Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
study acc. to OECD 405 conducted in 2013
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 of November till 13 of December 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted and well documented study under GLP condition.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
ZnHBED
IUPAC Name:
ZnHBED
Constituent 2
Chemical structure
Reference substance name:
disodium [2,2'-(ethane-1,2-diylbis{[2-(hydroxy-kO)benzyl]imino-kN})diacetato-kO(4-)]zinc(2-)
Cas Number:
1263416-97-2
Molecular formula:
C20 H20 N2 Na2 O6 Zn
IUPAC Name:
disodium [2,2'-(ethane-1,2-diylbis{[2-(hydroxy-kO)benzyl]imino-kN})diacetato-kO(4-)]zinc(2-)
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Two albino rabbits of the New Zealand strain coming from the conventional husbandry of the Experimental Department of the National Research Institute of Animal Production, Balice near Kraków. The animals’ good health state was confirmed by Certificate issued by National Research Institute of Animal Production Department of Animals Genetics and Breeding in Balice. The rabbits were acclimatized for 5 days and carefully observed during this time. General medical-veterinary examination was performed on day of introduction of animals to acclimatization and detailed medical-veterinary examination was performed prior to the beginning of experiment. The animals without any pathological signs were introduced to the experiment. They were randomly selected to the experiment. The animals were individually marked. The experiment was conducted on one 7-month-old female – rabbit No. 1 and one 6-mounths-old male – rabbit No. 2.

Housing conditions
During acclimatization and experiment the animals were kept in air-conditioned room with the following parameters:
- air temperature: 20 - 22C;
- relative air humidity: 45 – 60%;
- artificial fluorescent lighting: 12 hours light / 12 hours dark
- facility air exchange about 16 times/h [SOP/T/9].
The animals were kept individually in metal cages with dimensions (length x width x height): 60 x 35 x 40 cm.
The animals were given ad libitum standard granulated "LSK" and tap water.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The second eye of animal was used as the control one
Amount / concentration applied:
The test item in amount of 0.085 g was administered as a single dose to conjunctival sack of one eye of rabbit by gentle distraction of lower eyelid. Then both eyelids were kept together for a moment to protect loosing of test item. The second eye was used as the control one
Observation period (in vivo):
Detailed clinical observations for changes in cornea, iris and conjunctiva were performed after 1, 24, 48 and 72 hours and after 7, 14 and 21 days since administration of the test item
Number of animals or in vitro replicates:
2
Details on study design:
Before the test item application, an anesthetics were administered to each animal. The study started with a preliminary study on one animal. The test item in amount of 0.085 g was administered to conjunctival sack of one eye of the animal (rabbit No. 1). The second eye served as a control. The animal was observed for 21 days.
After evaluation of the treated eye in order to confirm irritation of its lack, the test item was given to eye of another animal (rabbit No. 2). Manner of administration was the same as in case of animal No. 1. The animal was observed for 21 days.
General clinical observations for morbidity and mortality of the animals were performed daily during the entire experiment. Detailed clinical observations for changes in cornea, iris and conjunctiva were performed after 1, 24, 48 and 72 hours and after 7, 14 and 21 days since administration of test item.
Body weight of animals was determined on day of test item administration (day 0) – directly before administration and on the last day of experiment.
After period of observation the animals were humanely killed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: average of readings after 24,47,72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: average of readings after 24,48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
erythema
Basis:
animal #1
Time point:
other: average of readings after 24, 48,72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
animal #1
Time point:
other: average of readings after 24,48, 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: average of readings after 24,48,72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: average of readings after 24,48,72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Remarks:
erythema
Basis:
animal #2
Time point:
other: average of readings after 24, 48, 72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
animal #2
Time point:
other: average of readings after 24, 48, 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
After administration of the test item the changes in cornea, iris and conjunctiva were stated in eye of animals. The changes were transient.
Other effects:
Transient discharge from coniunctivae sack. No other effects were observed.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Category 2 Criteria used for interpretation of results: EU
Conclusions:
After administration of the test item the changes in cornea, iris and conjunctiva were stated in eye of animals. All changes were transient and they fully revrsibled before 21 days.
Executive summary:

On the ground of the study the test item Zn (II) HBED:

- it irritates the rabbit eye – according to the Annex to the Decree of the Minister of Health of August 10, 2012 on classification of chemical substances and mixtures (Journal of Laws, item 1018),

- it belongs to category 2 – according to the Regulation (EC) of the European Parliament and of the Council No 1272/2008 of 16 December, 2008 on classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006.