Bis(D-gluconato-O1,O2)zinc

Skin irritation / corrosion

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

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

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.

Test animals

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.

Test system

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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 6

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.