Bis(D-gluconato-O1,O2)zinc

Endpoint summary

Description of key information

Skin irritation test performed in vivo :

The relative level of primary skin irritation of the test sample "zinc gluconate granular" was investigated in one group three rabbits. The exposition period of the test substance was 4 hours. Any signs of erythema, eschar and edema formation were recorded during the observation period of 72 hours. The judgement of the skin alterations was done 30' - 60', 24h, 48h and 72h p.a. after the patch removal. The sample did not induce any skin irritation during the entire observation period of 72 h. The primary irritation index was 0.0. All animals showed a normal food consumption and a normal weight gain. The sample "zinc gluconate granular" is considered to be not irritating under the conditions described.

Eye irritation test performed in vivo:

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 considered slightly irritant in this study.

A second in vivo study was performed on 3 rabbits (New Zeland white). The substance tested (zinc gluconate) is considered irritant to eyes with risk of serious damage. Considering the irreversible effects observed during the study period, the substance shloud be considered in category 1 based on GHS criteria.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin 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

Remarks:

equivalent to OECD 404

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

- Source of test material: The test compound "zinc glucona te granular" was supplied by the sponsor Akzo Chemie BV, Amersfoort.
- General characteristics: The test substance is a fine, white granular.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harald SChriever, Kan inchen farm, D - 2140 Bremervörde, Neuendamm 88
- Weight at study initiation: 2,4 - 2,6 kg
- Diet: Mümmel Z Kaninchenzuchtkorn produced by Ssniff Spezialfutter GmbH. (Pellets, 1,0 - 1,5 cm large, 0,5 cm diameter, detailled composition in the study report) + Feed additives (vitamines A, D and E. Butylhydroxytoluol).
- Water: ad libitum (quality: aqua fontana as for human consumption)
- Acclimation period: 7 days at least
- Size: 35 cm high, 35 cm wide, 50 cm long

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C ± 2°C
- Humidity (%): 50 - 85 %
- Lighting: fluorescent light, 4000 K, 120 Lux
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
- Caging: single caging in battery of cages
- Cagetype: lattice plate boxes with feacel bassin underneath.

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
Amount applied: 0,5 g of the powder was applied to both intact and scarified skin sites on the dorsal area.

VEHICLE
No vehicle used.

Duration of treatment / exposure:

4 hours later the test sites were uncovered and the test substance was removed

Observation period:

The judgement of the skin alterations was done 30' - 60', 24h, 48h and 72h p.a. after the patch removal

Number of animals:

3

Details on study design:

The left side of the back was scarified with a clean clipper blade, so as to penetrate the horny layer of the epidermis, but without causing bleeding. The right side was left intact. The results of both left and right side are presented independently.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

The judgement of the skin alterations was done 30' - 60', 24h, 48h and 72h p.a. after the patch removal. The sample did not induce any skin irritation during the entire observation period of 72 h. The primary irritation index was 0.0.

Animal N°		30’-60’+24h				48h				72h
		erythema		edema		erythema		edema		erythema		edema
		T	C	T	C	T	C	T	C	T	C	T	C
1	Scarified	0	0	0	0	0	0	0	0	0	0	0	0
	Intact	0	0	0	0	0	0	0	0	0	0	0	0
2	Scarified	0	0	0	0	0	0	0	0	0	0	0	0
	Intact	0	0	0	0	0	0	0	0	0	0	0	0
3	Scarified	0	0	0	0	0	0	0	0	0	0	0	0
	Intact	0	0	0	0	0	0	0	0	0	0	0	0

Interpretation of results:

GHS criteria not met

Conclusions:

The sample "zinc gluconate granular" is considered to be not irritating under the conditions described.

Executive summary:

The relative level of primary skin irritation of the test sample "zinc gluconate granular" was investigated in one group three rabbits. The exposition period of the test substance was 4 hours. Any signs of erythema, eschar and edema formation were recorded during the observation period of 72 hours. The judgement of the skin alterations was done 30' - 60', 24h, 48h and 72h p.a. after the patch removal. The sample did not induce any skin irritation during the entire observation period of 72 h. The primary irritation index was 0.0. All animals showed a normal food consumption and a normal weight gain. The sample "zinc gluconate granular" is considered to be not irritating under the conditions described.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

The sample is a fine white powder. The sample was applied unmodified.

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.

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.

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.

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

 

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.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Reference 60041M Gluconate de Zinc USP
Batch 96024007
Analytical sheet reportedd in appendix of the study report

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Reason frr species selection is that the New-zealand albino rabbit is the animal traditionally used for the evaluation of irritant potential of products and is the animal chosen by the regulatorv authorities.
- Weight at study initiation: 2.6kg (average)
- Housing: environmental conditions and controls in accordance with the requirements of the 86/609/EEC guideline (individual housing on floor grid).
- Diet: Ad libitum. Complete pelleted rabbit maintenance diet Energie H326, COFNA (37000 - TOURS, FRANCE)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
Not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: the test material is placed as such at a dose of 0.1g in the conjunctival sac of the right eye after gently pulling the lower lid away from the eyeball.
The other eye, which remains untreated, serves as a control.

VEHICLE
Test material is placed as such.

Duration of treatment / exposure:

The test material is placed in the conjunctival sac, then the rabbit is observed during 22days.

Observation period (in vivo):

22 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: After a one hour period of contention, the animal is returned to its individual cage. Score are determined at 24, 48 and 72h after application.

SCORING SYSTEM:
OECD guidline system

Irritation parameter:

chemosis score

Basis:

animal: 5804

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 12 days

Irritation parameter:

chemosis score

Basis:

animal: 5805

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

chemosis score

Basis:

animal: 5837

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

conjunctivae score

Basis:

animal: 5804

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 12 days

Irritation parameter:

conjunctivae score

Basis:

animal: 5805

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

conjunctivae score

Basis:

animal: 5837

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

iris score

Basis:

animal: 5804

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal: 5805

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 12 days

Irritation parameter:

iris score

Basis:

animal: 5837

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 72h

Irritation parameter:

cornea opacity score

Basis:

animal: 5804

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal: 5805

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Irritation parameter:

cornea opacity score

Basis:

animal: 5837

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Irritant / corrosive response data:

One hour after instillation of the substance, reactions are noticed in all animals at the level of the conjunctivae (diffuse purple enanthemae, lacrimations and chemosis) and at the level of the iris (congestion). 24 hours later, some of these reactions increase ; a comeal opacity is also noticed in the three rabbits. 72 hours after instillation, the mean conjunctival irritation signs have disappeared for one rabbit, excepted enanthema that is no more visible at the day 12.

CONJUNCTIVA

Chemosis (A)

Animal N°	D1 (1h)	24 hours	48 hours	72 hours	Mean
5804	1	1	1	0	0.7
5805	1	3	3	3	3.0
5837	2	3	3	2	2.7

 

Discharge (B)

Animal N°	D1 (1h)	24 hours	48 hours	72 hours	Mean
5804	2	2	2	0	1.3
5805	3	2	2	1	1.7
5837	3	3	3	0	2.0

 

Redness (C)

Animal N°	D1 (1h)	24 hours	48 hours	72 hours	Mean
5804	2	3	3	2	2.7
5805	2	3	3	3	3.0
5837	2	3	3	3	3.0

 

IRIS (D)

Animal N°	D1 (1h)	24 hours	48 hours	72 hours	Mean
5804	1	1	1	0	0.7
5805	1	2	2	1	1.7
5837	1	1	1	0	0.7

 

CORNEA

Opacity (E)

Animal N°	D1 (1h)	24 hours	48 hours	72 hours	Mean
5804	0	1	1	0	0.7
5805	0	2	2	2	2.0
5837	0	2	2	2	2.0

 

Opacity Area (F)

Animal N°	D1 (1h)	24 hours	48 hours	72 hours	Mean
5804	0	1	1	0	0.7
5805	0	2	2	1	1.7
5837	0	2	2	1	1.7

 

 

 

 

CONJUNCTIVA

Chemosis (A)

Animal N°	D7	D8	D9	D10	D11	D12	D13	D14	D15	D16	D17	D18	D19	D20	D21	D22
5804	0	0	1	1	1	0	-	-	-	-	-	-	-	-	-	-
5805	3	3	3	3	3	3	3	3	3	3	3	3	3	3	3	3
5837	2	1	1	1	1	1	1	1	1	1	3	3	3	3	3	3

 

Discharge (B)

Animal N°	D7	D8	D9	D10	D11	D12	D13	D14	D15	D16	D17	D18	D19	D20	D21	D22
5804	0	0	0	0	0	0	-	-	-	-	-	-	-	-	-	-
5805	0	1	2	1	1	0	1	1	1	1	1	1	1	1	1	1
5837	0	1	2	2	1	1	1	1	1	2	1	1	1	1	1	2

 

Redness (C)

Animal N°	D7	D8	D9	D10	D11	D12	D13	D14	D15	D16	D17	D18	D19	D20	D21	D22
5804	2	2	1	1	1	0	-	-	-	-	-	-	-	-	-	-
5805	3	3	3	3	3	3	3	3	3	3	3	3	3	3	3	2
5837	2	2	2	2	2	2	2	2	2	2	3	3	3	3	3	3

 

IRIS (D)

Animal N°	D7	D8	D9	D10	D11	D12	D13	D14	D15	D16	D17	D18	D19	D20	D21	D22
5804	0	0	0	0	0	0	-	-	-	-	-	-	-	-	-	-
5805	1	1	1	1	1	0	0	0	0	0	0	0	0	0	0	0
5837	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

CORNEA

Opacity (E)

Animal N°	D7	D8	D9	D10	D11	D12	D13	D14	D15	D16	D17	D18	D19	D20	D21	D22
5804	0	0	0	0	0	0	-	-	-	-	-	-	-	-	-	-
5805	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1
5837	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1

 

Opacity Area (F)

Animal N°	D7	D8	D9	D10	D11	D12	D13	D14	D15	D16	D17	D18	D19	D20	D21	D22
5804	0	0	0	0	0	0	-	-	-	-	-	-	-	-	-	-
5805	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1
5837	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1

 

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The substance tested (zinc gluconate) is considered irritant to eyes with risk of serious damage. Considering the irreversible effects observed during the study period, the substance shloud be considered in category 1 based on GHS criteria.

Executive summary:

One hour after instillation of the substance, reactions are noticed in all animals at the level of the conjunctivae (diffuse purple enanthemae, lacrimations and chemosis) and at the level of the iris (congestion). 24 hours later, some of these reactions increase ; a comeal opacity is also noticed in the three rabbits. 72 hours after instillation, the mean conjunctival irritation signs have disappeared for one rabbit, excepted enanthema that is no more visible at the day 12.

For the two other animals, all irritation signs, excepted iris congestion, are still visible at the end of the observation period.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No skin irritation is observed in an in vivo study.

Two in vivo studies are available. The most recent study was considered considering that it is more reliable and that it correspond to a conservative approach. In this study, the substance is irritant and cause irreversible damage. This correspond to the classification as eye irritant category 1 (H318: cause serious eye damage).