Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.5
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
Nature of substance: Feststoff

Test animals / tissue source

Species:
other: rbt, Himalayan

Test system

Amount / concentration applied:
100 MG
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
1
Remarks on result:
other: Max. duration: 5 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Max. score:
1
Remarks on result:
other: Max. duration: 1 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
cornea opacity score
Max. score:
1
Remarks on result:
other: Max. duration: 8 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
iris score
Max. score:
1
Remarks on result:
other: Max. duration: 8 h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 9 days
Other effects:
Eine Hornhauttrübung (Grad 1) wurde bei Tier zwei und drei
24 bis 72 Stunden, bei Tier zwei bis 8 Tage und bei Tier
eins, 4 bis 8 Tage nach Verabreichung beobachtet.

Beim Fluorescein-Test, durchgeführt nach 24 Stunden, waren
bei Tier zwei 50 % und bei Tier drei 25 % der
Hornhautoberfläche verfärbt.

Beim Fluorescein-Test, durchgeführt nach 7 Tagen, waren bei
Tier eins 75 % und bei Tier zwei 50 % der Hornhautoberfläche
verfärbt.

Eine Reizung der Iris (Grad 1) wurde bei Tier zwei und drei
24 bis 72 Stunden, bei Tier zwei bis 8 Tage und bei Tier
eins 72 Stunden bis 8 Tage nach Instillation beobachtet.
Eine Rötung der Bindehaut (Grad 1) wurde erstmalig eine
Stunde (Tier zwei) oder 4 Stunden (Tier eins) nach
Verabreichung beobachtet und hielt bis 4 Tage (Tier eins)
oder 5 Tage (Tier zwei) an.

Eine Bindehautschwellung (Grad 1) wurde an Tier drei eine
Stunde nach Verabreichung der Testsubstanz beobachtet.

Bei allen Tieren wurde Substanz im Bindehautsack ab 24
Stunden, bis 48 Stunden (Tier drei), bis 72 Stunden (Tier
zwei) oder bis 6 Tage (Tier eins) nach Verabreichung
festgestellt.

"ENGLISH"

Corneal clouding (grade 1) was observed in animals two and
three from 24 to 72 hours, in animal two up to 8 days and

in animal one 4 to 8 days after administration.

In the fluorescein test performed after 24 hours, in animal
two 50 % and in animal three 25 % of the surface of the
cornea were discolored.

Irritation of the iris (grade 1) was observed in animals two
and three 24 to 72 hours, in animal two up to 8 days and in
animal one 72 hours to 8 days after instillation.
Conjunctival redness (grade 1) was first observed one hour
(animal two) or four hours (animal one) after administration
and persisted up to 4 days (animal one) or five days (animal
two).

Conjunctival chemosis (grade 1) was observed in animal three
one hour after administration of the test substance.
Substance was found in the conjunctival sac of all animals
as from 24 hours, up to 48 hours (animal three), up to 72
hours (animal two) or up to 6 days (animal one) after
administration.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information