required
depending on the Nickel content: In Annex VI of the 1st ATP to the
CLP-Regulation (Commission Regulation (EC) No 790/2009 of 10 August
2009) “nickel sulfate” EC 232-104-9, CAS 7786-81-4, Index no.
028-009-00-5 (Tables 3.1 and 3.2 on pages L 235/11 and 243,
respectively) and “nickel dichloride” EC 231-743-0, CAS 7718-54-9 Index
no. 028-011-00-6 (Tables 3.1 and 3.2 on pages L 235/135 and 354,
respectively) are listed with a specific concentration limit of ≥ 0.01 %
w/w triggering classification as skin sensitizing class 1 according to
directive 67/548/EWG. The risk phrase R43 (symbol Xi, the indication of
danger “Irritant”) or the hazard statement H317 is required according to
DSD and CLP, respectively.
Table: Skin sensitisation label elements for category 1 (CLP,
5th ATP, Annex I, 22.214.171.124, Table 3.4.7)
GHS07 exclamation mark
H317: May cause an allergic skin reaction
P261, P272, P280
P302 + P352, P333 + P313, P321, P362 + P364 (4th ATP change)
As no data on respiratory sensitisation is available for iron
salts a classification is not possible according to Council Directive
2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (5th
ATP of 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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