Registration Dossier
Registration Dossier
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EC number: 224-736-9 | CAS number: 4468-02-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(D-gluconato-O1,O2)zinc
- EC Number:
- 224-736-9
- EC Name:
- Bis(D-gluconato-O1,O2)zinc
- Cas Number:
- 4468-02-4
- Molecular formula:
- C12H22O14Zn
- IUPAC Name:
- bis(D-gluconato-O1,O2)zinc
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance : White cristalline powder:
- Batch number: 1700001575
- Manufacturing date: 10.08.2017
- Expiry date: 09.08.2020
Constituent 1
- Specific details on test material used for the study:
- The sample is a fine white powder. The sample was applied unmodified.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Body weight ranging from 2.4 to 2.6 Kg.
- Housing: Albino rabbits were housed in individual cages
- Diet: Animals received a rabbit standard diet ad libitum.
- Water: Animals received a rabbit standard water ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): The room temperature was kept at 20°C±1
- Humidity (%): relative humidity varying between 45 and 55 percent.
- Photoperiod: The duration of lighting was 12hours per day.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
Amount applied: 0.1g of the test material was placed into the conjunctival sac of the left eye while the right eye served as control. - Duration of treatment / exposure:
- Once the test material applied, the left eye was examined during 24h and if meaningful, 7 days post-treatment.
- Observation period (in vivo):
- The eyes were scored at 1, 2, 8 hours and 1, 2, 3, 4, 5, 6 & 7 days after the treatment.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The untreated eye serves as the control, as recommended by the OECD Guideline.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48 h
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Irritant / corrosive response data:
- The test item is slightly irritant.
Any other information on results incl. tables
Cornea : A = opacity - degree of density ; B = Area of cornea involved
Conjunctivae : A = Redness ; B = Chemosis ; C = Discharge
|
Days |
|||||||
Anim. 1 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
Cornea |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
A |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae |
A |
3 |
2 |
1 |
0 |
0 |
0 |
0 |
|
B |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
|
C |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Hours |
||||
Anim. 1 |
1 |
2 |
8 |
24 |
|
Cornea |
A |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
Iris |
A |
1 |
1 |
1 |
1 |
Conjunctivae |
A |
3 |
3 |
3 |
3 |
|
B |
2 |
2 |
2 |
2 |
|
C |
1 |
2 |
2 |
1 |
|
Days |
|||||||
Anim. 2 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
Cornea |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
A |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae |
A |
2 |
2 |
1 |
0 |
0 |
0 |
0 |
|
B |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
|
C |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Hours |
||||
Anim. 2 |
1 |
2 |
8 |
24 |
|
Cornea |
A |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
Iris |
A |
0 |
1 |
1 |
1 |
Conjunctivae |
A |
2 |
2 |
2 |
2 |
|
B |
2 |
2 |
2 |
2 |
|
C |
2 |
2 |
2 |
0 |
|
Days |
|||||||
Anim. 3 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
Cornea |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
A |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae |
A |
3 |
2 |
1 |
0 |
0 |
0 |
0 |
|
B |
3 |
2 |
1 |
0 |
0 |
0 |
0 |
|
C |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Hours |
||||
Anim. 3 |
1 |
2 |
8 |
24 |
|
Cornea |
A |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
Iris |
A |
1 |
1 |
1 |
1 |
Conjunctivae |
A |
3 |
3 |
3 |
3 |
|
B |
3 |
3 |
3 |
3 |
|
C |
2 |
2 |
2 |
0 |
|
Days |
|||||||
Anim. 4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
Cornea |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
A |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae |
A |
3 |
2 |
1 |
0 |
0 |
0 |
0 |
|
B |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
|
C |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Hours |
||||
Anim. 4 |
1 |
2 |
8 |
24 |
|
Cornea |
A |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
Iris |
A |
1 |
1 |
1 |
1 |
Conjunctivae |
A |
2 |
2 |
3 |
3 |
|
B |
2 |
2 |
2 |
2 |
|
C |
2 |
2 |
2 |
1 |
|
Days |
|||||||
Anim. 5 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
Cornea |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
A |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae |
A |
3 |
2 |
1 |
0 |
0 |
0 |
0 |
|
B |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
|
C |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Hours |
||||
Anim. 5 |
1 |
2 |
8 |
24 |
|
Cornea |
A |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
Iris |
A |
1 |
1 |
1 |
1 |
Conjunctivae |
A |
2 |
3 |
3 |
3 |
|
B |
2 |
3 |
3 |
2 |
|
C |
2 |
2 |
2 |
0 |
|
Days |
|||||||
Anim. 6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
Cornea |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
A |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae |
A |
3 |
2 |
1 |
0 |
0 |
0 |
0 |
|
B |
3 |
2 |
0 |
0 |
0 |
0 |
0 |
|
C |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Hours |
||||
Anim. 6 |
1 |
2 |
8 |
24 |
|
Cornea |
A |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
Iris |
A |
1 |
1 |
1 |
1 |
Conjunctivae |
A |
2 |
3 |
3 |
3 |
|
B |
2 |
2 |
3 |
3 |
|
C |
3 |
3 |
3 |
1 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Zinc gluconate granular is slightly irritant.
- Executive summary:
An in vivo eye irritation test was conduct on 6 rabbits (New Zealand white). The eyes were scored at 1, 2, 8 hours and 1, 2, 3, 4, 5, 6 & 7 days after the treatment. The untreated eye serves as the control, as recommended by the OECD Guideline. No cornea opacity was observed. The maximum iris score was 1. The maximal conjunctivae score was 3. The maximal chemosis score was 3. All the effects observed were fully reversible (within four days maximum). The substance is slightly irritant.
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.
