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EC number: 231-843-4
CAS number: 7758-94-3
After 0.1 g of the test substance was applied in the conjunctiva to
study the eye irritation of iron dichloride(Ⅱ)(CAS No.7758-94-3) in
three New Zealand White female rabbits. Mortality, clinical signs and
body weight changes were observed for 21 days and the eye irritation was
evaluated at 1 hour, and Days 1, 2, 3, 7, 14 and 21. During the test
period, all the animals showed reduced mobility and two rabbits were
observed to rub their eyes with front paws. This was the reaction of
rabbits sensitive to the eye irritation because the substance irritates
the mucosa of the eye. No mortality was observed during the test period.
Head tilting was observed in the rabbit in the initial test and one
rabbit in the confirmative test. It seemed to be caused by the substance
that melted in tear and flowed into the nasal cavity through the
lacrimal gland. The histopathological examination found that lymphocyte
nodule was formed in the submucosa of the paranasal sinus and the test
substance solution affected the nasal cavity tissue through the lacrimal
gland. All the animals were observed to weigh more at Day 21 than Day 0,
which indicated the test substance did affect topical irritation but not
the whole body.
As a result of observing the applied region at 1 hour, and Days 1, 2, 3,
7, 14, and 21, an opaque area was observed throughout the cornea of all
the animals at each time. One rabbit showed stage one recovery at Day 21
and the opacity did not disappear in the rest two rabbits. All the
animals showed no response of the iris to light at Days 2 ~ 3 and
hyperaemia was observed. Severe redness (Grade 1-3), severe excretion
and yellow pigmentation were observed in the conjunctiva of all the
subjects. Severe edema (Grade 2-4) was found in the conjunctiva and
nictitating membrane of all the animals. The redness and edema began to
relieve in Animal No. 1 at Day 7, Animal No. 2 at Day 4 and Animal No. 3
at Day 14. However, with the relieved edema, the deformation of upper
and lower eyelids was observed, which indicated that the test substance
caused severe purulent and inflammatory lesion because hemosiderosis and
severe lymphocyte infiltration were found in the dermis in the deformed
eyelids. High scores appeared even in the determination based on the
Grading of eye lesion.
As a result of the histopathological examination on eyeball, conjunctiva
and lesion of eyelid, granulomatous inflammation was observed in the
conjunctiva, so necrosis, deformed collagen fiber and mineralization
were found in the giant cell and the central part. As purulent keratitis
made of neutrophils was observed in the stroma of the cornea, the test
substance seemed to cause deformation in the cornea and conjunctiva.
Given the fact that the iris had no histopathological lesion, the
symptom in the iris was thought to disappear within 21 days. Corneal
perforation, severe corneal ulcer including staphyloma, hyphema,
conjunctival ulcer, and necrosis or subcutaneous tissue of the
conjunctiva and nictitating membrane were not observed. The opacity of 4
scores lasted 48 hours in the cornea, but one animal was observed to be
in the stage one recovery and the keratitis was diagnosed as corneal
lesion which could be recovered. The response to light did not show up
for 72 hours, but the histopathological examination found no abnormality
in the iris. So, it was regarded as not irreversible lesion.
As a result of medicating iron dichloride to New Zealand White rabbits,
the test substance was regarded as corrosive material because the lesion
was not completely recovered for 21 days after the application.
To study eye irritation of iron dichloride (CAS No.7758-94-3) in three
New Zealand White female rabbits, the subjects were dosed with the test
substance. At 1 hour, and at Days 1, 2, 3, 7, 14, and 21, eye response
and irritation in the cornea, iris and conjunctiva were evaluated and
clinical signs were observed and body weight was measured.
The test results are as follows.
Granulomatous inflammation was found in the conjunctiva and purulent
keratitis was observed in the corneal stroma.
Hemosiderosis and severe lymphocyte infiltration were found in the
dermis of the eyelid of one animal.
In conclusion, iron dichloride (CAS No. 7758-94-3) was evaluated as a
corrosive substance that caused purulent inflammation in the conjunctiva
and eyelid and granulomatous inflammation and purulent keratitis in the
cornea, when applied to the eye of New Zealand White rabbits. Due to
this the substance has been classified as R41 - Risk of serious damage
to the eye according to the Dangerous Substances Directive (DSD). The
substance has also been classified as category 1 (can cause serious
damage to the eye) according to the CLP regulations EC No 1272/2008.
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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