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EC number: 231-955-3
CAS number: 7782-42-5
Assessment of ocular damages in the animal No. 4145 used for the initial
test and in the animals No. 3813 as well as No. 3985 used for the
Body weight in kg
Opacity of the cornea
after the instillation of Fluorescein.
the scores from the readings after 24 hours, 48 hours and 72 hours were
included in the calculation of the individual meanvalues.
of hair below the eye (probably caused by behaviour of intensive
One hour after the application of the
test item animal No. 4145 showed a conjunctiva with diffuse crimson
colour and individual vessels not easily discernible as well as a
swelling above normal. Some hyperaemic conjunctival blood vessels and a
swelling above normal were observed in animals No. 3813 and No. 3985. 24
hrs after the application of the test item, animal No. 4145 showed some
hyperaemic conjunctival blood vessels, an obvious swelling with partial
eversion of lids and loss of hair below the eye probably caused by
behaviour of intensive cleaning. Some hyperaemic conjunctival blood
vessels and a swelling above normal were observed in animal No. 3813 and
No. 3985. After the instillation of Fluorescein only animal No. 4145
showed scattered or diffuse areas of opacity of the cornea with details
of the iris clearly visible on about one quarter of the cornea area. 48
hrs and 72 hrs after the application of the test item, some hyperaemic
conjunctival blood vessels and a swelling above normal were observed in
animal No. 4145. Animals No. 3813 and No. 3985 showed no ocular
reactions. After the instillation of Fluorescein no changes of the
cornea were revealed also in animal No. 4145. Seven days after the
application of the test item, animal No. 4145 was free of any signs of
eye irritation, too.
The local effect of EXPANDED GRAPHITE
POWDER was investigated according to the method recommended in the OECD
Guideline 405 and the council regulation (EC) No 440/2008 part B.5.
Based on the critical analysis of all known data performed by the
sponsor or monitor in his own responsibility the in vivo testing of the
test item was considered to be justified. During an initial test, an
amount of approx. 0.1 g of the undiluted test item was applied in one
eye of a female albino rabbit. The eye was examined and the changes were
graded according to a numerical scale after 1 hr, 24 hrs, 48 hrs and 72
hrs as well as on day 7. Changes ranging between slight and well defined
were observed in the treated eye. Based on these findings two more
female albino rabbits were treated with approx 0.1 g of the undiluted
test item each. Likewise ocular defects were graded after 1 hr, 24 hrs,
48 hrs and 72 hrs. Both of the test animals showed slight changes
concerning eyes. All effects were fully reversible within 7 days.
The following mean values, based on
the results from the 24-hour-, 48-hour- and 72 hour-readings were
Opacity of the Cornea
Redness of Conjunctiva
Oedema of Conjunctiva
*after instillation of Fluorscein
Based on the results of the study
described in this final report, EXPANDED GRAPHITE POWDER has not to be
classified as irritating to the eye according to the provisions laid
down in regulation (EC) No 1272/2008.
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